FOSUN PHARMA (02196.HK): FXS5626 Approved for Phase II/III Trial in Non-Segmental Vitiligo

NewTimeSpace News: On 8 September 2026, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (stock code: 02196) disclosed that its controlling subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. has received NMPA approval for FXS5626 tablets (formerly development code AC-201) to conduct Phase II/III adaptive seamless design clinical trials for the treatment of non-segmental vitiligo.

According to the announcement, FXS5626 is an oral small-molecule JAK inhibitor (a TYK2/JAK1 dual-target inhibitor) licensed in by the Group, which holds exclusive rights to research, develop, manufacture, register and commercialise the drug in mainland China, Hong Kong and Macao, with intended use primarily in autoimmune diseases. The drug has completed Phase II clinical trials in mainland China for moderate-to-severe plaque psoriasis and is in Phase II development for non-infectious uveitis. As of August 2026, the Group's cumulative R&D investment in FXS5626 was approximately RMB 108 million.

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