CMS (867.HK/8A8.SG): NDA for Additional Indication Atopic Dermatitis (AD) for Ruxolitinib Phosphate Cream Accepted and Granted Priority Review in China

Core Viewpoint - China Medical System Holdings Limited's subsidiary, Dermavon Holdings Limited, has received acceptance from the National Medical Products Administration of China for the New Drug Application of ruxolitinib phosphate cream for treating mild to moderate atopic dermatitis, which is expected to accelerate the marketing approval process [1][4]. Group 1: Product Development and Approval - Ruxolitinib phosphate cream has been approved for marketing by the NMPA for the treatment of vitiligo and is now expanding its indications to atopic dermatitis, marking a significant milestone in its therapeutic applications [2]. - The NDA for ruxolitinib phosphate cream has been included in the Priority Review List, reducing the review timeline from 200 days to 130 days, which is anticipated to expedite the product's availability to patients [4]. Group 2: Clinical Trial Results - The product demonstrated robust efficacy in a Phase III clinical trial, achieving a significantly higher proportion of subjects reaching an Investigator's Global Assessment score of 0 or 1 compared to placebo (63.0% vs 9.2%, P < 0.001) [6]. - For the secondary endpoint, 78.0% of subjects treated with ruxolitinib phosphate cream achieved at least a 75% improvement in the Eczema Area and Severity Index score compared to 15.4% in the placebo group (P < 0.001) [6]. Group 3: Market Potential and Strategic Positioning - Atopic dermatitis affects over 54 million patients in China, with mild to moderate cases accounting for 98% of these, indicating a substantial market opportunity for ruxolitinib phosphate cream [5]. - Dermavon is developing a comprehensive "treatment + care" solution for atopic dermatitis, which includes ruxolitinib phosphate cream and other therapeutic options, enhancing its leadership in dermatology [6][7]. - The acceptance of the NDA for atopic dermatitis is expected to strengthen Dermavon's strategic positioning in skin treatments and create synergies with its existing product portfolio, potentially enhancing market competitiveness [8].