CMS (00867): Class 1 New Drug MG-K10 Humanized Monoclonal Antibody Injection Receives Additional Phase III Clinical Trial Approval for Chronic Spontaneous Urticaria Indication

Stock News
09/28

CMS (00867) announced that its subsidiary Dermax Pharmaceutical Co., Ltd. (Dermax Pharmaceutical, an innovative pharmaceutical company specializing in skin health, currently applying for independent listing on the Main Board of The Stock Exchange of Hong Kong Limited), together with its subsidiaries holding co-development rights (except for atopic dermatitis (AD)) and exclusive commercialization rights for the Class 1 new drug anti-IL-4Rα MG-K10 humanized monoclonal antibody injection (MG-K10), received a Drug Clinical Trial Approval Notice issued by China's National Medical Products Administration (NMPA) on September 28, 2025. NMPA approved the Phase III clinical trial of MG-K10 for chronic spontaneous urticaria (CSU). MG-K10 is an innovative long-acting anti-IL-4Rα humanized monoclonal antibody that can simultaneously block the signaling pathways of key type 2 inflammatory factors IL-4 and IL-13, used for treating type 2 inflammatory diseases. Currently marketed anti-IL-4Rα drugs all require dosing every 2 weeks, while MG-K10 has a longer half-life, enabling a 4-week dosing frequency, with potential to become the world's first marketed long-acting anti-IL-4Rα monoclonal antibody and the potential to become best-in-class. The Group is actively preparing to conduct relevant clinical trial work together with Hunan Maizel Biotechnology Co., Ltd. (Maizel Biotechnology). Additionally, MG-K10 has achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical study for moderate-to-severe AD in adults, meeting the primary endpoint designed in the protocol. Asthma, prurigo nodularis, and seasonal allergic rhinitis have all entered Phase III clinical trial stages in China. In the previously completed Phase II clinical trial for moderate-to-severe asthma in adults, MG-K10 also demonstrated good efficacy and safety. The product's eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps indications have also received Drug Clinical Trial Approval Notices issued by NMPA.

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