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2021

Korea Innovative
PHARMACEUTICAL Company

This brochure illustrates a project promoted by Korean pharmaceutical companies


and with support from the Korean government, to enter global markets.
You’ll meet the Korean pharmaceutical industry as a reliable partner for global
collaboration.
Contents

02 Current Status of Korean Pharmaceutical Market

09 Introduction of Korean Innovative Pharmaceutical Company Certification System

11 Information of Korean Innovative Pharmaceutical Company

57 Supplement
2021
Korea Innovative
PHARMACEUTICAL Company

This brochure illustrates a project promoted by Korean pharmaceutical companies


and with support from the Korean government, to enter global markets.
You’ll meet the Korean pharmaceutical industry as a reliable partner for global
collaboration.
Current Status of Korean
Pharmaceutical Market

Current Status of Korean Pharmaceutical Market

□ (Market size) Korean pharmaceutical market passed the $20.8 billion mark in 2019. Its growth
has been driven by leading Korean companies, which have been releasing new global drugs
and achieving technology exports.

ㅇ Pharmaceuticals exports have increased at a CAGR of 15.2% for the past five years (2015-2019), fueled
especially by increases in Korean drugs entering into global markets.

<Current status of Korean pharmaceutical market>


(unit: million dollar, %)

Year-on-year CAGR
Category 2015 2016 2017 2018 2019
growth rate (`15~`19)
Market size 16,992 18,711 19,515 20,995 20,840 Δ0.7 5.2
Production 14,989 16,197 18,006 19,168 19,128 Δ0.2 6.3
Exports 2,946 3,118 4,071 4,671 5,193 11.2 15.2
Imports 4,948 5,633 5,579 6,498 6,905 6.3 6.9
Trade balance Δ2,002 Δ2,514 Δ1,508 Δ1,827 Δ1,712 Δ6.3 Δ3.1

* Source: Press release by the Ministry of Food and Drug Safety (2020)

ㅇ Among the world’s top 100 pharmaceutical companies, 2 korean companies are included.

* ‘19 drug sales and global ranking (Informa Pharma Intelligence Outlook2021, Scrip100): GC Pharma (93th place, $ 1,176
million), Kwang-Dong Pharmaceutical (96th place, $ 1,063 million)

ㅇ The Korean biologics market is valued around $2,229 million (2019), accounting for 10.2% of the entire
pharmaceutical market, which is lower than the international level (29% in 2019).

- Yet it has very high growth potential, with its production and export values rising greatly at a CAGR of 9.4%
and 12.2% respectively, for the last five years (2015-2019).
- Biosimilars in particular are expected to become a next-generation growth engine as 20 of the 27 drugs
approved in Korea were developed by Korean companies.
* With the focus on biopharmaceutical pharmaceutical companies such as Samsung Biologics and Celltrion, the world’s
largest biopharmaceutical production facility is being built and in operation (production capacity of 554K liters, more than
70 companies)

<Current status of Korean biopharmaceutical market>


(unit: million dollar, %)

Year-on-year CAGR
Category 2015 2016 2017 2018 2019
growth rate (`15~`19)
Market size 1,449 1,577 1,975 2,026 2,229 10.0 11.4
Production 1,520 1,729 2,301 2,372 2,175 Δ8.3 9.4
Exports 809 1,063 1,368 1,559 1,283 Δ17.7 12.2
Imports 738 911 1,042 1,213 1,337 10.2 16.0
Trade balance 71 152 326 346 Δ53 Δ115.5 -

* Source: Press release by the Ministry of Food and Drug Safety (2020)

2
Current Status of Korean
Pharmaceutical Market
□ (Current status of businesses) 612(95.7%) of 639 pharmaceutical companies in Korea reported
production records for 2019, indicating an average production of 46 items per company.

<Current status of Korean pharmaceutical companies>


(unit: number, %)

CAGR
Category 2015 2016 2017 2018 2019
('15~'19)
Number of manufacturers 586 635 623 616 639 2.2
Manufacturers with production records 597 599 588 571 612 0.6
Number of items 25,890 26,397 26,293 26,239 28,363 2.3
Drug product 17,907 18,546 19,291 19,539 20,703 3.7
Drug substance 7,983 7,851 7,002 6,700 7,660 Δ1.0
Number of sellers 24,693 25,862 24,951 26,233 26,817 2.1

* Source: Press release by the Ministry of Food and Drug Safety(2020)

□ (Current status of R&D) Striving to enhance competitiveness to the level of advanced countries
by launching new drugs developed in Korea in overseas markets through the continuous
expansion of R&D investments

ㅇ The total R&D investment by the pharmaceutical companies listed in Korea (312 companies) was $2,537 million
in 2020, which accounts for 7.9% of the total sales.

- The R&D investment by the top 10 companies was $1,002 million, which is more than half of the total amount
of R&D investment by all the listed pharmaceutical companies, reaching 9.5% of the total sales.
- The total R&D expenditure of domestic listed innovative pharmaceutical companies (41 companies) accounted
for 52.6% of total listed companies and the proportion of R&D expenses was 11.0%.

<R&D investment of major Korean pharmaceutical companies>


(unit: million dollar, %)

Category 2016 2017 2018 2019 2020


Listed companies 1,580 1,980 2,051 2,273 2,537
Top 10 companies 642 896 744 757 1,002
R&D investment
Innovative Pharmaceutical
924 923 1,077 1,112 1,334
Company
Listed companies 7.0 7.8 7.3 7.8 7.9
Top 10 companies 10.6 12.3 9.4 8.9 9.5
Ratio to sales
Innovative Pharmaceutical
10.3 9.4 10.1 10.3 11.0
Company

* Source: Korea Health Industry Development Institute (KHIDI)

3
Current Status of Korean
Pharmaceutical Market

□ (Current status of new drug development) A total of 32 new drugs were developed as of
September 2021 by these efforts of Korean pharmaceutical companies.

* 1999-2014: 21 new Korean drugs were developed → 2015-2021: 11 new Korean drugs were developed.

<New drugs developed since 2015>

Company Product Efficacy/Effectiveness Approval Date

Crystal Genomics Inc. Acelex Capsule Treatment for osteoarthritis February 5, 2015

DongWha Pharm. Co., Ltd. Zabolante tablet Antimicrobial agent (antibiotics) March 20, 2015

Sivextro tablet
Antimicrobial agent (antibiotics) April 17, 2015
Dong-A ST Co., Ltd. Sivextro injection

Suganon tablet Antidiabetic drug October 2, 2015

Hanmi Pharmaceutical Co., Ltd. Olita tablet Cancer drug (lung cancer) May 13, 2016

Ildong Pharmaceutical Co., Ltd. Besivo tablet Hepatitis B treatment May 15, 2017

CJ Healthcare K-Cab Tab gastroesophageal reflux disease (GORD) July 5, 2018

Yuhan Corporation Leclaza tablet NSNLC(Non-Small Cell Lung Cancer) January 18, 2021

Regkirona injection
Celltrion, Inc. COVID-19 February 5, 2021
(CT-P59)

Hanmi Pharmaceutical Co., Ltd. Rolontis injection Neutropenia March 18, 2021

□ (Overseas market entry) Korean companies are creating high value-added through the
expansion of their global market shares by launching domestically-developed new drugs in
the global market and increasing licensing-out to overseas markets.

ㅇ 16 Korean drugs have obtained approval in the US and EU since 2014, putting sales to developed markets into
high gear.
- SK Biofarm independently proceeded to the third phase of clinical trials and released it to the United States
following new drugs developed in Korea, such as Excopre (‘19), which was approved by the FDA.

4
Current Status of Korean
Pharmaceutical Market
<Current status of domestically-developed drugs in terms of approval at home and abroad>

Reference Drug Efficacy/ Approved Approved Overseas


Company Trade Name
(Manufacturer) Effectiveness in Korea EMA FDA
Dong-A ST Co.,
Sivextro New drug Oxazolidinone antibiotic Apr 17, 2015 Mar 2015 Jun 2014
Ltd.
Merrem
Daewoong Meropenem Carbapenem antibiotic Apr 14, 2010 - Dec 2015
(AstraZeneca)
Pharmaceutical Co.
Ltd. Botulinum toxin
Nabota Glabellar wrinkles Nov 2013 - Jan 2019
(Allergan)
Remicade Rheumatoid
Remsima
(Johnson & arthritis(RA), Jul 20, 2012 Aug 2013 Apr 2016
injection*
Johnson) ulcerative colitis, etc.
RA, chronic
Rituxan lymphocytic leukemia,
Truxima* Nov 16, 2016 Feb 2017 -
(Roche) non-Hodgkin’s
lymphoma, etc.
Celltrion Inc.
Herceptin
Herzuma* Breast cancer Jan 2014 Feb 2018 Dec 2018
(Roche)
Tuberculosis,
Zyvox
Linezolid Wide range of - - Apr 2019
(Pfizer)
antibiotics
Zeffix (GSK),
TEMIXYS AIDS - - Nov 2018
Viread (Gilead)
Benepali (EU)*
Enbrel
Eticobo (US) RA, psoriasis, etc. Sep 7, 2015 Jan 2016 Apr 2019
(Amgen)
Etoloce (Korea)

Flixabi (EU)*
Remicade
Renflexis (US)* RA, ulcerative colitis,
(Johnson & Dec 4, 2015 May 2016 Apr 2017
Remaroche etc.
Johnson)
(Korea)
Samsung Bioepis
Co., Ltd. Imraldi (EU)* RA, Crohn's disease,
Humira
Hadlima (US)* inflammatory bowel Sep 20, 2017 Aug 2017 July 2019
(AbbVie)
Adalloce (Korea)* diseases, etc.

Ontruzant(EU)* Herceptin
Breast cancer Nov 9, 2017 Nov 2017 Jan 2019
Samfenet(Korea)* (Roche)

Avincio(EU)* Avastin((Roche) Anticancer - Aug 2020 -

SK Chemicals AFSTYLA New biologic Antihemophilic drug Jan 2020 Jan 2017 May 2016

Sunosi New drug Sleep disorder - Jan 2020 Mar 2019


SK
Biopharmaceuticals
XCOPRI® New drug Epilepsy - - Nov 2019

* Source: Korea Health Industry Development Institute (KHIDI) (The * mark for the trade name indicates biosimilars.)

5
Current Status of Korean
Pharmaceutical Market

ㅇ Large-scale license agreements with global pharmaceutical companies are accelerating exports of technologies
developed by Korean pharmaceutical companies.

* A total of 17 worth maximum $9,569 million in 2020

<License agreements signed by Korean pharmaceutical companies in 2020>

Contract Exported Contract


Company Product Partner
date to Value
Daewoong Fexuprazan
Jan Mexico Moksha8 $50 million
Pharmaceutical Co. Ltd. (GERD treatment)
LegoChem Biosciences, ADC source technology
April England Iksuda Therapeutics $407 million
Inc. (ConjuALL)
LegoChem Biosciences, LCB73
May England Iksuda Therapeutics $227 million
Inc. (anti-ROR1 ADC)
Nose neoplasm treatment
Pharmabcine Inc. US Wincal Biopharm Private
(New drug candidate substance)
M002-A Tube Pharmaceuticals
Mecoxcuremed Europe Private
June (COVID-19 treatment) GmbH
One of the top 10
Alteogen, Inc. ALT-B4 - global pharmaceutical $3,865 million
companies
Hanmi LAPSGLP/GCG
US MSD $870 million
Pharmaceutical Co. Ltd. (NASH treatment)
Daewoong Fexuprazan
Brazil EMS $72.58 million
Aug Pharmaceutical Co. Ltd. (GERD treatment)
YH12852
Processa
Yuhan Corporation (Functional gastrointestinal disease US $410.5 million
Pharmaceuticals
treatment)
2020
Sept SCM Lifescience High purity mesenchymal stem cell Russia Pharmimex JSC Private

OLX301D
OliX Pharmaceuticals (subretinal fibrosis, Wet age-related France Thea Open Innovation $197 million
macular degeneration)
Cenobamate Ono Pharmaceutical
SK Biopharmaceuticals Japan $48.16 million
(Epilepsy treatment) Co., Ltd.
Oct VRN07
Voronoi, Inc. NSNLC(Non-Small Cell Lung Cancer US ORIC Pharmaceuticals $621 million
candidate substance)
LCB71/ABL202
CStone
ABLBio, lnc. (ADC anticancer drug candidate China $363.5 million
Pharmaceuticals
substance)
ISU305
JSC Pharmasyntez-
Nov Isu Abxis Co., Ltd. (paroxysmal nocturnal haemoglobinuria Russia Private
Nord
treatment)
GX-P1
Genexine, Inc. US Turret Capital $1,500 million
(immunosuppressant)
Dec LCB67
LegoChem Biosciences,
(ADC anticancer drug candidate US Pyxis Oncology $2,994 million
Inc.
substance)

* Source: IR data of the companies

6
Current Status of Korean
Pharmaceutical Market
ㅇ Based on its technological competitiveness and quality drugs, the pharmaceutical industry in Korea has taken
a stride in strengthening its ability to develop innovative drugs in a short period of time, including R&D, clinical
trials and drug manufacturing. Impressive growth made in the last few years suggests that Korea based
pharmaceutical companies are ready to take a leap forward as global players.

□ (Pipeline) Development of innovative medicines and strong pipelines across various


therapeutic areas

ㅇ The local pharmaceutical industry began manufacturing both finished products and drug substances in the
1960s, and developed new processes in the 1980s. Following the early phase of drug development in the late
1980s, Korean pharmaceutical industry began to develop innovative drugs in the 2000s. Since then, Korean
pharmaceutical industry has been successfully developing one of the most innovative and incrementally modified
drugs.

ㅇ Since the introduction of the chemical compound patent system in 1987, the number of innovative drugs
introduced in the country has also increased at a very fast pace. Korea has seen development of innovative
drugs across various therapeutic areas, from “Sunpla Injection”a treatment for stomach cancer developed by SK
Pharmaceuticals in 1999 to “Rolontis injection”a treatment for Neutropenia developed by Hanmi Pharmaceutical
in 2021. So far, Korean pharmaceutical companies have developed therapies in an array of areas including
oncology, antibacterial, gastritis, respiratory infections, duodenal ulcer, diabetic foot ulcer, erectile dysfunction,
hepatitis B and hypertension.

ㅇ Launch of innovative drugs(Total of 32)

7
Current Status of Korean
Pharmaceutical Market

□ (Clinical Trials) Clinical trials grew dramatically from both qualitative and quantitative
perspectives

ㅇ Already on a clear growth track with its high level of clinical trial capabilities and reliable data, Korea is emerging
as a core clinical trial destination in the pharmaceutical market in Asia. Korea-based 32 major healthcare
organizations, including Seoul National University Hospital, Samsung Seoul Medical Center and Asan Medical
Center, have won global certifications for their clinical study environment helping the country to build a clinical
infrastructure on a global level. With this advanced infrastructure, Korea ranked 6th in the world for global clinical
trial protocol market share in 2020, moving two level up from the 8th at the previous year. Its share in global
clinical trials increased from 3.25% in 2019 to 3.68% in 2020. The number of domestic clinical trials came to 799
in 2020, up nearly 11.9% compared to 714 in 2019.

ㅇ The number of multinational regional clinical trials (MRCTs) conducted by multinational pharmaceutical companies
in Korea has also increased sharply since the country introduced International Conference on Harmonization
Good Clinical Practice (ICH GCP) in 2000. Especially, Pfizer formed a partnership with Korea as part of its global
clinical program in 2008, selecting 4 of its 9 global Core Research Sites (CRSs) in Korea.

ㅇ The platform technologies developed through the ‘Smart Clinical Trial Platform’program are widely adopted by
Korean hospitals and contribute to achieving higher clinical trial efficiency of Korea. Active use of the EMR data in
conducting feasibilities and matching patients with the complex inclusion/exclusion criteria would greatly improve
efficiency together with a more streamlined and transparent clinical trial authorization process by Korean health
authorities.

□ (Manufacturing) High level of competitiveness and ability to generate rich pipelines of


innovative drugs

ㅇ Pharmaceutical companies in Korea have been working to ensure that their drug manufacturing facilities meet
rigorous global standards. To reflect global trends, the guidelines on Good Manufacturing Practices(GMP)
changed from dosage forms to prior approval of individual items in 2008. As the guidelines shifted from
management of dosage forms to that of individual items based on a step-by-step process through 2010, the
quality assurance system for domestically manufactured drugs reached a global level.

ㅇ In addition, Korea has the ability to conduct drug R&D for compounds and commercial technologies, including
organic synthesis, agents and global clinical trials. This ability was gained through development of generics
and incrementally modified drugs. Korea is also a leader in the pharmaceutical biological technology area. With
fruitful results from R&D including development of the world’s first stem cell therapy and xenotransplantation of
pancreatic ducts, Korea is in an advantageous position to be a leader in promising future industries. The level of
therapeutic technologies in cardiac surgery and management, and cervical cancer in Korea is the best among
other OECD countries, according to OECD Health Data 2009.

ㅇ Korea pharmaceutical industry is shifting its focus from the domestic market to the global market, and the world
now pays attention to Korean pharmas as successful partners.

8
Pharmaceutical Company Certification System
Introduction of Korean Innovative
Introduction of Korean Innovative Pharmaceutical Company Certification System

Public-private Partnership for Development of


1 Pharmaceutical Industry Contributing to Global Health

Korea aspiring to transforming itself into one of the top seven pharmaceutical powerhouses
Korea has designated the pharmaceutical industry as one of the future growth engines, In order to foster the industry,
the Korean government has been placing emphasis on enhancing growth potential through far-reaching policy
measures, ranging from technology innovation to promoting market transparency, boosting global competitiveness
of companies, and establishing infrastructure for sustainable development, Moreover, with knowledge and capacity
mustered, the government, industry, medical society, and academic community are devoting themselves to make a
leap forward into global markets. Under the circumstance where the Korean population has been aging rapidly, the
Korean government has keen interest in the pharmaceutical industry, which serves as a foundation for the quality of
life of the public, The government introduced “Accreditation of Innovative Pharmaceutical Company” in 2012, and will
reinforce its efforts to support the industry every year with a view to reinventing the nation into one of the top seven
pharmaceutical titans.

Introduction of Promotion and Support of Innovative


2 Pharmaceutical Company

2-1. What Company Can Be an Innovative Pharmaceutical Company?


Special Act on Pharmaceutical Industry Promotion and Support (enacted in March 2011) serves as the legal
foundation to designate innovative pharmaceutical companies verified to possess high R&D capacity for new drug
development and to be globally competitive, Those companies are expected to play a leading role in developing the
domestic pharmaceutical industry into a future growth engine.

In particular, ‘innovative pharmaceutical company’ is the government’s ambitious pharmaceutical industry fostering
policy adopted as a concept that refers to a company that has been recognized as having superior capability in
new drug development as well as overseas expansion based on the ‘Special Act on Fostering and Supporting
the Pharmaceutical Industry’. To scope with the rapid changes in the environment surrounding the pharmaceutical
industry, such as during price cuts and effect of the Korea-US FTA, the Ministry of Health and Welfare aims to
support the ‘innovative pharmaceutical company’ with research, development and overseas advancement capability
as the core of ‘2012 Pharmaceutical Industry Competitiveness Enhancement Plan’, which was arranged together
with the related ministries in January 2012, to foster Specialized Pharma which is specialized in specific medical
conditions, Global Genenric Pharma which does mass production of generics, or Global Major Pharma which is
at the level of advanced multinational corporations, and to lead the advanced pharmaceutical ecosystem led by 3
global corporations. This is a big sketch that government has envisioned.

Above all, ‘innovative pharmaceutical company’ was accepted as a very honorable medal to select the
companies that play a leading role in fostering domestic pharmaceutical industry as future growth engine industry.
Moreover, ‘innovative pharmaceutical company’ will be the scale to read the will of the government to cultivate the
pharmaceutical industry in the future since it is the only carrots proposed by the government, which has consistently
been in whipping, including the introduction of the rebate dual punishment system and implementation of the batch
drug price cut.

9
Pharmaceutical Company Certification System
Introduction of Korean Innovative

2-2. What are the Criteria for Selecting an Innovative Pharmaceutical Company?
In order to be selected as an innovative pharmaceutical company, it was necessary to have a research and
development investment or facilities of a certain scale or more. Inother words, the R&D expenditure relative to
average gross drug salws in the last 3 years has had to meet the requirements as follows: 1) companies with an
annual sales of more than KRW 100 billion would have a R&D cost of at least 5%, 2) companies with less that KRW
100 biliion would have a R&D cost of more that 7% or an absolute amount of more than KRW 5 billion, and 3) for US
or EU GMP facilities, a R&D cost relative to sales would be at least 3%.

2-3. Accreditation Process


The Accreditation Screening Committee conducted written and verbal evaluations on candidate pharmaceutical
firms which met the requirements (Article 2 of the Enforcement Decree of the Special Act: investment volume over
a certain level), In the evaluations, the committee assessed candidate companies based on specific requirements,
such as R&D performance in the past, company’s capacity, vision and investment plan, ethical business practice,
etc, The results of the evaluations delivered by the screening committee were finalized after the review carried out
by the Committee for Pharmaceutical Industry Promotion and Support, which is chaired by the Minister of Health and
Welfare.

2-4. Composition of Designated Innovative Pharmaceutical Companies


• General pharma firms [32]: 32 leading firms that have marked high scores in terms of R&D investment as well
as researchers, manufacturing facilities, patent and license-out, and overseas market advancing plus ten SMEs
that have built on expertise in specialized areas such as development of incrementally modified drugs
• Bio venture companies [10]: firms with relatively low sales but highly competitive technology and creative
business models
• Multinational pharma firms [3]: one local company of an MNC considered outstanding in terms of R&D investment
(in early clinical trials), local production performance, overseas market advancing, etc.

2-5. List of Companies Certified as Innovative Pharmaceutical Companies [45]


(June, 2021)

Category Name of Company

BMI Korea, Boryung Pharm, Bukwang Pharm, Celltrion, Chong Kun Dang Pharm, Dae Hwa
Pharm, Daewon Pharm, Daewoong Pharm, Dongkoo Bio&Pharm, Dongkook Pharm, Dongwha
Pharm, GC Pharma, Genuonesciences, Handok, Hanlim Pharm, Hanmi Pharm, HK inno.N,
General pharma firms [32]
Hyundai Pharm, Ildong Pharmaceutical, Isu Abxis, JW Pharm, Korea United Pharm, LG Chem,
Pharma Research, Pharmicell, Samyang holdings, Shin Poong Pharm, SK Chemicals, ST Pharm,
Taejoon Pharm, Yuhan, Yungjin Pharm

ABL Bio, Alteogen, BC World Pharm, Corestem, CrystalGenomics, Genexine, Helixmith, Medytox,
Bio venture companies [10]
Olix Pharma, Tego Science

Multinational pharma firms [3] AstraZeneca Korea, Janssen Korea, Korea Otsuka Pharm

10
Information of
Korean Innovative
Pharmaceutical Company
1) ABL Bio, lnc. 24) Helixmith
2) Alteogen, Inc. 25) HK inno.N
3) AstraZeneca Korea 26) HYUNDAI Pharm.
4) BCWORLD PHARM. CO., LTD. 27) Ildong Pharmaceutical Co., Ltd.
5) BMI Korea Co., Ltd. 28) ISU ABXIS Co., Ltd.
6) Boryung Pharmaceutical Co., Ltd. 29) Janssen Korea Ltd.
7) Bukwang Pharmaceutical Co., Ltd. 30) JW Pharmaceutical
8) Celltrion, Inc. 31) Korea Otsuka Pharmaceutical Co., Ltd.
9) Chong Kun Dang 32) KOREA UNITED PHARM. INC.
10) Corestem, Inc. 33) LG Chem, Ltd.
11) CrystalGenomics, Inc. 34) Medytox, Inc.
12) Daehwa Pharmaceutical Co., Ltd. 35) OliX Pharmaceuticals, Inc.
13) Daewon Pharm. Co., Ltd. 36) PharamResearch Products Co., Ltd.
14) Daewoong Pharmaceutical Co., Ltd. 37) Pharmicell Co., Ltd.
15) DongKoo Bio & Pharma Co., Ltd. 38) Samyang Holdings Corporation
16) Dongkook Pharmaceutical Co., Ltd. 39) Shin Poong Pharm. Co., Ltd.
17) DONGWHA PHARM 40) SK Chemicals Co., Ltd.
18) GC Pharma 41) ST PHARM Co., Ltd.
19) Genexine, Inc. 42) Taejoon Pharmaceutical Co., Ltd.
20) GENUONE Sciences Inc. 43) Tego Science, Inc.
21) HANDOK, Inc. 44) Yuhan Corporation
22) HANLIM PHARM. CO., LTD. 45) Yungjin Pharm Co., Ltd.
23) Hanmi Pharmaceutical Co., Ltd.
Information of Korean Innovative
Pharmaceutical Company

South Korea’s leading biotech developing bispecific antibody-based innovative thera-


peutics for the treatment of cancer and neurological diseases.

ABL Bio, lnc. www.ablbio.com/en

ABL Bio is a leader in bispecific antibody therapeutics for immuno-oncology and neurodegenerative diseases. ABL
CEO owns a productive set of innovative bsAb platforms and pipelines. It discovered ABL001, the first bsAb to start
clinical trials in the country and ABL503, the first bispecific in Korea to start trials in the U.S. ABL also developed
Sang Hoon Lee
‘Grabody-B,’ a bsAb platform maximizing BBB penetrance and is applicable to various CNS targets, including
Parkinson’s disease.
Location
2nd Floor, 16 Daewangpangyo-Ro 712
Beon-Gil, Bundang-Gu, Seongnam-Si,
Gyeonggi-Do, 13488, South Korea

Specialty
Bispecific Antibody, Immuno-oncology
Therapeutics, BBB Shuttle Platform
Technology

Tel/Fax/E-mail
T. +82-31-8014-7032
F. +82-31-8018-9836 Lead Candidates
E. Info@ablbio.com
Product Use Progress
ABL001(NOV1501) a bispecific antibody therapeutics for solid tumor currently in Phase 1b/2 clinical trials in South Korea

ABL503 a bispecific antibody for solid tumor currently in Phase 1 clinical trial in U.S.

ABL111 a bispecific antibody for pancreatic, gastric cancer currently in Phase 1 clinical trial in U.S.
expected to begin Phase 1 clinical trial in South
ABL501 a bispecific antibody for solid tumor Korea
CONTACT US 245.168.25
ABL301 a bispecific antibody therapeutics for Parkinson’s disease preclinical stage
Technology Transfer/251.175.40 ABL Bio Pipeline
Licensing
Weonkyoo You
252.215.145
R&D Pipeline
R&D/Head of R&D 255.239.213
PROGRAM INDICATION
EARLY LATE
PRE-CLINICAL PHASE Ⅰ PHASE Ⅱ / Ⅲ
DISCOVERY DISCOVERY
T. +82-31-8018-9803 77.73.70
E. weonkyoo.you@ablbio.com Angiogenesis ABL001 Solid
77.73.74
(Anti-VEGF/DLL4 BsAb) Cancer

Overseas export/Overseas146.146.146 Antibody-Drug


Conjugate ABL20X Cancer
Office (ADC)
75.73.74
Bryan Kang
Strategy&Planning 164.164.164 (4-1BB))
Cancer
ABL10X
/Head of Department 202.199.201

T. +82-31-8018-9825 Immuno- (PD-L1)


238.238.238
Cancer
E. bryan.kang@ablbio.com Oncology ABL50X
62.176.54

etc I/O mAb


169.206.5 Cancer
ABL40X
Hee Jun Park
1.70.129
Strategy&Planning Parkinson’s
Neurology ABL301
/Senior Manager 208.19.26
(ɑ-Synuclein / IGF1R)
Disease

T. +82-31-8014-7032 230.156.161
Investor Relations 2021 │ 1
E. heejun.park@ablbio.com
236.180.183

12
Information of Korean Innovative
Pharmaceutical Company
“Novel Biologics for Better Life”

Alteogen, Inc. www.alteogen.com

ALTEOGEN, located in Daejeon, South Korea, is a biotech venture company established in 2008. ALTEOGEN has
developed proprietary NexPTM, NexMabTM and HybrozymeTM platform technologies for long-acting biobetters, site- CEO
specific conjugated ADC and novel recombinant human hyaluronidase, respectively. ALTEOGEN aims to transform
Soon Jae Park
and improve care for the lives of those who are suffering from serious diseases, in search of therapies with our
cutting-edge science and technology. ALTEOGEN was listed on KOSDAQ in 2014.
Location
Main Products 62, Yuseong-daero 1628 beon-gil,
Yuseong-gu, Daejeon, 34054, Korea
Product type Code indication specific indication Development
name Stage
Recombinant fusion Specialty
ALT-P1 Growth hormone deficiency Growth hormone deficiency Phase 2
protein
1. NexMab™ Technology for site-
Novel Antibody drug ALT-P7 Oncology Breast cancer Phase 1 specific ADC conjugation
Biologics conjugate
(Biobetter) Subcutaneous 2. NexP™ Technology for long-acting
Recombinant ALT-B4 Oncology Pre-clinical
Absorption Accelerator biobetter recombinant therapeutics
protein
ALT-BB4 stand-alone Hyaluronidase Oncology Phase 1 3. Hybrozyme™ Technology for
ALT-L9 Ophthalmic diseases Wet Age Macular Degen- Phase 1 the novel human recombinant
Biosimilar eration Hyaluronidase.
ALT-LS2 Oncology Breast cancer Pre-clinical 4. Biosimilars – Leading biosimilar
technology
R&D Pipeline
Tel/Fax/E-mail
Stage Research ProcessDev. Pre-clinic Phase 1 Phase 2 Phase 3
Project T. +82-42-384-8780
F. +82-42-384-8770
Adult Phase 2 in Korea E. shareholder@alteogen.com
ALT-P1
(NexPTM-hGH)
Long-Acting Pediatric Phase 1 in India CONTACT US
Biobetter
Technology Transfer/
ALT-B8 Licensing
(Long-acting GLP1-Fc-FGF19)
(NASH) Hee Ho Cho
ALT-P7
BD/Manager
NexMabTM
(ADC) (HM2-MMAE) Phase 1 completed in Korea T. +82-70-7721-8755
(Breast/Gastric cancers)
E. erica.hh.cho@alteogen.com
ALT-LS2
(Herceptin® SC biosimilar)
(Breast/Gastric cancer) etc
Biosimilars Min Suk Lee, Ph.D.
ALT-L9
(Eylea® biosimilar) Phase 1 completed in Korea Global Phase 3 planned* Strategic Planning/
(wAMD)
Senior Vice President
ALT-B4 T. +82-42-384-8780
(SC drug Delivery) Licensees proceed to Phase 1 Clinical Study
E. superlee63@alteogen.com
Hyaluronidase
(HybrozymeTM)
ALT-BB4
(Standalone)

* Biosimilars are exempted from Phase 2 study

13
Information of Korean Innovative
Pharmaceutical Company

We push the boundaries of science to deliver life-changing medicines.

