Korea Biomedicine Industry Association Status of BiopharmaceuticalIndustry in Korea

- ‌CBSBioscience: developed the first drug repositioning technique in Korea, Category Company Technology Development status
Develop new antitumor agent based on biomarkers Develop independent Three pipelines are in
Hanwha
* ‌In the US, it is mandatory to use biomarkers for targeted antitumor agent when seeking conjugation technique discovery stage
approval for clinical trials and launching. (Jun 2014) Develop a linker specifically
Alteogen conjugated the drug to Discovery stage
Annex1 | Status of Biosimilar/Better Development in Korea antibody
Develop Dolastin10 derivatives
Celltrion Discovery stage
Product name Comparator as a drug binding to antibody
Company Indication Phase Develop new antibody for
(Code name) (constituent) Discovery stage, Collaborates
ANRT ADC, based on fully humanized
Samsung Bioepis SB5 Rheumatoid arthritis 3 with Asan Medical Center
antibody library technique
LG Life Sciences LBAL Humira Healthy volunteer 1 Preclinical stage, Seoul
Humanized antibody specified National University,
Bio C&D BCD100 Healthy volunteer 1 ANRT
to ANFA and IP10 Metabolab and KRIBB
Schnell Life Sciences GS071 Rheumatoid arthritis 1 Double targeted collabolate
Remicade antibody Humanized antibody targeting
Samsung Bioepis SB2 Rheumatoid arthritis 3 Hanwha Pre-clinical stage
VEGFR2 and DLL4
Healthy volunteer 1 PharmAbcine DIG-KT, PIG-KM Discovery
LG Life Sciences LBEC0101
Enbrel Rheumatoid arthritis 3 Immunotherapy Humanized antibody targeting Discovery stage, Collaborates
ANRT
Daewoong antibody new immune check point with Busan Baik Hospital
DWP422 Healthy volunteer 1
Pharmaceutical co.
Non Hodgkin’s lymphoma 1
Samsung Electronics SAIT101 Annex3 | Status of Stem Cell Therapy Development
Rheumatoid arthritis 1
Mabthera
Follicular lymphoma 3 Company Product Category Target disease Phase
Celltrion CT-P10
Rheumatoid arthritis 3 Bone marrow derived Acute cerebral
MSC1 Auto 3
mesenchymal stem cell infarction
Samsung Bioepis SB3 Herceptin Breast ca. 3
Chongkeundang CKD-11101 Chronic renal failure, anemia 3 Cerecellgram- Bone marrow derived Chronic spinal
Auto 2/3
Nesp spine mesenchymal stem cell cord injury
CJ Cheil Jedang CJ-40001 Healthy volunteer 1
Pharmicell
PanGen PDA10 Eprex Chronic renal failure, anemia 3 Bone marrow derived
Livercellgram Auto Liver chirrhosis 2
mesenchymal stem cell

Hearticellgram- Bone marrow derived Acute myocardial

Auto 3
Annex2 | Status of Antibody Product Development AMI mesenchymal stem cell infarction

Category Company Technology Development status Adipose cell derived 1/2

Kstemcell Bascostem Auto Buerger’s disease
stem cell (Completed)
Next generation resource (previous RNL life
Green Cross and
technology, overcoming science) Adipose cell derived
ADC Legochem Neopharm collaborates for RNL-Astrostem Auto Spinal cord injury 1/2
previous ADC technology by stem cell
preclinical investigation.
using an unique linker

8 9
 Korea Biomedicine Industry Association Status of BiopharmaceuticalIndustry in Korea

Company Product Category Target disease Phase Company Product Category Target disease Phase
Adipose cell derived Degenerative 1/2 Cord blood derived Rheumatoid
ANL-Jointstem Auto Purestem-RA inj Allo 1
stem cell arthritis (Completed) mesenchymal stem cell arthritis
Adipose cell derived Embryogenic stem cell
Jointstem-Allo Allo Osteoarthritis 1
stem cell hES-RPE Allo derived retina epithelial Stargardt disease 1
Adipose cell derived 1 CHA bio and cell
ANT-SM Auto Fecal incontinence
stem cell Diostech Embryogenic stem cell
Senile dryform
Adipose cell derived Complex anal hES-RPE Allo derived retina epithelial 1/2a
ANTG-ASC Auto 2 AMD
stem cell fissure cell
Anterogen
Adipose cell derived Fistula from
ALLO-ASC Allo 1/2a
stem cell Crohn’s disease
Adipose cell derived Tennis elbow
ALLO-ASC-TI Allo 1/2 Annex4 | Status of Gene Therapy Development
stem cell (Epicondylitis)
Support an
Company Product Target disease Phase
Cord blood derived unrelated
Promostem Allo 1/2
mesenchymal stem cell hemopoietic stem Pusan National University JX-594 Renal cell carcinoma 2a
cell transplantation
Kolon Life Science Tissuegene-C Degenerative arthritis 3
Premature
Medipost Cord blood derived
Pneumostem Allo bronchopulmonary 2 Seropositive recipients undergoing
mesenchymal stem cell Astellas Pharma Global
dysplasia ASP0113 Inj. HCT (Hematopoietic Cell 3
Development Inc.
Transplant)
Cord blood derived Alzheimer’s
Neurostem Allo 1/2a VGX Internationals VGX-6150 Chronic Hepatitis B 1
mesenchymal stem cell dementia
Genexine HB-110 Chronic Hepatitis B 2a
Bone marrow derived 1 Oncolys Biopharm Inc. Telomerlycin HCC 1/2
Homeotherapy Homeo-GH Allo GVHD
stem cell (Completed) Colon cancer with hepatic
Recombinant
HYNR-CS Bone marrow derived 1/2 National Cancer Center metastasis, Gastric cancer with 1
Auto ALS Adenovirus
HYNR-CS inj stem cell (Completed) hepatic metastasis
Corestem Recombinant
HYNR-CS-Allo Bone marrow derived Dong-A University Hospital Advanced HCC 1
Allo ALS 1 Adenovirus
HYNR-CS-Allo inj stem cell Quintiles Telomerlycin HCC 1
Cord blood Long-term
derived Cord blood derived follow up
Allo Leg ischemia 1
mesenchymal mesenchymal stem cell Genexine GX-188E Premalignancy of Cervix (CIN3) observations
stem cell therapy from completed
BRIC phase 2
Cord blood derived
Kangstembiotech Purestem-AD inj Allo Atopic dermatitis 1/2a
mesenchymal stem cell Genexine GX-051 Head and neck cancer 1/2

Cord blood derived Shillajen SJ-103β Hepatic carcinoma 1

Purestem-CD inj Allo Crohn’s disease 1/2a
mesenchymal stem cell

10 11
 WHO Prequalification(WHO-PQ) Products

II WHO Prequalification(WHO-PQ)
Products

Product name Applicant Date of PQ Product name Applicant Date of PQ

GC FLU Multi NOV 2012

Influenza
Medicines (Seasonal) Green Cross
GC FLU APR 2011
Corporation
Influenza A
Shin Poong Green Flu-S MAY 2015
Artesunate + Pyronaridine (H1N1)
Malaria Pharmaceutical Co, FEB 2012
tetraphosphate
Ltd
in vitro diagnostics
Tuberculosis Cycloserine Dong-A ST Co, Ltd NOV 2012

SD BIOLINE Malaria Ag P.f/P.v 2015

Vaccines
Malaria SD BIOLINE Malaria Ag P.f 2015
RDT
Berna Biotech Korea SD BIOLINE Malaria Ag P.f Standard FEB 2010
Polyvalent
Quinvaxem in cPAD SEP 2006 Diagnostics
vaccine Corporation
SD BIOLINE Malaria Ag P.f/Pan JUL 2013
Polyvalent
vaccine Euforvac-Hib LG Life Sciences AUG 2012 SD BIOLINE HIV-1/2 3.0 MAR 2013
HIV RDT
SD Bioline HIV Ag/Ab Combo MAY 2013
Hepavax-Gene MAR 2004
Berna Biotech Korea * Sources : WHO, 2015
Corporation
Hepatitis B Hepavax-Gene TF JUL 2012

