South Korea’s Celltrion Inc. announced the China Food and Drug Administration (CFDA) has approved a clinical trial for Remsima, its biosimilar drug to treat autoimmune diseases such as rheumatoid arthritis, making it the first foreign antibody biosimilar approved for an efficacy and safety test in the world’s most populated country.

The drug is already marketed in Europe and the U.S.

At 1:15 p.m. in Seoul trading Thursday, shares of Kosdaq-listed Celltrion were down 0.6 percent at 94,400 won ($84.5).

Celltrion filed for approval of the clinical study with Chinese health authorities in January 2014. The company said it will use the momentum to submit an application seeking clinical research approval for two more biosimilars: Truxima to treat blood cancer and Hurzuma to treat breast cancer.

The approval is credited to Celltrion chairman Seo Jung-jin who has visited China many times to push for the approval. He also vowed to set up a joint venture with its Chinese partner and to consider establishing a local plant to better meet patient needs across China.

China is a leading “pharmerging” market, which indicates the most promising emerging market in the pharmaceutical domain. In particular, the antibody biopharmaceutical market in China is estimated to grow at an average annual rate of 30 percent or higher to take leadership in the global biopharma market, according to analysts. Demands for biopharmaceuticals will increase explosively when the country of 1.3 billion population enters an aging stage.

By Shin Chan-ok

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