AstraZeneca Korea www.astrazeneca.com

AstraZeneca Korea is a science-led biopharmaceutical business delivering life changing medicines to patients
CEO through innovative science and excellence in development and commercialization. It focuses on the discovery,
development and commercialisation of prescription medicines, primarily for the treatment of diseases in three
Juno Kim
main therapy areas – Oncology, Cardiovascular, Renal & Metabolism ,and Respiratory and immunology.

Location
Main Products R&D Pipeline
21F ASEM Tower, 517 Yeongdong-
daero, Gangnam-gu, Seoul, Korea IRESSA (Non-small cell lung cancer)
TAGRISSO (Small cell lung cancer,
Non-small cell lung cancer)
Specialty Imfinzi (Non-small cell lung cancer)
Lynparza (Ovarian Cancer, Breast Cancer)
Oncology, Cardiovascular, Renal & Oncology Faslodex (Breast Cancer)
Metabolism, and Respiratory and Calquence (Chronic lymphocytic leukemia)
Immunology
Forxiga
Tel/Fax/E-mail (Type 2 diabetes, Chronic heart failure)
Brilinta (Acute coronary syndrome)
T. +82-2-2188-0800 Cardiovascular and
F. +82-2-2188-0852 Metabolism
E. webmaster.korea@astrazeneca.com

Symbicort (Asthma, COPD)


Daxas (COPD)
Fasenra (Asthma)
Respiratory and
Immunology

CONTACT US
Technology Transfer/
Licensing
Yunkyong Kim
Business Development/BD Director
T. +82-2-2188-0800

14
Information of Korean Innovative
Pharmaceutical Company
Esteemed Global Healthcare Group focusing on R&D

BCWORLD PHARM. CO., LTD. en.bcwp.co.kr

BC World Pharm. Co., Ltd.(BCWP) has expertise in formulation and process development to provide quality
generics. BCWP is not only certified as Korea Innovative pharmaceutical company, but also designated as CEO
Advanced Technology Center. In 2019, Carbapenem injections facility has been completed its construction in
Sung Han Hong
Wonju city. Starting with the commercialization of Carbapenem product, BCWP is preparing to enter global market
such as US and Japan. Accordingly, the inspections for cGMP and PMDA are scheduled in this year.
Location
Main Products Gyung Bilding, 78, 22-gil Gaepo-
ro, Gangnam-gu, Seoul, Republic of
Korea

Specialty
1. Incrementally Modified Drugs
2. Drug Delivery System (DDS)
3. Generic
Therapeutic class Products Remarks
Tel/Fax/E-mail
Antibiotics (Carbapenem) Meropenem Inj., Imipenem+Cilastatin Inj., Ertapenem Inj., Etc Launched
T. +82-2-2182-0400
Anti-Infectives Vancomycin Inj., Metronidazole Gel., Etc. Launched
F. +82-2-574-5064
Anti-TB Rifampicin+Isoniazid+Pyrazinamide+Ethambutol Tab. Launched E. tree365@bcwp.co.kr
Anti-Hyperlipidemia Atorvastatin Tab., Rosuvastatin Tab. Launched
Anti-Hypertensive Nicardipine HCl Inj., Amlodipine+Valsartan Tab., Etc Launched
Gastrointestinal Agents Rebamipide Tab., Etc Launched
Narcotics Fentanyl Sublingual Tab., Fentanyl Inj., Remifentanil Inj., Morphine Inj., Etc. Launched
Glutathione Inj., Zinc sulfate hydrate Inj., Ascorbic Inj.,
Well-being Product Launched
Multipotent Inj. (Zn, Cu, Se, Cr, Mn, F, Fe, I, Mo), Etc.
CONTACT US

R&D Pipeline Technology Transfer/


Licensing
Category Item Indications Stage
Lena Jung
BCWP_D001 Anti-cancer Pre-clinical
Global business/BD Manager
BCWP_D003 Anti-cancer Pre-clinical T. +82-2-2182-0420
BCWP_D006 Anti-cancer Pre-clinical E. lenajung@bcwh.co.kr
BCWP_D007 Parkinson’s disease Pre-clinical
Injection BCWP_D008 Osteoarthritis pain of the knee Formulation Overseas export
BCWP_D009 Anti-psychotic Pre-clinical
David Kim
Business Unit/Director
BCWP_D010 Anti-psychotic Phase 1
T. +82-2-2182-0432
BCWP_D011 Anti-psychotic Pre-clinical
E. tree365@bcwp.co.kr
BCWP_D012 Anti-psychotic Pre-clinical
BCWP_E008 Anti-Parkinson Formulation

Oral Dosage BCWP_C003 Anti-hyperlipidemia Phase 1


Form BCWP_G1904 Antihistamine Formulation
BCWP_G1905 Antispasmodic Formulation

15
Information of Korean Innovative
Pharmaceutical Company

Specialized pharmaceutical company aiming to improve people’s quality of


life in the aging society

BMI Korea Co., Ltd. http://koreabmi.godohosting.com/index.php

BMI Korea is a manufacturer of pharmaceutical formulations & medical devices in South Korea.
CEO Based on novel experiences, know-hows & technologies from generics to biopharmaceuticals for more than a
decade, we have been developing & manufacturing various formulations (including Oral Solids & Solutions). Our
Kwang in,Lee/Koo,Woo
specialty is in sterile formulations (Liquid vial, Lyophilized vial, Prefilled syringe) & aesthetic products and these
days expanding into the biopharmaceutical area.
Location
11, Cheomdan-7-gil, Jeju-si, Jeju-do, Main Products
South Korea

Specialty
1. Regenerative osteoarthritis
treatment
2. Cosmeceutical drug
3. Edema treatment & drug dispersion
agent
4. Hemophilia treatment

Tel/Fax/E-mail
T. +82-31-426-4780~3
F. +82-31-426-5225
E. bmikorea@bill36524.co.kr Project Indication Efficacy/Effectiveness
bmibill@bmikr.co.kr
- Enhances permeation of subcutaneous or intramuscular injections, local
Hirax Hyaluronidase anesthetics and subcutaneous infusions.
(Liquid vial) 300/750/1500/2000/5000 IU - Promotes resorption of excess fluids and blood in the tissues
Hidr Sodium Polydeoxyribonucleo- - Treatment for wounds and tissue restoration caused by skin grafts
(vial/Pre-filled syringe) tide 5.625mg/3ml
CONTACT US BM Hyal Sodium Hyaluronate - Treatment of osteoarthritis of the knee and periarteritis of shoulder
(Pre-filled syringe) 10mg/ml
Technology Transfer/ Hyalprotec Sodium Hyaluronate - Cataract, keratotransplantation, glaucoma, etc.
Licensing (Pre-filled syringe) 15mg/ml - Ophthalmic surgical adjuvant
Kyoengwoo Min Immualpha Thymosin Alpha1 - Adjuvant therapy for influenza vaccination in elderly patients with reduced
1.6mg/ml immune function
Business Development/Director
T. +82-31-429-4781
E. kwmin@bmikr.co.kr R&D Pipeline
Development stage
Overseas export TA Project Indication
discovery preclinic phase1 phase2 phase3 approved
Nogil Park
Edema, drug
Int’l Sales&Marketion/ Hirax dispersion &
Director Generic absorption
T. +82-70-8891-6627 Tissue regenera-
HiDr tion
E. ngpark@bmikr.co.kr
Hileukin Metastatic renal
Biosimiar cell carcinoma
(Orphan)
BMI2007 Hemophilia

Glabellar wrin-
Hitox kle etc

New drug BMI1009 Osteoarthritis

Edema, drug
BMI2004 dispersion &
absorption

16
Information of Korean Innovative
Pharmaceutical Company
Lifetime Care Company

Boryung Pharmaceutical Co., Ltd. www.boryung.co.kr/eng

Boryung Pharmaceutical was founded in 1963 with the vision of “Lifetime Care Company” with the spirit of
coexistence and co-prosperity that contributes to human health. CEO
Boryung Pharmaceutical is focusing R&D for new anticancer drugs, and also developing “improved new drugs”
Jae-hyun Ahn, Sam-soo Lee
such as treatments for cardiovascular and metabolic diseases, and produce the high-quality medicines in Yesan
campus where the recently constructed as smart factory with cutting edge technology .
Anti-hypertensive medicine “Kanarb”, Boryung Pharm's first commercialized new drug, is the No. 1 sales position Location
in Korea and has been contracted for out license to about 40 countries around the world. 136, Changgyeonggung-ro,
In addition, Boryung Pharmaceutical has focused the “anti-cancer drugs” as a one of future growth engines and Chongro-ku, Seoul
make full effort for R&D and investment.
For the better future, the company is expanding product portfolio by acquiring brand medicine and developing Specialty
improved new drugs, while expanding and reinforcing R&D capabilities and pipeline through open innovation. Hypertension NCE, Oncology NCE,
Cardiovascular disease IMD
Main Products
Product (Ingredient) Use Exporting Countries Remarks Tel/Fax/E-mail
Kanarb 13 Latin countries, Russia, T. +82-2-708-8000
Hypertension 4 Southeast Asian countries, Launched
(Fimasartan) F. +82-31-491-5340
10 African countries
Dukarb 25 Latin countries,
Hypertension Launched
(Fimasartan+Amlodipine) 4 Southeast Asian countries
Tuvero Essential hypertension and 25 Latin countries Launched
(Fimasartan+Rosuvastatin) dyslipidemia
Kanarb plus 13 Latin countries, 8 African
Hypertension Launched
(Fimasartan+HTCZ) countries
Dukaro
(Fimasartan+Amlodipine+Rosuvastatin) Hypertension and dyslipidemia Launched
Akarb Hypertension and dyslipidemia Launched
(Fimasartan+Atorvastatin)
Gelfos M
(Colloidal Aluminum Phosphate, Magne- Gastric antacid China, Taiwan Launched
sium hydroxide, Simethicone) CONTACT US
Besto Technology Transfer/
Gastric ulcer Launched
(Lafutidine)
Licensing
Mim Park
R&D Pipeline
R&D strategy & BD Team/Manager
Project Discovery Preclinical Phase I Phase II Phase III Launch approved
T. +82-2-708-8371
BR2002 Lymphoma E. Parkmin@boryung.co.kr

NCE BR2006 Cancer


Overseas export
BR2007 Cancer Jung_Min Choi
GS 1 Team/Head of Global Sales
Hypertension
BR1006 T. +82-2-740-4106
Dyslipidemia
E. choijm@boryung.co.kr
BR1007 CKD

IMD Hypertension etc


BR1008 Dyslipidemia
Hee_Young Kim
BR1010 Hypertension Administration/General Manager
Alzheimer’s T. +82-31-491-2271
BR4002 disease E. kimhy5959@boryung.co.kr

17
Information of Korean Innovative
Pharmaceutical Company

Dedicated to delivering new and value-added products to patients for


improving global health and well-being

Bukwang Pharmaceutical Co., Ltd. www.bukwangpharm.com

Bukwang, founded in 1960, is dedicated to bringing novel and outstanding medicines to the public.
CEO As in-house developed products, Levovir® was developed as the 4th new drug in the world for the treatment of
hepatitis B and licensed-out to Asia. Dexid® was developed for the treatment of diabetic polyneuropathy, and has
Hee-Won Yoo
been exporting to Southeast-Asia.
With the aim of improving health of human-being, Bukwang is pursuing the development of innovative novel drugs
Location and actively investing in R&D.
7, Sangdo-ro, Dongjak-gu, Seoul,
Korea Main Products

Specialty
1. CNS Small molecules
2. Metabolic disorder Small
molecules
3. Oncology Small molecules
(including IMDs)

Tel/Fax/E-mail
T. +82-2-8288-114
F. +82-2-8288-029
E. bukwang@bukwang.co.kr
Product (ingredient/ Indication Exporting countries Remarks
formulation)
Chronic hepatitis B virus infec-
Levovir®capsule (Clevudine) Philippines Launched
tion
®
Dexid tablet (R-thioctic acid Diabetic neuropathy East-Asian countries Launched
tromethamine)

CONTACT US
Overseas export
R&D Pipeline
Young-wook Chang
Development phase
BD/Manager TA Project Indication Category
E. young.wook.chang@bukwang.co.kr Discovery Preclinical Phase I Phase II Phase III
Schizophrenia/
CNS Lurasidone biopolar depression

Metabolism MLR-1023 T2DM

CNS JM-010 Dyskinesia

Anti-Infection Clevudine COVID-19

Oncology SOL-804 Prostate cancer


Chemical
Immunology BKC-1501A Immune disorders

Anti-diabetes/Obe-
Metabolism BK-1701 sity

CNS USP8 Program Neurodegeneration

I-O AhR inhibitor Cancers

CNS PKR inhibitor Neurodegeneration

18
Information of Korean Innovative
Pharmaceutical Company
A global pharmaceutical company that promotes health and welfare for all

Celltrion, Inc. www.celltrion.com/en-us/home/index

Celltrion, Inc. is a leading Korean biopharmaceutical company that launched the world’s very first antibody
biosimilar product, Remsima®. As one of the first companies to chart the Korean biopharmaceutical sector, CEO
Celltrion pioneered many previously unexplored areas and evolved into one of the leaders in the biosimilar
Woo Sung Kee
development and manufacturing sector with numerous milestone achievements. The company now plans to
keep the momentum and continue the legacy as it ventures into new business areas such as small molecule
pharmaceuticals and Ubiquitous-healthcare system with unique Celltrion approaches. Location
23 Academy-ro, Yeonsu-gu, Incheon
Main Products
Specialty
1. Biosimilars
2. New Drugs
3. Small Molcules
Remsima Truxima Herzuma

1. Bio pharmaceutical Tel/Fax/E-mail


Product Reference Product INN Indications
T. +82-32-850-5000
Yuflyma Humira Adalimumab Rheumatoid Arthritis , IBD, Lymphoma E. Contact@celltrion.com
Regkirona - Regdanvimab COVID-19
Infliximab Rheumatoid Arthritis, Ankylsoing Spondylitis, Ulcerative Colitis,
Remsima SC - Crohn's Disease, Psoriasis, psoriatic arthritis
Infliximab Rheumatoid Arthritis, Ankylsoing Spondylitis, Ulcerative Colitis,
Remsima Remicade Crohn's Disease, Psoriasis, psoriatic arthritis
Rituximab Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid
Truxima Rituxan Arthritis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis
Trastuzumab HER2-Positive Metastatic Breast Cancer, Early Breast Cancer,
Herzuma Herceptin Metastatic Gastric Cancer

2. Chemical pharmaceutical
Product Ingredient Indications CONTACT US
Temyxis Lamivudine, Tenofovir AIDS (Acquired Immune Deficiency Syndrome) Technology Transfer/
Pneumonia, Skin and Skin Structure Infections, Licensing
Linezolid Linezolid Vancomycin-resistant Enterococcus faecium Infections
Jong Won Jung
3. COVID-19 Test Kit Strategic Planning Department/Asst.
Product Indications Manager
Celltrion DiaTrust™ COVID-19 Ag Rapid Test COVID-19 T. +82-32-850-8425
E. jongwon.jung@celltrion.com
R&D Pipeline
1. Antibody Biosimilars
Project Original INN Indications Status
CT-P39 Xolair Omalizumab Asthma, Urticaria Phase 1·3
CT-P16 Avastin Bevacizumab Metastatic Colorectal Cancer, Metastatic Breast Cancer, NSCLC Phase 3
CT-P41 Prolia Denosumab Osteoporosis, Bone Loss Phase 1
CT-P43 Stelara Ustekinumab Psoriasis, Crohn's disease, Ulcerative colitis Phase 3
CT-P42 Eylea Aflibercept Diabetic Macular Edema Phase 3

2. New Antibodies
Project Indications Status
CT-P27 Pandemic·Seasonal influenza Phase 2
CT-P59 COVID-19 Phase 3

3. IMDs
Project Indications Status
CT-G20 Cardiomyopathy Phase 1

19
Information of Korean Innovative
Pharmaceutical Company

VALUABLE COMPANY, CREATIVE COMPANY, BEAUTIFUL COMPANY

CHONG KUN DANG www.ckdpharm.com/en/home

Chong Kun Dang Pharmaceutical Corp. (CKD) was established in 1941 with a goal of supplying the best quality
CEO medicines. In 1968, CKD received US FDA approval for Chloramphenicol. Remarkably, CKD is one of the first
Korean pharmaceutical companies to establish Research Center in early 1970's to accelerate the development
YOUNG JOO KIM
of novel technologies and therapeutics. As a result, CKD has successfully launched two novel therapeutics,
Camtobell for anti-cancer and Duvie for type 2 diabetes, and world’s first NESP biosimilar, Nesbell.
Location
8 Chungjeong-ro, Seodaemun-gu, Main Products
Seoul, Korea
Brand Name Ingredients Notes
Specialty
Oncology Camtobell Inj Belotecan Our New Drugs
1. Anticancer New Drugs
2. Antidiabetic New Drugs Type 2 diabetes Duvie Tab Lobeglitazone Our New Drugs
3. Autoimmune Diseases
Anemia for chronic kidney Nesbell Inj Darbepoetin-α Our Biosimilar
disease
Tel/Fax/E-mail
T. +82-2-2194-0300 Antihypertensive drugs Dilatrend Tab Carvedilol

F. +82-2-2194-0369 Immunology Tarcrobell Cap Tacrolimus


E. youngjookim@ckdpharm.com
Antihyperlipidemic agent Lipilou Tab Atrovastain

PIPELINE
R&D Pipeline
New Chemical Drugs/Biologics
DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III LAUNCH
CV & METABOLIC DISEASE
Diabetes (PPAR-γ agonist) Duvie

Dyslipidemia (CETP inhibitor) CKD-508


CONTACT US Atrial fibrillation (HDAC6 inhibitor) CKD-510

Technology Transfer/ ONCOLOGY


Ovarian Cancer, SCLC Camtobell
Licensing (Camptothecin analogue)
CKD-950*
Rachel Eunjin Shim Liver Cancer (A3 adenosine receptor agonist)
Colorectal Cancer (VDA) CKD-516
Business Development Team/Team Multiple Myeloma
CKD-581
Manager (Pan-HDAC inhibitor)
∞ NSCLC, Colorectal Cancer CKD-702
T. +82-2-2194-0414 (Bi-specific antibody)

E. ellej800@ckdpharm.com IMMUNOLOGY
SLE, Dermatomyositis (anti-INFα) CKD-971*

COVID-19 (HDAC6 inhibitor) CKD-314


Overseas export
CNS
Il Hyeong Cheong Neurodegenerative Disease CKD-504
(HDAC6 inhibitor)
Global Business Planning Team/Team
OTHERS
Manager CKD-11101
∞ Anemia (Darbepoetin-α)
T. +82-2-2194-0423 ∞ Ophthalmology (Ranibizumab) CKD-701
CKD-943**
E. ihch@ckdpharm.com Pain, Uremic Pruritus (Opioid κ receptor agonist) CKD-943*
Rare Disease (Charcot-Marie-Tooth, CMT) CKD-510
(HDAC6 inhibitor)

∞ Biologics / * In-licensed product

20
Information of Korean Innovative
Pharmaceutical Company
CORESTEM creates new hope for treatment of intractable diseases.

CORESTEM, Inc. http://corestem.com/en/

CORESTEM is a bio-pharmaceutical company specializing in research and development of personalized stem cell
therapies for incurable disease. We developed the world’s first stem cell therapeutic product for ALS (Amyotrophic CEO
Lateral Sclerosis), name of NEURONATA-R® Inj, received the permission of medicines by Korea’s Ministry of Food
Kyung Suk Kim
and Drug Safety in July 2014 and began commercialized medication to patients in February 2015. CORESTEM
leads the market in meeting patient expectations beyond national, ethical, and economic limitations through
ongoing research into incurable diseases. Location
In order to maximize therapeutic efficacy and provide the best healing value, we are developing treatments by 24, Pangyo-ro 255 beong-gil,
selecting the most suitable stem cells and internal technologies required for commercialization. In addition to ALS Bundang-gu, Seongnam-si,
treatments, we have a pipeline for various diseases such as lupus and multiple system atrophy, and we plan to Gyeonggi-do, Korea
dominate the market by focusing on the development of treatments for rare and intractable diseases based on the
successful development of ALS stem cell treatments. CORESTEM will be a company that offers new treatment Specialty
options for incurable diseases. 1. Stem Cell Therapy
2. Cell based Therapy
Main Products
Tel/Fax/E-mail
T. +82-2-497-3711
F. +82-2-6349-8666
E. corestem@corestem.com

Neuronata-R®

Product Ingredient Use

R&D Pipeline
Neurological
NEURONATA-R
Disease
®
Inj Autologous bone marrow derived
mesenchymal stem cell
Mitigation of amyotrophic lateral sclerosis
(ALS) progression.
CONTACT US
Technology Transfer/
Licensing
R&D Pipeline
Yung Man Lee
Neurological PRECLINICAL PHASE 1 PHASE 2 PHASE 3
Head of Strategic & Business
Disease Development Team/Director
ALS: Amyotrophic Neuronata-R® inj. T. +82-70-4706-9604
Lateral Sclerosis E. ymlee@corestem.com
MSA: Multiple System CS10BR05
Atrophy etc
CA: Cerebellar ataxia CS20BR08 IIT Soo Hyun Moon
Strategic & Business Development
NMO: Neuromyelitis CS20BR08 Team/Manager
Optica T. +82-70-4706-9713
E. shmoon@corestem.com
PD: Parkinson’s disease CS31PD10

SLE: Systemic lupus CS20AT04 IIT (KR)


erythematosus
Fibrosis CS30LU11

21
Information of Korean Innovative
Pharmaceutical Company

To become a global biopharma company

CrystalGenomics, Inc. www.crystalgenomics.com/en

CrystalGenomics is a commercial stage biopharmaceutical company dedicated to the R&D and commercialization
CEO of novel pharmaceuticals to address significant unmet medical needs in the therapeutic area of infectious disease,
oncology and inflammatory diseases.
Joong Myung Cho
CrystalGenomics has a marketed product, Acelex (Polmacoxib), which has been approved by the MFDS and several
export agreements has been signed with several countries. In addition to Acelex, CrystalGenomics is developing
Location several first-in class/best-in class drug candidates.
5th F, Bldg A, Korea Bio Park, 700,
Daewangpangyo-ro, Bundang-gu, Main Products
Seongnam-si, Gyeonggi-do 13488,
Republic of Korea

Specialty
1. Inflammatory disease
2. Oncology
3. Infectious disease
Acelex (Polmacoxib) Acelex (Polmacoxib)
2mg Tablet 2mg Capsule
Tel/Fax/E-mail
T. +82-31-628-2700 Products (Ingredient/Formulation) Use Exporting Countries
F. +82-31-628-2701 Nonsteroidal anti-inflammatory Turkey & MENA 19 countries, Brazil, Eurasian Economic
Acelex (Polmacoxib) 2mg Capsule
E. info@cgxinc.com drug for osteoarthritis Union (Russia, Belarus, Kazakhstan, Kyrgyzstan, Armenia)
Nonsteroidal anti-inflammatory
Acelex (Polmacoxib) 2mg Tablet drug for osteoarthritis

R&D Pipeline
Pre-
Program Therapeutic Area Indication Phase 1 Phase 2 Phase 3
Clinical
CONTACT US
Ivaltinostat IV(2) Oncology Pancreatic Cancer
Technology Transfer/ (1st Line Therapy: Korea)
Licensing/Overseas export/ Ivaltinostat IV(2) Oncology Pancreatic Cancer
Overseas Office (Maintenance Therapy: US)
Steven Kim Ivaltinostat IV(2) Oncology MDS

Business Development/ Ivaltinostat + PD-1 Inhibitor Oncology HCC(1)


Executive Managing Director CG-806(1) Oncology AML
T. +82-31-628-2720
CG-806(1) Oncology CLL/SLL, nHL
E. skim@cgxinc.com
Camrelizumab(3) Oncology Solid Tumors BLA in Korea

CG-750 CAP(2) Fibrosis IPF


etc
CG-650 Pain/Inflammation Acute/Chronic Pain
Hae Joo Wi
Strategy Planning Team/Manager CG-651 Pain/Inflammation Neuropathic Pain

T. +82-31-628-2718 CG-549(1) Infectious Disease MRSA, ABSSSI

E. hjwi@cgxinc.com (1) First-in-class, (2) Best-in-class, (3) Korea only

22
Information of Korean Innovative
Pharmaceutical Company
Be the No. 1 Pharmaceutical company with slogan of “Dispense in Handy/Think more,
Act faster” for improving Quality of Life.

Daehwa Pharmaceutical Co., Ltd. www.dhpharm.co.kr

Daehwa Pharmaceutical Co., Ltd., was established in 1984 with spirit of “Serving society and creating the better
place for human being through the pharmaceutical business”. Its main goal is to improve Global health and CEO
people’s Quality of Life. Daehwa has specialized platform technologies such like DH-LASED(DaeHwa Lipid-bAsed
Byung-Tae No, Eun-Seok Kim
Self-Emulsifying Drug delivery technology) and DH-TDDS(DaeHwa Transdermal Drug Delivery technology), etc.
Then as the results, they were developed world firstly approved oral Paclitaxel call as Liporaxel Sol’n, and 1st
generic of bronchodilator Resnalin Patch(Tulubuterol) and local action NSAIDs Loxona Cataplasma(Loxoprofen Location
sodium). And as the diversity of business, Daehwa has acquired German aesthetic medical device company also 495 Hanu-ro, Hoengseong-eup,
established joint venture company in China, too. Also, with motto of “Dispense in Handy”, Daehwa is striving to Hoengseong-gun, Gangwon-do,
grow into a global pharmaceutical company with the Vision 2030 project that “Think more, Act faster” to create a Republic of Korea
better tomorrow that mankind dreams of.
Specialty
Main Products 1. New anticancer combination drug
Product Use Ingredient/Formulation Exporting Countries Remarks 2. Incrementally modified drug
Liporaxel Anti-cancer Paclitaxel/Oral Sol’n Asia Approved 3. Transdermal drug
Methyl cephalexin 4. First generic
Cephamethyl Anti-biotics - Launched
lysinate/Tab. & Cap.
Resnalin Bronchodilator Tulobuterol Asia Launched Tel/Fax/E-mail
Loxona External analgesics Loxoprofen sodium Asia Launched T. +82-2-586-6451
Demacot Anti-infective Betamethasone dipropio- Asia & Africa Launched F. +82-2-587-0566
nate and others
BD. crispaul@dhpharm.co.kr
Overseas. shw0817@dhpharm.co.kr
R&D Pipeline
Platform Technology Indication Non-clinical Phase 1 Phase 2 Phase3 Launch
DH-LASED Technology
Liporaxel®(DHP107): Gastric cancer
Oral paclitaxel formula Breast cancer
- USA / E EU / KR / CN CONTACT US
Solid tumor (PK study)

Liporaxel® Capsule Breast cancer


BD(Technology transfer /
Licensing)
DHP23001: Oral HC-docetaxel formula Pancreatic cancer

DHP23002: Oral HC-paclitaxel formula Breast cancer


Young-Sang Cho
DHP23003: Oral irinotecan formula Colorectal cancer
Business Development/Head
DHP23007: Oral zanamivir formula Influenza
T. +82-2-6716-1072
DHP33001: Oral GLP-1 agonist formula Diabetes & Obesity
E. crispaul@dhpharm.co.kr
DH-BIO/HERBAL Technology
DHP1401: DH-Herbal agent Dementia
Overseas export
Han Wong Seo
DHP32005: DH-Wnt-targeted agent Osteoarthritis
Overseas business team/Director
DHP32007: DH-targeted agent Colon cancer
T. +82-2-6716-1071
DHP32006A: DH-immune-oncology agent Breast cancer
E. shw0817@dhpharm.co.kr
DHP21001: ScFv AMD

etc
Platform Technology Indication Optimization Safety & Manufacture Domestic Launch Global Launch
DH-TDDS Technology
Hye Min Kim
DHP26008: Tulobuterol patch Bronchial asthma
Development team/Manager
DHP26005: Rivastigmine patch Dementia
T. +82-2-6716-1068
E. hmkim@dhpharm.co.kr
DHP27013: Loxoprofen sodium plaster Inflammation

23
Information of Korean Innovative
Pharmaceutical Company

Be a partner who protects healthy life of Human beings based on a reliability and trust
of customers.

