CMS (867.HK; 8A8.SG) NDA for AD Indication of Long-acting Anti-IL-4Rα Humanized Monoclonal Antibody Injection MG-K10 Accepted in China

Core Viewpoint - China Medical System Holdings Limited (CMS) announced that its subsidiary Dermavon Holdings Limited has obtained co-development and exclusive commercialization rights for the innovative drug MG-K10, which has received New Drug Application acceptance from the National Medical Products Administration (NMPA) for treating moderate-to-severe atopic dermatitis (AD) [1][3]. Group 1: Product Overview - MG-K10 is a long-acting anti-IL-4Rα humanized monoclonal antibody designed to block IL-4 and IL-13 signaling, allowing for a four-week dosing frequency, which is expected to enhance patient adherence compared to existing biweekly treatments [2][8]. - The product has shown promising results in a Phase III clinical study, with 76.6% of participants achieving an Investigator Global Assessment (IGA) score of 0 or 1, and 94.3% showing a ≥75% reduction in Eczema Area and Severity Index (EASI 75) [3][5]. Group 2: Market Potential - If approved, MG-K10 could serve as a new treatment option for approximately 14.5 million patients with moderate-to-severe AD in China, addressing significant unmet medical needs in this patient population [5][7]. - The product also has potential applications for other type 2 inflammatory diseases, with ongoing Phase III trials for asthma, prurigo nodularis, and seasonal allergic rhinitis in China [4][5]. Group 3: Strategic Partnerships - CMS has entered into a Collaboration Agreement with Hunan Mabgeek Biotech Co., LTD for MG-K10, securing rights for co-development and commercialization in various regions including Mainland China and Hong Kong [6][9]. Group 4: Company Background - CMS focuses on innovative pharmaceutical products, particularly first-in-class and best-in-class therapies, and has established a strong presence in specialty therapeutic fields, including skin health through its subsidiary Dermavon [9][10][11].