China Medical System Holdings Limited (CMS) reported that its subsidiary Dermavon Holdings Limited (Dermavon) received acceptance from the National Medical Products Administration (NMPA) on 24 February 2026 for the New Drug Application of ruxolitinib phosphate cream in treating mild to moderate atopic dermatitis (AD). This application was also granted Priority Review qualification based on its status as a “new variety, dosage form and specification of pediatric drug that conforms to the physiological characteristics of children,” outlining the potential acceleration of the review process.
Ruxolitinib phosphate cream, a selective JAK1/JAK2 inhibitor originally developed by Incyte, was previously approved in China in January 2026 for vitiligo, becoming the first and only targeted drug in China for that indication. The Product’s additional NDA acceptance for AD marks a significant step in expanding to multiple therapeutic areas. In a randomized, double-blind, placebo-controlled Phase III trial in China, 63.00% of patients receiving ruxolitinib phosphate cream achieved an Investigator’s Global Assessment of 0 or 1 with at least a two-grade reduction from baseline at week 8, compared with 9.20% in the placebo group. The treatment arm also showed a higher Eczema Area and Severity Index (EASI) 75 response rate of 78.00%, against 15.40% in the placebo group. Adverse events were primarily mild or moderate, with none leading to treatment discontinuation.
It is estimated that there were over 54.00 million AD patients in China as of 2024, with over 98% (52.50 million) classified as mild to moderate cases. Ruxolitinib phosphate cream is positioned as part of Dermavon’s comprehensive “treatment + care” approach for AD, encompassing topical, injectable, and oral therapeutic options, as well as daily repair products. This initiative is further supported by Dermavon’s existing commercialized product portfolio, including ILUMETRI (tildrakizumab injection), Hirudoid (mucopolysaccharide polysulfate cream), and other innovative skin health drugs and care products in development.
CMS, through Dermavon, signed a collaboration and license agreement with Incyte on 2 December 2022, securing exclusive rights to develop, register, and commercialize ruxolitinib phosphate cream in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region, and eleven Southeast Asian countries, along with certain manufacturing rights. Incyte retains worldwide rights for the cream, marketed under the trademark Opzelura® in the United States and Europe.
Shareholders and investors are advised to exercise caution regarding any trading of the Company’s securities, as this update is provided solely to inform interested parties of the Company’s latest business developments.
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