Daewon Pharm. Co., Ltd. www.daewonpharm.com/eng/main/index.jsp

Daewon Pharmaceutical's believe that customers is the most important core value of corporate management.
CEO Since Established in 1958 based on the founding philosophy of "partner for people to promise their healthy lives",
we have effort to protect the healthy life of people as a company specialized in pure competent pharmaceutical
Seung Ryel Baek
company.
Daewon Pharm is a pharmaceutical company that based on its advanced facility & Plant, investment and excellent
Location R&D capabilities, we have developed the ' Pelubi Tab', a new drug for the Korean & Global market.
386 cheonhodae-ro, Seongdong-gu,
Seoul #04808, Korea Main Products
Category Product Molecule
Specialty
Pelubi CR Tab. Pelubiprofen
1. IMD (incrementally modified drug)
Analgesic Pelubi Tab. Pelubiprofen
2. NCE (New chemical entity)
3. First Generic Nerexone SR Tab. Eperisone
Clow Tab. Rosuvastatin
Tel/Fax/E-mail Lipiwon Tab. Atorvastatin
T. +82-2-2204-7000 Exombi Tab. Varsartan/amlodipine
F. +82-2-3436-4878 Cardiovascular TG Fenone Tab. Choline Fenofibrate
Twincombi Tab. Telmisartan/amlodipine
Tri-in-one Tab. Telmisartan/amlodipine/Rosuvastatin
Uptava Cap. Pitavastatin/Fenofibrate
Eswonamp Tab. Esomeprazole
Gastrointestinal
Otillen F Tab. Artemisia herb isopropanol soft extract(20→1)
Dihydrocodeine/ammonium chloride
Codaewon Forte Syr. /chlorpheniramine/dl-methylephedrine

CONTACT US Respiratory Beposta Tab. Bepotastine


Beposta Tab. Bepotastine
Technology Transfer/
Licensing Elsteine Tab. Erdosteine
MINPYO KIM Wontran ER Tab. Acetaminophen/Tramadol
Business Development/Manager Analgesic Lyicaneuro ER Tab. Pregabalin
T. +82-2-2204-6960 Freefol MCT Inj.1,2% Propofol
E. nuboti@daewonpharm.com Others Renamezin Cap. Spherical adsorptive carbon

Overseas export R&D Pipeline


STEVE KIM
Category Project Code Indication Stage
Overseas Business Dept./Manager
DW-4301 Cardiovascular Disease Phase I
T. +82-2-2204-6976 New chemical entity
stevekim@daewonpharm.com DW-4902 uterine disease Phase I
DW-2801 Gastrointestinal disease Phase I
Generic
DW-5903 Cardiovascular Disease Pre-Clinical
DW-1601 Respiratory Disease Phase III
DW-1807 Respiratory Disease Phase I
DW-1806 Metabolic Disorders Phase I
DW-1805 Metabolic Disorders Pre-Clinical
Incrementally modified drug
DW-8809 Gastrointestinal disease Pre-Clinical
DW-1804 Metabolic Disorders NDA submit
DW-1808 degenerative disease Pre-Clinical
DW-1809 degenerative disease Phase I

24
Information of Korean Innovative
Pharmaceutical Company
A global healthcare group dedicated to improving quality of life

Daewoong Pharmaceutical Co., Ltd. www.daewoong.co.kr/en

Since 1945, we have grown into Korea’s leading company in line with corporate philosophy of ‘developing quality
medicine to safeguard the people’s health and contribute to a healthier society.’ CEO
With $1.2B revenues, we have 8 manufacturing sites globally and branches in China, Japan, Indonesia, Thailand,
Jeon Seng Ho
Vietnam, Philippines, India and USA. We are the no.1 Korean player in Chinese GI market, and we acquired the
no.2 Vietnamese company (Traphaco). We have the first Halal certified Indonesian bio facility and a POC center in
India. Location
Bongeunsa-ro 114-gil 12 Gangnam-gu
Main Products Seoul 06170 Korea
Brands
Specialty
Product name Description 1. new chemical entities for
Ursa® Liver diseases & dysfunction improvement intractable disease
Bearse® Multilayer digestives 2. stem cell therapy for rare diseases
(cell & gene therapy)
Biologics
3. new formulation technology
Product name Description
®
Easyef (EGF) Diabetic foot ulcer, Acute wounds Tel/Fax/E-mail
®
Novosis (rh BMP-2) Dental sinus lift graft T. +82-2-550-8533
Caretropin® (hGH) Growth hormone deficiency F. +82-2-550-8400
® E. stomeve@daewoong.co.kr
Eposis (EPO) Anemia in chronic kidney disease
Nabota® (Botulinum toxin) Anti-wrinkles

Formulation
Product name Description
Luphere ® Depot Peptide delivery system for prostate cancer
CONTACT US
New combination drug for Hyperlipidemia/hyper-
Olostar tension Technology Transfer/
Licensing/Overseas export
R&D Pipeline Doyoung Kim
Global Development Center/Head
T. +82-10-7474-4247
E. Doyoung.kim@ daewoong.co.kr

Overseas Office
CHO JOONG YOUN
Global Corporation
Business/Team Manager
T. +82-10-5736-1575
E. yamyam2000@daewoong.co.kr

25
Information of Korean Innovative
Pharmaceutical Company

To be a leader of total healthcare company which considers the customer’s satisfaction


as the top priority and leads the health & medical industry

DongKoo Bio & Pharma Co., Ltd. www.dongkoo.com/eng

DongKoo Bio&Pharma has been established in 1970 with the core business of production and selling ethical
CEO drugs. An industry leader specializing in Dermatology and Urology for many years, DongKoo Bio&Pharma in 2020
recorded #1 in Dermatology and #5 in Urology in terms of numbers of prescriptions issued. All employees of
Cho Yong Joon
DongKoo Bio&Pharma strive to optimize the Company for the upcoming Quality of Life period by building a Total
Business Model that covers a broad and complete business portfolio from developing cure for senile diseases
Location and chronic diseases (such as diabetes, high blood pressure), strengthening the presence in ethical drugs market
B-14F, 114 Beobwon-ro, Sonpa-gu, and CMO to trailblazing in new areas including, but not limited to, healthcare and cosmeceuticals. As a result,
Seoul, Korea DongKoo Bio&Pharma constantly re-innovates itself as the Total Healthcare Leader who contributes to improving
the well-being of mankind.
Specialty
1. Incrementally Modified Main Products
Drug(Endocrine Disorder, Urologic PHARMACOLOGIC
CATEGORY BRAND NAME GENERIC NAME INDICATIONS
Diseases)
2. First Generic Dermotasone MLE Lotion/ inflammatory and pruritic manifes-
3. ETC(Dermatologic Disorder) Mometasone Furoate tations of corticosteroid-responsive
Cream
Topical Corticosteroid dermatoses
eczema, dermatitis, psoriasis of corti-
Tel/Fax/E-mail Bade Cream Prednicarbate costeroid-responsive dermatoses
T. +82-2-2684-5421 Antihistamine & Antialler- bronchial asthma, allergic rhinitis, skin
Allestin Tab. Epinastine
F. +82-2-2681-1880 gic rash
E. dkbpmed@dongkoo.co.kr Cernitin T60 chronic prostatitis, benign prostatic
Cernilton Tab.
Urogenital agents Cernitin GBX hyperplasia
Uropa SR Tab. Tamsulosin benign prostatic hyperplasia
Atorvastatin essential hypertension and dyslipid-
CONTACT US Avaltan A Plus Tab. Amlodipine
Cardiovascular agents emia
Valsartan
Technology Transfer/ Atostan Tab. Atorvastatin dyslipidemia
Licensing
Prolactin inhibitor Caverlactin Tab. Cabergoline hyperprolactinemia
Im Byung Wook
stomach ulcer, duodenal ulcer, gastro-
BD Team/General manager Antiulcer Rabepri Tab. Rabeprazole esophageal reflux
T. +82-2-2684-5421(236) otitis media, sinusitis, tonsillitis,
Antibacterial Newroxime Tab. Cefuroxime axetil
E. bryan.im@dongkoo.co.kr pneumonia

Overseas export R&D Pipeline


Kim Kyung ho
Category Project Code Indication Stage
Overseas Business Team/Assistant
DKB1903 Diabetes NDA Submission
Manager
DKB2002 Diabetes BE Study
T. +82-2-2684-5421(318)
DKB2001 Diabetes Formulation Study
E. kyungho.kim@dongkoo.co.kr Differentiated
Generic Drugs DKB1902 First line therapy for psoriasis NDA Submission

DKB2014 Second line therapy for psoriasis Formulation Study


Overseas Office
DKB1904 Anti-allergic disease Phase Ⅰ
Lee Dae Liul
DKB1801 Acne NDA preparation
Chinese Business DIvision/General
Manager DKB15003 Dyslipidemia IND Submission

T. +86 187-2171-7220 DKB17001 Urinary diseases Phase Ⅰ, Ⅲ

E. daniel.lee@dongkoo.co.kr DKB17002 Lumbago Phase Ⅰ, Ⅲ

DKB19001 Circulatory On Market


Incrementally
etc Modified Drugs
DKB19002 Diabetes Phase Ⅰ

Ki No Kwang DKB19003 Anti-allergic disease Formulation Study

Management Planning Team/General DKB20001 Diabetes Phase Ⅰ


manager DKB20002 Diabetes Phase Ⅰ
T. +82-2-2684-5421(237) DKB20003 Atopy Phase Ⅱ
E. fin4@dongkoo.co.kr

26
Information of Korean Innovative
Pharmaceutical Company
Total healthcare group in Korea that delivers healthy value with sincere
heart and contributes to customers’ life and society

Dongkook Pharmaceutical Co., Ltd. www.dkpharm.co.kr/en

Dongkook Pharmaceutical is a Korean pharmaceutical company founded in 1968 and listed on the KOSDAQ
in 2007. OTC medicines for periodontal disease, wound, and women’s menopausal symptoms, etc, and ETC CEO
medicines such as the contrast agent and the anticancer drug, are well known not only in Korea but also in
Heung-Ju, Oh
overseas markets. Currently, we export drug substances and products to more than 50 countries around the world,
especially in advanced countries such as EU and Japan.
Location
Main Products 7, Teheran-ro 108-gil, Gangnam-gu,
Seoul, Republic of Korea
Product Main Ingredients Use Exporting Countries
Titrated extract of Zea Mays L,
Peridol Plus Tablet Periodontal disease Specialty
Magnolia extract
1. Periodontal disease (Natural
Lipossol Ointment Titrated extract of centella Skin disease
OTC medicine),
Black cohosh extract, Female menopausal
Feramin Q Tablet 2. Anticancer agent (First generic
St. John's wort extract symptoms
product),
Pansidil Capsule Medicinal yeast Hair loss
3. Contrast agent
9 countries
Lorelin Depot Injection Leuprolide acetate Prostate cancer (Mexico, Uruguay, Iran, etc.)
26 countries Tel/Fax/E-mail
Pofol Injection Propofol anaesthesia
ETC (Japan, Brazil, UAE, Thailand, etc.) T. +82-2-2191-9800
Teicon Injection Teicoplanin Infectious disease 3 countries F. +82-2-6234-0483
(Japan, Mongol, Syria)
E. kjw6@dkpharm.co.kr
Hyaron Injection Sodium hyaluronate Osteoarthritis Vietnam, etc
Temporal correction of
Bellast Series Hyaluronic acid Vietnam, etc
Others wrinkles
Centellian24 Centella Asiatica Extract Cosmetic

R&D Pipeline CONTACT US

Technology Transfer/
Licensing
Kyu Hwan Kim
Strategic Management/
Senior Manager
T. +82-2-2191-9277
E. kkh8@dkpharm.co.kr

Overseas export
Alice Jungyeon Lee
BD Team/Overseas Business Dept.
T. +82-2-2191-9896
E. ljy12@dkpharm.co.kr

etc
Jaewon Kim
Research Managemnet/Senior
Manager
T. +82-31-888-6330
E. kjw6@dkpharm.co.kr

27
Information of Korean Innovative
Pharmaceutical Company

Human & Happiness

DONGWHA PHARM www.dong-wha.co.kr/english

Established as the first Korean pharmaceutical company in 1897, Dongwha has always remained committed to
CEO bringing happiness to customers and employees with its management focusing on happiness of people. Whal
Myung Su, Korea’s first western-style medicine, by integrating the advantages of Western medicine into the royal
Junha Yoo
court’s secret recipe in 1897. The key R&D outcomes include successful development of "Zabolante" in 2015, as a
next-generation antibacterial agent, and currently distributing in Korea.
Location
6~8F, FastFive Tower, 24, Main Products
Namdaemun-ro 9-gil, Jung-gu, Seoul,
KOREA

Specialty
1. COVID-19 NCE
2. Astma/COVID-19 Natural Drug
3. Diabetes IMD

Tel/Fax/E-mail
Category Product Ingredient Use
T. +82-2-2021-9300
F. +82-2-778-2336 Antibacterial agent Zabolante Zabofloxacin AE COPD
E. dongwha@dong-wha.co.kr Digestive System Whal Myung Su Gambir, Ginger etc. Anorexia, Indigestion, etc.

Cold Remedy Pancold Acetaminophen etc. Relief of common cold symptoms


Myrrh, Rhatany,
Gum treatment toothpaste Each Paste gingivitis and alveolar pyorrhea
Chamomile

R&D Pipeline
CONTACT US Category Project Indication Discovery Preclinical Phase I Phase II Phase III
Technology Transfer/ DW2008
Licensing
Mase Lee DW1027 Antiviral drug
Research Institue/Senior Managing
DW1026
Director
T. +82-31-270-0601 NCE DW1022
Autoimmune
E. mase.lee@dong-wha.co.kr Disease
DW1024
Overseas export DW1023 Oncology
Wena Cho
Global Business Team/Manager DW1025 Asthma
T. +82-2-2021-9345
DW6012
E. wena.cho@dong-wha.co.kr
Diabetes
IMD DW6013
DW6014

28
Information of Korean Innovative
Pharmaceutical Company
A Global Leader in Healthcare Industry

GC Pharma (Former Green Cross Corp.) www.globalgreencross.com/eng

GC Pharma has been a leading biotech company for developing innovative biotherapies including vaccines,
plasma-derivatives, recombinant proteins and therapeutic antibodies. CEO
GC Pharma developed the world's first vaccine against epidemic hemorrhagic fever “Hantavax” and the world's
Eun-chul Huh
second vaccine for varicella zoster virus vaccine “Suduvax”.
GC Pharma is also pursuing opportunities in rare diseases by developing therapies such as Hunterase (world’s
second ERT for Hunter syndrome) and GreengeneF (3rd generation of hemophilia A treatment. Also, GC Pharma is). Location
GC Pharma is developing a COVID-19 antibody treatment. 107, Ihyeon-ro 30beon–gil,
Giheung-gu, Yongin-si, Gyeonggi-do
Main Products 16924, Korea

Product Name Indication Active Ingredient Category


Specialty
A-/Hypogammaglobulinemia
Combined therapy with antibiotics for 1. Plasma derivatives
I.V.-Globulin SN inj. 5% severe bacterial or viral infections Human Intravenous Immuno- Plasma Derivatives 2. Vaccines
I.V.-Globulin SN inj. 10% Idiopathic thrombocytopenic purpura globulin
Guillain-Barre syndrome 3. Recombinant Products
Kawasaki syndrome
Hypoalbuminemia and shock in acute
hemorrhage from loss of albumin (burns, nephrotic Human Albumin Solution Plasma Derivatives Tel/Fax/E-mail
Albumin inj.-GCC syndrome, etc.) and low T. +82-31-260-9300
synthesis of albumin (hepatic cirrhosis, etc.)
F. +82-31-260-9412
Treatment of hemophilia A with supplies of blood Human Blood Coagulation Plasma Derivatives
Green-VIII inj coagulation factor VIII Factor VIII
Prevention and control of bleeding Recombinant Coagulation
GreenGene F inj. episodes and preoperative management Recombinant
Factor VIII (Beroctocog ∝)
in hemophilia A
Prevention of recurrence of hepatitis B in patients Human Hepatitis B Immuno- Plasma Derivatives
I.V.-Hepabig inj. with liver transplants globulin
Prophylaxis of tetanus and the reduction of tetanus Human Tetanus Immunoglob- Plasma Derivatives
Sero-Tet inj. (Hyper-Tet inj.) symptoms ulin
GCFLU Quadrivalent Split Virion Inactivated Influ-
Pre-filled syringe inj. Prophylaxis against influenza enza Vaccine Vaccines CONTACT US

Live Attenuated Varicella Technology Transfer/


BARYCELA Inj. Prophylaxis against varicella Vaccines
Vaccine Licensing
Patients with Hunter syndrome (MPS II) which is Young Seoub Park
Hunterase caused by a deficiency of the Idursulfase beta Recombinant
lysosomal disease, Iduronate 2-sulfatase (IDS) BD/General Manager
Decrease the duration of severe T. +82-31-260-9417
Neulapeg Pre-filled syringe neutropenia for patients receiving cytotoxic PEG-GCSF Recombinant E. perious@gccorp.com
chemotherapy for solid tumor and 기준일자 

혁신형제약기업홍보책자B영 malignant lymphoma


문 Overseas export
R&D Pipeline Byung Lim Lee
5HJLVWUDWLRQ Global biz./General Manager
3UH&OLQLFDO 3KDVH, 3KDVH,, 3KDVH,,, 3ULFLQJ
T. +82-31-260-9493
3&& 9=9 VXEXQLW 
$QWKUD[ %&* ,9,* 86 
%OHHGLQJGLVRUGHU 9DFFLQDWLRQIRU9DULFHOOD
9DFFLQDWLRQIRU$QWKUD[ 9DFFLQDWLRQIRU%&* ,PPXQHGHILFLHQF\ E. bllee@gccorp.com
WUHDWPHQW ]RVWHUYLUXV

Y:) 7)3, 7GDS 68'8,,


+HSDELJJHQH /7 
%OHHGLQJGLVRUGHU +HPRSKLOLD$% 9DFFLQDWLRQIRU7HWDQXV 9DFFLQDWLRQIRU9DULFHOOD
+HSDWLWLV%SUHYHQWLRQ
WUHDWPHQW WUHDWPHQW 'LSKWKHULD3HUWXVVLV ]RVWHUYLUXV

)DFWRU; +HSDELJJHQH &+%  *UHHQ*HQH) &1 


)DFWRU;GHILFLHQF\ Hepatitis B treatment +HPRSKLOLD$WUHDWPHQW

+XQWHUDVH ,&9-3 
)DFWRU;,,, (*)5
+XQWHUV\QGURPH
)DFWRU;,,,GHILFLHQF\ &DQFHUWKHUDS\
WUHDWPHQW

3URWHLQ&
3URWHLQ&GHILFLHQF\


3ODVPD 9DFFLQH 5HFRPELQDQW

29
Information of Korean Innovative
Pharmaceutical Company

To Save the Lives of Patients and Improve Patients’ Quality of Life

Genexine, Inc. www.genexine.com

Genexine (KOSDAQ, 095700) is a clinical stage biotechnology company focused on the development and
CEO commercialization of innovative immunotherapeutics and next generation novel long-acting biologics. Our goal is to bring
to patients medicines that will transform their lives. hyFc platform and DNA therapeutic vaccine platform are our own
Young Chul Sung, Jung Won Woo
core proprietary technologies, which are designed to drive the discovery of a wide range of differentiated therapeutics.

Location R&D Pipeline


700 Daewangpangyo-ro, GX-I7 (Long-acting IL-7)
GX-I7 (Long-acting IL-7)
Korea Bio ParkBldg. B, Bundang-gu, Areas Indication Regimen Non-clinical Phase 1 Phase 2 Site
Seongnam-si,Gyeonggi-do 13488, Healthy
SAD Completed KR
Republic of Korea Volunteers

Mono
Completed KR
Solid tumor
Specialty Mono Ongoing Ph 1 CN
Cancer Immunotherapeutics,
Therapeutic and Preventive DNA Immuno-
Mono
Completed KR

Vaccines, Oncology
Glioblastoma TMZ Combo Ongoing Ph2 CN
Next Generation Long-acting
AVASTIN® Combo Ongoing Ph2 KR
Biologics.
Triple Negative
Breast Cancer
KEYTRUDA® Combo Ongoing Ph 1b/2 KR

Tel/Fax/E-mail Infectious
COVID-19 Mono Ongoing Ph 1b & Ph 2 KR/ID
T. +82-31-628-3200 Disease
GX-188 (HPV DNA Therapeutic Vaccine)
F. +82-31-628-3229 GX-188 (HPV DNA Therapeutic Vaccine)
E. bd@genexine.com Areas Indication Regimen Non-clinical Phase 1 Phase 2 Site
GX-H9 (Long-acting hGH)
ir@genexine.com Immuno-
GX-H9 (Long-acting hGH)
Cervical Cancer KEYTRUDA® Combo Ongoing Ph 1b/2 KR
Oncology
Areas Indication
GX-H9 (Long-acting hGH)Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
GX-H9 (Long-acting
Areas AGHD
hGH)
Indication Regimen
Mono Non-clinical Phase 1 Phase 2
Completed Phase 3 Site
KR/EU
Endocrine
Areas Indication Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
Mono Completed
CONTACT US disease
Endocrine
AGHD
PGHD Mono Ongoing Ph 3
KR/EU
CN
disease AGHD Mono Completed KR/EU
Technology Transfer/ Endocrine PGHD Mono
*AGHD; Adult Growth hormone
Ongoing Ph 3
Deficiency, PGHD; Pediatric Growth CN
hormone Deficiency
disease
Licensing GX-G3 (Long-acting
PGHD G-CSF)Mono Ongoing Ph 3 CN
*AGHD; Adult Growth hormone Deficiency, PGHD; Pediatric Growth hormone Deficiency

Pio (Jae Beom) Kim GX-G3 (Long-acting G-CSF) *AGHD; Adult Growth hormone Deficiency, PGHD; Pediatric Growth hormone Deficiency
GX-G3
GX-G3(Long-acting
Areas
(Long-actingG-CSF)
Indication Regimen
G-CSF) Non-clinical Phase 1 Phase 2 Phase 3 Site
Business Development/Director Hematologic
Areas Indication Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
Neutropenia Mono Completed KR/EU
T. +82-31-628-3401 diseases
Areas
Hematologic Indication Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
Neutropenia Mono Completed KR/EU
E. piokim.jb@genexine.com diseases
Hematologic
Completed
GX-E4
diseases(Long-acting
Neutropenia EPO) Mono KR/EU
GX-E4 (Long-acting
GX-E4 (Long-acting
GX-G6
EPO)
(Long-acting EPO)
GLP-1)
GX-G6
Areas
(Long-acting
Indication
GLP-1)
GX-E4 (Long-acting EPO) Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
GX-G6
Areas (Long-acting
Hematologic GLP-1)
CKD-induced
Indication Regimen
Mono Non-clinical Phase 1 Phase 2 PhPhase
Ongoing 3 3 KR/ASEAN
Site
Areas
diseases Indication
Anemia Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
Areas
Hematologic
Metabolic Indication
CKD-induced
Type 2 Regimen Non-clinical Phase 1 Phase
Phase 2
2 IND Phase 3 Site
GX-G6
Metabolic (Long-acting
Type 2 GLP-1)Mono Completed Ongoing
Phase Ph 3Chronic kidney
2 IND *CKD; KR/ASEAN
EU
disease
diseases
disease
Areas Anemia
Diabetes
Indication Regimen
Mono Non-clinical Completed
Phase 1 Approved
Phase 2 Phase 3 Site
EU
GX-G6 (Long-acting GLP-1)
disease
Hematologic Diabetes
CKD-induced
Mono
Approved
Ongoing Ph 3 KR/ASEAN
diseases
Metabolic Anemia
Type 2 Phase 2 IND *CKD; Chronic kidney disease
Areas
disease Indication
Diabetes Regimen
Mono Non-clinical Completed
Phase 1 Phase
Approved2 Phase 3 Site
EU
*CKD; Chronic kidney disease
GX-G8
GX-G8 (Long-acting GLP-2)
Metabolic(Long-acting
Type 2 GLP-2)Mono Phase 2 IND
disease Diabetes Completed Approved EU

GX-G8
Areas (Long-acting
Indication GLP-2)
Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
Areas Indication Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
GX-G8 (Long-acting
Metabolic
GLP-2)
Short Bowel Phase 1 IND
GX-G8
Metabolic(Long-acting
disease
Short Bowel GLP-2)Mono
Syndrome
Phase 1 IND
Approved EU
Areas
disease Indication
Syndrome Regimen
Mono Non-clinical Phase
Approved1 Phase 2 Phase 3 Site
EU

Metabolic Short Bowel Phase 1 IND


Areas
disease Indication
Syndrome Regimen
Mono Non-clinical Phase
Approved1 Phase 2 Phase 3 Site
EU
GX-P1
GX-P1 (Long-acting
(Long-acting PD-L1)
Metabolic Short Bowel PD-L1) Phase 1 IND
Mono EU
GX-P1 (Long-acting
disease PD-L1)
Syndrome Approved
GX-P1
Areas (Long-acting
Indication PD-L1)
Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
Areas Indication Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
Autoimmune
GX-P1 (Long-acting
Autoimmune Autoimmune PD-L1)Mono Completed KR
Areas
Autoimmune Transplantation
Indication
Transplantation Regimen
Mono Non-clinical Completed
Phase 1 Phase 2 Phase 3 Site
KR

GX-19N
GX-19N
Autoimmune (COVID-19
Autoimmune
Areas (COVID-19
Indication
preventive
Monovaccine)
preventive vaccine)
Regimen Non-clinical Completed
Phase 1 Phase 2 Phase 3 Site
KR
GX-19N (COVID-19 preventive vaccine)
Transplantation
Autoimmune
GX-19N
Areas (COVID-19
Autoimmune Indication preventive
Transplantation
Monovaccine)
Regimen Non-clinical Completed
Phase 1 Phase 2 Phase 3 KR
Site
Areas Indication Regimen Non-clinical Phase 1 Phase 2 Phase 3 Site
Preventive
GX-19N
Preventive (COVID-19
COVID-19 preventive
Monovaccine) Ongoing Ph 1/2a KR
Vaccine
Areas
Vaccine Indication
COVID-19 Regimen
Mono Non-clinical Phase 1 Ongoing Ph 1/2a
Phase 2 Phase 3 Site
KR

Preventive
Areas
Vaccine Indication
COVID-19 Regimen
Mono Non-clinical Phase 1 Ongoing Ph 1/2a
Phase 2 Phase 3 Site
KR

30 Preventive
Vaccine
COVID-19 Mono Ongoing Ph 1/2a KR
Information of Korean Innovative
Pharmaceutical Company
Building Trust Through Integrity

GENUONE Sciences Inc. www.genuonesciences.com/en/main.html#

GENUONE Sciences (the integrated entity from the acquisition of Kolmar Korea’s Pharmaceutical Division and
Kolmar Pharma in December, 2020) is South Korea’s top CMO pharmaceutical company, specializing in the full CEO
range of services from formulation development to manufacturing and clinical development of small molecule.
Miyeon Kim
Since 2002, provided complete services from product development to finished dose formulations including
regulatory services. About 80% of K-pharmaceutical companies (Hanmi, Yuhan, LG, etc.) have business relationship
as our customers. We are exporting 250 products to 20 countries through cooperation with overseas partners, and Location
also have global CMO capabilities such as supplying hepatitis B treatment to the Hong Kong government. (Major 14F, MajestaCity Tower 1, 12, Seocho-
Exporting Countries: Hong Kong, Japan, Vietnam, Russia, Peru.) daero 38-gil, Secho-gu, Seoul,
South Korea
Main Products
Dosage Indication Product Name API Specialty
Form Description
Hiforge Tab Valsartan, Amlodipine 1) First Generic and incrementally
Oral Solid Tablets, Capsules, Powder Circulatory / Telopin Tab Telmisartan, Amlodipine
modified drug
Cardiovascular
Lipar Tab Atorvastain 2) PreMix Injection
Injection(Ample, Vial, Bag), Eye- 3) Topical (ex. Nail Lacquer)
Sterile Endocrine K-Tosmet Tab Pioglitazone, Metformin
drops, Lyophilized injectables
System Febuxt Tab Febuxostat
Oral Solu- Syrup, Suspension Gastro-Intesti- Nexpesol Tab Esomeprazole Tel/Fax/E-mail
tions
nal Lafuton Tab Lafutidine T. +82-80-601-0090
Oinment. Cream, Lotion, Solution,
Topical Painless Tab Acetaminophen, Tramadol HCI
Nail Lacquer NSAIDS F. +82-2-3487-3051
Celecoxib Cap Celecoxib E. Contact@genuonesciences.com
Quasi Drup Toothpaste, Gargle, Sanitizer Pelium Syrup, Tab Pelagonium Sidoides
Respiratory
Liquid filling in Hard Capsules Eldobron Tab/Cap Erdosteine
Lid-cap Ciclopirox Nail Lacquer Ciclopirox
(GENUONE’s innovative Tech)
Dermatologicals
Prosol Oinment, Lotion Clobetasol Propionate
Para-K Acetaminophen
Infusion
Penta-amin, Suppramin Amino acid
CONTACT US
Lid-cap(Liquid Colin-K Lidcap Choline alfoscerate
Hardcap)
R&D Pipeline Technology Transfer/
Licensing
Classification R&D IND NDA E/O
Aekyoung Lee
2 cases 2cases
Development Group/
ETC Head of Development Group
Cardiovascular system ETC T. +82-2-2059-2710
ETC E. aekyoung.lee@genuonesciences.com
ETC
6 cases 1 case Overseas export
Suna Ryu
ETC
Overseas Group/Team Leader
ETC
T. +82-2-2059-2800
ETC E. suna.ryu@genuonesciences.com
Endocrine system
ETC
ETC
ETC
ETC
2 cases
Musculoskeletal ETC
system
ETC
1 case
Digestive system
ETC

31
Information of Korean Innovative
Pharmaceutical Company

“The Health Innovator” as Korea’s leading global total healthcare company.

