CMS (00867) announced that the marketing authorization application (MAA) for its innovative Class 1 new drug, anti-IL-4Rα humanized monoclonal antibody injection MG-K10 (generic name: Komeqimab injection, "MG-K10" or "the Product"), has been accepted by China's National Medical Products Administration (NMPA) on October 30, 2025. The Product is intended for treating moderate-to-severe atopic dermatitis (AD) in adults inadequately controlled by or unsuitable for topical therapies.
MG-K10 is a novel long-acting anti-IL-4Rα monoclonal antibody that simultaneously blocks signaling of key type 2 inflammatory cytokines IL-4 and IL-13. In a randomized, double-blind, placebo-controlled Phase III clinical trial for moderate-to-severe AD, MG-K10 demonstrated positive results, meeting the primary endpoint. At week 52, 76.6% of subjects achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 with ≥2-point improvement from baseline, while 94.3% achieved ≥75% improvement in Eczema Area and Severity Index (EASI75) and 79.1% achieved ≥90% improvement (EASI90).
Safety data showed most treatment-emergent adverse events (TEAEs) were grade 1-2, with no special adverse events of interest (AESI) or fatal events reported. MG-K10 exhibited lower incidence of common target-related adverse reactions (e.g., conjunctivitis, injection-site reactions) compared to existing anti-IL-4Rα drugs. Notably, MG-K10’s extended half-life enables dosing every four weeks—potentially making it the first long-acting anti-IL-4Rα monoclonal antibody globally, with best-in-class potential.
Beyond AD, MG-K10 holds promise for other type 2 inflammatory diseases, including asthma, prurigo nodularis, seasonal allergic rhinitis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Asthma, prurigo nodularis, and seasonal allergic rhinitis are already in Phase III trials in China.
AD, the lead indication, is a chronic inflammatory skin disease with severe itching and represents the highest non-fatal skin disease burden globally. In China, AD affects over 54 million patients (2024 estimate), with 27% (14.5 million) classified as moderate-to-severe. Current systemic therapies face limitations in efficacy and safety, leading to delayed treatment initiation, poor adherence, and suboptimal control rates. MG-K10’s extended dosing interval may improve adherence and offer a new effective and safe systemic option.
If approved, MG-K10 will expand CMS’s dermatology portfolio and strengthen its subsidiary’s market position. The Product will synergize with existing prescription dermatology drugs and dermo-cosmetic products. Additionally, a comprehensive "treatment + care" solution for AD has been developed, including topical ruxolitinib phosphate cream (mild-to-moderate AD), oral targeted therapy CMS-D001 (moderate-to-severe AD), and dermatological skincare products.
On January 24, 2025, CMS’s subsidiary entered an agreement with MaiJi Biotech for MG-K10, securing co-development rights (excluding AD) and exclusive commercialization rights in mainland China, Hong Kong, Macau, Taiwan, and Singapore. Its dermatology-focused subsidiary holds these rights for skin-related indications in mainland China.