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.

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