CMS(00867): Class 1 new drug MG-K10 humanized monoclonal antibody injection has obtained the approval notification for Phase III clinical trials for the indication of chronic idiopathic urticaria.

CMS (00867) announced that its subsidiary, Demei Pharmaceuticals Limited (Demei Pharmaceuticals), a innovative pharmaceutical company specializing in skin health, is currently applying for an independent listing on the main board of the Hong Kong Stock Exchange. Together with its affiliated companies, Demei Pharmaceuticals holds the joint development rights (excluding atopic dermatitis (AD)) and exclusive commercialization rights for a new class 1 drug, anti-IL-4R MG-K10 humanized monoclonal antibody injection (MG-K10), which obtained a drug clinical trial approval notice from the National Medical Products Administration (NMPA) of China on September 28, 2025. NMPA has approved the conduct of phase III clinical trials of MG-K10 for the treatment of chronic spontaneous urticaria (CSU). MG-K10 is an innovative long-acting anti-IL-4R humanized monoclonal antibody that can simultaneously block the signaling of key type 2 inflammatory cytokines IL-4 and IL-13, and is used to treat type 2 inflammatory diseases. Currently available anti-IL-4R drugs require dosing every 2 weeks, while MG-K10 has a longer half-life, allowing for dosing every 4 weeks, making it potentially the world's first long-acting anti-IL-4R monoclonal antibody on the market with the potential to be the best-in-class. The group is actively preparing for relevant clinical trials with Hunan Maji Biotechnology Co., Ltd. (Maji Biotechnology). In addition, MG-K10 has shown positive results in a randomized, double-blind, placebo-controlled phase III clinical study in adults with severe AD, meeting the primary endpoints of the clinical trial design. Asthma, nodular prurigo, and seasonal allergic rhinitis have all entered phase III clinical trials in China. In a previously completed phase II clinical trial in adults with severe asthma, MG-K10 demonstrated good efficacy and safety. Product indications for eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps have also obtained drug clinical trial approval notices from NMPA.