Shanghai-based Fosun Pharma announced that its wholly owned subsidiary, Shanghai Fosun Pharmaceutical Industrial Development, has secured National Medical Products Administration (NMPA) clearance to initiate a Phase II/III adaptive seamless clinical trial of FXS5626 for the treatment of non-segmental vitiligo in mainland China. The trial will commence once preparatory conditions are met.

FXS5626 (formerly AC-201) is an oral small-molecule that targets both TYK2 and JAK1. Fosun Pharma holds exclusive rights to research, develop, manufacture, register and commercialise the candidate across mainland China, Hong Kong and Macau. The molecule is part of the company’s autoimmune disease pipeline and represents the first TYK2/JAK1 dual-target inhibitor moving into late-stage trials in the Chinese market.

Development progress to date includes completion of a Phase II study for moderate-to-severe plaque psoriasis in mainland China and an ongoing Phase II trial for non-infectious uveitis. Cumulative R&D spending on FXS5626 has reached approximately RMB108.00 million (USD14.80 million) as of August 2026.

Market data from IQVIA CHPA indicate that JAK inhibitor sales in mainland China totalled about RMB1.98 billion (USD270 million) in 2025, underscoring the commercial potential of novel agents targeting this pathway. Currently, no TYK2/JAK1 dual-target inhibitor is approved for sale in the region.

Fosun Pharma cautions that FXS5626 must complete all requisite clinical studies and obtain regulatory approvals before commercial launch, and acknowledges the inherent uncertainties of drug development, including potential safety or efficacy setbacks that could halt the programme.