CMS (867.HK/8A8.SG): Ruxolitinib Phosphate Cream Obtained China NDA Approval, Becoming The First and Only Targeted Drug for Vitiligo in China

Core Viewpoint - China Medical System Holdings Limited's subsidiary, Dermavon Holdings Limited, received approval for ruxolitinib phosphate cream, the first targeted drug for non-segmental vitiligo in China, addressing a significant unmet clinical need for over 10 million patients [1][4]. Group 1: Product Approval and Market Potential - Ruxolitinib phosphate cream is the first drug approved by both the U.S. FDA and the European Medicines Agency for repigmentation in non-segmental vitiligo [2]. - The product has been prescribed to over 7,000 patients at Boao Super Hospital and is available in more than twenty hospitals across major cities in China, indicating strong clinical demand [2]. - The approval is expected to enhance Dermavon's product portfolio in skin treatment, potentially synergizing with existing products like ILUMETRI and Hirudoid [4]. Group 2: Clinical Efficacy and Safety - In overseas Phase III clinical studies, 29.9% of patients achieved at least 75% improvement in the Facial Vitiligo Area Score Index after 24 weeks of treatment, compared to 7.5% and 12.9% in placebo groups [3]. - Real-world studies in China showed consistent positive efficacy with no new safety events reported, indicating a favorable safety profile for the product [3]. Group 3: Future Developments - The Phase III clinical trial for ruxolitinib phosphate cream in treating mild to moderate atopic dermatitis has also shown positive results, with an NDA actively being pursued for this indication [5]. - The approval of ruxolitinib phosphate cream fills a significant gap in targeted treatment options for vitiligo, which affects approximately 10.3 million patients in China [6].