HANDOK, Inc. www.handok.co.kr/eng

Handok, a leading innovation-driven pharmaceutical/healthcare company in Korea, develops, manufactures and


CEO distributes healthcare solutions to improve the health and quality of human life. Handok has a core business
focus in diabetes, cardiovascular, muscular skeletal, psychoneurotic disease, human vaccines, medical devices,
Young Jin Kim, Jin Ki Baik
diagnostics and consumer health. Handok, founded in 1954, grew as a joint venture with Hoechst/Aventis/
Sanofi from 1964 to 2012. Handok has also established strategic collaborations in several areas with multiple
Location multinational pharmaceutical companies. For more information, please visit www.handok.co.kr.
132, Teheran-ro, Gangnam-gu, Seoul,
06235, Korea Main Products
Category Products Description
Specialty
Amaryl Tab, Amaryl M Tab, Amaryl Mex SR Tab
1. Anti-diabetics New Chemical Leader in Diabetes Market
ETC Tenelia Tab, Tenelia M SR Tab.
Entities Soliris Inj. Specialized in Orphan Drugs and Rare Diseases
2. Anti-diabetics Diabetes Ketotop Plaster No 1. Topical Pain Relief Product
OTC
Incrementally Modified Drugs Festal Plus Tab. No 1. Digestive Product
3. Anti-arthritis Plaster Medical Devices & Diagnostics Brozen Blood Glucose Monitors
NatureSet Food Supplements
Tel/Fax/E-mail Healthcare Products Hangover remedy
Ready Q (High-Absorption Curcumin)
T. +82-2-527-5114
F. +82-2-527-5001
E. Handok@handok.com R&D Pipeline
Therapeutic Resear Pre-
Project Category Indication P1 P2 P3 Remarks
Area ch Clinical
Therapeutic Resear Pre-
Project Category Indication P1 P2 P3 Remarks
Area ch Clinical
Growth Hormone
Deficiency in
Growth Hormone
HL2356 Adults
Orphan Bio-better Deficiency in
(GX-H9)
HL2356 Adults
Growth Hormone Genexine partnered
Orphan Bio-better Deficiency in Genexine partnered
(GX-H9) Growth Hormone
Pediatrics
Deficiency in
Pediatrics
CONTACT US Oncology HL5101 NCE Cancer CMG Pharm. partnered
Oncology HL5101 NCE Cancer CMG Pharm. partnered
Technology Transfer/
Licensing
Therapeutic Regulatory
Project Category Indication Development Clinical Remarks
Overseas export Area
Therapeutic
Approval
Regulatory
Project Category Indication Development Clinical Remarks
Area Approval
SoHyun Kwon • CE mark (2016)
Medical Refractory
Corporate&Business Development/ CV DENEX • CE mark (2016)
Devices
Medical Hypertension
Refractory Handok Kalos Medical
CV DENEX
Senior Vice President Devices Hypertension partnered
Handok Kalos Medical
T. +82-2-527-5316 Open
CV/ Innovation Project
RST Kit Diagnostics CV/Infection
partnered
NB POSTECH partnered
Infection
CV/
E. sohyun.kwon@handok.com Infection
RST Kit Diagnostics CV/Infection NB POSTECH partnered

Pre-
Therapeutic Resea
Project Category Indication Clinic P1 P2 P3 Remarks
Area rch
etc al

HyoJoo Cha ABL001 VEGF/DLL4


Planning&Coordination Office/Team ABL103 4-1BB/B7H4
Leader
Oncology ABL501 PD-L1/LAG3 Solid cancer
T. +82-2-527-5157
ABL Bio partnered
E. hyojoo.cha@handok.com ABL503 PD-L1/4-1BB

ABL506 PD-L1/B7-H3

Parkinson’s
CNS ABL301 SNCA x IGF1R
Disease
Intravenous
monoclonal
RZ358 Bio antibody for
Congenital
Orphan Hyperinsulinism REZOLUTE partnered
Oral Plasma
Kallikrein Inhibitor
RZ402 Bio for Diabetic
Macular Edema

Stem Cell Atopic SCM Lifescience


Derma SCM-AD Therapy Dermatitis partnered

32
Information of Korean Innovative
Pharmaceutical Company
R&D, Manufacturing of API/BPIs and Pharmaceutical Product

HANLIM PHARM. CO., LTD. www.hanlim.com/eng

With the corporate mission of protecting the precious human life from various forms of diseases, HANLIM has
consistently endeavored to improve the health standards of people, and we have grown to become one of the CEO
leading companies in Korea.
Jae Yoon Kim, Jung Jin Kim
In 1993, the future-oriented GMP factory was completed together with the founding of the central research
center. As a part of the long-term investment scheme of the company, we continue to make a great investment
in accumulating advanced technologies and reorganizing manufacturing facilities lately to enhance the health of Location
mankind as a leading pharmaceutical company. 42, Seocho-Daero 52 Gil, Seocho-Gu,
Seoul 06634 Republic of Korea
Main Products
Product Name Active Ingredient(s) Category Remark Specialty
T-Sporin R&D, Manufacturing of API/BPIs and
Cyclosporin 0.5mg Ophthalmic IMD Product Pharmaceutical Product
Eye Drops
Nasaflex Mometasone furoate 0.5mg, Allergy&ENT IMD Product
Nasal Spray Azelastine HCl 1.4 mg
Tel/Fax/E-mail
Sodium Risedronate 35mg,
Risenex Plus Tab. Endocrine IMD Product T. +82-2-3489-6000
Cholecalciferol 5,600IU
Dages Cap. Pepsin 25mg, Papain 50mg, Diastase 15mg, Cellulase Digestive F. +82-2-3489-6101
15mg, Pancreatin 50mg, Pancrelipase 13mg, UDCA 25mg
E. master@hanlim.com

R&D Pipeline
Mesenchymal stem cells
Clinical phase
Prodocut Indication Pre-clinical
1 2 3
HL401 Lupus Nephritis

NCE (New Chemical Entity) Discovery CONTACT US


Clinical phase Technology Transfer/
Prodocut Indication Pre-clinical NDA
1 2 3 Licensing
Mi Jin O
HL301 Acute Bronchitis
Delveopment Dept./Director
HL301A Radiation Pneumonia T. +82-2-3489-6166
E. omijin@hanlim.com
HL301B Chronic Bronchitis

HL217 AMD Overseas export


Jeonghwa Jenny Yang
HL237 Rheumatoid Arthritis Global Business Dept./Director
T. +82-2-3489-6214
HL237A Liver Transplantation
E. yjh0717@hanlim.com
HL237B Sjogren’s Syndrome

IMD (Incrementally Modified Drug)


Clinical phase
Prodocut Indication Pre-clinical NDA
1 2 3
Lodien-T Tab. Hypertension
Hyperlipidemia+ Hyper-
HL188 tension
Breast Lesion Surgery
Lumino-mark Inj. Marker
Jakfas XR Tab. Rheumatoid Arthritis

33
Information of Korean Innovative
Pharmaceutical Company

R&D Driven Pioneer for Innovation in Life Sciences

Hanmi Pharmaceutical Co., Ltd. www.hanmipharm.com

Hanmi Pharmaceutical Co., Ltd. is a global pharmaceutical focused on the development and commercialization of new
CEO pharmaceutical products. The Company invested nearly 21% of its sales on R&D in 2020. Hanmi Pharmaceutical Co., Ltd.
plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting drug for
Jong-Soo Woo, Se Chang Kwon
NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and
rare disease fields. Hanmi Pharm is continuing its endless challenges by raising synergy of various R&Ds such as AI drug
Location development and immune anticancer development through the “Open Innovation” strategy that opens the door to excellent
14, Wiryeseong-daero, Songpa-gu, externals. R&D capabilities of Hanmi Pharmaceutical Co., Ltd. and the strong trust among multiple partners remain solid.
Seoul, 05545, Korea
Main Products
Specialty Category Product Use Ingredient Exporting countries
R&D based pharmaceutical products 21 countries in APAC, LAT-
Amosartan Hypertension Amlodipine AM, CIS, AFRICA continents
Amosartan Plus Hypertension Amloidpine + Losartan + Chlorthalidone LATAM
Tel/Fax/E-mail
Amosartan Q Hypertension, dyslipidemia Amloidpine + Losartan + Rosuvastatin CIS, LATAM
T. +82-2-410-9114
Amosartan XQ Hypertension, dyslipidemia Amloidpine Rosuvastatin
+ Losartan + Ezetimibe + Do not export
Cardiovascular
disease Rosuzet Dyslipidemia Ezetimibe + Rosuvastatin CIS, LATAM, SEA
Amodipin Hypertension Amlodipine camsylate Do not export
Rovelito Hypertension, dyslipidemia Irbesartan + Atorvastatin Do not export
Alzheimer’s disease,
Carnitil Acetyl-L-carnitine hydrochloride Do not export
dementia
Pidogul Antiplatelet Clopidogrel napadisilate APAC
Gastrointestinal Esomezol GERD, Gastric ulcer Esomeprazole strontium Do not export
disease
Palpal Erectile dysfunction Sildenafil JAPAN
Urology Gugu Erectile dysfunction Tadalafil JAPAN
HANMI TAMS BPH Tamsulosin hydrochloride Do not export
Neurology Naxozol Anti-inflammatory Naproxen + Esomeprazole Do not export
CONTACT US Hyalumini eye Artificial tear, Sjögren's
Ophthalmology, Sodium hyaluronate Do not export
drop syndrome
Technology transfer/ etc
Rabone D Osteoporosis Raloxifene + cholecalciferol Do not export
Licensing-in
Inkie Chung R&D
Global BD Pipeline
T. +82-2-410-0408
E. smile7921@hanmi.co.kr

Overseas export
Steven Cho
Finished products/APIs/CMO
business/Team Leader
T. +82-2-410-0462
E. haamincho@hanmi.co.kr

34
Information of Korean Innovative
Pharmaceutical Company
The frontrunner in gene therapy

Helixmith www.helixmith.com/eng

Helixmith has expanded its products and pipelines with biologics and phytotherapeutics.Helixmith’s lead gene
therapy product in the biologics business is Engensis (VM202), currently in phase III clinical study targeting CEO
diabetic peripheral neuropathy (DPN) in the US. Engensis is a plasmid DNA designed to simultaneously express
Sunyoung Kim, Seungshin Yu
two isoforms of hepatocyte growth factor (HGF), HGF728 and HGF723. In addition to DPN, Engensis is being studied
for the treatment of diabetic foot ulcers (DFU), amyotrophic lateral sclerosis (ALS), and Charcot-Marie-Tooth
disease (CMT). Helixmith has the experience and capabilities necessary to advance a product through the entire Location
drug development process. The company is focused on developing innovative products to address unmet needs 21, Magokjungang 8-ro 7-gil,
in both chronic and rare diseases. Helixmith is also developing phytotherapeutics with excellent efficacy and low Gangseo-gu, Seoul 07794, Korea
side effects, utilizing experience and knowledge in research and development accumulated over the past 20 years.
The company has unique experience in areas including drugs, health functional food and cosmetic products using Specialty
botanical sources. Helixmith possesses the organization and abilities that exceeds most leading global biotech Plasmid DNA-based gene therapy
companies. The company has experience in basic science, candidate screening, preclinical, analytical processing,
production, quality control, regulatory and clinical development. Helixmith will continue to strengthen our pipelines
Tel/Fax/E-mail
with new technologies and knowledge to maintain a high growth and create a high revenue business.
T. +82-2-2102-7200
F. +82-2-887-0011
Main Products E. contact@helixmith.com

Gene Therapy
Phytotherapeutics​
Products

Antibody
Plasmid DNA
treatment Drugs Nutraceuticals

Engensis PG201 PG102


VM507 HX204
(VM202) HX106
CONTACT US
Diabetic peripheral
neuropathy(DPN) Osteoarthritis
Improvement of
immune
Technology Transfer/
Amyotrophic lateral sclerosis
(ALS) Chronic Kidney
(PG201) hypersensitivity
(PG102) Licensing
Diabetic foot ulcers(DFU)
Claudication
Disease
(VM507)
Inflammatory Bowel Improvement Sunkyung Yang
Charcot Marie Tooth Disease of
disease(CMT) (HX204) Woking memory
(HX106)
Business Development
Coronary artery disease(CAD)
T. +82-2-2102-7238
E. contact@helixmith.com
R&D Pipeline
Indication Status of clinical trials
Pre-clinical Phase 1 Phase 2 Phase 3 BLA
G
e Diabetic peripheral neuropathy (DPN)
n
e
Diabetic foot ulcers (DFU)
T
h
e Engensis Claudication
r
Plasmid (VM202)
a DNA Amyotrophic lateral sclerosis (ALS)
p
y

P
Charcot Marie Tooth disease (CMT)
r
o
d
Coronary artery disease (CAD)
u
c
t Antibody
VM507 Chronic kidney disease
s treatment

Indication & Function Development Status


Basic research Pre-clinical Clinical study Market

PG201 Osteoarthritis LAYLA Tab.


P
h
Drugs​
y HX204 Inflammatory bowel disease
t
o
t PG102 Hypersensitivity improvement ALLEX
h
e
r HX106 Memory improvement​ MNEMOSYNE
a
p
Nutraceu Prostate health​
e HX109
u ticals
t
i HX110 Respiratory health
c
s​
HX112 Climacteric women’s health

35
Information of Korean Innovative
Pharmaceutical Company

Global Top Tier Biohealth Company

HK inno. N www.inno-n.com/eng

inno.N has technology-focused business competitiveness in the fields of ETC Drugs, APIs, and Health & Beauty
CEO Care. In 2019, inno.N launched the new medicine for gastroesophageal reflux disease, "K-CAB Tab.," was released
as the 30th new drug in Korea. Furthermore, inno.N unrivaled in the basic IV fluids and anti-hangover drink
Seok Hee Kang
markets. It has more than 20 new drug and biopharmaceutical pipelines centered on digestion, oncology, liver,
Auto immune, and infection, and recently established a future growth engine by entering the cell gene therapy
Location business. With the 'Heal the World For Better Life' mission, inno.N will develop innovative new drugs and become
Pine Avenue Tower A, 100, Euljiro, a global pharmaceutical company that customers can trust.
Jung-gu, Seoul, 04551, Korea
Main Products
Specialty Product Indication & Use Exporting Countries
ETC (CVs, Antibiotics, IV Solution, China, Vietnam, Latin America
K-CAB Tab. (Tegoprazan) Gastroesophageal reflux disease (GERD)
Oncology, Endocrinology, 24 countries including Mexico
Nephrology&Urology, Anemia of hemodialysis patients with end-stage Asia, Latin America and Africa
Epokine Inj.(rh-EPO) renal disease
Gastro Intestinal, Musculoskeletal,
Serious, life-threatening infections by gram-posi-
Respiratory, Others) & Health Vancorin Inj. (Vancomycin) Asia
tive bacteria
functional products Tapocin Inj. (Teicoplanin) Serious infections by gram-positive bacteria Aisa
Acute bacterial sinusitis, acute bacterial exacer-
Moveloxin I.V. solution bag (Moxifloxacin) bation of chronic bronchitis, community acquired Asia
Tel/Fax/E-mail pneumonia and so on
T. +82-2-6477-0000 Vancomycin-resistant Enterococcus faecium
Cinezolid I.V. solution bag (Linezolid) -
F. +82-2-6477-0698 infections
E. HKIN_business@inno-n.com Citopcin I.V. Solution bag (Ciprofloxacin) Infections caused by microorganism Asia
Levotopcin I.V. Solution bag (Levofloxacin) Infections caused by microorganism -
Calmtop Inj. (Irinotecan) Colorectal cancer -
Pleural mesothelioma and non-small cell lung
Pemta Inj. (Pemetrexed) -
cancer
OmapOne Lipid Inj. bag (Fish/MCT/Soybean/ Supplying energy, essential fatty acids and
CONTACT US Olive oiil) omega-3 fatty acids to patients. -
OmapOne Peripheral Inj. bag (Lipid, Amino acid, Supplying Lipid, Amino acid and Glucose to
Technology Transfer/ Aisa
Glucose) patients
Licensing Atomet XR Tab. (Atorvastatin/Metformin) Type2 Diabetes/Hyperlipidemia -
Hyunjung Kim Exone Tab (Valsartan/Amlodipine) Hypertension -
Innovation Team/Manager Machkhan Tab. (Candesartan/Amlodipine) Hypertension -
T. +82-2-6477-0183 CONDITION (Hyaluronic acid) Anti-hangover drink China, Japan
Outstanding energy drink produced with 6-yeared
E. hyunjung.kim@inno-n.com HongSamJin Gold (Red Ginseng drink) red ginseng China

Overseas export R&D Pipeline


Jinho Maeng Clinical Trial Partnering
Pipeline Target Indication DS PC NDA MKT availability
Global Business/Manager PI PII PIII
T. +82-2-6477-0190 IN-A002 Autoimmune disease
E. jinho.maeng@inno-n.com IN-A011 Nutrition
A2AR inhibitor Cancer
NCE
FER/T inhibitor Cancer
Overseas Office
DCLK1 inhibitor Cancer
Sungbin Cho IN-A013 Cancer
K-CAB BD/Manager IN-C008 Hypertension/yperlipidemia
T. +81-80-1249-0427 IN-C009 Type 2 Diabetes
Global
E. sungbin.cho@inno-n.com IMD IN-C010 Type 2 Diabetes
IN-C011 Type 2 Diabetes
Overseas Office IN-C001 Gastroesophageal reflux disease
Minki Ku IN-B001 Hand, Foot & Mouth Disease
Vietnam branch office/Manager IN-B002 Smallpox
Biologicals IN-B003 Pneumonia
T. +82-70-4990-2712
IN-B009 Covid-19
E. minki.ku@inno-n.com
TANKIO Cancer
DS: Discovery, PC: Preclinical Studies, MKT: Market, IMD: Incrementally Modified Drug

36
Information of Korean Innovative
Pharmaceutical Company
People-centered R&D and Future Innovation

HYUNDAI Pharm. www.hyundaipharm.co.kr/english

HYUNDAI Pharm. was founded in 1965 as a pharmaceutical company with the corporate philosophy of
"Contributing to the improvement of the health of mankind” based on the philosophy of the CEO who aims at CEO
the esteem of human respect and transparent corporate spirit. As a global R&D company, we aim to fulfill our
Sang-Joon, Lee
responsibilities for improving public health by focusing on developing new drugs and incrementally modified drugs
through continuous investment.
Location
Main Products Hyundai Pharm Bldg, Bongeunsa
Street 135, Gangnam-Gu, Seoul
Product name Active ingredients Indications
Minoxyl Specialty
- 3%, 5% Solution Minoxidil Androgenetic alopecia
- 3%, 5% Gel 1. NCE - Diabetes
Minoxyl complex Solution 5% Minoxidil, Vitamin V6 / E, L-menthol Androgenetic alopecia 2. IMD – Fixed dose combination of
Alzheimer’s disease
Tenormin Tab. Atenolol Hypertension, Angina Pectoris
3. IMD – Fixed dose combination of
Uremin Tab. Desmopressin acetate Nocturnal enuresis Respiratory disease

Mirtapin Tab. Mirtazapine Major depressive disorder


Tel/Fax/E-mail
Mirap Tab. / ER Tab. Pramipexole HCl Parkinson's disease T. +82-2-1666-9979
Hipezil Tab. Donepezil HCl Alzheimer's disease F. +82-2-2693-7628
E. jhhwang@hdpharm.co.kr
Dimantin Tab. Memantine HCl Alzheimer's disease

Tamirin SR Tab. Galantamine HCl Alzheimer's disease

Pemirosal Tab. / Dry Syrup Pemirolast potassium Bronchial Asthma, Allergic Rhinitis

Surfolase Cap. / CR Tab. Acebrophylline Acute & chronic Bronchitis

Levotuss Tab. / Syrup Levodropropizine Acute & chronic Bronchitis CONTACT US

Clinium Vaginal Tab. Dequalinium Chloride Bacterial & Candida Vaginitis Technology Transfer/
Licensing
Overseas export
R&D Pipeline Shin-Sook, Ryou
CODE PROJECT INDICATION Disco-
very
Pre-
clinical Phase I Phase II Phase III NDA VP, Head of Global Business,
RA & MA
NCE HDNO-1605 HD-6277 Type-2 T. +82-2-2600-3803
[HOB-047] Novel antidiabetics Diabetes
E. ssryou@hdpharm.co.kr
BPDO-1603 New fixed-dose combina- Senile
[BPS-034] tion disease

Senile
HDDO-1728 New dosage form disease
IMD
HDDO-1756 New fixed-dose combina- Endocrine
tion disease

HDDO-1801 New fixed-dose combina- Respiratory


tion disease

37
Information of Korean Innovative
Pharmaceutical Company

An elite organization contributing to the health and happiness of humankind

Ildong Pharmaceutical Co., Ltd. www.ildong.com/eng

Since Ildong Pharmaceutical Group was founded in 1941 under the philosophy of ‘pharmaceuticals are rooted in
CEO humans’, We have created and shared significant value for health and prosperity throughout many years and will
continue this endeavor. Ildong has become one of the leading pharmaceuticals in South Korea with powerful brand
Paul Woong - sup Yun
lineups including Aronamin, Biovita, and other major OTC products. We developed robust product pipelines for
ethical drugs using our advanced technologies and diverse strategic partnerships.
Location
2, Baumoe-ro 27-gil, Seocho-gu, Main Products
Seoul, Korea

Specialty
1. Ethical drug/Over-the-counter
drug(Vitamins, Probiotics)
2. Antibiotics
3. Anticancer drug Myni GQlab Telostop, Twotops

Tel/Fax/E-mail
T. +82-2-526-3114
F. +82-2-526-3030

Meditouch Aronamin 비오비타 Besivo


Development Pipeline
R&D Pipeline
Preclinical Phase 1/2
CONTACT US
IDB0076 ID11916 IDX1197
Technology Transfer/ Solid tumor
VEGF-A/ Solid tumor Solid tumor
NRP1 N.G. Antiandrogen
Licensing Oncology
ID11902 A PARP-i licensed out to an
Dong Young Park Solid tumor Ildong group NRDO, idience in
A2A August 2019
Business Development Team/
Manager ID11905 ID11903
Liver disease NASH NASH
T. +82-2-526-3383 ATX FXR

E. black4ra@ildong.com ID11904
CNS disease Parkinson
A2A/A1

Overseas export ID13010


ID11041 ID11901
wAMD
Nathan Ahn Eye Disease Dry eye
CFTR
Glaucoma
NO/PDE
VEGF-A
/NRP1
Overseas Business Team/Manager
ID11052 ID11014
T. +82-2-526-3500 Metabolic
T2DM T2DM
disease GLP-1R GPR40
E. any@ildong.com
ID-COVID-01
ARDS
Undisclosed
COVID19
ID-COVID-02
Anti-Virus
Undisclosed
GPR40: G-Protein-coupled Receptor 40, NASH: Non-Alcoholic SteatoHepatitis, FXR: Farnesoid X Receptor, A2A: ATX: Autotaxin,
CFTR: Cystic Fibrosis Transmembrane Conductance Regulator, NO/PDE: Nitric Oxide/Phosphodiesterase E
VEGF-A/NRP1: Vascular Endothelial Growth Factor-A/Neuropilin-1, GLP-1R: Glucagon-Like Peptide-1 Receptor 2

38
Information of Korean Innovative
Pharmaceutical Company
Biopharmaceutical Company Developing Innovative Treatment of Cancer

ISU ABXIS Co., Ltd. www.abxis.com/eng/index.do

ISU ABXIS is a biopharmaceutical company founded in 2001 with a desire of being an axis of therapeutic antibody
as its names stands for ABXIS = AntiBody + aXIS. Beginning with the successful development and market launch CEO
of the Korean first therapeutic antibody Clotinab® in 2007, ISU ABXIS has established its own biotherapeutics
Seok Joo Lee
development technologies and led Korean biopharmaceutical industry. ISU ABXIS will be dedicated to improving
the lives of patients with cancers and incurable diseases.
Location
Main Products Global R&D Center Building C 5th Fl,
22 Daewangpangyo-ro, 712 Beongil,
Bundang-gu, Seongnam-si,
Gyoenggi-do 13488

Specialty
1. Novel biological cancer drugs
2. Biosimilars in rare diseases
Abcertin® Fabagal® Clotinab®
Tel/Fax/E-mail
T. +82-31-696-4700
Therapeutic Area Product Generic Name Major Market
F. +82-31-696-4690
Abcertin® Imiglucerase Korea, Iran
Rare Disease E. abxis@isu.co.kr
®
Fabagal Agalsidase beta Korea
Cardiovascular Clotinab® Abciximab Korea, Turkey

R&D Pipeline
Development Status
Category Project INN Indication Non-
Discovery clinical Phase 1 Phase 2 Phase 3 CONTACT US

Head and Neck Cancer Technology Transfer/


Licensing
ISU104 Barecetamab Colorectal Cancer Junho Lim
Strategic Planning/Deputy General
Manager
Breast Cancer
T. +82-31-696-4671
Oncology
ISU104 E. junho.lim@isu.co.kr
- Solid Tumor
ADC
Overseas export
ABX1701 - Solid Tumor
Henry Sung
Pharmaceutical Business/Manager
ABX2001 - Solid Tumor
T. +82-31-696-4717
E. ezvill@isu.co.kr
Dalcinonacog
ISU304 Hemophilia B
alfa
ISU305 Overseas export
(Soliris® Eculizumab Paroxysmal Nocturnal
Rare Incur- Biosimilar) Hemoglobinuria Daniel Yang
able Pharmaceutical Business/Manager
Disease Abcertin®
(Cerezyme® Imiglucerase Gaucher’s Disease T. +82-31-696-4644
Biosimilar)
E. danielyang@isu.co.kr
Novel - Alzheimer’s Disease
Target A

39
Information of Korean Innovative
Pharmaceutical Company

Innovative and Responsible

Janssen Korea Ltd. www.janssen.com

Janssen Korea, the Korean branch of the pharmaceutical division of Johnson & Johnson, started as a joint
CEO company with Yuhan Corporation in 1983. For the last 30 years, it has been committed to provide useful medicines
for the treatment of diverse diseases.
Cherry Huang
We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism,
Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Location
25F LS-Yongsan Tower, 92 Main Products
Hangangdaero, Yongsan-gu, Seoul,
Theraputic Area Product Ingredient Indication
Korea
Invega Sustenna Paliperidone palmitate Schizophrenia
Specialty Neuroscience Invega Trinza Paliperidone palmitate Schizophrenia
· Invega Sustenna/Invega Trinza: TRD(Treatment Resistant Depression), MDSI(Major Depressive
SPRAVATO Esketamine Disorder who have acute Suicidal Ideation or behavior)
Schizophrenia
Multiple Myeloma,
· SPRAVATO®/Depression Velcade Bortezomib Mantle Cell Lymphoma
· Sirturo: Multi-drug-resistant Darzalex Daratumumab Multiple Myeloma
tuberculosis(MDR-TB) Oncology
Mantle Cell Lymphoma,
Imbruvica Ibrutinib
· Velcade/Darzalex: Multiple Chronic Lymphocytic Leukemia
Myeloma Zytiga Abiraterone acetate Meta Castration-Resistant Prostate Cancer
· Imbruvica: Mantle Cell Lymphoma Infectious Diease Sirturo Bedaquiline Multi-Drug Resistant Tuberculosis
· Zytiga: Prostate Cancer Pulmonary Hypertension Opsumit Macitentan Pulmonary Hypertension
· Ultracet: Moderate to severe Pain
Ultracet Tramadol Moderate to severe Pain
· Nucynta: Severe Chronic Pain Pain
Nucynta Tapentadol Severe Pain
· Simponi: Rheumatoid Arthritis,
Ankylosing Spondylitis Simponi Golimumab Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
· Remicade: Rheumatoid Arthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Crohn’s Disease,
Remicade Infliximab
Immunology Ulcerative Colitis
Ankylosing Spondylitis, Crohn’s
Disease, Ulcerative Colitis Stelara Ustekinumab Psoriasis, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis
· Stelara: Psoriasis, Psoriatic Arthritis, Tremfya Guselkumab Psoriasis
Crohn’s Disease, Ulcerative Colitis
· Tremfya: Psoriasis R&D Pipeline
TA Project/Product Indication Phase 2 Phase 3
Tel/Fax/E-mail ®
TREMFYA Crohn's Disease, Pediatric Psoriasis, Ulcerative Colitis ∨
T. +82-2-2094-4500
®
F. +82-2-2094-4570 Immunology SIMPONI Pediatric Ulcerative Colitis ∨

E. hsuh2@its.jnj.com nipocalimab Warm Autoimmune Hemolytic Anemia ∨


Urothelial cancer, Tumor Agnostic, Non-muscle Invasive Bladder
BALVERSATM ∨ ∨
Cancer (NMIBC)
®
ERLEADA Prostate cancer ∨
CONTACT US
niraparib L3 Prostate cancer metastatic castration-resistant ∨
Technology Transfer/ Oncology
Lazertinib / amivantamab Non Small Cell Lung Cancer ∨
Licensing
ciltacabtagene Autoleu-
Lee, JoonYup Relapsed refractory multiple myeloma ∨ ∨
cel (BCMA CAR-T)
MESO/Business Intelligence & teclistamab Relapsed refractory multiple myeloma ∨
Innovation Sr. Manager Adjunctive treatment for major depressive disorder with insomnia
Neuroscience seltorexant ∨
T. +82-10-8928-5651 symptoms
E. jlee61@its.jnj.com VAC31518 Janssen COVID-19 Vaccine ∨
Infectious VAC52150 Monovalent Ebola Virus Vaccine ∨
Disease
VAC89220 HIV Prevention Vaccine ∨
Fontan-palliated in adolescent (>12 years old) and adult patients,
OPSUMIT® Pediatric pulmonary arterial hypertension, Chronic thromboem- ∨
Pulmonary Hyper- bolic pulmonary hypertension
tension
Chronic thromboembolic pulmonary hypertension, Pediatric
UPTRAVI® ∨
pulmonary arterial hypertension

40
Information of Korean Innovative
Pharmaceutical Company
We are a healthcare leader & pioneer making what is impossible today,
possible tomorrow with the innovative technology.

