Fosun Pharmaceuticals (02196) Holdings Subsidiary Drugs Approved for Clinical Trials

Zhitongcaijing · 2d ago

Zhitong Finance App News, Fosun Pharmaceutical (02196) issued an announcement. Shanghai Fosun Pharmaceutical Industry Development Co., Ltd. (hereinafter referred to as “Fosun Pharmaceutical Industry”), a holding subsidiary of the Company, received approval from the State Drug Administration for FXS5626 tablets (original project code: AC-201, hereinafter referred to as “FXS5626”) for the treatment of non-segmental vitiligo to conduct phase II/III adaptive seamless design clinical trials. Fosun Pharmaceutical Industry plans to carry out clinical research on this drug in China when conditions are met.

FXS5626 is an oral small molecule JAK inhibitor (TYK2/JAK1 dual-target inhibitor) approved by the Group (i.e. the Company and its holding subsidiaries/units, the same below). The Group enjoys the exclusive right to research, develop, produce, register and commercialize this drug in China, Hong Kong and Macao regions. FXS5626 is intended to be mainly used in the field of autoimmune diseases. As of the date of this announcement (i.e. September 8, 2026, same below), the drug has completed phase II clinical trials for moderate to severe plaque psoriasis in China, and is in phase II clinical trials for non-infectious uveitis in China.

As of August 2026, the Group's cumulative R&D investment for FXS5626 at this stage is approximately RMB 108 million (including licensing fees; unaudited).

According to the latest IQVIA CHPA data, sales of JAK inhibitors in China in 2025 will be approximately RMB 1,980 billion. As of the date of this announcement, no TYK2/JAK1 dual-target inhibitors have been approved for marketing in China.

According to relevant regulations, FXS5626 still needs to carry out a series of clinical studies in China and be approved by the National Drug Evaluation Department before it can be marketed. According to research and development experience, there are certain risks in drug development. For example, clinical trials may be terminated due to safety and/or efficacy issues.