China Medical System Holdings Limited announced that its skin-health subsidiary Dermavon Holdings Limited has received National Medical Products Administration approval for the New Drug Application of ruxolitinib phosphate cream Lumirix, clearing the product for the topical short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised patients aged two years and older. The decision was granted on Sep, 02 2026, with the drug registration certificate issued on Sep, 03 2026.

Lumirix is already marketed in China for vitiligo following a Jan, 2026 approval. In a China phase III trial for atopic dermatitis, 63.0% of patients who received Lumirix achieved an Investigator’s Global Assessment score of 0 or 1 with at least a two-grade reduction at week 8, compared with 9.2% for placebo (P < 0.001). The key secondary endpoint, EASI 75, was met by 78.0% of Lumirix patients versus 15.4% for placebo (P < 0.001). Reported treatment-emergent adverse events were mainly mild or moderate, with no discontinuations.

Dermavon estimates more than 54 million people in China suffer from atopic dermatitis, about 98% of them with mild-to-moderate disease. The company is building an integrated “treatment + care” AD portfolio that includes Lumirix, the investigational biologic Comekibart Injection (MG-K10), the oral small-molecule CMS-D001 and the Heling Soothing skincare range.

Under a December 2 2022 collaboration and licence agreement with Incyte, Dermavon holds exclusive rights to develop, register and commercialise ruxolitinib phosphate cream in mainland China, Hong Kong, Macau, Taiwan and 11 Southeast Asian markets, with non-exclusive manufacturing rights in the same territory. Incyte markets the product as Opzelura in the United States and Europe.

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