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Fosun Pharma Secures China's Approval for Phase II/III Vitiligo Drug Trial
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (600196.SH) announced its subsidiary has received regulatory approval from China's National Medical Products Administration (NMPA) to begin a late-stage clinical trial for its drug candidate, FXS5626. The trial will evaluate the tablet's efficacy in treating patients with non-segmental vitiligo.
Regulatory Green Light
According to a company announcement, the NMPA approved a Phase II/III adaptive seamless design clinical trial for the drug. The clearance was granted to Shanghai Fosun Pharmaceutical Industrial Development Co., a holding subsidiary of Fosun Pharma.
The company stated its intention to initiate the clinical research within mainland China as soon as conditions are suitable. This approval marks a significant step in advancing the drug's development pipeline for a new indication.
Drug Candidate Profile
FXS5626 is an orally administered, small-molecule Janus kinase (JAK) inhibitor, specifically designed as a dual-target inhibitor of TYK2 and JAK1. These enzymes play a key role in the inflammatory pathways associated with many autoimmune diseases.
AdFosun Pharma licensed the compound and holds the exclusive rights for its research, development, manufacturing, registration, and commercialization in mainland China, Hong Kong, and Macau. The drug is primarily being developed for the treatment of various autoimmune disorders.
Pipeline and Investment
Beyond vitiligo, FXS5626 is being evaluated for other conditions. The candidate has already completed a Phase II clinical trial in China for moderate-to-severe plaque psoriasis and is currently in a separate Phase II trial for non-infectious uveitis.
As of August 2026, Fosun Pharma reported a cumulative R&D investment in the FXS5626 program of approximately RMB 108 million. The company noted that this unaudited figure includes licensing fees.
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