Euvax B LG Life Sciences NOV 1996

12 13
III
Company Introduction

Anterogen Co., Ltd

Bioneer Corporation
Boryung Pharmaceutical co., Ltd
Celltrion, Inc.
CJ HealthCare Corp.
Daewoong Pharmaceutical Co., Ltd
GeneOne Life Science, Inc.
Genexine, Inc.
Green Cross Corp.
HanAll BioPharma Co. Ltd.
Hugel
IL-YANG PHARMACEUTICAL CO., LTD.
ISU Abxis Co., Ltd.
GemVax & KAEL Co., Ltd.
Kolon Life Science, Inc.
LG Life Sciences, Ltd.
MEDIPOST Co., Ltd
Medytox
Samsung Biologics
Samyang Biopharmaceuticals Corporation.
Sewon Cellontech Co., Ltd.
SK Chemicals Co. Ltd.
Tego Science, Inc.
ViroMed. Co., Ltd.
 Company Introduction
Company introduction

Product
Product Image Classification Applications
Name

Anterogen Co., Ltd Cupistem® ETC, orphan drug

Autologous adipose-derived
mesenchymal cells for
treatment of Crohn’s fisulta

Promotes skin regeneration

Anterogen is a leading pharmaceutical company SCM2 cosmetics
after laser or MTS therapy.
for adipose-derived stem cell technology
Anterogen is a leading pharmaceutical company for stem cell research Home-care use for skin
Therastem
and development. The main objective is to develop a unique stem cell cosmetics regeneration after laser of
Derma
therapy for intractable, rare, and degenerative diseases that cannot be MTS therapy.
treated with current medical treatments.
Anterogen was established in 2000 as a biopharmaceutical company,
Stem Cell
focusing on development of adult stem cell therapy. Anterogen was the Skin care products for home-
Media cosmetics
first company within South Korea to research for commercialization of care and professionals.
Program Set
adipose-derived stem cells.
Moreover, Anterogen licensed stem cell technology to overseas in 2004,
and established a GMP factory in 2006 for production of all stem cell
R&D Pipeline
therapy products in sales and clinical trials field.
Anterogen has a potential technology to overcome limitations in stem Development
Cell type Project Indication
cell therapies. Our future objective is to become a world-class stem cell Stage
pharmaceutical company in global market by expanding the field of Autologous adipose- Registered,
Complex Crohn’s
stem cell therapy in intractable and degenerative diseases, and provide derived mesenchymal Cupistem available on
Fistula
a breakthrough in today’s medical treatments. stem cells market
ALLO-ASC-DFU Diabetic Foot Ulcer Phase II
Products Allogeneic ALLO-ASC-BI Burn Injury Phase II
Cupistem® is the world’s first registered product as autologous adipose- mesenchymal stem cell Dystrophic
derived stem cells. Cupistem®’s immunosuppressive effects with wound sheet ALLO-ASC-EB Epidermolysis Phase I
CEO repair abilities are highly effective for treatment of Complex Crohn’s
Sung Koo Lee
Bullosa
fistula. In clinical trials, 82% of patients with complex Crohn’s Fistula Allogeneic adipose- ALLO-ASC-TI Tendon Injury Phase II
Location observed healing effects after 8 weeks from treatment with good derived mesenchymal
(Namsung Plaza, Gasan-dong) tolerance, and long term observation showed 88% of fistulae remain stem cells ALLO-ASC-CD Crohn’s Disease Phase I
405, 130, Digital-ro, Geumcheon-
sealed after 12 months from treatment. 83% of fistulae closed after 24
gu, Seoul, South Korea
months from treatment.
Homepage
Despite complex Crohn’s Fistula is difficult to treat with standard therapies,
http://anterogen.com/main/en/ Cupistem® showed its efficacy without any harm on sphincter muscles.
* Reference : ‌Cell Transplant. 2013;22(2):279-85, Stem Cells. 2013
Nov;31(11):2575-81, Stem Cells Transl Med. 2015 May;4(5):532-7

16 17
 Company Introduction
Company introduction

discovery and development, from siRNA design/synthesis and preclinical tests to IND filing.
With its world’s-best RNAi core technologies and manufacturing infrastructure, Bioneer is the ideal
partner for pharmaceutical and biotechnology companies currently working on the development
Bioneer Corporation of RNAi therapeutics, or seeking to enter the RNAi field. Bioneer’s research and technical support
teams ensure top-quality products and services to meet your unique needs.

R&D Pipeline
Bioneer is currently advancing clinical development of pipeline programs for previously non-
Leadership in RNAi Therapeutics druggable targets, including cancer, IPF/COPD, liver fibrosis, and antivirals, internally with
our research and development resources as well as through partnerships with major global
pharmaceutical companies.
ABioneer Corporation is Korea’s leading biotech company. Bioneer
was the first Korean biotechnology company when it was established
in 1992. The company has developed state of art molecular biology
products and technologies including oligonucleotides/siRNA and
instruments of gene manipulation. The company is positioned to
fullyintegrate its capability to develop next generation technologies
in the post-genome era through the invention of new biochemistry
and instruments. By capitalizing on the foundational technologies
and products developed over 10 years, Bioneer has developed a solid
vertically integrated infrastructure to support new higher value-added
businesses such as novel RNAi drug development and molecular
diagnostics.

SAMiRNA™ Technology
SAMiRNA (Self-Assembled-Micelle-inhibitory-RNA) is a novel class of
RNAi molecule, developed by Bioneer, which allows efficient and safe
in vivo delivery of siRNA to target tissues. SAMiRNA is a SCE (single
Chemical Entity), which is manufactured using a proprietary process
that greatly simplifies the manufacture and QC process relative to other
state-of-the-art RNAi delivery platforms. SAMiRNA overcomes major
challenges for safe and effective siRNA delivery as well as adverse
CEO effects of delivery vehicle. Other advantages of SAMiRNA include its
Han-Oh Park, Ph.D. flexibility to incorporate siRNA sequences against any disease target, as
Location well as enhancement of its therapeutic potential as a delivery platform
49-3, Munpyeong-dong, through the use of cell-type specific targeting ligands. These features
Daedeok-gu, Daejeon 306-220, and pre-clinical research data suggest that SAMiRNA is the most unique
Korea and singularly effective RNAi prodrug system developed to date.
Homepage Vertically integrated processes within Bioneer’s siRNA Drug
www.bioneer.com Development Program provide a total solution for siRNA therapeutics

18 19
 Company Introduction
Company introduction

Boryung
Pharmaceutical co., Ltd.

Total Healthcare Company Contributing to the

Human Health

Boryung Pharmaceutical company (here after Boryung), since founded

in 1963, has been trying its best to contribute to the health and well-
being of humanity with corporate mission to ‘realize mutual health
and coprosperity based on human centered values’.
Boryung has invested continually on research and development
and made continuous efforts to produce highquality products in the
specialty areas such as cardiovascular, antineoplastic and antibiotics
drugs. As a result, our products such as Gelfos M, Yongkaksan and
Kyushin have become the best selling products and Boryung has
emerged as the most familiar and trusted brand in Korea.

R&D pipeline
Category Product RS PC PI PII PIII RG Launch

BVN
Vaccine ○
001

BVN
CEO Vaccine ○
Han-Oh Park, Ph.D.
002
Biologics
Location
BVN
49-3, Munpyeong-dong, Vaccine ○
Daedeok-gu, Daejeon 306-220, 003
Korea
Liver BCB
Homepage ○
www.bioneer.com Cancer 002

20 21
 Company Introduction
Company introduction

R&D Pipeline
Celltrion currently has 8 biosimilars candidates in various stages of development. The CT-P6 (Breast
Cancer) Project is in their most advanced stages of development, successful completion of clinical
celltrion Inc trials conducted in over twenty countries and completed submission for approval in Korea.

