China Medical System receives Chinese approval for Phase III trial of MG-K10 in chronic spontaneous urticaria

SGX Filings2025-09-28

China Medical System Holdings Limited announced that its subsidiary Dermavon Holdings Limited, together with Hunan Mabgeek Biotechnology Co., Ltd., obtained National Medical Products Administration approval on Sep, 28 2025 to begin a Phase III clinical study of MG-K10 humanized monoclonal antibody injection for chronic spontaneous urticaria (CSU).

MG-K10 is a long-acting anti-IL-4Rα monoclonal antibody designed for four-week dosing. The product has already met the primary endpoint in a Phase III trial for moderate-to-severe atopic dermatitis and is in Phase III trials for asthma, prurigo nodularis and seasonal allergic rhinitis in China. It also holds investigational new drug approvals for eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps.

Under existing collaboration agreements, the Group holds co-development rights and exclusive commercialization rights for MG-K10 in Mainland China, Hong Kong, Macao, Taiwan and Singapore, while Dermavon controls co-development rights (excluding atopic dermatitis) and exclusive commercialization rights for dermatological indications in Mainland China.

The company said that MG-K10 is expected to become the first long-acting anti-IL-4Rα monoclonal antibody on the market and that adding CSU as an indication could extend the product’s competitive profile.

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