Hengrui Medicine gets nod for vitiligo drug clinical trials

Jiangsu Hengrui Medicine Co., Ltd. and its subsidiary, Raybow Pharmaceuticals Co., Ltd., announced receiving drug clinical trial approval from the National Medical Products Administration for amcasertib sulfate tablets and SHR0302 alkaline gel. The approval, granted on August 29, 2025, allows for clinical trials for vitiligo treatment, either as monotherapy with amcasertib sulfate tablets or in combination with SHR0302 alkaline gel.

Amcasertib sulfate tablets, a highly selective JAK1 inhibitor, already have four approved indications in China, including ankylosing spondylitis, rheumatoid arthritis, atopic dermatitis, and severe alopecia areata. The cumulative research and development investment for amcasertib sulfate-related projects totals approximately CNY 109,100万元.

The company cautioned that drug development is a lengthy and complex process with various uncertainties from clinical trial approval to market launch. Investors are advised to exercise caution due to inherent risks. Jiangsu Hengrui Medicine will continue to advance these R&D projects and provide timely disclosure of their progress.