PROJECT CT-P06
- Indication: Metastatic and early breast cancer that over express HER2 gene (Protein Type: mAb)
Celltrion’s goal is to provide affordable
PROJECT CT-P10
alternatives to the high-priced antibody drugs, - Indication: Rheumatoid arthritis, Non-Hodgkin’s lymphoma (Protein Type: mAb)
price of which limits broad usage of the drugs. As a company specialized in antibody drug development, Celltrion is also developing innovative
antibody drug (PROJECT CT-P27) to overcome the limitations of existing vaccines and synthetic
drugs for pandemic or seasonal influenza viruses. Celltrion received IND approval from England’s
Celltrion prides itself in being the first company in the world to apply for
Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase 1 clinical trial for
global regulatory approval of an antibody biosimilar. We are using our accu-
CT-P27, an influenza antibody shown to have efficacy for pandemic and seasonal flu strains, includ-
mulated R&D technology and manufacturing capabilities to develop, man-
ing various subtypes of influenza viruses. The results of animal tests conducted by the US Center for
ufacture and market antibody biosimilars and innovative drugs to patients
Disease Control and Prevention showed that this new antibody drug may be effective in treating
in need. Celltrion hopes that more suffering patients will be able to have
avian influenza, influenza A and many other variationsof influenza viruses. Thus, this new drug is
access to and benefit from the new availability of advanced biomedicines.
expected to become the world’s first comprehensive influenza virus treatment antibody, if succeed-
ed.
Products Additionally, Celltrion is developing innovative drug to cure rabies by collaborrating with the US
emsima™ (infliximab) is the world’s first biosimilar mAb to receive pos- Center for Disease Control and Prevention. Celltrion is also working with a US biotech company
itive opinion from an advanced and developed nations’ regulatory body, to develop an antibody drug that is expected to be a cure for breast cancer and lung cancer. Other
which is a monoclonal antibody against tumor necrosis factor alpha than the antibody drugs pipeline, Celltrion is focusing on developing antibody-drug conjugate that
(TNF-α) used to treat autoimmune diseases like ankylosing spondylitis, minimizes side effects and maximizes efficacy by integrating antibodies with synthetic drug sub-
rheumatoid arthritis, Crohn’s Disease, ulcerative colitis, psoriasis and stances. Celltrion’s broad innovative drug pipeline is expected to serve as the driving force behind
psoriatic arthritis. The European Medicines Agency’s (EMA) Committee Celltrion’s future growth.
for Medicinal Products for Human Use (CHMP) had given positive opin-
ion for Celltrion-developed Remsima™ for sale in the European Union
(EU) in June 2013. With this positive CHMP opinion, Celltrion is per-
mitted to obtain marketing authorization approval (MAA) from 27 EU
countries and 3 EEA (European Economic Area) countries (for a total of
CEO 30 countries) through simple administrative procedures. Remsima has
JungJin Seo already received approval from the MFDS (former KFDA) in July, 2012.
Location Global launch of Remsima™ is remarkably good news for patients who pre-
13-6, Songdo-dong, viously had limited access to advanced therapeutics, in particular, those hin-
Yeonsu-gu, Incheon, 406-840, dered by the high cost of antibody biopharmaceuticals. We believe that the
South Korea first biosimilar mAb approval by the EMA will spearhead the start of a new
Homepage era of biosimilar mAbs in the pharmaceutical industry. Celltrion, Inc. also has
www.celltrion.com gained entry into the $24 billion TNF-α antagonist market and is likely to
be the only biosimilar product in the market for the next 4 to 5 years.

22 23
 Company Introduction
Company introduction

Products
Product Details

CJ HealthCare Corp. Epokine ® was developed 1st in Korea and 3rd in the
1. Epokine Inj. (rh-EPO) world. Epokine ® is safe and effective in treating anemia
of hemodialysis patients with end-stage renal disease.

Chemotherapy in advanced cancer patients and in acute

Heal the World, Better Life Leukemia patients can cause the Neutropenia. Leukokine
2. Leukokine Inj. (rh- G-CSF)
® can help to support their natural defenses during
CJ HealthCare started its business as Pharmaceuticals Business Unit at strong chemotherapy.
CJ CheilJedang Corporation from 1984.
In line with CJ’s corporate vision, CJ HealthCare has been striving for
making people healthier, happier and better convenient with innovative R&D Pipeline
and differentiated pharmaceutical products. As of 1 st April, 2014, CJ Pipeline Description DS PC PI PII PIII NDA
HealthCare was spun off from CJ CheilJedang Corporation and became CJ-40001 Anemia ○
a separate pharmaceutical corporate entity with purpose of enhance-
ment of expertise in pharmaceutical business to grow globally. Hand-Foot-Mouth Hand-Foot-Mouth
○
CJ HealthCare has become a representative Korean pharmaceutical Disease vaccine Disease
company in promising therapeutic areas such as oncology, cardiology, LUCENTIS Biosimilar Retinopathy ○
endocrinology and nephrology. CJ HealthCare is working hard to grow
globally, focusing on rapidly growing China and Southeast Asian mar-
kets as well as highly-regulated but attractive Japan and EU markets.
Through our newly established cGMP compliant plant in Osong, CJ
HealthCare can secure global standard manufacturing facilities and op-
eration capabilities.
CJ HealthCare will make its best efforts to jump into a leading position
among global pharmaceutical companies.

CEO
Dal won Kwak, Chul ha Kim
Location
CJ CheilJedang Center, 330,
Dongho-ro, Jung-gu,
Seoul 100-400, Korea
Homepage
www.cjp.co.kr

24 25
 Company Introduction
Company introduction

R&D Pipeline
Daewoong
Pharmaceutical Co., Ltd.

Daewoong Pharmaceutical is the pharmaceutical

company with the No. 1 sales of prescription
drugs in the Korean market.
Established in 1945 in Seoul, South Korea, Daewoong Pharmaceutical
offers high-quality and innovative pharmaceutical products and is one
of the top market leaders in Korea.
For over 60 years, Daewoong Pharmaceutical has been providing better
health for people through its total dedication to healthcare. Daewoong
has built strong core competency for new drug development to meet
diverse medical needs and enhance human life.
Building on our core strength, Daewoong Pharmaceutical has involved
in becoming a global healthcare group by operating our foreign branch-
es in SE Asia and by collaborating with global partners. We have an
inspiring mission to become a top 50 global healthcare company which
contributes to improving the quality of life for people worldwide.
The reinforcement of the R&D capacities through the establishment of
R&D center in the USA, China and India.
Daewoong Lifescience Research Institute has been focused on devel-
oping new chemical entities, biologics, incrementally modified drugs
CEO and high-value added APIs. Daewoong has also been studying to find
Lee, Jong Wook
solutions for the unmet therapeutic needs of neuropathic pain disease,
Location
Alzheimer’s disease as well as other innovative programs like anticancer
163-3, Samsung-dong,
Kangnam-gu, Seoul, gene therapy. Daewoong is operating several overseas offices in China,
Korea Vietnam, Indonesia, Thailand, Philippines, USA, and India and has R&D
Homepage centers in China, India and America.
www.daewoong.com

26 27
 Company Introduction
Company introduction

R&D Pipeline
GeneOne Life
Science, Inc.

GeneOne Life Science, Inc. is a biopharmaceutical

R&D company dedicated to the development
and contract manufacturing of plasmid-based
biomedicines, including DNA vaccines.

With exclusive rights to use core technologies of DNA design and in

vivo delivery that are critical in development of gene-based biomedi-
cines – including DNA vaccines – GeneOne Life Science, Inc. is distin-
guished from most global competitors that use partial technologies.
The company is recognized as a global leading company in this field
with advanced technologies and patents in manufacturing of DNA
vaccines and plasmid medicines and wholly owns an international-
ly-recognized plasmid contract manufacturing organization (CMO)
called VGXI, Inc. that satisfies international standards for clinical
pharmaceutical products.
CEO
Young K. Park
Location
223 Teheran-Ro, Suite 1903,
Gangnam-Gu, Seoul, Korea
Homepage
www.genels.com
Homepage
Moonsup JEONG (Director/
Pharma R&D Division),
(msjeong@genels.com,
+82-2-557-6784)

