By Fineline Cube 
China Medical System Holdings Limited (CMS, HKG: 0867) reported that its Phase 3, randomized, double‑blind, placebo‑controlled trial of ruxolitinib cream (Opzelura) achieved its primary endpoint in patients with mild‑to‑moderate atopic dermatitis (AD) across China.
Trial Design & Scale
- Sample Size: 192 patients enrolled at multiple centers nationwide.
- Comparator: Placebo‑controlled, double‑blind, with 1:1 randomization.
- Primary Endpoint: Proportion achieving IGA 0/1 with ≥ 2‑grade improvement at week 8.
Key Results
- IGA Success: 63.0 % of ruxolitinib‑treated patients vs. 9.2 % of placebo (P < 0.001).
- EASI 75: 78.0 % vs. 15.4 % (P < 0.001).
- Safety: Cream was well‑tolerated; adverse events comparable to placebo.
Strategic Context
- Product Portfolio: Opzelura is the first FDA‑approved topical JAK1/2 inhibitor, currently indicated for non‑segmental vitiligo and mild‑to‑moderate AD in adults and children ≥ 2 years.
- Partnership: CMS holds an exclusive license from Incyte (NASDAQ: INCY) for mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries.
- Regulatory Milestones: NMPA has accepted the NDA for the vitiligo indication; CMS is actively pursuing the AD indication in China.
Market Implications
- Competitive Edge: Demonstrated efficacy positions CMS to capture a growing segment of the AD market, potentially displacing conventional topical corticosteroids.
- Revenue Outlook: Successful registration of the AD indication could unlock multi‑billion‑dollar sales in the region, aligning with CMS’s growth strategy in dermatology.
- Investor Sentiment: Positive Phase 3 data are likely to bolster analyst coverage and support the stock’s recent rally.-Fineline Info & Tech