Fosun Pharma's Subsidiary Obtains Regulatory Nod for FXS5626 Tablet Trial in Vitiligo Indication

Stock News
Sep 08

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SH: 600196) has announced that its controlling subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., recently received approval from the National Medical Products Administration to initiate a phase II/III adaptive seamless design clinical trial for FXS5626 tablets (formerly project code AC-201) targeting non-segmental vitiligo. The subsidiary plans to proceed with the related clinical research in mainland China once conditions are deemed suitable.

FXS5626 is an orally administered small-molecule JAK inhibitor (specifically a dual TYK2/JAK1 inhibitor) that the company licensed in, holding exclusive rights to its research, development, manufacturing, registration, and commercialization within mainland China, Hong Kong, and Macau. The drug is primarily intended for autoimmune disease applications, with its development pipeline showing notable progress: as of the announcement date (September 8, 2026), a phase II clinical trial for moderate-to-severe plaque psoriasis has already been completed in mainland China, while a separate phase II trial for non-infectious uveitis is currently underway in the same region.

As of August 2026, Fosun Pharma has accumulated approximately RMB 108 million in research and development investment for FXS5626 (including licensing fees, unaudited), reflecting the company's continued commitment to advancing this therapeutic candidate through the clinical development process.

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