28 29

Company introduction
Genexine, Inc.
CEO
Young Chul Sung, Ph.D
Location
700 Daewangpangyo-ro, Korea
Bio Park Bldg. B, Bundang-gu,
Seongnam-si, Gyeonggi-do
463-400, South Korea
Homepage
http://genexine.com
30
Genexine, Inc. is a leading biotechnology company
specializing in immunotherapeutics, based on its
strong immunology expertise and R&D capabilities.
Founded in 1999, Genexine consists of about hundred employees, half
of which are scientists with MSc or PhD. Genexine is located in Korea
Bio Park, Pangyo Techno Valley near Seoul, Korea.
Platform Technology
1) hyFc
‌ technology – next generation half-life extension
technology
Genexine creatively invented hybrid Fc fusion half-life extension
technology that enables long-acting protein therapeutics with well-
balanced benefit of efficacy, safety, convenience, cost-efficiency as well
as substantially low risk of immunogenicity.
2) therapeutic DNA vaccine technology for infectious diseases
and cancer
Through long history of DNA vaccine R&D, Genexine has
accumulated extensive technology and know-how of therapeutic
DNA vaccines against viruses such as HPV, HBV, TB, etc. DNA vaccine
induces robust antigen-specific immune response against infected
cells or cancer.
Based on proprietary innovative platform technology, Genexine
has developed various products in preclinical and clinical-stages.
Genexine’s major clinical pipelines are GX-H9 (long-acting hGH-
hyFc) in Phase II in EU and Korea and GX-188E (therapeutic HPV
DNA vaccine) in Phase II in EU and Korea. In pre-clinical stage,
Genexine has GX-P2 (PD-L1-hyFc as a PD-1 agonist) for autoimmune
diseases, GX-I7 (IL-7-hyFc), GX-F7 (long-acting Factor VII-hyFc), etc.
Company Introduction
R&D Pipeline
1) GX-H9 (Long-acting hGH-hyFc): Long-acting human growth hormone (hGH) genetically fused
with Genexine’s proprietary hybrid Fc (hyFc) platform. The first in human trial has been completed
in EU and currently a multinational AGHD patient phase 2 clinical study is being conducted in EU
and Korea. In phase I clinical trial, no SAEs and ADA formation were reported, and dose-dependent
PK and PD (IGF-1 level) profiles were demonstrated. GX-H9 is targeting pediatric and adult growth
hormone deficiency patients with weekly and semi-monthly administration and being co-developed
with Handok Pharmaceuticals.
2) GX-188E (HPV therapeutic DNA vaccine): HPV therapeutic DNA vaccine for Cervical
Intraepithelial Neoplasia (CIN) / Cervical Dysplasia in Phase II clinical trial. GX-188E has the
potential to induce complete regression from high grade Cervical Intraepithelial Neoplasia caused
by high-risk types of HPV16/18 infection. In Phase I clinical trial, Genexine demonstrated that
electroporation(Ichor Medical Systems)-enhanced immunization with a rationally designed HPV
DNA vaccine (GX-188E), preferentially targeting HPV antigens to dendritic cells, elicits a significant
E6/E7-specific IFN-γ-producing T-cell response in all nine cervical intraepithelial neoplasia 3 (CIN3)
patients. Seven out of nine patients displayed complete regression of their CIN3 lesions and viral
clearance and exhibited an enhanced polyfunctional antigen-specific CD8 T-cell response within 36
weeks of follow up. These results were recently published in Nature Communications (Kim et al.,
Nature Comm., 2014; 5,5317).
3) GX-P2 (PD-L1-hyFc as a PD-1 agonist): GX-P2 is PD-L1-hyFc as a PD-1 agonist, which is
a first-in-class drug candidate in preclinical stage for autoimmune diseases. It is based on our
innovative long-acting hyFc technology (next generation Fc fusion technology). GX-P2 is designed
to induce T-cell tolerance by targeting PD-1 and/or B7.1 and able to regulate uncontrolled T-cell
activation or proliferation in autoimmune diseases. We confirmed animal PoC in inflammatory
bowel disease (IBD) and published the results in Gut journal (Song et al., Gut, 2015; 64(2):260-
271).
31
 Company Introduction
Company introduction

R&D Pipeline

Green Cross Corp.

Development of Medications That Are Difficult to

Produce but Necessary
Green Cross is an exemplary R&D-oriented company that leads the bio-
technology industry in Korea. This is clear given what Green Cross has
achieved since its foundation in 1967.
GCC has pioneered in the field of biopharmaceuticals, such as vaccines,
plasma-derivatives, diagnostics, recombinant proteins and therapeutic an-
tibodies. GCC has been well known for the R&D and commercialization of
‘Hepavax™ B’, a world’s biggest selling hepatitis B vaccine, ‘Hantavax™
’, a world’s first epidemic hemorrhagic fever vaccine, and ‘Suduvax™’,
a world’s second chicken pox vaccine. A complete flu pipeline includes
seasonal flu vaccine (GCFLU TM ), H1N1 vaccine, avian flu vaccine and etc.
GCC is also pursuing opportunities in rare diseases developing therapies for
Hunter syndrome (Hunterase™) and Fabry disease (GC1119). With contin-
uous investment in R&D, its portfolio now includes gene/cell therapeutics
and small molecule drugs. In 2011, GCC earned $616 million in revenue
recording it as 3 rd largest Korean pharmaceutical company and invested
$51.7 million in R&D which is one of the highest in Korea.

Products
Plasma Fractions & Recombinants
Starting from the nation’s first Albumin production in 1971, Green Cross
currently manufactures more than 12 plasma fractions including immu-
CEO noglobulin, anti-hemophilic factors, and anti-thrombin factor. Recent
Il-Sup, Huh innovations include ‘BDD rhFVIII (GreenGene TM F)’, a 3 rd Generation
Location of recombinant Factor VIII for hemophilia A treatment.
303 Bojeong-dong, Vaccines
Giheung-gu, Yongin, Korea We succeeded to develop the world’s third Hepatitis B vaccine in 1983,
Homepage the world’s first epidemic hemorrhagic fever vaccine in 1988. With the
www.greencross.com construction of Hwasun plant, a vaccine-oriented manufacturing facility,
the influenza vaccine GC Flu TM became the fourth in the world to ob-
tain PQ (Pre-Qualification) approval from the WHO.

32 33

Company introduction
HanAll BioPharma Co. Ltd.
nnovative Medicines to Improve the Quality of
Human Life
HanAll BioPharma is a R&D-oriented pharmaceutical company, currently
listed on the Korean Stock Exchange (KOSPI).
R&D Pilpeline
Product Information
HL156Can, a mitochondrial primer, is a New
Chemical Entity (NCE) targeting cancer
metabolism, inhibiting mitochondrial OXPHOS
system. This inhibition leads to ATP depletion,
which increases metabolic stress in cancer
cells. HL156Can exhibits cytotoxic effect in
cancer cells with defected AMPK signaling
function and cytostatic effect in cancer cells
HL156CAN
with normal AMPK signaling function. HanAll
has confirmed potential efficacy of HL156Can
to overcome resistance in number of selected
CEO
cell lines. Currently, HanAll is conducting in-vivo
Dr. Sungwuk Kim,
Dr. Seungkook Park
experiments with LKB1 -/- (NSCLC) xenograft
Location
model, Braf V600E inhibitor resistant melanoma
11-10 Sincheon-dong, HL040, a fixed dose combination product, is composed of atorvastatin and
Songpa-gu, Seoul, Korea xenograft model, and lapatinib resistant
Homepage xenograft model.
www.hanallbiopharma.com
34
Company Introduction
HL036 is TNF-alpha receptor fragment for the treatment of local inflammatory
diseases caused by TNFalpha such as uveitis, dry eyes, and AMD. Current
systemic anti-TNF drugs’ limitations include small volume of distribution and
adverse drug events due to high dosage. Therefore, by utilizing fragment,
HanAll’s TNF receptor fragment will have greater volume of distribution when
administered topically compared to currently marketed anti-TNF-alpha products
HL036 having larger molecular size. Furthermore, via protein engineering, HL036 will
have greater affinity to allow smaller doses and increase the efficacy.
It is anticipated that higher concentrations of HL036 will be found in targeted
ocular areas when administered topically, preventing systemic ADEs. HanAll
aims to utilize this unique property of HL036 for the indication of dry eyes by
developing ophthalmic solution.
HanAll is currently developing fully human monoclonal antibodies targeting the
Fc Neonatal Receptor (FcRn) for the treatment of autoimmune diseases caused
by IgG autoantibodies.
FcRn plays an essential role in IgG homeostasis by regulating a salvage pathway
that prevents lysosomal degradation of IgG, thus contributing to a long half-life
HL161 in the circulation. While FcRn-mediated half-life extension is beneficial for IgG
antibody responses against pathogens, it also prolongs the serum half-life of
IgG autoantibodies and thus promotes tissue damage in autoimmune diseases.
Hence, HL161 will reduce overall concentration of IgG by blocking FcRn, leading
to reduced levels of pathogenic IgG.
HL009, adenosylcobalamin liposomal gel, has three different potential
mechanisms of actions for the treatment of atopic dermatitis. HL009 can
bind to nitric oxide (NO) which causes dermatitis; also it can inhibit inducible
nitric oxide synthase (iNOS) to further reduce NO levels. From an immunology
perspective, HL009 can activate T regulatory cells which excrete IL-10 and TGF-
beta suppressing immune response.
HL009
Adenosylcobalamin has low permeability through skin due to its large
molecular size and relatively high hydrophilicity. Thus, HanAll has formulated
adenosylcobalamin topical product utilizing liposomal formulation technology.
Benefits of liposomal formulation technology include improved stability,
enhanced skin penetration due to increased lipophilicity, and reduced skin
irritation by using lipids with proven safety.
losartan for the treatment of hyperlipidemia and hypertension. HanAll finished
HL040 the phase I study, and currently conducting phase III trial in Korea and phase I
study in US.
35
 Company Introduction
Company introduction

