China Medical System Holdings Limited said on Jan, 30 2026 that its skin-health subsidiary Dermavon Holdings Limited has received National Medical Products Administration approval for ruxolitinib phosphate cream to treat non-segmental vitiligo with facial involvement in patients aged 12 years and older.

The product, licensed from U.S. biotech firm Incyte and marketed overseas as Opzelura®, is the first targeted medicine cleared in China for vitiligo, a chronic autoimmune disorder that affects about 10.3 million people in the country, including an estimated 8.2 million non-segmental cases.

In two international Phase III trials (TRuE-V1 and TRuE-V2), 29.9% of patients achieved at least 75% improvement in the Facial Vitiligo Area Score Index at week 24 versus 7.5% and 12.9% for placebo. A real-world study in China’s Hainan Lecheng Pilot Zone showed efficacy and safety consistent with global data, with no drug-related serious adverse events reported among more than 7,000 treated patients.

Dermavon plans to leverage the new approval alongside its existing dermatology portfolio, which includes ILUMETRI (tildrakizumab injection) and Hirudoid (mucopolysaccharide polysulfate cream). A China Phase III trial of ruxolitinib phosphate cream for mild to moderate atopic dermatitis has also yielded positive results, and an NDA filing is being prepared.

Under a December 2022 collaboration and licence deal, Dermavon holds exclusive rights to develop, register and commercialise ruxolitinib phosphate cream in Mainland China, Hong Kong, Macau, Taiwan and 11 Southeast Asian countries, with non-exclusive manufacturing rights in the same territories.

The company advised investors to exercise caution when dealing in its securities.