China Medical System Holdings Ltd

China Medical System Holdings announced that its subsidiary Dermavon received approval from China's National Medical Products Administration for the New Drug Application of ruxolitinib phosphate cream, marketed as Lumirix, for the treatment of mild to moderate atopic dermatitis in patients aged two and older. This marks the second approved indication for Lumirix, which in January 2026 became China's first topical JAK inhibitor approved for vitiligo. The approval was expedited through a priority review due to its qualification as a pediatric drug. Clinical data from a Phase III trial in China showed that 63.0% of patients treated with Lumirix achieved clear or almost clear skin at week eight, compared to 9.2% for placebo, with a favorable safety profile. Dermavon is building a comprehensive treatment and care solution for atopic dermatitis, which affects over 54 million people in China, including the marketed Lumirix, an injectable biologic under review, an oral drug in Phase II trials, and a daily repair product line.

China’s National Medical Products Administration has approved Silevimig Injection, a Class 1 therapeutic biological product from China Medical System Holdings, for passive immunization in adults following rabies virus exposure. The drug is the world’s first fully human bispecific antibody targeting dual epitopes of the rabies virus, consistent with WHO recommendations for a cocktail therapeutic paradigm. It demonstrated non-inferior protective efficacy compared with human rabies immune globulin in a Phase III trial and is the smallest-dose passive immunization product for rabies, reducing injection volume and patient pain. The approval expands CMS’s commercialized innovative drug portfolio to eight products, with six more under marketing review and about 20 in clinical development. CMS holds exclusive commercialization rights in mainland China and exclusive licensing rights for the rest of Asia-Pacific, the Middle East, and North Africa under a 2025 agreement with Chongqing Genrix Biopharmaceutical.