JW Pharmaceutical www.jw-pharma.co.kr

JW group Provides pharmaceuticals vital for maintaining the lives of patients such as anticancer drugs and
antibiotics, and has developed into a leading pharmaceutical company and global manufacturer of I.V. Solutions. CEO
For 75 Years ever since its foundation in 1945, JW group focuses on healthcare, ETC, OTC, diagnostics and medical
SHIN YOUNG SUB
equipment. Based on new technologies and services for healthy lives of human beings, JW group has built up
LEE SEUNG RYLL
strong sales network across the country and superior pipelines in I.V. solutions, antibiotics, oncology, cardiology,
rheumatology and gout.
Location
Main Products 2477, Nambusunhwan-ro, Seocho-gu,
Seoul, 06725, Korea
1. Finished Product
- Carbapenem Antibiotics
Specialty
- Amino Acid Solutions
- General I.V Solutions & Other Sterile Solutions I.V-solutions, antibiotic,
- Antimicrobial & Antifungal Agents cardiovascular, urology,
- Gastrointestinal Agents gastrointestinal, nephrology and
- Topical anticancer
- Multivitamins
- Agents for Antibiotics Tel/Fax/E-mail
- Miscellaneous T. +82-2-840-6777
F. +82-2-831-8351
2. API (Active Pharmaceutical Ingredient)
- Carbapenem Antibiotics: Imipenem/Cilastatin
- Anti-fungals: Ketoconazole, Itraconazole, Fluconazole
- Chiral Products for Custom Synthesis & Specialty Amino Acid
- Miscellaneous

R&D
R&D Pipeline
Pipeline
CONTACT US
Preclinical Phase 1 Phase 2 Phase 3 Registration
Technology Transfer/
Project A1 JW2286 CWP291 Licensing
WNT inhibitor STAT3 inhibitor WNT inhibitor
Jiseon Lim
CreaVax-BC CreaVax-HCC CreaVax-RCC
Oncology Project B1 Project B2
Licensing/Manager
GBM* HCC* RCC*

T. +82-2-840-6883
Project B3 Project B4
E. jiseon_lim@jw-pharma.co.kr
Immune Project A2 JWP1601 URC102
Project B5
diseases WNT inhibitor H4R antagonist Anti-gout
Overseas export
LIVALO
Jungoo Lee
Cardiovascular
and
LIVALO E LIVALO V
Global Sales/Director
Metabolic
diseases T. +82-2-840-6718
J-DART E. jimmy@jw-holdings.co.kr
Regenerative CWL080061 Project A3
medicine WNT activator WNT activator etc
Orphan
Project A4 HEMLIBRA Gyungmo Yeun
WNT activator Hemophilia
Corp. Planning Office/Associate
Eye Project A5
diseases H4R antagonist
T. +82-2-840-6836
*GBM : glioblastoma multiforme *HCC : Hepatocellular carcinoma *RCC : Renal Cell Carcinoma E. 20170347@jw-group.co.kr

41
Information of Korean Innovative
Pharmaceutical Company

Korea Otsuka Pharmaceutical Co., Ltd.

Korea Otsuka Pharmaceutical Co., Ltd. www.otsuka.co.kr/introduction_en

Korea Otsuka Pharmaceutical supplies excellent and innovative pharmaceutical and healthcare products. At a
CEO multinational pharmaceutical company equipped with large-scale production facilities in Korea, we contribute to
the growth of national economy through domestic production as well as export. With understanding of customers,
Moon, Sung-ho
markets and social responsibilities, we are fulfilling our role and mission to become a company contributing to the
healthy life of Koreans.
Location
226, Yeoksam-ro, Gangnam-gu, Seoul, Main Products
Republic of Korea
Category Product Generic name Export
Abilify Tab.
Specialty
1. Chemical drug of CNS category Abilify OD Tab.
Aripiprazole EU,Hongkong,Thailand, Indonesia,Philippine,Taiwan
2. Chemical drug of Oncology CNS Abilify Maintena Inj.
category Abilify Oral Solution
3. Orphan drugs & First in class Rexulti Tab. Brexipiprazole Indonesia
products
Pletaal Tab. Japan,China,Indonesia,Taiwan,Philippine,Thailand,Malaysia,
Cilostazol Myanmar,Pakistan,Vietnam,Hongkong
Tel/Fax/E-mail Renal/CV Pletaal SR Cap.
T. +82-2-3287-9000 Samsca Tab. Tolvaptan Thailand,Phillippine,Indonesia,Vietnam,Myanmar
F. +82-2-3287-9069 Mucosta Tab. Japan,China,Indonesia,Philippine,Cambodia,Macau,Malaysia,
GI Rebamipide
E. otsuka@otsuka.co.kr Mucosta SR Tab. Myanmar,Pakistan,Thailand,Vietnam

Busulfex Inj. Busulfan


Oncology
Iclusig Tab. Ponatinib
Pulmonary Deltyba Tab. Delamanid

CONTACT US R&D Pipeline


Technology Transfer/ Development
TA Product Indication
Licensing Discovery Preclinical Phase1 Phase2 Phase3 Launch
Lee sang wook Multi-drug resistant
Deltyba Tab tuberculosis
Market Access Team/Team Leader Orphan
Iclusig Tab CML, Ph+ ALL
T. +82-2-3287-9150
E. hufs91@otsuka.co.kr OPB-111077 DLBCL

ASTX-727 AML, MDS


Overseas export
Heo won nyoung OPA-15406 Atopic dermatitis

Resource Management Team/ SGI-110-04,06,07,12 AML, MDS


Team Leader New drug
TEV-48125 Migraine
T. +82-2-3287-9060
Schizophrenia,
E. tank@otsuka.co.kr Rexulti Pediatric
Abilify Maintena Inj Schizophrenia, etc.
Hyponatremia,
Samsca Tab ADPKD
Cerebral infarction,
Pletaal SR Cap etc.
Incrementally
Modified Abilify OD Tab Schizophrenia, etc.
Drug
Mucosta SR Tab Gastritis
Medical Resistant hyperten-
Paradise
Device sion

42
Information of Korean Innovative
Pharmaceutical Company
For the Best Global Pharmaceutical Company

KOREA UNITED PHARM. INC. kup.co.kr/main.do?lang=en_us

Established in 1987, Korea United Pharm. Inc. has continued to develop various products through prestigious R&D
investment. It was named one of Asia's 200 most promising companies by the US economy magazine Forbes in CEO
recognition of its growth potential. it has established several overseas branches and corporations to make inroads
DUK YOUNG KANG
into the global market. Also, it is striving to do the best to fulfill social responsibilities through various social
contribution activities.
Location
Main Products Seoul, Gangnam-gu, Nonhyeon-ro
121 street 22
Product Active ingredient Indication
Clanza CR Tab Aceclofenac anti-inflammatory
Specialty
Clavixin Duo Cap. Clopidogrel + Aspirin antithrombatic Incrementally Modified Drugs for
Cilostan CR Tab. Cilostazol antithrombatic 1. Antithrombotic
Gastiin CR Tab. Mosapride functional dyspepsia 2. Gastrointestinal
Levotics CR Tab. Levodropropizine bronchitis 3. Bronchitis disease
Unigril CR Tab. Sarpogrelate HCl antithrombatic
Tel/Fax/E-mail
Fenorics EH Tab. Fenofibric acid Dyslipidemia
T. +82-2-512-9981
Kalomin S Tab. Pelargonium sidoides bronchitis
F. +82-2-548-4599
Glicetil Syrup Choline alfoscerate brain functioning E. webmaster@kup.co.kr
Omethyl QTlet Soft Cap. Omega-3-acids ethyl esters 90 2g Dyslipidemia
Lomincomp 9ml/pkg syrup (pelargonium sidoides/coptidis
Romin Comp Syrup Bronchitis
rhizome extract)
Atorvastatin + Omega-3-acids ethyl
ATMEG Combigel softcap. Dyslipidemia
esters

R&D Pipeline CONTACT US


Technology Transfer/
Licensing
Won-Wook Lee
BD Licensing/Senior Manager
T. +82-2-558-8612
E. wwlee@kup.co.kr

Overseas export
Hans Cho
Overseas Business/General Manager
T. +82-2-543-4079
E. hanscho@kup.co.kr

Overseas Office
Jae Hyeok Choi
Overseas Marketing/Assistant Manager
T. +82-2-512-9982
E. joyful0710@kup.co.kr

etc
JUNGWOOK LEE
Public Relations/Manager
T. +82-2-512-9981
E. imurmvp@kup.co.kr

43
Information of Korean Innovative
Pharmaceutical Company

We connect science fo life for a better future

LG Chem, Ltd. www.lgchem.com

Since its foundation in 1947, LG Chem has served as Korea’s representative chemical company, contributing to the
CEO development of the national economy and the enhancement of the quality of life through continuous technological
development, new product introduction, and quality innovation based on its stable growth.
Hak Cheol Shin
We have established the production, sales, and R&D networks at home and abroad, expanding our business into
the global market, aiming to become a world-class company that provides innovative materials and solutions by
Location sharpening our competitive edge in high-value added core businesses while expanding new business opportunites
LG Twin Towers, 128, Yeoui-daero, in IT & Electronic Materials and Energy Solutions.
Yeongdeungpo-gu, Seoul, South In addition, we have recently merged LG Life Sciences, a former subsidiary of LG Chem in order to strengthen and
Korea expand its business in Life Science area.
In the business area which LG Chem has focused on nurturing as a new growth engine of the future, LG Chem
Specialty became the first in Korea to develop gamma interferon by applying genetic engineering technologies in 1989 and
Small molecules/biologics-based the first to receive approval for a new drug from U.S Food and Drug Administration (FDA) with its development
new medicine in oncology and of “Factive”(quinolone antibiotic) in 2003. LG Chem will continue to secure competitiveness in the global market
immunology, Small molecules/ through aggressive investment and enhancement of its R&D capabilites based on its technological prowess that
biologics-based new medicine for has succeeded in commercializing the drugs.
diabetes and metabolic disease,
Vaccine Main Products
Product Description
Tel/Fax/E-mail The optimized DPP-4 inhibitor having potent efficacy, reliable safety and better compliance benefits/Once
Zemiglo/ Zemimet
T. +82-2-3773-1114 daily DPP-IV inhibitor and Metformin SR combination product
F. +82-2-3773-7813 Eucept The first biosimilar of Etanercept ever developed by LG Chem
The right choice for managing short stature recombinant human growth hormone with proven efficacy and
Eutropin safety since 1993
Combined Diphtheria, Tetanus, whole cell Pertussis, Hepatitis B and Haemophilus influenza typeB.Eupen-
Eupenta ta can prevent five different childhood disease with a single injection
Eupolio the first Sabin-Inactivated Polio Vaccine pre-qualified by the WHO
CONTACT US Cross-linked sodium hyaluronate made by microbial fermentation for tissue augmentation and wrinkle
YVOIRE correction
Technology Transfer/
Licensing
Jong Heon Won R&D Pipeline
Business Development Team/ Clinical Trial
Manager Field Projects Indication Discovery Preclinical
Phase I Phase II Phase III
T. +82-2-6987-4072
Vaccine LR19114 DTP/HepB/Hib/IPV prevention ●
E. jayden@lgchem.com
LR19055 Autoimmune disease ●
LR19127 HNSCC ●
LR19125 NSCLC ●
Biologics
LR19156 (Undisclosed) Obesity ●
LR19023 Cancer ●
LR19129 Cancer ●
LR19052 Diabetes ●
LR19019 Ulcerative colitis ●
LR19074 Gout ●
LR19021 Obesity ●
Chemicals
LR19123 Diabetes ●
LR19018 (Undisclosed) NASH ●
LR19024 (Undisclosed) OA ●
LR20009 (Undisclosed) Cancer ●

44
Information of Korean Innovative
Pharmaceutical Company
Leap forward to become one of the world’s top bio-pharmaceutical companies

Medytox, Inc. www.medytox.com/?site_id=en

Medytox is a biopharmaceutical company that changes the future with ceaseless R&D.
As the first company in Korea to develop a botulinum toxin type A product, Medytox feels a sense of pride and CEO
responsibility for the Korean biopharmaceutical industry. Therefore Medytox is leading the efforts to improve the Jung Hyun Ho
transparency and the competitiveness by pushing for implementation of more objective and scientific guidelines.
Medytox has been working towards the vision of growing as a global biotechnology company. Linked to this,
Location
Medytox strives to tackle the advanced markets such as USA, EU and to directly penetrate and expand into the
78, Gangni 1-gil, Ochang-eup,
emerging markets. In addition, Medytox will continue to develop and commercialize new products by increasing
Cheongwon-gu, Cheongju-si,
investment in R&D to create meaningful results.
Chungcheongbuk-do, Republic of
Korea
Main Products
Specialty
Botulinum toxin products,
Medical aesthetics,
Bio-pharmaceuticals

Tel/Fax/E-mail
T. +82-43-217-1555
F. +82-2-3476-8372

Products Content Characteristic


®
Clostridium botulinum toxin type A Neuronox is the first botulinum toxin type A product developed in Korea. Neu-
Neuronox® ronox(R) ranked No.1 market share in major countires including Korea, and has
(Hall group) also been registered in 34 countries such as Brazil, Saudi Arabia, etc.
®
Clostridium botulinum toxin type A INNOTOX is the world’s first liquid formulation of botulinum toxin type A CONTACT US
Innotox® product which has been developed by totally excluding animal derived ingredi-
(Hall group) ents and human serum albumin (HSA) in order to enhance product safety. Technology Transfer/
Coretox® is an advanced new botulinum toxin type A product that also ex- Licensing
animal derivatives and HSA. Especially, Coretox® successfully excludes
Clostridium botulinum toxin type A cludes Yoon Sukwon
Coretox® non-toxin proteins from its ingredients to prevent the immune system from de-
(150kDa) (Hall group) veloping antibodies that would eventually wear down the effects of botulinum Business Development Team/Director
toxin.
T. +82-2-6901-5825
E. swyoon@medytox.com
R&D Pipeline
Division Code Indication Stage Overseas export
Benign Masseteric Hypertrophy, Overactive Bladder, Migraine, Gla- Oh Yongki
® Approved
Neuronox bellar Line(US, EU, China, Taiwan, Russia), Lateral Canthal Line(US, + clinical International Business Team/Director
EU), Blepharospasm(China)
Approved T. +82-2-6901-5463
Innotox® Aesthetic and Treatment (US, EU) + Clinical E. yongki_oh@medytox.com
Approved
Coretox® Upperlimb Spasticity + Clinical
Biodrug MT912 Macular degeneration Preclinical Overseas Office
MT107 Anticancer drugs Preclinical
Park Youngsang
Northeast Asia Biz Team/Director
MT981 Solid Cancer Preclinical
T. +82-2-6901-5875
MT971 Inflammatory bowel disease Preclinical
E. yspark@medy-tox.co.kr
MT116 Solid Cancer Preclinical
MT921 Fat Reduction Clinical
Synthetic Drugs
MT106 Lymphoma Preclinical

45
Information of Korean Innovative
Pharmaceutical Company

Become one of the world’s top three nucleic acid companies


Become a world-class advanced research center for biomedical technology

OliX Pharmaceuticals, Inc. www.olixpharma.com/eng

OliX Pharmaceuticals (KOSDAQ, 226950) is an RNAi-based pharmaceutical company developing innovative


CEO therapeutics against a variety of disorders. Based on its proprietary cp-asiRNA technology that minimizes adverse
effects and maximizes intracellular delivery, OliX is focused to address significant unmet medical needs in dermal,
Dong Ki Lee
ophthalmic, and liver areas. Over the past years, the excellence of its technology has been globally recognized
through notable license and collaboration agreements. Since the 2018 KOSDAQ listing, OliX is actively expanding
Location its business by establishing subsidiaries and labs in the US.
Ace Gwanggyo Tower1, Suite
1014, 17, Daehak 4-ro, Yeongtong- Main Products
gu, Suwon-si, Gyeonggi-do, 16226,
Indication Area Program Indication Remarks
Republic of Korea
OLX101A Hypertrophic Scar Hugel (Asia)
Skin
Specialty OLX104C Androgenic Alopecia
1. RNAi based therapeutics OLX301A Dry & Wet AMD Théa (Worldwide Excl. Asia-Pacific)
2. Nucleic acid therapeutics OLX301D Subretinal Fibrosis Théa (Worldwide Excl. Asia-Pacific)
3. New drug development Eye
OLX301E Wet AMD
OLX304A Retinitis Pigmentosa
Tel/Fax/E-mail
OLX701 Liver Fibrosis
T. +82-31-779-8400
F. +82-31-779-8499 Liver OLX702 Liver Disease (NASH, Diabetes etc.)
E. olixpharma@olixpharma.com OLX703 HBV
OLX201A Idiopathic Pulmonary Fibrosis
Lung
OLX204A COVID-19
CNS OLX401A Neuropathic Pain
Oncology OLX801A Cancer Immunotherapy
CONTACT US
R&D Pipeline
Technology Transfer/
Program Indication R&D Animal Pre clinical Clinical
Licensing/Overseas export POC
Sun Woo Hong (Korea) Currently in Phase2
OLX101A Hypertrophic Scar (US) Currently in Phase2
Business development team
/Vice President OLX104C Androgenic Alopecia
T. +82-31-779-8407 OLX301A Dry & Wet AMD
E. hongsunwoo@olixpharma.com
OLX301D Subretinal Fibrosis

Overseas Office OLX301E Wet AMD


Jason choi OLX304A Retinitis Pigmentosa
Director
OLX701 Liver Fibrosis
E. jasonchoi@olixpharma.com
OLX702 Liver Disease (NASH, Diabetes etc.)

OLX703 HBV

OLX201A Idiopathic Pulmonary Fibrosis

OLX204A COVID-19

OLX401A Neuropathic Pain

OLX801A Cancer Immunotherapy

46
Information of Korean Innovative
Pharmaceutical Company
REGENERATIVE SCIENCE FOR A BETTER & LONGER LIFE

PharmaResearch Co., Ltd. www.pharmaresearch.co.kr/eng

PharmaResearch Co., LTd has been researching and developing healthcare products for anti-aging and improving
Quality of Life. In 2007, PharmaResearchProducts stood up as a leading regenerative medicine company by CEO
developing endogenous repair stimulator PDRN®
Ki-Seock Kang, Thin-Kyu Kim
Moreover, PharmaResearch Co., LTd diversified the product pipelines for regenerative medicine from on license-
in, co-developments to strategic investments. PharmaResearch Products is promoting market expansion in both Location
domestic and global. 77-19, Gwahakdanji-ro,
Gangneung-si, Gangwon-do, Korea
Main Products
Specialty
1. Regenerative and immuno-
stimulative medicine
2. Advanced medicine to improve
QOL(Quality of life)

Tel/Fax/E-mail
Re-an eye drop Rejuvenex Injcetion Rejuran Conjuran
T. +82-31-8039-1500
F. +82-31-8039-1501
Category Product name Use
Re-an eye drop Cornea and conjunctiva regenerative eye drop
Drug
Rejuvenex Injcetion Wound healing and tissue regenerative injection
New Regenerative Filler (Healer) for Satisfying both skin regeneration and
Rejuran filler effect
Medical Device
Conjuran Intra-articular injection for Cartilage regenerative osteoarthritis treatment

R&D Pipeline
Projects 2019 2020 2021 2022
Clinical Study
Tendinopathy IND Approval
(Phase 3)
Atopy medicines IND Clinical Study Approval

Dry eye syndromes Pre-review Approval


Clinical study
PXL01(Global) IND Approval in Europe
(Phase 3)
PXL01(Domestic) IND Clinical study Approval
Clinical study
LL-37 Licessing out
(Phase 2)
Non-Clinical Clinical Study
PDRN New Formulation IND Clinical Study
Study (Phase 3)
Non-Clinical Clinical Study Clinical Study
Zadaxin New Formulation IND
Study (Phase 1) (Phase 2)

47
Information of Korean Innovative
Pharmaceutical Company

Respected Company for curing obstinate disease and improving human health.

Pharmicell Co., Ltd. www.pharmicell.com/eng

Pharmicell Co., Ltd. is a biopharmaceutical company that developed the world's first stem cell therapy
CEO (Hearticellgram-AMI) in 2011. The company's business area divided into two sectors(bio and biochemical) as
below in detail.
Kim, Hyun Soo
First, in the bio business sector, stem cell therapy R&D and sales business for curing obstinate disease and
improving human health and stem cell storage business preparing for the outbreak of the disease. We are focusing
Location on bio-based construction business and cosmetic business based on stem cells.
7th floor, Ssangbong Building, 874 Second, the biochemical division develops and produces Raw Material Pharmaceutical Intermediates (Nucleoside
Unju-ro, Gangnam-gu, Seoul-si and mPEGs) needed for the development of new pharmaceuticals by global pharmaceutical companies.
Furthermore, we also provide Low Dielectric Constant Resin required for cutting edge network equipment such
Specialty as 5G network boards, base station antennas, and mobile devices. Now, we are diversifying our business by
1. Stem Cell Therapeutics producing Reactive and Additive Flame Retardants used in Printed Circuit Board (PCB) such as mobile and home
2. Next Generation Dendritic Cell appliances.
Therapeutic Vaccines Pharmicell Co., Ltd. will do its best to grow into a respected company for curing obstinate disease and improving
human health.
3. Raw Material Pharmaceutical
Intermediates
Main Products
Tel/Fax/E-mail
T. +82-2-3496-0114
F. +82-2-3496-0159
E. pmc@pharmicell.com

Product Use Exporting Remarks


(Ingredient/Formulation) Countries
Hearticellgram-AMI
(Autologous Bone Marrow-Derived Mesenchymal Stem Cell) Acute Myocardial Infarction - Launched
CONTACT US
Developing
Cellgram-LC
Technology Transfer/ Alcoholic Liver cirrhosis - (Clinical Trial, Phase II
(Autologous Bone Marrow-Derived Mesenchymal Stem Cell) completed)
Licensing/Overseas export/
Developing
Overseas Office/etc Cellgram-ED Erectile Dysfunction - (Clinical Trial, Phase I
(Autologous Bone Marrow-Derived Mesenchymal Stem Cell)
DongHuk Jang completed)
Planning & Coordination Dept./ AnticancerImmuncell Thera-
Cellgram-DC-PC Developing
(Autologous Dendritc Cell pulsed with prostate cancer antigen) peutic Vaccine for Prostate -
Manager (Clinical Trails)
Cancer.
T. +82-10-4056-5753 AnticancerImmuncell Thera-
E. dhjang@Pharmicell.com R&D Pipeline (출판용) Cellgram-DC-OC
(Autologous Dendritc Cell pulsed with ovarian cancer antigen) peutic Vaccine for Ovarian - Developing
(Clinical Trails)
Cancer.

R&D Pipeline

Cellgram®-AMI
It is the world first stem cell drug approved
by MFDS (The Ministry of Foods and Drug
Acute Myocardial Infarction Safety of Korea) in July 2011.