Products
Product Details
Botulax There are three product types, 50, 100, and 200 units, per vial. The ap-
Hugel Injection proved indications are blepharospasm and glabellar line improvement,
(Botulinum and will be expanded to post stroke upper limb spasticity and pediatric
Toxin Type A) cerebral palsy. Currently, expansion of the range of treatment such as
hyperhidrosis, painless liquid product, non-animal origin products, and
etc. are under development.
Hugel Inc. was established in 2001 aiming to The Chaeum It is a low-pain hyaluronic acid product containing lidocaine and
improve the quality of humans’ blissful lives by (‌Crosslinked consisted of four types, No.1, No. 2, No. 3 and No. 4, according to its
providing “healthy and long-lasting beauty to hyaluronic viscoelasticity. The Chaeum is provided with a dedicated injection
acid) cartridge which considers the convenient injection and patients’ safety.
human kind” It functions as temporary facial wrinkle improvement and tissue resto-
ration.
Hugel Inc. developed biological product “Botulax” using botulinum tox-
Wellage It is a skin cosmetic line enhancing moisturizing and antioxidant
in and gained 40% of market share in Korea. Since 2009, we have been
(Cosmetics) functions, being consisted of ‘Vital Neo Water-Lock-Toner’, ‘Enrich
exporting “Botulax” to 19 countries including Asia, such as Japan, Thai-
Emulsion’, and ‘Nutritious Rich Cream’. This bio-cosmetic, Wellage,
land, Philippine and etc., and South America, such as Peru, Paraguay,
provides proper cares per each skin type as cosmeceuticals with use of
Bolivia, Chile, Columbia, Ecuador, and etc.
key ingredients such as nero-peptide, melatoine and plant-based stem
In more than 30 countries, the registration including clinical trials is in
cell extractions.
progress, expecting to get approval for Russia in 2016, China and Eu-
rope in 2018, the United States in 2019. In order to ensure the increas- Bluerose It is a facial fixing thread having Polydioxanone as main ingredient. It
ing market demand, the second plant with cGMP standards has been (Facial tissue is absorbable in human body as medical thread for facial tissue fixing,
completed and will be operated from 2016. fixing thread) which has skin lifting effect by barbs around the thread when inserted
In 2014, we launched ‘The Chaum’ which is a filler product, the most to loosen or dented parts caused by facial tissue loss and etc.
popularly used in plastic surgery and cosmetic field along with botu-
linum toxin. Also, we accelerate our growth by introducing facial lifting R&D Pilpeline
product (Blue Rose), cosmeceutical (Wellage), and etc. to create synergy Pipeline Description DS PC PⅠ PⅡ PⅢ NDA
effect with existing products. We, Hugel Inc., try to grow as an interna- siRNA products to prevent
tional specialty pharmaceutical company that continuously research and BMT101 and inhibit intractable ○
develop pharmaceutical products in various markets including indication hypertrophic scar
expansion of botulinum toxin, scar treatment development and etc.
CEO
Dynamic equinus foot
Kyeong Yeop Moon deformity in children with ○
Botulax cerebral palsy
Location
61-20, Sinbuk-ro, Sinbuk-eup, (Botulinum Post stroke upper limb
○
Chuncheon-si, Gangwon-do, neurotoxin spasticity
24206, Korea Type A) Hyperhidrosis ○
Homepage Painless liquid product
www.hugel.co.kr
○
development

36 37
 Company Introduction
Company introduction

3) Indication: Prevention of influenza for persons above 6 months

IL-YANG 4) ‌Development stage:
- WHO Prequalification submitted on JAN, 2015
PHARMACEUTICAL CO., LTD. - BLA approval on 8th AUG, 2013 in Republic of KOREA
5) Key features
- The IL-YANG Inactivated Split Influenza Vaccine showed HI antibody met the US FDA guideline
for both age groups, the 6 month to < 18 year age group (Children) and the ≥ 18 year age group
(Adults)
Respect Humanity, Promote Human’s Health, - The long-term safety assessments showed low frequency serious adverse events
Improve Welfare
R&D Pilpeline
IL-YANG Pharmaceutical Co., Ltd. has been exerting its intended
efforts to manufacture superior pharmaceutical products for the last
half a century and it is still going on. Since it took the first step to
supply pharmaceutical products in Korea, since 1946, IL-YANG has
been advancing into a top-ranking pharmaceutical company in the
world with developing in the area of Gastrointestinal, Hematology,
Vaccine, and Virology. IL-YANG established vaccine plant in April 2011
with production capacity of 60mil doses per year. IL-YANG has been
exporting a variety of pharmaceuticals to approximately 30 countries
including USA and Europe. IL-YANG established two branches in
China, YANGZHOU IL-YANG PHARM. Co., Ltd. and TONGHUA IL-YANG
HEALTH PRODUCTS Co., Ltd. for manufacturing and distribution of
finished pharmaceuticals in China. Since their establishment, the sales
and business are expanding enormously. In Sept. 2014, YANGZHOU IL-
YANG had completion ceremony for newly built cGMP plant which is
compliance to EU-GMP standard.

Products
IL-Yang Flu Vaccine INJ.
1) ‌Purified inactivated trivalent influenza split vaccine (Vial & Prefilled
CEO syringe)
DONG YEON, KIM 2) Thimerosal-free & preservative-free product (fertilized embryo based)
Location
IL-YANG BLDG. 194 Dogok-ro,
Gangnam-gu, Seoul, Korea
Homepage
www.ilyang.co.kr

38 39
 Company Introduction
Company introduction

ISU’s excellent bio-technology expertise provides a global and local potential partner with (1) the
higher productivity at CMO level (2-5g/L), (2) development management system enabling the first-
in-human IND from the cell line development within 24 months, and (3) higher biosimilarity to its
ISU Abxis Co., Ltd. original product.

