Hisun Biologics ``Infliximab'' biosimilar drug approved for marketing

September 29, 2021

On September 28, Hisun Pharmaceuticals announced that Hisun Bio, a wholly-owned subsidiary of Borui Bio, received the "Drug Registration Certificate" for "Infliximab for Injection" approved and issued by the State Food and Drug Administration. This is the second infliximab biosimilar approved in China.

Hisun Biologics’ infliximab for injection is a biosimilar of Janssen Biologics BV. It is a human-mouse chimeric monoclonal antibody that specifically blocks tumor necrosis factor (TNF-α). It binds to the soluble form (sTNF-α) and transmembrane form (tmTNF-α) of TNF-α with high affinity and inhibits the binding of TNF-α to the receptor, thereby depriving the biological activity of TNF. On May 6, 2020, the State Food and Drug Administration accepted the company’s application for registration of infliximab for injection, with indications for rheumatoid arthritis, Crohn’s disease in adults and children over 6 years old, and Crohn’s fistula Disease, ankylosing spondylitis, psoriasis and adult ulcerative colitis. Leike was listed in the United States in 1998 and entered the Chinese market in 2007, with global sales of 4.195 billion U.S. dollars in 2020 (data source: EvaluatePharma). Since its launch in China in 2006, Leike has been approved for multiple indications in China, including patients with ulcerative colitis, Crohn’s disease, patients with active rheumatoid arthritis, patients with active ankylosing spondylitis, and plaque Adult patients with type psoriasis. At present, only the infliximab biosimilar of Taizhou Maibotek Pharmaceutical Co., Ltd. is on the market in China.

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