®-LC
Phase III clinical trial

Liver Cirrhosis (KR)

Liver Cirrhosis (US)


Phase 1 clinical trial

Erectile Dysfunction Phase 2 clinical trial

Chronic kidney disease Phase 1 clinical trial (planned)

Cancer Cellgram-DC

Prostate Cancer
Phase 1 clinical trial
Ovarian Cancer

48
Information of Korean Innovative
Pharmaceutical Company
Value Generating Pharma Company

Samyang Holdings Corporation www.samyangbiopharm.com/eng

(Biopharmaceuticals Business)
Samyang Holdings Corporation(Biopharmaceuticals Business) is specialized in development of small-molecule
drugs, new biologic drugs and virus vaccines, and commercialization of DDS-based modified drugs and first CEO
generics for cancer treatment. Samyang is exporting its oncology products and expanding its product portfolio.
Tae-Ung Eom
Samyang’s cytotoxic facility obtained GMP certifications from KR, EU, and JP. The new facility is expected
to achieve full cGMP operation. Samyang Biopharm USA Inc. in Cambridge concentrates on global new drug
development in immune-oncology and rare diseases. Location
295, Pangyo-ro, Bundang-gu,
Main Products Seongnam-si, Gyeonggi-do, Republic
FDF Product Formulation Strength Specifications
of Korea
Polymeric Genexol® PM Lyophilized Injection 30mg, 100mg/vial In-house
Micelle Nanoxel® M Lyophilized Injection 20mg, 80mg/vial In-house Specialty
Paclitaxel Liquid Injection 30mg, 100mg, 150mg, 300mg/vial USP, EP 1. Drug delivery system of anti-cancer
Docetaxel Liquid Injection 20mg, 80mg, 140mg, 160mg/vial EP
drugs based on small molecules,
Oxaliplatin Liquid Injection 50mg, 100mg, 200mg/vial EP, JP
Generics for Gemcitabine Liquid Injection 200mg, 1g/vial USP virus and nucleic acid
Solid Tumors Liquid Injection 1g/vial In-house 2. New biologic anticancer drugs and
Pemetrexed Liquid Injection 100mg, 500mg/vial In-house Rare disease drugs
Lyophilized Injection 100mg, 500mg/vial In-house 3. Cytotoxic anticancer drugs
Everolimus Oral Tablet 2.5mg, 5mg, 10mg/tab In-house
Azacitidine Lyophilized Injection 100mg, 150mg/vial In-house 4. Small molecule anticancer drugs
Decitabine Liquid Injection 40mg, 50mg/vial In-house
Generics for Bortezomib Lyophilized Injection 2.5mg, 3.5mg/vial In-house Tel/Fax/E-mail
Blood Cancers
Bendamustine Liquid Injection 25mg, 100mg/vial USP
T. +82-2-2157-9808
Lenalidomide Oral Tablet 2.5mg, 5mg, 10mg, 15mg, 20mg, 25 mg/tab KP
Generis for Palonosetron Liquid Injection 0.075mg, 0.25mg, 0.4mg/vial KP F. +82-2-2157-9062
Supportive Care Zoledronic Acid Liquid Injection 4mg/vial KP E. jinwoo.kim11@samyang.com
Diclofenac Plaster 120mg BP
Patch 14mg, 28mg, 42mg EP
Nicotine
Gum 2mg USP
Transdermal Drug Fentanyl Patch 12㎍, 25㎍, 50㎍, 100㎍/h EP CONTACT US
Delivery System
Rivastigmine Patch 6mg(4.6mg/24hr), 12mg(9.5mg/24hr) EP
Tulobuterol Patch 0.5mg, 1mg, 2mg In-house Technology Transfer/
Nitroglycerin Patch 22.4mg(0.2mg/hr) USP Licensing
Choi Hyang
API Product Package DMF R&D Planning/Manager
Paclitaxel Up to 500 g US DMF, CEP, KDMF
T. +82-2-2157-9814
Docetaxel Up to 500 g US DMF, CEP, KDMF
Cytotoxic APIs Pemetrexed Up to 500 g KDMF E. hyang.choi@samyang.com
Bortezomib Up to 500 g KDMF
Cabazitaxel Up to 500 g - Overseas export
Seo Yoon Cheong
R&D Pipeline Overseas Business Team/
Assistant Manager
Technology Research Clinical Registration
T. +82-2-2157-9867
Paclitaxel E. seoyooon.cheong@samyang.com
PM Docetaxel
SYP-1261 Overseas Office
SYP-0709 Seyoon Kim
PNP
SYP-0709S BD/Senior Manager
SEMP SYO-1906 T. +1-617-812-6969
FDT Ramosetron E. seyoon.kim@samyang.com
CSDS Prednisolone
Administration
SYP-1758
Jin Woo Kim
SENS SYP-1765
Biopharm. Planning Team
SYP-1914
T. +82-2-2157-9808
Metabolic Anticancer SYO-2001 E. jinwoo.kim11@samyang.com

49
Information of Korean Innovative
Pharmaceutical Company

We never compromise on quality of drugs to create a healthy and desease - free society

SHIN POONG PHARM. CO., LTD. www.shinpoong.co.kr/en/main/main.php

Shin Poong Pharm. Co., Ltd. is a R&D oriented pharmaceutical company with global presence in over 50 countries,
CEO and specializes in one-stop manufacturing from API to FPP from quality generics to NCE development. Under the
management philosophy of “for the health of the People”, an EMA-approved new anti-malarial is well-exemplified,
Jei Man, Ryu
Pyramax®. Shin Poong Pharm.Co.,Ltd. is sustaining its efforts to fulfill the corporate goals of developing cutting-
edge technologies for public health of our people.
Location
161, Yeoksam-ro, Gangnam-gu, Seoul, Main Products
06246, Republic of Korea

Specialty
1. Synthesis of antibiotic raw
materials and dedicated production
line
2. New drug and first generic drug in
finished products
3. API

Tel/Fax/E-mail
T. +82-2-2189-3400
F. +82-2-553-2578
Classification Name Active Ingredient Indication
E. sptrade@shinpoong.co.kr
Pyronaridine tetraphosphate
Pyramax® Tablets Malaria
& Artesunate
NCE
Pyronaridine tetraphosphate Malaria
Pyramax® Granules & Artesunate (Pediatric formulation)
CandeAmlo® Tablets Amlodipine & Candesartan Hypertension
IMD/FDC
CONTACT US ®
EzeRosu Tablets Rosuvastatin & Ezetimibe Hyperlipidemia
Technology Transfer/ Generic ®
Hyalforte Injection Sodium hyaluronate Osteoarthritis
Licensing
※ NCE (New Chemical Entity), FDC (Fixed Dose Combination), IMD (Incrementally Modified Drug)
Tae Hoon Kim
BD/Senior Manager
T. +82-2-2189-3483
R&D Pipeline
E. thkim1@shinpoong.co.kr Classification Products Indication Stage
SP-8203 Acute ischemic stroke Phase 2b (Korea) On-going
Overseas export
SP-8008 Anti-platelet Phase 1(Europe) On-going
John H, Won
Global Marketing & BD Team/Chief SP-8356 Cerebro-cardiovascular diseases Phase 1(Europe) On-going
Manager
NCE SP-8416 Heart failure Lead compound (Korea) On-going
T. +82-2-2189-3511
Osteoarthritis
E. wonjh@shinpoong.co.kr SP5M001 (Long-lasting) Phase 3 IND (Korea) Completed
Osteoarthritis
SP5M002 Phase 1/2 IND (Korea) On-going
Overseas Office (Rapid pain relief)
Osteoarthritis
Sung Je, Chu SP1M002 (Anti-inflammatory) Non-clinical (Korea) On-going
Global Branch Mgt. Team/Chief
IMD SPC1001 Hypertension Phase 2 IND (Korea) On-going
Manager
®
Drug Pyramax Phase 2 (Korea, South Africa)
T. +82-2-2189-3510 repositioning tablets COVID-19 Phase 2/3 (The Philippines) On-going
E. chu@shinpoong.co.kr

50
Information of Korean Innovative
Pharmaceutical Company
Global leading Solution Provider in ECO-friendly material and Total Healthcare

SK chemicals Co., Ltd. https://www.skchemicals.com

Beginning with "Sunpla“, the nation's first self-developed drug that opened a new chapter in Korea’s synthetic
drug business, SK Chemical has since continued to launch new drugs such as "Mvix"(for erectile dysfunction) and CEO
"Joins"(the nation's first natural medicine), establishing a sizable product portfolio. In addition, SK Chemical has
Kwanghyun Jeon
marketed a variety of drugs including "Trast"(the world's first patch for arthritis), "Ginexin"(No.1 market share drug
for improving blood circulation), and ”Rinexin“(platelet aggregation inhibitor).
Location
Main Products 310, Pangyo-ro, Bundang-gu,
Seongnam-si, Gyeonggi-do, Korea

Specialty
1. Arthritis drug (the nation’s first
natural medicine)
R&D Pipeline 2. Blood circulation improvement drug
(natural medicine)
Indication Product Product type
3. Patch formulation arthritis drug
Arthritis Joins Natural Medicine
(Incrementally modified drug)
Erectile Dysfunction MVIX Chemical Drug
Blood circulation Ginexin Natural Medicine Tel/Fax/E-mail
blood aggregation inhibitor Rinexin Natural Medicine T. +82-2-2008-2149
Anti inflammatory analgesic Trast Patch Chemical Drug F. +82-2-2008-2329
E. jeeho.heo@sk.com
R&D Pipeline
TA Project indication Discovery Preclinical Phase Ⅰ Phase Ⅱ Phase Ⅲ launch
CNS SID710 dementia FDA approval
CNS SID1606 Parkinson Disease
CONTACT US
CV SID1901 hypertension
Technology Transfer/
CV SID1902 hypertension Licensing/Overseas export
Peripheral Artery Jeonghyun Moon
CV SID142 Disease Licensing & Development Team/Team
SID1806 leader
RA T. +82-2-2008-2551
Rheumatology SKR201 (Rheumatoid Arthri-
tis) E. mjh@sk.com
SKR202

SKR203

SKR204
NASH
Metabolic NCE201 alcoholic(Non-
disease Steatohep-
atitis)
NCE202

NCE204
CNS SKP161 Parkinson Disease
Neurology SKP191 insomnia
MFDS
Rheumatology SKP201 RA approval
MFDS
CV SKP203 hyperlipidemia approval
amyotrophic lateral MSDS approval
CNS SKP204 scerlosis (on-going)

51
Information of Korean Innovative
Pharmaceutical Company

VISION - To Be a Global Healthcare Player by Establishing Distinctive


Competencies in Each Business Area

ST PHARM Co., Ltd. www.stpharm.co.kr

cGMP compliant ST Pharm is providing top manufacturing services to satisfy our customers’ high expectations to
CEO use our products in pharmaceutical industry.
As a member of Dong-A Socio Holdings, ST Pharm is proactively investing our manufacturing equipments to
Kyungjin Kim
provide cutting edge services which are comprehensive and matching to the fast phased global market.
ST Pharm will continually challenge ourselves to prosper as not only a leading pharmaceutica l company but also a
Location global chemical company.
231, Hyeomnyeok-ro, Siheung-si,
Gyeonggi-do, 15086 Korea Main Products
Category Products Customer Indication/Stage
Specialty
Oligo APIs and New Drug HCV drug Originator (Global) HCV/Marketed
Development, CMO(New Drug APIs & Diabetes drug Originator (Global) Diabetes/Marketed
Intermediates), Generic APIs
New Drug APIs Antibiotics drug Originator (Global) Antibiotics/Marketed
Tel/Fax/E-mail Gastric Cancer Originator (Global) Gastric Cancer / Phase 3
T. +82-31-310-1270 Mitochondrial DNA Originator (Global) MDDs/Phase 3
F. +82-31-310-1200 Depletion Syndrome
E. ywshin@stpharm.co.kr Chiral epoxide Originator (Global) HIV/Marketed
Pharmaceutical Chloro-(L)-sugar Originator (Global) HBV/Marketed
Intermediates
Nucleoside monomers US/EP/JP Various RNA therapeutics/Clinical

Atorvastatin Domestic/JP Hyperlipidemia/Marketed

Clopidogrel Domestic Anticoagulant/Marketed

APIs d-Cycloserine Domestic/JP/WHO/ROW Tuberculosis/Marketed


CONTACT US
Terizidone S.Africa/Germany/CIS Tuberculosis/Marketed
Technology Transfer /
Gadobutrol Domestic/EU/CIS MRI contract/Marketed
Licensing
Seohyun Ahn
New Drug Development R&D Pipeline
T. +82-2-527-6331
Category Project (Indications) Stage (on going)
E. seohyun.ahn@stpharm.co.kr
STP1002 (cancer) Phase I
Domestic Sales STP0404 (HIV ALLINI) Phase I
Dong-Soo Lee
STP3725 (Anticoagulants) Preclinical
Generic APIs New Drug
T. +82-2-527-6364 NASH Discovery
E. dslee01@stpharm.co.kr IBD Discovery

Influenza Discovery
Overseas Sales
Kris S. Choi
Marketing & Business Development/
Bio Division
T. +82-2-527-6329
E. choicsw@stpharm.co.kr

52
Information of Korean Innovative
Pharmaceutical Company
For Happiness of Humanity and Respect for Life

Taejoon Pharmaceutical Co., Ltd. www.taejoon.co.kr/en

Established in 1978, Taejoon Pharmaceutical Co., Ltd. ("Taejoon") is one of the leading specialty pharmaceutical
companies in ophthalmology, radiology, and GI. With a vision to become the best global pharmaceutical company CEO
in the specialized area, Taejoon has been building up company’s future growth by focusing its corporate resources;
Tae Young Lee
specialization, global marketing, and R&D innovation. In particular, Taejoon has acquired US and EU GMP
certifications to secure global competitiveness and maintains state-of-the-art manufacturing facilities.
Location
8 Daesagwan-ro 31 gil, Yongsan-gu,
Main Products Seoul, Republic of Korea

Product (Ingredient/Formulation) Use Exporting Countries Remarks


Specialty
Cyporin N Eye Drop 0.05% (Cyclosporin) Dry eye Launched 1. Ophthalmic IMD
2. Contrast media IMD
Xalost-S Ophthalmic Solution (Latanoprost) Glaucoma Launched 3. GI IMD
EU, China, Nigeria,
Xalost Ophthalmic Solution (Latanoprost) Glaucoma Launched
Indonesia Tel/Fax/E-mail
Xalostplus Ophthalmic Solution T. +82-2-798-6601
Glaucoma EU, Hong Kong Launched
(Latanoprost, Timolol maleate)
Contrast enhancement of cranial F. +82-2-798-6608
Gadobirx Pre-filled Syringe Injection (Gadobutrol) Launched
and spinal MRI
Iobrix INJ 240/300/350 (Iohexol) Contrast enhancement Thailand, Philippines Launched

CleanViewAL Powder (Polyethylene glycol3350) Bowel cleansing Launched

R&D Pipeline
Development process
Category Project Indication
Discovery Preclinical PhaseⅠ PhaseⅡ PhaseⅢ Launch CONTACT US
IMD Undecided Eye disease Technology Transfer/
Licensing
IMD Undecided Eye disease Jun Hee Lee
Business Development/
IMD Undecided Eye disease
Director
IMD Undecided Gastrointestinal T. +82-2-799-0072
disease
E. jhlee2@taejoon.co.kr
Gastrointestinal
IMD Undecided disease
Overseas export
Ga Ram Choi
Business Development/
Assistant Manager
T. +82-2-799-0164
E. grchoi@taejoon.co.kr

53
Information of Korean Innovative
Pharmaceutical Company

WORLD LEADER IN CELL THERAPY

Tego Science, Inc. www.tegoscience.com/kor/main.do

A World Leader in Cell Therapy & Advanced Regenerative Medicine


CEO Tego Science is a Seoul-based biopharmaceutical company specializing in regenerative skin cell therapy for wound
Saewha Jeon healing. Tego’s chief strengths have been leading-edge technologies in cell culture, skin-graft manufacturing
and cryopreservation. It is now evolving into wider regenerative medicine areas involving musculo-skeletal,
ophtalmological and dematological targets, with plans for overseas expansion. Tego Science has been listed in
Location
KOSDAQ since 2014.
93, Magokjungang 8-ro, Gangseo-Gu,
Seoul 07794, Korea
Main Products
Specialty
1. Dematological cell therapy
2. Musculo-skeletal cell therapy
3. Ophtamological cell therapy

Tel/Fax/E-mail
T. +82-2-818-2900
F. +82-2-2107-3173 Holoderm® Kaloderm®
E. swbaek@tegoscience.com

R&D Pipeline

Rosmir® Neoderm®
CONTACT US 초기 비 임상
제품/성분명 적응증 NDA
연구 임상
Technology Transfer/ Product(Ingredient/Formulation) Use Exporting Countries(E)
Ⅰ Ⅱ ⅢRemark
Licensing/Overseas export/ TPX-114 / 자기유래
® 배양섬유아세포 회전근개 전층 파열
Holoderm (Autologous Keratinocytes) 3rd degree burn - Launched
Overseas Office/etc TPX-115 / 동종유래 배양섬유아세포 회전근개 부분층 파열
Seungwun Baek ® Deep 2rd degree burn, Diabet-
Kaloderm
TPX-113 (Allogenic
/ 자기/동종유래 배양점막Keratinocytes) 구강점막결손 Mongolia, Indonesia Launched
ic Foot Ulcer
Business Development/Team TPX-107 / 자기유래
® 배양각막 각막이식 연구자 임상
Rosmir (Autologous Fibroblasts) Wrinkles Vietnam Launched
Manager TPX-108 / 케모카인을 이용한 상처치유용 드레싱제 피부상처
T. +82-2-818-2900 Neoderm 이용한
TPX-109/ 케모카인을
®
(3D Human Skin) 드레싱제
상처치유용 Replacing
연골재생 animal testing Japan Launched
E. swbaek@tegoscience.com * Arrows indicate current progress with MFDS.
R&D Pipeline

Pre- Clinical Trial


Project / Cell & Protein therapy Indications Discovery NDA
Clinical Ⅰ Ⅱ Ⅲ
TPX-114 / Dermal fibroblasts (auto) Full-thickness rotator-cuff tear

TPX-115 / Dermal fibroblasts (allo) Partial-thickness rotator-cuff tear

TPX-113 / Keratinocytes(auto/allo) Oral mucosal defects

TPX-107 / Mucosal keratinocytes (auto) Cutaneous wounds Investigator Initiated Trial (IIT)

TPX-108 / Chemokine Cartilage defects

TPX-109/ Chemokine Rotator-cuff tear

* Arrows indicate current progress with MFDS.

54
Information of Korean Innovative
Pharmaceutical Company
Great Yuhan, Global Yuhan

Yuhan Corporation eng.yuhan.co.kr

Yuhan Corporation continues to focus on innovation through breakthrough therapy R&D, new business
opportunities and global network-building initiatives to grow into a leading global pharmaceutical company. CEO
Yuhan’s priority lies on targeting cancer, metabolic diseases and CNS diseases. Currently, our R&D pipeline
Wook Je Cho
consists of 30 new drugs and 22 incrementally modified drugs (IMDs). In pursuit of breakthrough therapies, we
are developing 15 oncology programs including immunotherapies and next-generation targeted drugs to fight
against cancer and the best example is the newly launched Leclaza® (Lazertinib). Yuhan has incorporated an Location
IMD-developer AddPharma in 2017, which is expected to launch range of new products and contribute to the 74, Noryangjin-ro, Daebang-dong,
overall sales and profit growth. Within recent years, Yuhan signed out-license deals on disc degenerative disease Dongjak-gu, Seoul, Korea
treatment molecule with Spine Biopharma (2018), lazertinib with Janssen (2018), two NASH treatment programs
with Gilead (2019), another NASH program with Boehringer Ingelheim (2019), and a GI mobility disorder treatment Specialty
molecule with Processa Pharmaceuticals (2020). These five major deals add to total of KRW 4.0 trillion in value, 1. Chemical/Biologics New drug
repositioning us as a R&D-driven pharmaceutical company with the ultimate goal of developing standard of care 2. Incrementally Modified Drugs
treatment on a global level.
Tel/Fax/E-mail
Main Products
T. +82-2-828-0181
Products Ingredients Indications Exporting Countries
F. +82-2-828-0300
Gastric ulcer, Improvement of
Rebamipide SR Tablet Rebamipide 150mg Gastric mucosal lesion
Esomeprazole Combination Esomeprazole, Precipitated Calci- Gastroesophageal Reflux Dis-
Tablet um Carbonate ease, Antacid
Pregabalin SR Tablet Pregabalin Neuropathic pain
Telmisartan, Treatment for hypertension and
Duowell Tablet Uzbekistan
Rosuvastatin hyperlipidemia
Treatment for hypertension and
Rosuampine Tablet Amlodipine, Rosuvastatin hyperlipidemia
Rosumet SR Tablet Metformin SR, Rosuvastatin Antidiabetic
Treatment for respiratory distress Vietnam, Mongolia, Bolivia
Newfactan Bovine Lung Surfactant syndrome of newborns CONTACT US
Amoxicillin, Clavulanate Potassi-
Yucla Tablet Antibiotics Technology Transfer/
um
Almagate Suspension Almagate Antiacidic functions Licensing
Antiphlamine S Lotion Methyl Salicylate, L-menthol Anti-inflammatory agent Vietnam, Malaysia
Josephine Cho
Sodium alginate, Calcium
Licensing team/Team manager
Willogel Double Action Suspen- Alleviation of heartburn and T. +82-2-828-0093
carbonate,
sion indigest
Sodium bicarbonate
E. josephine@yuhan.co.kr
Nasal symptoms of allergic
Nazacare Nasal Spray Solution Momethasone Furoate rhinitis, Nasal polyps, Acute
rhinosinusitis Overseas export
R&D 파이프라인_영문 Seungdoug park
R&D Pipeline Overseas Business/Team manager
Discovery Lead
Preclinical
Phase 1 Phase 2 Phase 3
T. +82-2-828-0191
study
E. dougpark@yuhan.co.kr
YHC2118 (IO) YHC1108 (NASH) YHC1102 (NASH) YH25724 (NASH) YH14618 (DDD) LECLAZA (NSCLC)

YHC2115 (IO) YH34160 (Obesity) YH24931 (IO) YH35324 (CSU) YH12852 (FGID)

YHC2119 (IO) YHC1116 (Gaucher) YH29143 (IO)

YHC2122 (IO) YHC1104 (NSCLC) YH32367 (IO)

YHC2124 (IO) YHC1103 (IO)


IO : Immuno-oncology
YHC1128 (IO) YHC2120 (IO) CNS : Central nerve system
YHC1125 (CNS) YHC2126 (CNS) NASH : Non-alcoholic steatohepatitis
NSCLC : Non-small cell lung cancer
YHC2127 (CNS)
CSU : Chronic spontaneous urticaria
YHC2129 (Obesity) DDD : Degenerative disk disease
FGID : Functional gastrointestinal disorder
YHC1131 (NASH)

YHC1131 (NASH)

Copyright ⓒ 2021 by YUHAN. All rights 3


55
reserved.
Information of Korean Innovative
Pharmaceutical Company

The medicine for your life

Yungjin Pharm. Co., Ltd. eng.yungjin.co.kr

Since its establishment in 1952, YUNGJIN PHARM. CO., LTD. has been a pioneer in the Korean domestic
CEO pharmaceutical industry for national economic development and improving public health with the lofty mission
of saving humanity from disease and suffering through our medicines. As an affiliate of KT&G Group, YUNGJIN
Chae Joon, Lee
plays a pivotal role in the bio/pharmaceutical business within the group with outstanding drug production and
R&D know-how, and has grown into a global pharmaceutical company by developing new products and expanding
Location exports.
13, Olympic-ro 35da-gil, Songpa-gu,
Seoul, 05510, Korea Main Products
Product(Ingredient/Formulation) Use Exporting Remarks
Specialty Countries
1. NCE (Targeted cancer therapy, Cefcapene Pivoxil(Cefcapene Pivoxil) Bacterial infections Worldwide API, Tab., Fine Granule
Cancer immunotherapy, Rare Cefditoren Pivoxil(Cefditoren Pivoxil) Bacterial infections Worldwide API, Tab., Fine Granule
disease) Cefmetazole(Cefmetazole Sodium) Bacterial infections Worldwide API, Inj.
2. IMD & Generic (Cephalosporins, Cefotiam (Cefotiam HCl/HCl+Na2CO3) Bacterial infections Worldwide API, Inj.
Antipyretic-analgesics & Anti- Ceftizoxime(Ceftizoxime Sodium) Bacterial infections Worldwide API, Inj.
inflammatory, CNS, Rare disease) Ceftriaxone inj.(Ceftriaxone sodium) Bacterial infections Worldwide Inj.
3. API (Cephalosporins, Anti- Ceftazidime inj.(Ceftazidime hydrate) Bacterial infections Asia Inj.
hypertension, Anti-inflammatory, Cefpodoxime Proxetil(Cefpodoxime Proxetil) Bacterial infections Asia API, Tab, Dry Syrup
Analgesic) Cefdinir(Cefdinir) Bacterial infections Asia API, Tab, Fine Granule
Linezolin tablet (Linezolid) Bacterial infections Asia Tab
Meicelin injection (Cefminox sodium hydrate) Bacterial infections Inj.
Tel/Fax/E-mail
UK kit injection (Cefmetazole sodium / Cefotiam HCl / Cefo-
T. +82-2-2041-8200 tetan sodium / Cefoperazone sodium, Sulbactam sodium / Bacterial infections Inj.
F. +82-2-2041-8201 Ceftriaxone sodium / Vancomycin / Teicoplanin)
Opast tablet (Limaprost alfadex) lumbar spinal canal stenosis Asia Tab
Omaron soft capsule (Omega-3 acids ethyl esters 90) Hypertriglyceridemia soft capsule
Candesartan Cilexetil (Candesartan Cilexetil) Hypertension Asia API
CONTACT US Denogan injection (Propacetamol HCl) Pain, fever Inj.
Loxoprofen(Loxoprofen) Anti-inflammatory, Analgesic Worldwide API
Technology Transfer/
Licensing Fybro tablet (Pirfenidone) Idiopathic pulmonary fibrosis Tab
Pancron tablet
Yeonhee Pi Indigestion Tab
(Dimethicone, hemicellulose, ox bile extract, pancreatin)
BD&Licensing Division/Director Gastroesophageal reflux
Panprazol tablet (Pantoprazole) Tab
T. +82-2-2041-8226 disease, gastric duodenal ulcer
Baroscon double action suspension
E. yeonheepi@yungjin.co.kr (Sodium alginate, sodium bicarbonate, calcium carbonate) Indigestion Asia Oral liquids
Talimin tablet (Bepotastine nicotinate) Rhinitis, urticaria, itching Tab
Overseas export Hamonilan solution Enteral nutrition Solution
Sunyoung Jung (Protein, fat, carbohydrate, vitamin, mineral, fiber)

BD&Licensing division/Manager
T. +82-2-2041-8227 R&D Pipeline
E. syjung@yungjin.co.kr Therapeutic Development Phase
Project Area Target
Research Nonclinical Phase I Phase II Phase III Marketed
Overseas Office Metabolic
KL1333 Mitochondrial
Yunhee, Kim Disorder
Global Business Department/ YPN-005 Oncology CDK7
Assistant Manager YPN-006 Oncology Novel Target
T. +82-2-2041-8246
E. yunhee.kim@yungjin.co.kr YPN-007 CNS Novel Target

YPN-008 Oncology Novel Target

56
Supplement

1. Products Expected to Export


2. Technology Transfer
3. Certifications from Health Authorities
1. Product Expected to Export
Expected
Supplement

company Product name Active Ingredient Indication Category Country note


ALT-B4 Hyaluronidase IVF Media Worldwide
Alteogen
ALT-L9 Aflibercept wetAMD Injection Worldwide
Prescription
Mepem inj. 500mg Meropenem Antibiotics Global
Medicine
Prescription
Mepem inj. 1g Meropenem Antibiotics Global
Medicine
Prescription
Sinraci inj. 500mg Imipenem/Cilastatin sodium Antibiotics Global
Medicine
Prescription
Ertapenem inj. Ertapenem inj. Antibiotics Global
Medicine
Prescription
BCWORLD Merogel Metronidazole Antibiotics Global
Medicine
PHARM. CO.,
LTD. Prescription
Quprin inj. Norepinephrine Cardiac stimulant Global
Medicine
Prescription
Fentanyl inj. Fentanyl Narcotics Global
Medicine
Prescription
Sufentanil inj. Sufentail Narcotics Global
Medicine
Prescription
Guthione inj. Glutathione Well-being product Global
Medicine
Zn, Cu, Se, Cr, Mn, F, Fe, I, Prescription
Multipotent inj. Well-being product Global
Mo Medicine
worldwide
Hitox Botulinum toxin improvement of facial wrinkles vial (including USA,
EU)
1) Edema, Pain reduction 1) Japan, Asia
BMI Korea Hirax Hyaluronidase 2) Enhance drug permeation vial 2) EU, USA
by subcutaneous injection
1) * MRCC
Hileukin Interleukin-2 2) Media ingredient for cell therapy drug vial 2) Japan, China
development
Prescription
Kanarb® Fimasartan Hypertension Medicine
Kanarb Prescription
Fimasartan with HCTZ Hypertension CHINA, BRAZIL,
Plus® Medicine
PERU, ECUADOR,
Prescription MENA, CIS
Dukarb® Fimasartan with Amlodipine Hypertension Medicine
Fimasartan with Prescription
Tuvero® Hypertension/Dyslipidemia
Boryung Phar- Rosuvastatin Medicine
maceutical Prescription MENA, LATAM,
co.,Ltd. Alimxid Inj. Pemetrexed Antineoplastic Medicine ASIA, CIS
Prescription MENA, LATAM,
Velkin Inj. Bortezomib Antineoplastic Medicine ASIA, CIS
Prescription MENA, LATAM,
Oxalitin Inj. Oxaliplatin Antineoplastic Medicine ASIA, CIS
HONGKONG
Colloidal Aluminum Phos- Hyperchlorhydria Non-Prescription
Gelfos M® THAILAND
phate Heartburn Medicine INDONESIA
Agreement
Bukwang R-thioctic acid trometh- Prescription reached in
Pharmaceuti- Dexid® tab. Diabetic peripheral neuropathy Worldwide
amine Medicine Southeast
cal Co., Ltd. Asia
RheumatoidArthritis, Ankylsoing Spondy-
Remsima SC Infliximab litis, Ulcerative Colitis, Crohn's Disease, Biobetter Global
Psoriasis, psoriatic arthritis
RheumatoidArthritis, Ankylsoing Spondy-
Remsima Infliximab litis, Ulcerative Colitis, Crohn's Disease, Biosimilar Global
Celltrion Psoriasis, psoriatic arthritis
Non-Hodgkin's Lymphoma, Chronic-
Lymphocytic Leukemia, Rheumatoid
Truxima Rituximab Biosimilar Global
Arthritis,Granulomatosis with Polyangii-
tis, Microscopic Polyangiitis

58
Expected

Supplement
company Product name Active Ingredient Indication Category Country note

HER2-Positive Metastatic BreastCancer,


Herzuma Trastuzumab Early Breast Cancer, Metastatic Gastric Biosimilar Global
Cancer
Yuflyma Adalimumab Rheumatoid Arthritis ,IBD, Lymphoma Biosimilar Global
AIDS (Acquired ImmuneDeficiency
Celltrion Temyxis Lamivudine, Tenofovir IMD Global
Syndrome)
Pneumonia, Skin and SkinStructure Infec-
Linezolid linezolid tions, Vancomycin-resistant Enterococcus Generic Global
faeciumInfections
DiaTrust - COVID-19 IVD Test Kit Global
NCE(New Chemi- Korea's 20th
Duvie Tab. Lobeglitazone sulfate Type 2 diabetes ASEAN
cal Entity) new drug
The world's
first NESP
1. Anemia associated with chronic renal Biologic drug / biosimilar
Nesbell PFS Inj. Darbepoetin-α failure 2nd generation ASEAN and the
2. Anemia by cancer chemotherapy EPO Biosimilar first bio
medicine of
CKD Pharma- CKD
ceutical Corp.
Pemetrexed disodium 2.5 1. Non-small cell lung cancer Chemical generic
Pemecine liquid Inj. US, Europe
hydrate 2. Malignant pleural mesothelioma drug
The world's
first and
IMD
Esoduo Omeprazole only
Gastroesophageal reflux disease (GERD) (Incrementally US, Europe
Tab. +Sodium bicarbonate IR-Esome-
Modified Drug) prazole
as an IMD
MFDS
Autologous bone marrow Approval
Corestem ® Amyotrophic lateral sclerosis (ALS,L Lou Stem cell Thera-
Neuronata-R derived mesenchymal stem Global (2014.07)
Inc. Gehrig’s disease) py product
cell Release
(2015.01)
Worldwide
CrystalGe- (Except Turkey,
Acelex 2mg Polmacoxib Osteoarthritis Small molecule
nomics, Inc. MENA, Brazil,
EAEU countries)
Advanced and metastatic or local recur-
Liporaxel sol’n Paclitaxel rent gastric cancer and breast cancer IMD Global
(phase III ongoing)
Mild to moderately serve dementia of the
Rivamensa patch Rivastigmine Alzheimer type dementia associated with Generic Global
Parkinson’s disease
Daehwa Phar- External analgesics: Traumatic inflam-
maceutical Loxona plaster & Loxoprofen sodium mation of muscles, strains and sprains. Generic Global
Co., Ltd. cataplasma Relief of symptoms of muscular pain.
Antispasmodic: Renal and urinary colic
Flospan tab. & sol’n Phloroglucinol hepatic, gall bladder and spasmodic colic, Generic Global
intestinal colic and dysentery syndrome
Gastric and duodenal ulcer, acute gastri-
Gastric cap. Roxatidine acetate HCl Generic Global
tis, relapse period of chronic gastritis
Pelubi CR pelubiprofen Osteoarthritis, Rheumatoid, Back pain, Originatior Global