Products
Product Details
- Indication: Adjunct to Percutaneous Coronary Intervention (PCI)
Accumulation of High-value Core Technologies in - The first therapeutic antibody developed in Korea and the
Biotechnology to Develop Future Products Clotinab (Abciximab) world’s second Abciximab
- Launched in Korea in 2007 and exported to twelve countries
ISU Abxis is the leading Korean biopharmaceutical company which including India, Turkey, Columbia, Venezuela and etc.
succeeds in development on the first therapeutic antibody in Korea. ISU - ‌Indication: Enzyme Replacement Therapy (ERT) for Gaucher
Abxis provides the world-class products to MENA and Latin America disease (GD)
region and continues to expand its business portfolio by collaboration - The first drug for GD developed in Korea and the world’s
with the US and EU based pharmaceutical companies. Abcertin (Imiglucerase)
second Imiglucerase
Since 2001, ISU Abxis has established its own platform technologies - Launcher in Korea in 2013 and under the registration in
and product pipelines with a desire of being an axis of all therapeutic around 20 countries
antibody industry as its name stands (ABXIS=AntiBody + aXIS). Begin-
- Indication: Enzyme Replacement Therapy (ERT) for Fabry disease (FD)
ning with the successful development and market-launch of ISU’s first
Fabagal (Agalsidase - ‌‌The first drug for FD developed in Korea and the world’s second
therapeutic antibody in 2006, ISU Abxis has led Korean biopharmaceu-
beta) Agalsidase beta
tical industry specialized in biosimilars and biobetters. Consequently in
- Launched in Korea in 2014
2013 and 2014, ISU Abxis launched two biotherapeutics for orphan dis-
eases of Gaucher and Fabry. ISU Abxis has accumulated the world class - Indication: adjunctive therapy in the chronic management of
Pheburane (Sodium
manufacturing and QC/QA management through the full development urea cycle disorders
phenylbutyrate)
and manufacturing experiences in the globally harmonized compliance. - Imported product from EU (under the Korean registration)
ISU’s three products, supplied to around 30 countries including Turkey,
India, Algeria and Venezuela, are available as the only alternative R&D Pipeline
against the originator in the world. Furthermore, ISU Abxis operates the
mammalian production dedicated cGMP facility as obtained the GMP
certificates from Turkey, Brazil, Colombia and a number of major coun-
CEO
tries in Latin America and Middle East.
Daeseong Kim
Now ISU Abxis also makes its great efforts in the development of novel
Location biologics for the patients with cancer and hemophilia. Besides the inter-
Global R&D Center C-5F, 22
nal development activities, ISU Abxis recently does its best in importing
Daewangpangyo-ro, 712beon-
gil, Bundang-gu, Seongnam-si, and providing orphan drugs for Korean patients who suffer the lack of
Gyeonggi-do, 13488, Korea treatment option.
Homepage ISU Abxis will grow its advanced technology based business for diffi-
www.abxis.com cult-to-treat and orphan disease market both domestically and world-
wide

40 41
 Company Introduction
Company introduction

R&D pipeline

GemVax & KAEL Co., Ltd.

GemVax & KAEL Co., Ltd. is an innovative

company dedicated to development,
commercialization of anti-cancer vaccine, peptide
vaccine and infectious disease DNA vaccine.

Products
RIAVAX® (code name: GV1001)
RIAVAX is the “first-in-class” therapeutic vaccine for the treatment
of patients with pancreatic cancer. In September 15, 2014 Korean
Ministry of Food and Drug Safety (MFDS) granted RIAVAX marketing
and manufacturing authorization in Korea as a treatment of locally
advanced or metastatic pancreatic cancer patients whose serum
level is higher than 81.02pg/mL in combination with Gemcitabine/
Capecitabine.
RIAVAX is a peptide vaccine derived from human telomerase that is
abundantly expressed in most of human cancers. Briefly, the mechanism
by which RIAVAX kills cancer cells is to elicit combined CD4+/ CD8+
T cell responses, thereby inducing tumor eradication as well as long
term memory. The safety and efficacy/Immunogenicity of RIAVAX in
CEO
Sang Jae Kim, Kyung Hee Kim
pancreatic cancer has been investigated and confirmed in number of
Location previous thirteen clinical trials. In a large-scale phase lll trial TeloVac,
146 Unjung-ro, Bundang-gu, the safety and immune-modulating effect of RIAVAX were confirmed
Seongnam-si, Gyeonggi-do,
Korea in over 1,000 patients. The key finding obtained from the TeloVac trial
Homepage was that RIAVAX markedly prolonged the survival in a group of patients
www.gemvax.com having high serum eotaxin level (>81.02pg/mL).

42 43
 Company Introduction
Company introduction

At this stage of the development, Kolon Life Science is eager to find partners who are interested in
Kolon Life the collaboration opportunities for the product in the market of Latin America.
(Licensing Opportunities) Commercialization including necessary clinical development and Sales/
Science, Inc. Marketing in the countries

Products
Product Details
Kolon Life Science, Inc. as a biotech company
A single intra-articular injection to knee joint provides with almost 2
with gene and cell technical platform has been years' long-term management of symptoms and delaying in disease
investing to R&D in the field of orthopedics, Invossa™
progression by anti-inflammation and structural improvement through
autoimmune disease, pain and cancer. re-establishing cartilage homeostatic balance in the OA knee joint

Invossa™ is the company’s first in-house developing product which is a

single Intra-Articular (IA) injection based in cell-mediated gene therapy R&D Pipeline
for the treatment of Osteoarthritis (OA) and which is currently in clinical Licensed
phase 3 in both US and Korea. - The US trials have been being conduct- Pipelines Description DS PC PI PII PIII NDA MKT
Territory
ed by its US entity, TissueGene, Inc.
The company has been seeking for partners who are interested in com- A gene therapy which
mercialization and marketing of Invossa™ in their territory where the blocks the signal of
KLS-2020 ○
OA market is promising since no definite therapeutics have been so far pain to the brain using
while the product has a strong potential to be the first Disease Modify- a specific gene
ing OsteoArthritis Drug proven by clinical evidences.
A therapy which
Proposition attack and kill only
The advantages of Invossa™ over existing products satisfy the unmet cancer cells selectively
medical needs of patients who have had no choice but to relying on KLS-3020 without harming nor- ○
only the extensive surgical interventions (i.e., total knee arthroplasty) mal cells consequently
following after enduring the pain taking oral anti-inflammatories or IA increasing the immune
injections like Hyaluronic Acid and Steroid just for temporary symptom response to tumors.
CEO
Lee, Woosok
relief. The DMOAD profile which Invossa™ is targeting for is expected
to fulfil the requirement from the patients who need to delay the dis-
Location
ease progression as long as possible in consideration of proper timing
Kolon Tower Annex, 13
Kolon-ro, Gwacheon-si, of surgical interventions which have limited shelf-life in their lifetime.
Gyeonggi-do, 427-709, Invossa™ was completed in clinical trial phase 2 in US and reached to
Republic of Korea the agreement with FDA through Special Protocol Assessment for phase
Homepage 3 which is targeting to be entered in the first half of 2016. In Korea,
www.kolonls.com phase 3 clinical trial was recently finished and its BLA is going to be
submitted within 2015.

44 45
 Company Introduction
Company introduction

Follitrope® Recombinant FSH, used in the treatment of female infertility in

controlled ovarian hyperstimulation to induce the development of
multiple follicles in a medically assisted reproduction program as well
LG Life Sciences, Ltd. as anovulation

Hyruan Plus® High molecular weight hyaluronic acid viscosupplement made by

microbial fermentation for low side-effect,
quality proven by EMEA and CE marking
The First Pioneer in Korean Pharmaceutical R&D
Products
R&D Pipelines
LG Life Sciences is Korea’s leading biopharmaceutical company.
One of LG Group affi liate, demerged from LG Chem in 2002. LGLS
is leveraging its proven R&D capabilities to develop world-class
products, Factive® , the only US FDA approved novel chemical
drug, as well as Valtropin® , the fi rst biosimilar approved by the
EMEA and US
FDA developed in Korea. LGLS is building a network of strategic
alliances to extend its R&D and marketing reach.

Products
Products Details * HA = Hyaluronic acid

Fast Active, the most potent quinolone

Factive® antibiotic in the world, commercialized in over
30 countries worldwide

A novel dipeptidyl peptidase IV (DPP IV)

inhibitor for T2DM with good efficacy and
Zemiglo®
safety profiles.
Approved by the KFDA in June, 2012
CEO The right choice for managing short stature
Il-Jae Jung Eutropin® recombinant human growth hormone with
Location proven efficacy and safety since 1993
LG Gwanghwamun Bldg. 92,
Sinmunno-2ga, Jongno-gu,
Seoul, Korea Human recombinant erythropoietin, safe and
Espogen® effective treatment for anemia of chronic
Homepage
www.lgls.com
renal failure

