China Medical System Holdings Limited said on Feb, 24 2026 that its subsidiary Dermavon Holdings Limited has received National Medical Products Administration acceptance and Priority Review status for a New Drug Application covering ruxolitinib phosphate cream for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in patients aged two years and older.

The Priority Review was granted because the filing qualifies as a “new variety, dosage form and specification of pediatric drug that conforms to the physiological characteristics of children,” potentially shortening the review timeline.

Ruxolitinib phosphate cream, originally developed by Incyte and marketed as Opzelura in the United States and Europe, met its primary endpoint in a China phase III trial, with 63.0% of patients achieving an Investigator’s Global Assessment score of 0 or 1 at week 8 versus 9.2% for placebo (P < 0.001). The study also showed 78.0% of treated patients reached EASI-75 versus 15.4% for placebo (P < 0.001), and reported mainly mild or moderate adverse events.

The product was approved by the NMPA in Jan, 2026 for non-segmental vitiligo, making it the first targeted therapy for that indication in China. Acceptance of the new filing marks progress toward expanding the cream’s use into multiple dermatology indications.

Dermavon holds exclusive rights to develop, register and commercialize ruxolitinib phosphate cream in Mainland China, Hong Kong, Macau, Taiwan and 11 Southeast Asian countries under a December 2022 collaboration and license agreement with Incyte.