Ruxolitinib Cream Approved in China for Vitiligo Treatment

China Medical System Holdings Ltd. (CMS) announced on January 30, 2026, that its subsidiary has received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) for ruxolitinib phosphate cream. This approval makes it the first and only targeted drug available in China for the treatment of vitiligo, a condition causing depigmentation of the skin.

The drug is indicated for adult patients and children aged 12 and older with non-segmental vitiligo affecting the face. Ruxolitinib phosphate cream has previously been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Prior to this formal approval, the drug had been used in pilot programs in several Chinese free trade zones, with over 7,000 patients receiving prescriptions at Boao Super Hospital.

Clinical studies, including two overseas Phase III trials, demonstrated the cream's efficacy. After 24 weeks of treatment, 29.9% of patients achieved at least a 75% improvement in facial vitiligo area scores (F-VASI 75), a significantly higher rate compared to placebo groups. Continued treatment up to 52 weeks showed sustained repigmentation.

The approval offers new hope for over 10 million vitiligo patients in China. CMS is also pursuing NDA approval for ruxolitinib phosphate cream for mild to moderate atopic dermatitis, having already achieved positive results in Phase III clinical trials in China for this condition.