46 47
 Company Introduction
Company introduction

Products
Product Details

MEDIPOST Co., Ltd
M E D I P O S T h a s d e d i c a t e d i ts f o c us o n
biotechnology from its foundation in year 2000
until today, in spite of numerous adversities, rises
and falls within the stem cell area.
As a result, MEDIPOST has become a front-runner in the field of the bio-
pharmaceutical drug not only in Korea but also in the world. MEDIPOST
with its state-of-the-art platform technology has led to the development
and approval of the world’s first allogeneic stem cell therapy product –
CARTISTEM.
MEDIPOST continues its endeavors on clinical development and com-
mercialization of stem cell therapeutics to improve quality of lives of
many patients with intractable diseases not only in Korea, but also in
the global markets.
• ‌Stem Cell Therapy Product (Allogeneic umbilical cord blood-derived
mesenchymal stem cells)
• Approved by MFDS Korea in January, 2012.
CARTISTEM
• ‌Indication: For the treatment of knee articular cartilage defects
in patients with osteoarthritis (ICRS grade IV) as a result of
degenerative disease or repeated trauma.
Representative cord blood bank in Korea. Consistent No. 1 stem cell
technology in Korea.
The hematopoietic stem cells and other types of stem cells in cord
Stem Cell Bank:
blood are stored in cord blood bank and then supplied back when
Cord Blood Bank
transplantation is needed for the treatment of diseases.
The cord blood storage process of MEDIPOST is the current standard
of cord blood banks in Korea and is globally recognized as well.
R&D Pipeline

CEO
Yang, Yoon Sun
Location
21, Daewangpangyo-ro
644beon-gil, Bundang-gu,
Seongnam-si, Gyeonggi-do,
Korea
Homepage
http://www.medi-post.co.kr
Contact
Erica Y Ryu General Manager,
MEDIPOST America, Inc.
Rockville, MD 20850
Tel: +1 301 605 1087
E-mail: erica.ryu@
medipostamerica.com

48 49

Company introduction
Medytox
Toxin, Filler and Even More
We are at the forefront of Korean biopharmaceutical industry,
thanks to our excellent R&D capabilities based on our top-tier
biotechnologists, and to our state-of-the-art operations and production
facilities. Moreover, we are going to become a trailblazer in the field
of biotechnology due to our passion and courage to embrace global
challenges.
Since Botulinum Toxin Type A Neuronox (Neuronox is also being sold
worldwide under different brand names such as Siax, Botulift, Cunox
and Meditoxin) was launched in 2006, Medytox has shown a dramatic
growth.
Since 2009, we have ranked No. 1 market share in Korea and reached
near 40% of market share. As more diverse indications are added, it
appears that our market share would further increase.
Our company has successfully developed the fourth botulinum toxin
biopharmaceuticals in the world. We are exporting the products to
about 50 countries, including Japan, Thailand, India and Brazil. We are
also expecting to be a leading global biopharmaceutical company after
entering the North America and EU markets in 2016.
CEO
Jung Hyun Ho
Location
641-4 Gak-ri, Ochang-eup,
Cheongwon-gun, Chungbuk 363-
883, Korea
Homepage
www.medytox.com
50
Company Introduction
Products
Products Details
Medytox’s core business area is manufacturing botulinum toxin
type A biopharmaceuticals, Neuronox. It is widely used not only
Botulinum Toxin Type A
product
in the cosmetic field, including facial wrinkle reduction, but also
in the therapeutic field, for people with blepharospasm, cerebral
palsy, etc.
Medytox’s hyaluronic acid filler, Neuramis is currently being used
in the field of cosmetics to smoothen deep and fixed wrinkles on
Hyaluronic Acid skin tissue. Also, it is used as therapeutic agent for surgery and for
Dermal Filler treatment of arthritis.
As a partner product, it could maximize a synergy effect along
with Medytox’s core product Neuronox.
R&D Pipeline
Fueled by the success of Nueronox, we plan to perform a basic study for the development of
innovative bio pharmaceuticals to heal degenerative arthritis, senile ocular disease, skin disease
and cancer. We have strengthened base technology in protein engineering, antibody engineering
and cell biology by recruiting talented personnel. As the first achievement, we have completed
basic verification studies on degenerative arthritis and senile ocular disease (MT202 and MT401).
It appears that they would enter into the pre-clinical phase in 2013. We plan to keep making
investments with a long-term vision to be a global biopharmaceutical leader through development
of innovative drugs.
51

Company introduction
Samsung Biologics
CEO
Tae Han KIM (President & CEO)
Location
125, Cheomdan-daero, Yeonsu-
gu, Incheon, Korea 406-840
Homepage
https://www.samsungbiologics.
com
Contact
abin.yun@samsung.com
Tel : +82-32-455-3714
Fax : +82-32-455-3825
52
Company Introduction
Samsung BioLogics was established in April 2011
and is rapidly becoming a leader in the All plants are designed as multi-product facilities to meet the requirements of the U.S. FDA, EMA,
biopharmaceutical industry. and other global regulatory agencies. The layout allows for an optimal flow of personnel, materials,
samples, product, and waste. The two facilities are optimized for minimum change-over time
Our first two state-of-the-art, multi-product biologics facilities between batches, and the modular design of our filling suites seamlessly accommodates future
contain multiple production trains with separate suites for Upstream, expansions e.g. for pre-filled syringes, and additional liquid and lyophilization filling capacity.
Downstream and Fill & Finish, and a warehouse including long-term Samsung BioLogics’ facilities are capable of producing high quality bulk drug substances and drug
cold storage capacity. products within the same facility – thus being a truly integrated to maximize customer satisfaction
All production facilities are designed to meet the requirements of the U.S. while minimizing potential product risks and costs.
FDA, EMA, and other global regulatory agencies. They are designed to We are proud of our capabilities to deliver high quality products to our customers.
allow for optimal flow of personnel, materials, samples, products, and
waste, as well as, minimum product change-over time between batches.
Through modular design, our filing suites can accommodate liquid
fill, lyophilization unit production, labeling, primary and secondary
packaging, as well as room for future expansion.
Samsung’s Incheon bio-campus is truly a one-stop bio-manufacturing
location capable of producing high quality bulk Drug Substance and
Drug Product, thus delivering maximized customer satisfaction and
convenience.
Products - Biopharmaceuticals CMO
cGMP Manufacture of Drug Substance (DS) & Drug Product (DP)
Facility Overview
Samsung BioLogics facilities are located close to the Incheon Interna-
tional Airport in Incheon, South Korea, and are built on a single 68 acre
site, allowing for future expansion. The first two plants are designed
to support mammalian production requirements and contain suites for
upstream, downstream, fill & finish, an administration building, and a
warehouse including, a significant volume long-term cold storage ca-
pacity.
53
Company introduction

Company introduction
Samyang
Biopharmaceuticals Sewon Cellontech
Corporation. Co., Ltd.

Samyang Biopharmaceuticals Corporation, Sewon Cellontech Co., Ltd., established in 1971,

with its central research center is engaged in offers full-array of products through its three
the development and marketing of novel drug business divisions: Plant Equipment, Mechatronics
delivery systems and medical devices. System and RMS (Regenerative Medical System).
Samyang Biopharmaceuticals Corporation is focusing its efforts on Since 1996, RMS has conducted comprehensive researches to identify
healthcare as its core strategic business of the 21st century. Samyang the major key factors in the tissue regeneration. With the cutting-edge
Biopharmaceuticals Corporation is developing proprietary and unique technologies, RMS has developed innovative products in the field of
core technologies for the development of world class novel drug regenerative medicine and created two portfolios of products termed as
delivery systems. RegenGraft (BioCollagen Scaffold) and Stem Cell System(Cell therapy).
RMS’s mission is to design, develop and manufacture biocompatible
R&D Pipeline therapeutic materials according to specific design criteria to meet diverse
clinical needs. RMS has been dedicating in research to create a new CEO
Technology concept for regenerative medicine industry and to deliver the optimized Cheong-Ho Chang M.D.
Category Products Development Status
Description solution to clinicians throughout the world. Currently, RMS products are Location
in the world-wide market, especially in EU, North America and Japan. 8th FL. Wooyoung
Plant Cell Culture Paclitaxel Marketed Techno Center, 144 Achasan-ro,
Seongdong-Gu, Seoul 133-831,
Epothilones Pilot production Korea
Fermentation Homepage
Sirolimus Under development
contact@swcell.com
Fermentation / EC Representative
Liraglutide Under development
API Organic Synthesis RMS INNOVATIONS (U.K)
LIMITED
CEO
Taeung Eom Location
Paclitaxel Marketed 310 Centennial Park, Elstree,
Location Docetaxel Marketed Hertfordshire
31, Jong-ro 33-gil, Jongno-gu, Organic Synthesis Pemetrexed Marketed WD6 3TJ United Kingdom
Seoul, 110-725, Korea Bortezomib Pilot production Homepage
Homepage Cabazitaxel Under development sales@RMSbio.net
www.samyangbiopharm.com