Daewon Freefol MCT Propofol Anesthesia Generic Global


Pharm.Co.,Ltd. Renamezin oral adsorptive charcoal chronic renal failure Generic Global
TG-fenon Choline fenofibrate Hypertriglyceridemia IMD Global
FEXUCLUE Fexuprazan Anti-Peptic Ulcer Originator Brazil, Mexico
US, Canada,
Daewoong MENA, LATAM,
Pharmaceuti- Nabota Botulinum toxin Glabella lines Originator EU, ASIA, Austra-
cal lia, Philippines,
Thailand
TBD Enavogliflozin Type 2 Diabetes Originator

59
Expected
Supplement

company Product name Active Ingredient Indication Category Country note

Mexico,
Bolivia, Ecuador,
Concomitant hypertension and dyslipid- Central America,
Olostar Olmesartan/Rosuvastatin Originator
emia Malaysia, USA,
Canada, Australia,
Jordan, Iraq
Ecuador
Bolivia, CIS,
Recombinant human Epider- SriLanka, Jordan,
Easyef Diabetic foot ulcer Originator
mal Growth Factor Iraq, Myanmar,
Philippines,
Thailand
Bolivia
CIS
Daewoong Malaysia
Pharmaceuti- Ecuador, Sin-
cal Cholestasis (including PBC, PSC), viral
Ursa Ursodeoxycholic acid Originator gapore, Brunei,
hepatitis C, gallstone Philippines, China,
Vietnam, Cambo-
dia, Jordan, Iraq,
Myanmar
Indonesia, Thai-
Recombinant human Eryth- Anemia in end stage renal disease (ESRD) land, Philippines,
Eposis Biosimilar
ropoietin α Vietnam, Myan-
mar
Prostate cancer, endometriosis, uterine Japan, Malaysia,
Luphere Leuprorelin Acetate fibroid, postmenopausal breast cancer, Generic Russia, Philippines
central precocious puberty
UAE, Jordan,
COVIBLOCK Camostat Mesilate COVID19 Generic Egypt, Kuwait
Hydrous Benzoyl Peroxide Local treatment of acne, pustule, come- Mongolia, Iran,
AC Cure MLE Gel Dermatology
33.3mg, Adapalene done in age 9yrs+ Azerbaijan
Cernitin T60,
Cernilton Tablet BPH, CP/CPPS Urology Taiwan, Mongolia
Cernitin GBX 3mg
Heparos Soft Cap- L-cystine 250mg, Choline Supportive treatment of liver disease, Endocrine Vietnam
sule Bitrartate 250mg fatty liver
Prevention and
DongKoo inhibition of lactation Uzbekistan,
Bio&Pharma Caverlactine Tablet Cabergoline 0.5mg Endocrine
Treatment of Georgia
hyperprolactinemia
Plastic Surgery, Russia(Europe),
Treatment for Diabetic Foot Ulcer, Sys-
SmartX SVF Isolation Kit Aesthetics, Turkey, USA,
temic sclerosis, and Fat engraftment Chrinic diseases Middle east
Vietnam, Hong-
Anti-aging, Brightening, and Regerating
CELL BLOOM Stemcell, 8-Peptide Cosmeceuticals kong, Europe,
skin USA, Middle east
26 countries incl.
Pofol Injection Propofol General anesthetic, sedation Generic Japan, Brazil,
UAE, Thailand
Endometriosis, prostate cancer, premeno- 9 countries incl.
Lorelin Depot Injec- Leuprolide acetate pausal breast cancer, central puberty Generic Mexico,
tion puberty Uruguay Iran
Improvement of limb ulcer and resting
Alostin Injection Alprostadil pain in chronic arterial obstruction (Burg- Generic Japan
Dongkook er's disease, obstructive arteriosclerosis)
Pharmaceuti-
cal Octrin LAR Injection Octreotide acetate Acromegaly, endocrine tumors Generic Peru
Japan, Mongolia,
Teicon Injection Teicoplanin Antibiotics Generic Syeria
Bellast Hyaluronic acid Wrinkle reduction Generic Vietnam etc
Hyaron inection Sodium hyaluronate Osteoarthritis of the knee joint Generic Vietnam, etc
13 countries icl.
Teicoplanin (API) Teicoplanin Antibiotics Generic Japan, Spain,
Brazil, India

60
Expected

Supplement
company Product name Active Ingredient Indication Category Country note
Zabolante Zabofloxacin AE COPD NCE MX
Whal Myung Su Gambir, Ginger etc. Anorexia, Indigestion etc. OTC US, AU, PH
Myrrh, Rhatany,
DONGWHA Each Paste Gum treatment/Toothpaste OTC
Chamomile
PHARM
Pancold Acetaminophen etc. Relief of common cold symptoms OTC
- Ambroxol Hydrochloride Mucolytic agent API JP, ID, MX, PH
- Levosulpiride Antiemetic agent API ES, VN
HongKong,
Vietnam, Peru,
Bacterocin Oint. Mupirocin Topical antibacterial treatment Oinment Philippines,
Mongolia
Calcipotriol Monohydrate
Calmio Ointment & HongKong, Mon-
Betamethasone Dipropio- Complex psoriasis treatment Oinment/Gel
GENUONE Gel golia
nate
Sciences
Treatment of symptoms resulting from
Sodium Alginate
Munals double the reflux of acid, bile and pepsin into the Philippines,
Calcium Carbonate Oral Solution
action oesophagus such as acid regurgitation, Cambodia
Sodium Bicarbonate heartburn and indigestion
Treatment for chronic hepatitis B virus
Entekim Tablet Entecavir infection Tablet HongKong

Degenerative arthritis (Osteoarthritis),


Periarthritis, humeral epicondylitis (tennis
KETOTOP Plaster Ketoprofen elbow etc.), Peritendinitis, tendinitis, Drug Global
tendovaginitis, myalgia, post-traumatic
Handok Inc. swelling/pain
READY Q Drink Curcumin Use for Hangover remedies Food & Beverage Global
READY Q Chew Curcumin Use for Hangover remedies Food & Beverage Global
Nasaflex Mometasone furoate, Perennial allergic rhinitis Allergy & ENT Worldwide
Nasal Spray Azelastine HCl
T-Sporin Cyclosporin Increase tear production Ophthalmic Worldwide
Eye Drops
Hyaluron
HANLIM Sodium Endogenic disease, dry
Eye Drops Ophthalmic Worldwide
PHARM. Hyaluronate eye syndrome
(Single dose)
CO., LTD.
Risenex Plus Sodium Risedronate, Osteoporosis Endocrine Worldwide
Tab. Cholecalciferol
Heparin Sodium Inj. Heparin Sodium Anticoagulant Anticoagulant Worldwide
Hanlim Vasopressin Pituitary hormone agent Endocrine Worldwide
Vasopressin Inj.
Amosratan Amlodipine + Losartan Hypertension CV CIS
Amlodipine + Losartan + Hypertension
Amosartan Q CV LATAM
Rosuvastatin & Hyperlipidemia
Amlodipine +
Amosartan Plus Losartan + Hypertension CV LATAM
Chlortahlidone
Amlodipine + Losartan +
Amosartan Hypertension EU, LATAM
Rosuvastatin + CV
XQ & Dyslipidemia APAC, Etc.
Ezetimibe
Hanmi
Pharm. Rosuvastatin + Primary Hypercholesterolemia LATAM, APAC,
Rosuzet CV
Co.,Ltd Ezetimibe & Hyperlipidemia AFRICA
Tamsulosin + CIS
Gugutams ED, BPH Urology
Tadalafil LATAM
Montelukast+ LATAM
Monterizine Asthma Rhinitis
Levocetirizine Respiratory SEA
EU
Hyalrheuma Hyaluronic acid Osteoarthritis OA MENA
NA, EU
Esomesol Esomeprazole Magnesium GERD, NSAID Gastric ulcer GI APAC
DR Etc.

61
Expected
Supplement

company Product name Active Ingredient Indication Category Country note

K-CAB Tab. Tegoprazan Gastroesophageal reflux disease (GERD) Antiulcer Worldwide


Amlodipine/ Valsartan/ Fixed Dose
Ex-one A Tab. Hypertension with dyslipidemia Worldwide
Atorvastatin Combination
Ex-one R Amlodipine/Valsartan/ Fixed Dose
Hypertension with dyslipidemia Worldwide
Tab. Rosuvastatin Combination
Ex-one Fixed Dose
Amlodipine/Valsartan Hypertension Worldwide
Tab. Combination
Diabetes/
Atomet XR Tab. Atorvastatin/Metformin Type2 Diabetes/Hyperlipidemia Worldwide
Antihypertensive
Machkhan Tab. Candesartan/Amlodipine Hypertension Antihypertensive Worldwide
Hyperlipidemia Fixed Dose
Rovazet Tab. Ezetimibe/Rosuvastatin Worldwide
Primary hypercholesterinemia Combination
Closone Fixed Dose
Clopidogrel + Aspirin Atherosclerosis, thromboembolism Worldwide
Cap. Combination
Moveloxin Inj. Moxifloxacin Infection Antibiotics Worldwide
HK inno.N Cinezolid Tab&Inj. Linezolid Infection Antibiotics Worldwide
Citopcin Inj. Ciprofloxacin Infection Antibiotics Worldwide
Tapocin Inj. Teicoplanin Infection Antibiotics Worldwide
Vancorin Inj. Vancomycin Infection Antibiotics Worldwide
Epokine Inj. Erythropoietin Anemia Biologicals Worldwide
Ready-to-
Pemta RTU Inj. Pemetrexed Cancer Oncology Worldwide use
Calmtop Inj. Irinotecan Cancer Oncology Worldwide
Soybean oil, Olive oil, Fish IV Solution Generic of
OmapOne Lipid Inj. oil, Medium-Chain Parenteral Nutrition Worldwide
(1-chamber bag) Smof Lipid®
Triglycerides
Generic of
OmapOne IV Solution
Lipid, Amino acid, Glucose Total Parenteral Nutrition (TPN) Worldwide Smof Kabiv-
Peripheral Inj. (3-chamber bag) en Peri®
Enteone Tab. Entecavir Hepatitis B infection Antiviral Worldwide
First MA (Mar-
Levotuss Tab. /Syrup Levodropropizine Cough : acute and chronic bronchitis keting authoriza- Global
tion)
Uremin Tab Desmopressin acetate Nocturnal enuresis Generic Global
HYUNDAI
First MA (Mar-
Pharm. Tamirin SR Tab Galantamine HBr Alzheimer’s disease keting authoriza- Global
tion)
Mirap ER Tab. Pramipexole HCl Parkinson’s disease Generic Global
Minoxyl Gel / Sol. Minoxidil Alopecia Generic Global
Besivo Hepatitis B virus
Besifovir Antiviral SEA
Tab. (HBV) infection
SEA, CIS, Latin
Algik Pleural mesothelioma, NSCLC(Non-small
Pemetrexed Anticancer America,
Inj. cell lung cancer) MENA
Vicure Hepatitis B virus SEA, Latin Ameri-
ILDONG Entecavir Antiviral
Tab. (HBV) infection ca, CIS
PHARMACEU-
TICAL CO., TBD Rivaroxaban Prevent blood clots Anticoagulant TBD
LTD.
Droptop Rosuvastatin HMG-CoA reduc-
Hypercholesterolemia SEA
Tab. +Ezetimibe tase inhibitor
Memanto NMDA Receptor
Memantine Moderate-to-severe Alzheimer's disease SEA
Tab. Blocker
Anti-migraine
Reyvow lasmiditan Acute Migraine Southeast Asia
agent

62
Expected

Supplement
company Product name Active Ingredient Indication Category Country note

Worldwide
Abcertin® Imiglucerase Gaucher’s Disease Injection (excluding Korea,
Iran, Mexico)

Worldwide
ISU ABXIS Fabagal® Agalsidase beta Fabry’s Disease Injection (excluding Korea)

Worldwide
Clotinab® Abciximab Anti-thrombotic Injection (excluding Korea,
Turkey)

Refined soybean oil,


Combiflex Lipid Glucose, Amino Acid, Supply of all Nutrition I.V Solution Global
Electrolytes

Lipision Refined soybean oil Lipid based IV Solution I.V Solution Global

Freamine 15 amino acids Amino Acid IV Solution I.V Solution Global

8 amino acids & 4 electro-


Nephramine Amino Acid IV Solution I.V Solution Global
lytes

Prepenem Imipenem, Cilastatin Carbapenem Antibiotics Antibiotics Global

Pospenem Meropenem Carbapenem Antibiotics Antibiotics Global


JW Pharma-
ceutical
Ertapenem Ertapenem Carbapenem Antibiotics Antibiotics Global

Doripenem Doripenem Anhydrous Carbapenem Antibiotics Antibiotics Global

Levofloxacin Levofloxacin Quinolone Antibacterial Agent Antibacterial Global

Heparin Heparin thrombosis Anticoagulant Global

J-Dart tab. Dutasteride BPH, Alopecia Urological Global

Levetiram Premix Levetiracetam Epilepsy Premix Global

Acetamin Premix Acetaminophen Pain Premix Global

Controlled
Prescription
Clanza®CR Tab. Aceclofenac 200mg inflammation, pain Global Release
Medicine Formulation

Clavixin Duo Clopidogrel+ Prescription New fixed


Antiplatelet Global
Capsules Aspirin Medicine dose
Korea United
Pharm. INC.
Controlled
Prescription
Cilostan®CR Tab. Cilostazol 200mg Ischemic symptoms, Thrombosis Global Release
Medicine Formulation

Prescription New fixed


Fenorics EH Tab. Fenofibric acid 11mg Dyslipidemia Global
Medicine dose

Controlled
Prescription
Gastine ®CR Tab. Mosapride 15mg Gastrointestinal symtoms Global Release
Medicine Formulation

Losartan+ Prescription New fixed


Losasc® CR Tab. Antihypertensive Global
Korea United Amlodipine Medicine dose
Pharm. INC.
Omethyl Cutilet®Soft Omega-3 acid ethylester 90 Prescription New fixed
Dyslipidmeia Global
capsule 2g Medicine dose

ATMEG® Atorvastatin 1g+ Prescription New fixed


Dyslipidemia Global
Combigel® Omega-3-acid ethyelster90 Medicine Dose

63
Expected
Supplement

company Product name Active Ingredient Indication Category Country note


1. benign essential blepharospasm
2. equinus foot deformity due to spastici-
ty
3. serious glabellar wrinkles ranging from
moderate to severe associated with cor-
Neuronox,
Clostridium botulinum toxin rugator muscleactivities
and/or procerus muscle
Meditoxin, Biologics Global
Siax typeA (Hall strain) 4. upper limb spasticity associated with
etc. stroke
5. moderate to severe lateral canthal
lines (crow’s feet lines) associated with
orbicularis muscle activities
Medytox 6. cervical dystonia
Clostridium botulinum toxin moderate to serious glabella wrinkles
Coretox typeA (150kDa) related to corrugators muscle and/or Biologics Global
(Hall strain) procerus muscle activity
1. acute eczema, contact dermatitis,
atopic dermatitis, chronic eczema, rosa-
Neurakin Ibuprofen piconol cea-like dermatitis, perioral dermatitis Generic drugs Global
2. herpes zoster
3. acne vulgaris
Levocontra Levonorgestrel Emergency contraceptive Generic drugs Global
Autologous Bone Mar-
Pharmicell Cell Therapy
Cellgram-AMI row-Derived Mesenchymal Acute Myocardial Infarction Global -
Co., Ltd. Product
Stem Cell

South East Asia,


Genexol® PM Paclitaxel Breast cancer, NSCLC, Ovarian cancer India, CIS

Breast cancer, NSCLC, Esophageal can-


Nanoxel® M Docetaxel cer, H&N cancer, Ovarian cancer, Gastric -
cancer, Prostate cancer
Ovarian cancer, Breast cancer, NSCLC, Europe, South
Genexol® Paclitaxel Gastric cancer East Asia, CIS
Breast cancer, NSCLC, Esophageal can-
Docetaxel Docetaxel cer, Ovarian cancer, H&N cancer, Gastric Europe, CIS
cancer, Prostate cancer
Injection
Europe, Japan,
Nexatin® Oxaliplatin Colorectal cancer, Gastric cancer CIS
Pancreatic cancer, NSCLC, Ovarian can-
Crabcitabine® Gemcitabine cer, Breast cancer, Bladder cancer, Biliary -
tract cancer
Pemed® S Pemetrexed NSCLC, Mesothelioma -
Samyang
Holdings Cor- Azalid® Azacitidine MDS, AML, CMML CIS
poation(Bio- Decilid® Decitabine MDS, AML -
pharmaceuti-
cals Business) Protezomib® Bortezomib MCL, MM CIS
Bendalid® Bendamustine MM -
®
Lenalid Lenalidomide MM CIS
Breast cancer, Renal cancer, Pancreatic
Neuroendocrine tumor, GI and Lung Neu- Tablet
Everose® Everolimus -
roendocrine tumor, TSC-Renal Angiomyo-
lipoma, TSC-SEGA
Palonosetron Palonosetron Anti-emetics -
Hypercalcemia of malignancy, Bone Injection
Zolenic® Zoledronic Acid CIS
metastasis
Rheumastop® Diclofenac Rheumatoid arthritis Plaster -
®
Nicostop Nicotine Smoking cessation Patch, Gum -
®
Fentaderm Fentanyl Chronic pain -
Demencure® Rivastigmine Dementia -
Patch
Tulobuterol Tulobuterol Bronchial asthma -
Angiderm® Nitroglycerin Angina -

64
Expected

Supplement
company Product name Active Ingredient Indication Category Country note

USA, Europe,
Ovarian cancer, Breast cancer, NSCLC, Japan, South East
Paclitaxel Gastric cancer Asia, India, North
America

Samyang Breast cancer, NSCLC, Esophageal can-


Holdings Cor- Europe, Japan,
Docetaxel cer, Ovarian cancer, H&N cancer, Gastric
poation(Bio- API Middle East
cancer, Prostate cancer
pharmaceuti-
cals Business) Pemetrexed NSCLC, Mesothelioma Middle East

Bortezomib MCL, MM Middle East

Cabazitaxel Prostate cancer -

Pyronaridine tetraphos- Prescription


Pyramax® Tablets Malaria Global
phate & Artesunate Medicine

Pyronaridine tetraphos- Malaria Prescription


Pyramax® Granules Global
phate & Artesunate (Pediatric formulation) Medicine

Prescription
CandeAmlo® Tablets Amlodipine & Candesartan Hypertension Global
Shin Poong Medicine
Pharm.
Co., Ltd. Prescription
EzeRosu® Tablets Rosuvastatin & Ezetimibe Hyperlipidemia Global
Medicine

Hyalforte® Prescription
Sodium hyaluronate Osteoarthritis Global
Injection Medicine

Medicurtain® Injec- Anti-adhesion


Sodium hyaluronate & HES Medical Device Global
tion (Surgery)

Europe, Columbia,
SK Chemicals Rivastigmine Symptomatic therapy for alzheimer De-
rivastigmine Patch New zealand etc.
Co., Ltd. patch mentia or Parkinson’s disease Dementia (19 conturies)

Prescription
Cyporin N Cyclosporine Dry eye EU, Asia
medicine

Xalost Preservative Prescription


Latanoprost Anti-glaucoma US, EU, Asia
Free medicine

Prescription
Xalost Latanoprost Anti-glaucoma EU, Asia
medicine
Taejoon Phar-
maceutical
Co., Ltd. Latanoprost, Prescription
Xalost Plus Anti-glaucoma EU, Asia
Timolol Maleate medicine

Prescription
Gadobrix Gadobutrol MRI contrast enhancement US, EU, Asia
medicine

CleanViewAL Pow- Prescription


der (Polyethylene Polyethylene glycol3350 Bowel cleansing US, EU, Asia
medicine
glycol3350)

Cell Therapy
-Deep 2nd degree burn Product
Kaloderm® Allogeneic Keratinocytes Global
-Diabetic Foot Ulcer (Prescription
Medicine)

Cell Therapy
Tego Product
Rosmir® Autologous Fibroblasts Improvement of Nasojugal Grooves Global
Science (Prescription
Medicine)

Alternative
Reconstituted 3D Tester Kit for methods
Neoderm® For cosmetics testing and drug discovery Global
Human Skin Research to animal
testing

65
Expected
Supplement

company Product name Active Ingredient Indication Category Country note

Gastric ulcer,
Rebamipide SR Rebamipide 150mg ETC Medicine
Improvement of Gastric mucosal lesion

Esomeprazole + Esomeprazole +
Precipitated Calcium Gastroesophageal Reflux Disease,
Precipitated Calcium
Carbonate Tab. Antacid
Carbonate Tab.

Raloxifene Raloxifene Osteoporosis ETC Medicine

Atorvastatin + Atorvastatin + Hypercholesterolemia ETC Medicine


Ezetimibe Tab. Ezetimibe Tab.

Fenofibrate 145mg Fenofibrate 145mg Tab. Hyperlipidemia ETC Medicine


Tab.

Pregabalin SR Tablet Pregabalin Neuropathic pain ETC Medicine

Telmisartan, Treatment for hypertension and hyperlip-


Duowell Tablet ETC Medicine
Rosuvastatin idemia

Treatment for hypertension and hyperlip-


Rosuampine Tablet Amlodipine, Rosuvastatin ETC Medicine
idemia

Asia, Middle East,


Yuhan Corpo-
Rosumet SR Tablet Metformin SR, Rosuvastatin Antidiabetic ETC Medicine North Africa, CIS,
ration Latin America, etc.

Treatment for respiratory distress syn-


Newfactan Bovine Lung Surfactant ETC Medicine
drome of newborns

Amoxicillin, Clavulanate
Yucla Tablet Antibiotics ETC Medicine
Potassium

Almagate Suspen- Almagate Antiacidic functions OTC Medicine


sion

Antiphlamine S Methyl Salicylate, L-men- Anti-inflammatory agent OTC Medicine


Lotion thol

Sodium alginate, Calcium


Willogel Double carbonate, Alleviation of heartburn and indigest OTC Medicine
Action Suspension Sodium bicarbonate

Nazacare Nasal Nasal symptoms of allergic rhinitis, Nasal


Momethasone Furoate ETC Medicine
Spray Solution polyps, Acute rhinosinusitis

Ammonium Chloride,
Chlorpheniramine Maleate,
Cough-S Syrup Dextromethorphan Hydro- Cough, Sputum ETC Medicine
bromide Hydrate, DL-Meth-
ylephedrine Hydrochloride

66
Expected

Supplement
company Product name Active Ingredient Indication Category Country note

Cefcapene Pivoxil
(API, Tab., Fine Cefcapene Pivoxil Infection Antibiotics Worldwide
Granule)

Cefditoren Pivoxil
(API, Tab., Fine Cefditoren Pivoxil Infection Antibiotics Worldwide
Granule)

Cefmetazole Cefmetazole Sodium Infection Antibiotics Worldwide


(API, Inj.)

Cefotiam HCl/
Cefotiam (API, inj.) Infection Antibiotics Worldwide
HCl+Na2CO3

Ceftizoxime Ceftizoxime Sodium Infection Antibiotics Worldwide


(API, inj.)

Loxoprofen (API) Loxoprofen Anti-inflammatory, Analgesic CNS Worldwide

Febuxostat (API) Febuxostat Hyperuricemia Cardiovascular Worldwide

Alprostadil(prostaglandin E1) analogue,


OPAST tab. Limaprost alfadex and a vasodilator that increases blood Cardiovascular Asia
flow and inhibits platelet aggregation

Relieve mild to moderate pain, and


DENOGAN inj. Propacetamol HCl Antiinflammatory Asia
reduce fever
Yungjin
Pharm. Co.,
Ltd. Treatment of certain serious bacterial
LINEZOLIN tab. Linezolid Oxazolidinone Asia
infections

Treatment of serious infections and is


Imipenem-cilastatin Imipenem, cilastatin a potent broad spectrum antibacterial Antibiotics Asia
inj. agent for intravenous administration

Treatment of symptoms of gastro-oe-


Sodim alginate, calcium sophageal reflux such as acid regurgita-
BAROSCON DOUBLE carbonate, sodium bicar- tion, heartburn and indigestion, and for Gastro-intestinal Asia
ACTION susp.
bonate symptoms of excess stomach acid(hyper-
acidity)

Broad-spectrum cephalosporin antibiot-


Ceftriaxone inj. Ceftriaxone sodium ics with high degree of stability in the Antibiotics Asia
presence of beta-lactamases

Ceftazidime inj. Ceftazidime hydrate Infection Antibiotics Asia

Cefpodoxime Prox- Cefpodoxime


etil Infection Antibiotics Asia
Proxetil
(API, Tab, Dry Syrup)

Cefdinir
(API, Tab, Fine Cefdinir Infection Antibiotics Asia
Granule)

Candesartan Cilex- Angiotensin


Candesartan Cilexetil Hypertension Asia
etil(API) receptor blockers

67
2. Technology Transfer
Development Status
Supplement

Company Category Indication Targeted note


Korea Overseas Country
ABL503 Solid Tumor Phase 1 (U.S.)
Solid Tumor(Pancreatic,
ABL111 Phase 1 (U.S.)
ABL Bio, lnc. Gastric Cancer)
ABL501 Solid Tumor Phase 1 IND
ABL301 Parkinson’s Disease Preclinical
ALT-B4 Cancer Phase 1 - worldwide
Growth hormone deficien-
Alteogen ALT-P1 Phase 2 Phase 1 Brazil
cy
ALT-P7 Breast cancer Phase 1 - USA, EU
BCWP_Y001 Anti-Cancer - - Global
BCWORLD PARM. BCWP_Y002 Anti-fungal - - Global
CO., LTD.
BCWP_Y007 Antibiotics - - Global

Boryung New Chemical Entity Hypertension Launched N/A


Pharmaceutical (ARB: Fimasartan)
co.,Ltd. Oncology Antineoplastic Launched N/A
Amyotrophic Lateral Korea, United
Neuronata-R® Phase Ⅲ Phase Ⅲ On-going
Corestem Sclerosis (ALS) States (Global)
Inc. systemic lupus erythema- MFDS IND approval
CS20AT04 Phase Ⅰ NA Global
tosus (SLE) (2015.05)
Pancreatic cancer, Myelo-
Ivaltinostat Phase II Worldwide
dysplastic syndromes
CG-650 Acute/Chronic pain Phase I Worldwide
CrystalGenomics,
Inc. CG-651 Neuropathic pain Phase I Worldwide
ABSSSI, Osteomyelitis and
CG-549 other serious S. aureus Phase I Worldwide
infections including MRSA
DH-LASED platform - - - Global
Globally except
Liporaxel sol’n Gastric & Breast cancer ◯ ◯
China
DHP23001 Anticancer agent Non-clinical - Global
(Oral Docetaxel)
Daehwa Pharmaceu-
tical Co., Ltd. DHP23003 Anticancer agent Non-clinical - Global
(Oral Irinotecan)
DHP23007 Influenza Non-clinical - Global
(Oral Zanamivir)
DHP33001 Diabetes & Obesity Non-clinical - Global
(Oral GLP-1)
DWN12088 IPF Phase 1, AU TGA Global

Daewoong DWP17061 OA pain Global PC


Pharmaceutical DWP212525 Autoimmune disease Global PC
DWP213388 Autoimmune disease Global PC
Benign prostatic hyperpla-
DKF313 Phase 3 Japan, EU
sia
Dongkook Pharma- Osteoarthritis of the knee
ceutical DKM412 Phase 3 China
joint
DKF-5122 Fungal infection BE study Brazil, EU
NCE(Zabolante) COPD Phase III Global
DONGWHA PHARM NCE COVID-19 Preclinical Global
NCE Cancer Lead optimization Global

68
Development Status

Supplement
Company Category Indication Targeted note
Korea Overseas Country

Solid tumor Phase 1b - Global

Glioblastoma Phase 1b Phase 2 Global


GX-I7
(Long-acting IL-7) TNBC Phase 1b/2 - Global
(w/ KEYTRUDA®)

COVID-19 Phase 1b Phase 2 Global


Therapeutic

GX-188 Cervical Cancer


(HPV DNA therapeutic Phase 1b/2 - Global
(w/ KEYTRUDA®)
vaccine)

GX-H9 AGHD & PGHD Completed Phase 2 Ongoing Phase 3 Global


(Long-acting hGH)
Genexine, Inc.
GX-G3 Completed Completed
Neutropenia Global
(Long-acting G-CSF) Phase 2 Phase 2

GX-E4 CKD-induced Anemia Ongoing Phase 3 Ongoing Phase 3 Global


(Long-acting EPO)

GX-G6 Phase 2 IND


Type 2 Diabetes - Global
(Long-acting GLP-1) Approval

GX-G8 Phase 1 IND


Short Bowel Syndrome - Global
(Long-acting GLP-2) Approval

GX-P1 Autoimmune Transplanta- Completed Phase 1 - Global


(Long-acting PD-L1) tion

COVID-19 Ongoing Expand to Phase


GX-19N Global
Preventive Phase 1/2a 2/3

Adult growth hormone


Biologics Ph 2 completed Ph 2 completed USA/EU
deficiency (AGHD)
Handok Inc.
Pediatric growth hormone
Biologics Ph 2 completed Ph 2 completed USA/EU
deficiency (PGHD)

HL217 AMD EU Phase II USA, EU

HL237 Rheumatoid arthritis Phase II USA, EU

HL237A Liver transplantation Phase II USA, EU

HL237B Sjogren’s Syndrome Phase II USA, EU

HANLIM Japan, South-East


PHARM. Stafen Cap. Mixed hyperlipidemia Marketed Asia
CO., LTD.

