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Celltrion Finalizes Clinical Trials for Remsima SC, Planning to File a Marketing Authorization Application to the EMA in H2

August 29, 2018

INCHEON, South Korea--(BUSINESS WIRE)--Aug 28, 2018--Celltrion, Inc. (KRX:068270) today announced that the company has completed Phase 3 clinical trial for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab, with the preparation for filing a Marketing Authorization Application to the European Medicines Agency (EMA) now in the final stage, such as the analysis of clinical data.

Celltrion is set to complete the clinical analysis soon and to submit its application for Remsima SC to the EMA in the second half of this year.

In a bid to obtain its competitiveness in the TNF-α inhibitor (autoimmune disease therapeutic agent) market through ‘twin-track’ strategy together with the existing intravenous (IV) formulation of Remsima®, Celltrion has developed Remsima SC, the SC version of infliximab. Since May 2016, Celltrion has conducted Phase 1 and Phase 3 clinical trials on the safety, pharmacokinetic and efficacy assessment of Remsima SC.

The subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle unlike the intravenous formulation that require patients to visit hospitals for the administration thereof.

Celltrion expects that the potential demand base will include those patients who are satisfied with the therapeutic effects of infliximab and yet who want to be administered with the subcutaneous formulation, and those patients who are administered with the Abbvie’s Humira® and Amgen’s Enbrel ®, which are global blockbuster biopharmaceuticals as TNF-α inhibitor SC formulation.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA® and Remsima®(CT-P13), respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20180828005894/en/

CONTACT: Celltrion, Inc.

Gunn Lee, +82-32-850-5168

Gunhyuk.lee@celltrion.com

or

Heewon Park, +82-32-850-5356

Heewon.park@celltrion.com

KEYWORD: EUROPE ASIA PACIFIC NORTH AMERICA CANADA SOUTH KOREA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL RESEARCH SCIENCE GENERAL HEALTH

SOURCE: Celltrion Inc.

Copyright Business Wire 2018.

PUB: 08/28/2018 10:59 PM/DISC: 08/28/2018 10:59 PM

http://www.businesswire.com/news/home/20180828005894/en

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