54 55
 Sewon Cellontech Co., Ltd. Company Introduction

Products Global Approval Status

Classification Product Details Region
Classification Product Approval Date
(Regulatory Body)
Chondron™ Autologous Cartilage Cell
Korea (MFDS) 2001
Stem Cell System RMS Ossron™ Bone Marrow Stem Cell UK 2009
(Cell Therapy) BabyCell™ Cord Blood Stem Cell Chondron Netherland 2010
Poland 2008
Stem Cell System™ Stem Cell Platform
India 2011
TheraForm™ Skin Scaffold Membrane Korea (MFDS) 2009
Stem Cell System
UK 2010
SurgiFill™ (RegenSeal™) GTR Scaffold Gel / Membrane RMS Ossron
Poland 2008
OssFill™ Bone Scaffold Gel India 2011
CartiFill™ Cartilage Scaffold Gel Korea (MW) 2011
RegenGraft
Babycell EU (CE) 2006 (USCRM Kit only)
(BioCollagen Scaffold) CartiZol™ Joint Scaffold Gel India (DCGI) 2010
TheraFill™ Dermal Scaffold Gel Korea (MFDS) 2011
EU (CE) 2007
DuoFill™ PRP Scaffold Gel TheraForm USA (FDA 510(k)) 2009
SERAZENA™ Rejuvenative Bio-Cosmetics Argentina 2011
Turkey 2012
Korea (MFDS) 2012
SurgiFill
EU (CE) 2009
Korea (MFDS) 2012
OssFill
EU (CE) 2011
Korea (MFDS) 2013
RegenGraft EU (CE) 2009
CartiFill
Turkey 2012
Argentina 2013
Korea (MFDS) 2013
CartiZol
EU (CE) 2015
Korea (MFDS) 2010
EU (CE) 2006
TheraFill Israel 2010
Singapore 2012
Argentina 2012
DuoFill EU (CE) in process

56 57
 Company Introduction
Company introduction

Products
Product Details

SK Chemicals Co. Ltd. SKYCellflu

cell-culture based influenza vaccine in Korea and third worldwide.
Uses SK’s proprietary technology

R&D Pipeline
Since entering the vaccine industry in 2002, Pipeline Description DS PC PI PⅡ PⅢ NDA MKT
SK Chemicals has strongly focused on its Pneumococcal
vaccine R&D capability, obtaining fundamental NBP606 ○
Conjugate vaccine
proprietary technologies for developing vaccines
SKYCellflu Quadrivalent Cell-based
highly demanded around the world. Quadrivalent flu vaccine
○

In line with its R&D efforts, SK Chemicals constructed a new GMP-com- Varicella vaccine ○
pliant vaccine manufacturing facility in 2011 with cutting-edge NBP608 Herpes Zoster (Shingles)
single-use, modular production system, which allows highly efficient ○
vaccine
commercial scale production of different types of vaccines including the
company’s own vaccine. Typhoid Conjugate
SK Chemicals’ new “SKYCellflu” influenza vaccine is being manufac- NBP ○
vaccine
tured using cell-based production technology, which does not contains
antibiotics or preservatives. NBP Vaccine in development ○ ○
SK Chemicals has also entered collaboration with the IVI, the Gates
Foundation and Sanofi Pasteur for development of vaccines. In Latin
America, SK Chemicals is looking to pursue partnerships with variety of
collaboration model in consideration, ranging from transfer of technolo-
CEO
Mahnhoon Park
gy to distribution agreements.
Location
310, Pangyo-ro, Bundang-gu,
Seongnam-si, Gyeonggi-do,
13494 Republic of Korea
Homepage
www.skchemicals.com/en/
Contact
Jin Seon Park
Phone: +82-2-2008-2888
Fax: +82-2-2008-2959
Email: lifescience_global@sk.com

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Company introduction
Tego Science, Inc.
CEO
Dr. Saewha Jeon
Location
Daerung Technotown III, 1fl.,
115 Gasan digital 2-ro,
Gumcheon-gu, Seoul, Korea
Homepage
http://www.tegoscience.com
Contact
Dennis W. An, Director
Phone: 82-2-818-2900
E-mail: to be completed at the end of 2016. The new facility is designed to
dwan15@tegoscience.com
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Company Introduction
R&D Pipeline
Skin Cell Therapy… Tego Science will take the
initiative!
Tego Science is a biopharmaceutical manufacturer specializing in skin
cell therapy for wound healing. It has enjoyed the best reputation with
the leading edge of cell culture technology since 2001.
Its wound healing skin cell therapy products originating from human
epithelial cells are now a mainstay in burn and ulcer clinics with an
unmatched track record of safety and efficacy.
Products
Wound Healing
Kaloderm® – Kaloderm® is a Cultured Epidermal Allograft for deep 2nd
degree burn and diabetic foot ulcer. Kaloderm is the only cell therapy
product in the world that is indicated to use for a variety of wounds,
both acute and chronic.
Holoderm® – Holoderm® is a Cultured Epidermal Autograft for deep
2nd and 3rd degree burns with dermal loss. No immunological
rejection: 90% take rate in Phase III clinical trial.
Human Skin Model
Neoderm® – 3D human skin model for testing the safety and efficacy of
drugs and cosmetics substituting for inhumane and expensive animal
testing.
Facilities
Their KGMP-certified production facility is operated up to 75% of its
full capacity in accordance with the KFDA guidelines. Their new produc-
tion facility, also located in Seoul, is under construction and expected
conform to the global GMP standards and to have the capacity 5 times
bigger than the current one.
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 Company
company Introduction
introduction
Company introduction

Products
Product Details

ViroMed. Co., Ltd. PG102

Botanical functional food product made from the extract of hardy kiwi
and approved by KFDA for functional claim. May help improve immune
hypersensitivity.

Botanical functional food product made from the extract of 4 different herbs
HX106 and approved by KFDA for functional claim. May help improve working
ViroMed Co., Ltd. (ViroMed) is a leading memory.
biopharmaceutical company and a leader in
DNA based gene therapy with a focus on the HX811
Botanical functional food product made from the extract of 10 different
herbs that may improve joint health.
development of innovative drugs.
ViroMed was established in 1996 and is headquartered in Seoul, Korea R&D Pipeline
with a US presence in Atlanta. ViroMed has assembled a diverse, but
technologically and conceptually linked, pipeline of innovative thera- Licensed
Pipeline Description DS PC PI PII PIII NDA MKT
peutics in the areas of cardiovascular and neurological diseases, can- Territory
cers, and immune disorders, with 7 projects in clinical stages in the US, DNA based gene therapy target-
VM202-DPN
Korea, and China. ViroMed has successfully completed two separate ing diabetic peripheral neuropa- ○ Korea
(US) thy
phase II clinical studies for diabetic peripheral neuropathy and critical
limb ischemia (an extreme form of peripheral artery disease: PAD) in DNA based gene therapy
the US and Korea and received approval from the US FDA to initiate VM202-PAD targeting chronic non- Korea,
(US, China) healing ischemic foot ulcer in
○ China
phase III study. A phase I/II clinical study for amyotrophic lateral sclero-
sis in the US has also been completed. In China, a phase III clinical trial diabetes patients
is underway for chemotherapy-induced thrombocytopenia. ViroMed is DNA based gene therapy
VM202-ALS
also running a botanical therapeutics and functional food programs (US)
targeting amyotrophic lateral ○ Korea
with one prescription drug for osteoarthritis and three functional food sclerosis
products already in Korean market. DNA based gene therapy
CEO VM202-CAD
(Korea)
targeting coronary artery ○ Korea
Mr. Yong Soo Kim disease
Location Therapeutic cancer vaccine
5th Fl. Bldg. 203 Seoul
VM206 (Korea) targeting Her2 expressing ○ Korea
National University
Gwanak-ro, Gwanak-gu, Seoul, breast cancer
151-747 Recombinant IL-11 protein
Republic of Korea VM501 (China) targeting chemotherapy ○ China
Homepage induced thrombocytopenia
http://viromed.co.kr/kor/index_
intro.html

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