China Medical System Holdings Limited said on Sep, 26 2025 that its subsidiary Dermavon Holdings Limited has achieved positive top-line results from a randomized, double-blind, placebo-controlled Phase 3 study of ruxolitinib cream in 192 Chinese patients with mild to moderate atopic dermatitis.
The trial met its primary endpoint: 63.0% of patients receiving ruxolitinib cream achieved an Investigator’s Global Assessment score of 0 or 1 with at least a two-grade reduction from baseline at week 8, versus 9.2% for placebo (P<0.001).
For the key secondary endpoint, 78.0% of patients on the study drug reached EASI-75 (≥75% improvement in Eczema Area and Severity Index) at week 8, compared with 15.4% for placebo (P<0.001).
Treatment-emergent adverse events were mostly mild or moderate, and no events led to discontinuation. The company said the data will support a new drug application in China.
Ruxolitinib cream (marketed as Opzelura in the United States and Europe) is a topical JAK1/JAK2 inhibitor licensed from Incyte for development and commercialization in Mainland China, Hong Kong, Macau, Taiwan and 11 Southeast Asian countries.
China has an estimated 54 million atopic dermatitis patients as of 2024, with 73% classified as mild, 25% moderate and 2% severe according to SCORAD scores.
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