Japan, South-East
Belion CR Tab. Allergic rhinitis, Pruritus Marketed Asia

Breast lesion surgery


Lumino-mark Inj. Phase III USA, EU
marker

Japan, South-East
Jakfas Tab. Rheumatoid arthritis MFDS Approval Asia

69
Development Status
Supplement

Company Category Indication Targeted note


Korea Overseas Country
Amosratan Amlodipine + Losartan Hypertension CV CIS
Amlodipine + Losartan + Hypertension
Amosartan Q CV LATAM
Rosuvastatin & Hyperlipidemia
Amlodipine +
Amosartan Plus Losartan + Hypertension CV LATAM
Chlortahlidone
EU
Amlodipine + Losartan +
Amosartan Hypertension LATAM
Rosuvastatin + CV
XQ & Dyslipidemia APAC
Ezetimibe Etc.
Hanmi Primary Hypercho-
Pharm. Rosuvastatin + LATAM, APAC,
Rosuzet lesterolemia CV
Co.,Ltd Ezetimibe AFRICA
& Hyperlipidemia
Tamsulosin + CIS
Gugutams ED, BPH Urology
Tadalafil LATAM
Montelukast+ LATAM
Monterizine Asthma Rhinitis
Levocetirizine Respiratory SEA
EU
Hyalrheuma Hyaluronic acid Osteoarthritis OA MENA
NA, EU
Esomesol GERD, NSAID
Esomeprazole Magnesium GI APAC
DR Gastric ulcer Etc.
K-CAB Tab. (Tego- Gastroesophageal reflux Phase 1
Launched Worldwide NCE
prazan) disease (GERD) (Completed)
Rheumatoid Arthritis,
Atopy dermatitis, Crohn’s Phase I
IN-A002 N/A Worldwide NCE
disease, Ulcerative colitis, (ongoing)
Alopecia areta
NASH, Glaucoma, Diabetic
IN-A010 NA Phase II Asia NCD
nephropathy
EX-one R (Amlodipine +
HK inno.N Hypertension/Hyperlipid-
Valsartan + Rosuvasta- Launched N/A Worldwide IMD
emia
tin)
EX-one A Hypertension/Hyperlipid-
(Amlodipine + Valsar- Launched N/A Worldwide IMD
emia
tan + Atorvastatin)
IN-B001 Prevention of Hand, Foot & Phase I Phase II Worldwide Vaccine
(Vaccine) Mouth Disease (ongoing) (Planned)
IN-B009 Prevention of COVID19 Pre-clinical N/A Worldwide Vaccine
(Vaccine)
Phase 2 IND
HD-6277 Diabetes - approved Global
(US FDA)
BPDO-1603 Alzheimer’s disease Phase 3 - Global

HYUNDAI Pharm. HDDO-1728 Alzheimer’s disease Formulation - Global


HDDO-1756 Hyperlipidemia Phase 1 - Global
HDDO-1801 Respiratory disease Phase 1 - Global
Surgery (hardening soft
HDDI-1914 Pre-clinical - Global
tissue)
Age-related Macular
Ophthalmology Preclinical Global
Degeneration (AMD)
ILDONG PHARMA- Chronic Lymphocytic
CEUTICAL CO., LTD. Leukemia (CLL) / Relapsing
Anti-cancer / CNS - P3 / P2 Southeast Asia
form of Multiple Sclerosis
(RMS)

70
Development Status

Supplement
Company Category Indication Targeted note
Korea Overseas Country
ISU104 Head and Neck Cancer Phase 1 Worldwide Anti-ErbB3 antibody

Phase 1 Worldwide
Paroxysmal Nocturnal (excluding Russia/ Biosimilar to eculizum-
ISU305 (Australia/ New
Hemoglobinuria ab (Soliris®)
Zealand) CIS)
ISU
ABXIS Phase 1 Biosimilar to imiglu-
Abcertin® Gaucher’s Disease Worldwide
(Australia) cerase (Cerezyme®)

Phase 3 is planned to
be initiated in 2021;
Fabagal® Fabry’s Disease Phase 3 Worldwide launched in Korea in
2014

Acute Myeloid Leukemia, Phase 1b


CWP232291 Multiple Myeloma, Gastric - Global
(ongoing)
Cancer

JW Pharmaceutical Global
Phase 2b
URC102 Gout - except
(ongoing) China

CWL080061 Alopecia - - Global


®
Clavixin Duo Capsule antiplatelet Launched Global

Upper respiratory tract


Kalomin®Tab. Launched Global
infections
Korea United Pharm. Losasc®Tab 5/50 Hypertension Launched Global
INC.
Upper, chronic respiratory
Levotics®CR Launched Global
tract infections

Fenorics®EH Tab Hyperlipidemia Launched Global

LR19055 Autoimmune disease N/A Phase 3 ROW Antibody biosimilar

LR19074 Gout N/A Phase 2 Worldwide XO inhibitor


LG Chem, Ltd
S1P receptor modula-
LR19019 Ulcerative colitis N/A Phase 2 Worldwide tor

LR19021 Obesity N/A Phase 1 Worldwide MC4R agonist

MT912 Macular Degeneration TBD TBD Global Biobetter

Immune cell therapeu-


MT927 Immune Disorder TBD TBD Global tics

Inflammatory Bowel Live Biotherapeutic


Medytox MT971 TBD TBD Global
Disease Product

MT981 Solid cancers TBD TBD Global Antibody New Drug

MT921 Fat Reduction Phase 2 clinical trial TBD Global New Chemical Entity
in progress

Phase 2 Phase 2 Global


OLX101A Hypertrophic Scar 0n-going 0n-going(US) (Excl. Asia)

OLX104C Androgenic Alopecia Preclinical Preclinical Global

OLX301A Dry & Wet AMD Preclinical Preclinical Asia-Pacific


OliX Pharmaceuti- OLX301D Subretinal Fibrosis Preclinical Preclinical Asia-Pacific
cals,Inc.
OLX701 Liver Fibrosis Preclinical Preclinical Global

Liver Disease
OLX702 Preclinical Preclinical Global
(NASH, Diabetes etc.)

OLX703 HBV Preclinical Preclinical Global

Acute Myocardial Infarc-


Pharmicell Co., Ltd. Cellgram-AMI Launched - Global -
tion

71
Development Status
Supplement

Company Category Indication Targeted note


Korea Overseas Country

Polymer-based Solubility
parenteral DDS Renal cell carcinoma Preclinical - US, EU enhancing
Tech.

Solubility
Polymer-based enhancing,
parenteral DDS Cancer Ph 1 - US, EU Sustained
Tech. release

Samyang Holdings Absorption enhancing Bioavailability enhanc-


Corpoation(Bio- Emesis Preclinical - US, EU
oral DDS Tech. ing tablet
pharmaceuticals
Business)
Fast dissolving oral Ph 1 (BEQ complet-
Allergy, Emesis - US, EU Fast dissolving tablet
DDS Tech. ed)

Colon specific oral DDS Preclinical (com- Colon specific delivery


IBD, IBS - US, EU
Tech. pleted) system

Oncolytic virus, nucleic Cancer / Vaccine Preclinical Preclinical US, EU Stability enhanced
acid delivery Tech. nano shells

Otaplimastat Phase 2b
Acute Ischemic Stroke - Global Combination with tPA
(SP-8203) (On-going)

Phase 1 Oral,
SP-8008 Anti-platelet - (Europe) Global less bleeding
(On-going)

Phase 1 Oral,
Cerebro-cardiovascular
SP-8356 - (Europe) Global enhanced vessel
diseases (On-going) elasticity

Shin Poong Pharm.


Co., Ltd. Lead compound
SP-8416 Heart failure - Global -
(On-going)

Phase 3 IND Long-lasting viscosup-


SP5M001 Osteoarthritis - Global
(completed) plement

Phase 1/2 IND Rapid pain relief


SP5M002 Osteoarthritis - Global
(On-going) viscosupplement

Non-clinical Anti-inflammatory
SP1M002 Osteoarthritis - Global
(On-going) viscosupplement

Phase II complet-
Tego Improvement of Nasojugal
Rosmir® ed & Marketing Global
Science Grooves approved

Chronic Obstructive Pulmo-


Respiratory Phase 2 Worldwide
nary Disease

Mitochondrial Respiratory
Metabolic Phase 1 Japan Licensed out to Abliva
Chain Disorder
Yungjin Pharm. Co.,
Ltd.
Solid cancers, Hematologi-
Oncology Nonclinical Worldwide
cal cancers

Immunology Rheumatoid arthritis Phase 2 Korea

72
3. Certification from Health Authorities
Dosage

Supplement
Company Product name Active Ingredient form Indication International certification note

1) GMP Certificate
(by KFDA)
Hitox Botulinum toxin vial improvement of facial wrinkles 2) EU GMP, cGMP
BMI to be applied in 2022
Korea
Enhance drug permeation EU GMP, cGMP
Hirax Hyaluronidase vial by subcutaneous injection to be applied in 2022

Cefon Cefoperazone, Sulbact- FP Antibiotics PMDA


Inj. am

Fosomycin Fosfomycin FP Antibiotics PMDA


Inj. Salt

Roxithromycin Roxithromycin FP Antibiotics PMDA


Tab.

Gelfos ALPO 4 FP Gastrointestinal Taiwan FDA

Kanarb Fimasartan FP Cardiovascular Approved in 19 countries

EU GMP, Thailand, Malaysia,


Oxalitin Inj. Oxaliplatin FP Antineoplastic EU GMP scheduled
Philippine, Syria

Boryung Neoplatin Inj. Carboplatin FP Antineoplastic Thailand, Syria


Pharmaceutical
co.,Ltd. Thailand, Malaysia, Philip-
AD Mycin Inj. Doxorubicin FP Antineoplastic pine, Syria

Thailand, Vietnam, Syria,


VCS Inj. Vincristine FP Antineoplastic Iran

Effcil Inj. 5-FU FP Antineoplastic Thailand

Alacepril Alacepril API Cardiovascular PMDA

Pitavastatin Pitavastatin API Cardiovascular PMDA

Fexofenadine Fexofenadine API Antihistamine PMDA

Aripiprazole Aripiprazole API Schizophrenia PMDA

Tamsulosin Tamsulosin API Urology System PMDA, Russia

RheumatoidArthritis, Ankylsoing
Spondylitis, Ulcerative Colitis,
Remsima SC Infliximab SC EMA
Crohn's Disease, Psoriasis,
psoriatic arthritis

RheumatoidArthritis, Ankylsoing
Spondylitis, Ulcerative Colitis,
Remsima Infliximab IV EMA, FDA
Crohn's Disease, Psoriasis,
psoriatic arthritis

Non-Hodgkin's Lymphoma,
ChronicLymphocytic Leukemia,
Truxima Rituximab IV Rheumatoid Arthritis,Granuloma- EMA, FDA
tosis with Polyangiitis,
Microscopic Polyangiitis
Celltrion
HER2-Positive Metastatic Breast-
Herzuma Trastuzumab IV Cancer, Early Breast Cancer, EMA, FDA
Metastatic Gastric Cancer

Rheumatoid Arthritis ,IBD,


Yuflyma Adalimumab SC EMA
Lymphoma

AIDS (Acquired ImmuneDeficien-


Temyxis Lamivudine, Tenofovir Tab. FDA
cy Syndrome)

Pneumonia, Skin and SkinStruc-


ture Infections,
Linezolid Linezolid Tab. FDA
Vancomycin-resistant Enterococ-
cus faeciumInfections

73
Dosage
Supplement

Company Product name Active Ingredient form Indication International certification note
Tacrolimus
Tacrolimus Cap. Cap. Immunosuppressant GMP Japan/MHLW
0.5, 1, 5mg
Ceftriazone Ceftriaxone sodium Inj. Antibiotics GMP Japan/MHLW
sodium inj. 0.5, 1mg
Cefazolin sodium Cefazolin sodium Inj. Antibiotics GMP Japan/MHLW
inj. 0,5, 1, 2mg
Bacampicillin hydro-
Pengood Tab. Antibiotics GMP Japan/MHLW
chloride
Plant certification
(Sterile/Non-ster- GMP Japan/MHLW
ile drug)
Sudan/
Mycophenolate
Myrept Tab. Tab. Immunosuppresant GMP National Medicines
Mofetil 500mg and Poisons Board
Sudan/
Gemtan inj. Gemcitabin 200mg, 1g/
CKD Pharmaceuti- Inj. Anticancer GMP National Medicines
Belloxa Inj. Oxaliplatin 50, 100mg
cal Corp. and Poisons Board
Cypol Soft Cap, Thailand/
Cyclosporin 25, 100mg,
Cypol Oral Solu- Cap. Immunosuppresant GMP Thailand Food and
100mg/mL
tion Drug Administration
Kazakhstan
/Ministry of Health,
Gemtan inj. Gemcitabin 1g Inj. Anticancer GMP Republic of Kazakh-
stan
Tacrolimus 0.5, 1.0mg/
Tacrobell Cap. Philippine /Philip-
Mycophenolate Cap./
Myrept tab. Immunosuppresant GMP pine Food and Drug
Mofetil 500mg/ Cyclo- Tab.
Cypol Soft Cap. Administration
sporin 25, 100mg
Philippine /Philip-
Tazobactam 0.5g,
Tazoperan Inj. Inj. Antibiotics GMP pine Food and Drug
Piperacillin 4.0g Administration
Plant certification GMP Japan/MHLW
(Biologic drug)
Betamethasone,
Almetamin tab. Dexchlorpheniramine Tablet Acute urticaria and others Ethiopia and others / PICs
maleate
Kebanon plaster Ketoprofen Plaster Muscular pain Asian / PICs
Betametasone dipro- Allergic dermatitis, alopecia
Demacot cream pionate, Clotrimazole, Cream areata, first degree burn, derma- Asian and Africa / PICs
Daehwa Pharma- Gentamicin sulfate tomycosis
ceutical Co., Ltd. Fracture, sprain, internal,
external and incarcerated hem-
Crystalized trypsin, orrhoid after proctoptosis and a
Protase tab. Tablet Asian / PICs
Bromelain hemorrhoidal surgery, stagnant
breast, mammitis, hematoma and
thrombosis
Top-roll Ginseng powder and Soft Tonics and nutritional supple- Qatar / PICs
soft cap. others capsule mentation
Treatment of wrinkles between
Nabota Botulinum toxin Type A Injection cGMP, EU-GMP, Canada GMP
the eyebrows
Tablet, Cholestasis (including PBC, PSC),
Ursa Ursodeoxycholic acid PIC/S GMP
Capsule viral hepatitis C, gallstone
Olmesartan/Rosuvas- Concomitant hypertension and
Olostar Tablet PIC/S GMP
tatin dyslipidemia
Prostate cancer, endometriosis,
Depot uterine fibroid, postmenopausal
Daewoong Phar- Luphere Leuprorelin Acetate PIC/S GMP
Injection breast cancer, central precocious
maceutical puberty
Recombinant human
Easyef Epidermal Growth Solution Diabetic foot ulcer PIC/S GMP
Factor
Recombinant human Growth hormone deficiency and
Caretropin PFS PIC/S GMP
growth hormone Turner syndrome
Recombinant human Anemia in end stage renal
Eposis PFS PIC/S GMP
Erythropoietin α disease (ESRD)

74
Dosage

Supplement
Company Product name Active Ingredient form Indication International certification note

Tablets,
Capsule, Certified
Pharmaceuticals - - Taiwan GMP registered
Cream, Feb. 2018
Ointment

DongKoo Bio&- Tablets,


Pharma Capsule, Certified
Pharmaceuticals - - Vietnam GMP registered
Cream, Nov. 2019
Ointment

Gel, Certified
Pharmaceuticals - Cream, - Iran GMP registered April. 2020
Ointment

Brazil GMP, Ukraine GMP


Pofol Injection Propofol Injection General anesthetic, sedation Japan(PMDA) GMP

Improvement of limb ulcer and


resting pain in chronic arterial
Alostin Injection Alprostadil Injection Japan(PMDA) GMP
obstruction (Burger's disease,
obstructive arteriosclerosis)

Teicon Injection Teicoplanin Injection Antibiotic Japan(PMDA) GMP


Dongkook Pharma-
ceutical Active
Pharma-
- Teicoplanin ceutical Antibiotic Japan(PMDA)
Ingredi-
ent

Accredited
Foreign Manu- - - Japan(PMDA)
facturers (Sterile/ -
Non-sterile drug)

Amaryl M SR ANVISA
Glimepiride Metformin Tablet Type II diabetes
2/500mg Ukraine-PIC/S

Russia GMP
INVIMA, ANVISA
Amaryl M MCC–PIC/S
Glimepiride Metformin Tablet Type II diabetes
2/500mg Ukraine -PIC/S
Taiwan-PIC/S
Philippines-PIC/S

ANVISA,
Amaryl M Glimepiride Metformin Tablet Type II diabetes MCC–PIC/S
1mg/250mg Ukraine -PIC/S

Esperson oint. Desoxymethasone Semi- Corticosteroid-responsive derma-


0.25% Semi-solid solid toses

Daonil tab. Glibenclamide Tablet Type II diabetes

Handok Inc. Lasix tab. Furosemide Tablet Edema., Hypertensionos

Rheumatoid Arthritis, Osteoar-


Surgam tab. Tiaprofenic acid Tablet thritis, Taiwan(PIC/S)
200mg Ankylosing spondylitis, Backache

Stomach ulcer,
Duodenal ulcer,
Roxan Capsule Roxatidine acetate HCl Capsule Reflux esophagitis

Frisium tab. Clobazam Tablet Epilepsy


10mg

Degenerative arthritis (Osteo-


arthritis), Periarthritis, humeral Russia GMP
epicondylitis (tennis elbow etc.),
KETOTOP Plaster Ketoprofen Plaster Taiwan(PIC/S)
Peritendinitis, tendinitis, ten- Philippines(PIC/S)
dovaginitis, myalgia, post-trau-
matic swelling/pain

75
Dosage
Supplement

Company Product name Active Ingredient form Indication International certification note

Gugu Tadalafil Tab. Erectile Dysfunction PMDA (Japan) Global Smart Plant

Amlodipine +
Lozap AM Tab, Hypertension Russia GMP Global Smart Plant
Losartan

Hyalrheuma Hyaluronic acid Inj, Osteoarthritis US FDA(cGMP) Bioplant

Esomeprazole API GI US FDA(cGMP) Hanmi Fine Chem.

Hanmi Cefotaxime API Antibiotics EU GMP Hanmi Fine Chem.


Pharm. Co.,Ltd
Ceftriaxone API Antibiotics EU GMP Hanmi Fine Chem.

Ceftazidime API Antibiotics EU GMP Hanmi Fine Chem.

Ceftizoxime API Antibiotics PMDA (Japan) Hanmi Fine Chem.

Raloxifene API Osteoporosis PMDA (Japan) Hanmi Fine Chem.

Losartan API CV PMDA (Japan) Hanmi Fine Chem.

Best-Call® Cefmenoxime Hcl Inj. Infection Japan GMP Inspection


Supply APIs to a
Firstcin® Cefozopran Hcl Inj. Infection Japan GMP Inspection Japanese Company
Pan-Sprorin® Cefotiam Hcl Inj. Infection Japan GMP Inspection

Banan® tab. Cefopodoxime Tab. Infection Japan GMP Inspection


HK inno.N Supply bulk-prod-
ucts to a Japanese
Banan® company
Cefopodoxime Syrup Infection Japan GMP Inspection
dry syrup

Ceftazidime inj. Ceftazidime Inj. Infection Japan DMF

Ceftriaxone inj. Ceftriaxone Inj. Infection Japan DMF

Probiotic Digestion and Vitamin


Biovita Probiotics & Vitamin Granule USA
Supplement for babies

Breast cancer, colon cancer, PAKISTAN,


Xelobig Capecitabine Tablet rectal cancer MYANMAR

Injection Pleural mesothelioma, Non-small


Algik Pemetrexed PAKISTAN
cell lung cancer
ILDONG PHAR- AZERBAIJAN
MACEUTICAL CO., Hepatitis B virus PERU
LTD. Vicure Entecavir Tablet (HBV) infection MONGOLIA
HONG KONG

Moderate-to-severe Alzheimer's PHILIPPINES


Memanto Memantine Tablet disease MYANMAR

N/A Fursultiamine HCl API Vitamins JAPAN

N/A Topiramate API Anticonvulsant drug material JAPAN

Iran GMP 2014


Abcertin® Imiglucerase Injection Gaucher’s Disease Iran MOHME 2015

ISU ABXIS Mexico GMP 2014


Abcertin® Imiglucerase Injection Gaucher’s Disease Mexico MOH 2015

Abcertin® Imiglucerase Injection Gaucher’s Disease Russian GMP 2019

76
Dosage

Supplement
Company Product name Active Ingredient form Indication International certification note
Imipenem monohydrate
Prepenem Inj. and Injection Antibiotics PMDA
Cilastatin sodium
Pospenem Inj. Meropenem trihydrate Injection Antibiotics ANVISA
Itraconazole SD Itraconazole API Fungal Infection PMDA
Toracona tab Itraconazole Tablets Fungal Infection PMDA
Imipenem Imipenem monohydrate APi Antibiotics COFEPRIS
Mixture and Cilastatin sodium
JW Pharmaceuti- Meropenem
cal Meropenem trihydrate API Antibiotics COFEPRIS
Mixture
asthma symptoms and to relieve
Montelukast Montelukast sodium Tablets the symptoms of seasonal PMDA
tab. allergies
Treatment of pulmonary arterial
Bosentan tab. Bosentan API PMDA
hypertension
Olanzapine Tab. Olanzapine Tablet Treatment of schizophrenia PMDA
Treatment of male pattern alope-
Finasteride Tab. Finasteride Tablet PMDA
cia
Rebamipide Rebamipide API gastritis, gastric ulcer PMDA
Cilostazol Cilostazol API cerebral infarction, etc. FDA, PMDA
EMA, MHRA, TFDA, FDA
Abilify OD tablet Aripiprazole OD tablet schizophrenia, etc. Philippines
Abilify Oral oral EMA, MHRA, FDA Philip-
Aripiprazole schizophrenia, etc.
Korea Otsuka Phar- solution solution pines
maceutical Co., Abilify tablet Aripiprazole tablet schizophrenia, etc. FDA Philippines
Ltd.
Pletaal tablet Cilostazol tablet cerebral infarction, etc. FDA Philippines, NPCB
Pletaal SR cap- Cilostazol capsule cerebral infarction, etc. FDA Philippines
sule
Mucosta Rebamipide tablet gastritis, gastric ulcer DRAP, NPCB, FDA Philippines
Samsca Tolvaptan tablet hyponatremia, ADPKD FDA Philippines, BPOM
Korea United ®
Clanza CR Aceclofenac Tab inflammation, pain RussiaGMP
Pharm. INC.
1. benign essential blepharo-
spasm
Biophar- 2. equinus foot deformity due to
spasticity
maceu- 3. serious glabellar wrinkles
tical ranging from moderate to severe
prod- Brazil GMP
Neuronox, associated with corrugator
Clostridium botulinum ucts(Lyo- muscle Colombia GMP
Meditoxin, and/or procerus muscle
Medytox toxin typeA philized Iran GMP
Siax (Hall strain) powder 4. upper limbactivities Saudi Arabia GMP
etc. spasticity associat-
for etc.
ed with stroke
injection, 5. moderate to severe lateral
Injec- canthal lines (crow’s feet lines)
tions) associated with orbicularis
muscle activities
6. cervical dystonia
Ovarian cancer, Breast cancer,
Paclitaxel Inj. Paclitaxel Injection EU GMP
NSCLC, Gastric cancer
Breast cancer, NSCLC, Esopha-
Injection geal
Samyang Holdings cancer, Ovarian cancer, H&N
Docetaxel Inij. Docetaxel EU GMP
Corpoation(Bio- cancer, Gastric cancer, Prostate
pharmaceuticals cancer
Business) Pemetrexed Inj. Pemetrexed Injection NSCLC, Mesothelioma EU GMP
Oxaliplatin Inj. Oxaliplatin Injection Colorectal cancer, Gastric cancer EU GMP
Azacitidine Inj. Azacitidine Injection MDS, AML, CMML병 EU GMP

77
Dosage
Supplement

Company Product name Active Ingredient form Indication International certification note

Pyramax® Tablets Pyronaridine tetraphos- Tablets Anti-malarial EU GMP Certification


phate, Artesunate

Pyramax® Gran- Pyronaridine tetraphos- Granules Anti-malarial EU GMP Certification


ules phate, Artesunate (Pediatric formulation)

Medicurtain® Sodium hyaluronate, Anti-adhesion


Injection CE Certification
Injection Hydroxyethyl starch (Surgery)

Hyalforte® Sodium hyaluronate Injection Osteoarthritis CE Certification


Injection

Clopidogrel bisulfate API Anti-platelet PMDA

Shin Poong Pharm. Celecoxib API NSAID PMDA


Co., Ltd.
Loxoprofen sodium API NSAID PMDA

Telmisartan API Hypertension PMDA

API Sulbactam sodium API Anti-biotic PMDA

Valsartan API Hypertension PMDA

Irbesartan API Hypertension PMDA

Fosfomycin API Anti-biotic PMDA

Cilostazol API Antithrombotic PMDA

Omed omeprazole Tablet Gastric Ulcer EU GMP


SK Chemicals Co.,
Ltd.
Wondron Patch rivastigmine Patch Alzheimer Dementia EU GMP

EU GMP, ANVISA, NAFDAC


Xalost Latanoprost Solution Anti-glaucoma certification
Taejoon Pharma-
ceutical Co., Ltd.
Latanoprost, Timolol
Xalost Plus Solution Anti-glaucoma EU GMP certification
Maleate

-Deep
2nd
Autologous degree Cell Therapy Product
Holoderm® Global
Keratinocytes burn over (Prescription Medicine)
30% of
TBSA

-3nd
Tego degree
® Allogeneic Keratino- Cell Therapy Product
Science Kaloderm burn over Global
cytes (Prescription Medicine)
10% of
TBSA

Improve-
ment of
® Cell Therapy Product
Rosmir Autologous Fibroblasts Naso- Global
(Prescription Medicine)
jugal
Grooves

78
Dosage

Supplement
Company Product name Active Ingredient form Indication International certification note

API1 API1 - Antiviral USFDA, TGA, PMDA

API2 API2 - Antiviral USFDA, TGA, PMDA

API3 API3 - Antiviral USFDA, TGA, PMDA

API4 API4 - Antiviral USFDA

API5 API5 - Antiviral USFDA

API6 API6 - Antiviral USFDA


Yuhan Corporation

API7 API7 - Immunosuppressant USFDA

Piperacillin Piperacillin Monohy- - Antibiotic USFDA, TGA, EDQM


Monohydrate drate

Rosuvastatin Ca. Rosuvastatin Ca. - Antihyperlipidemic PMDA

Cilostazol Cilostazol - Antiplatelet PMDA

Levofloxacin Levofloxacin - Antibiotic PMDA

Cefaclor Cefaclor Monohydrate Capsule Infection PMDA

Cefmetazole Cefmetazole Sodium API Infection PMDA

Cefotiam Cefotiam HCl API Infection PMDA

API,
Cefdinir Cefdinir Infection PMDA
Tablet

API, Dry
Cefditoren Cefditoren Pivoxil Infection PMDA
syrup

Ceftriaxone Ceftriaxone Sodium Inj. Infection PMDA

API,
Tablet
Yungjin Cefcapene Cefcapene Pivoxil HCl Infection PMDA
Fine
Pharm. Granule
Co.,Ltd.

Caftazidime Pentahy- API,


Caftazidime Infection PMDA
drate Injection

API, Tab-
Cefpodoxime Cefpodoxime Proxetil let, Fine Infection PMDA
Granule

Candesartan Candesartan Cilexetil API Cardiovascular Agents PMDA

Antipyretics and analgesics,


Loxoprofen Loxoprofen Sodium API PMDA
anti-inflammatory agents

Rosuvastatin Rosuvastatin Calcium API Cardiovascular Agents PMDA

Febuxostat Febuxostat API Hyperuricemia TDMF

79
memo

80
Korea Innovative Pharmaceutical Company

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