China Medical System secures NMPA approval to begin COPD trials for MG-K10

SGX Filings2025-09-30

China Medical System Holdings Limited announced on Sep, 30 2025 that China’s National Medical Products Administration (NMPA) issued a Drug Clinical Trial Approval Notice on Sep, 29 2025, authorising the start of clinical trials for MG-K10 humanised monoclonal antibody injection in the treatment of chronic obstructive pulmonary disease (COPD).

MG-K10 is a long-acting anti-IL-4Rα antibody designed to block IL-4 and IL-13 pathways with a four-week dosing schedule. The company, together with Hunan Mabgeek Biotech Co., Ltd., holds co-development rights (excluding atopic dermatitis) and exclusive commercialisation rights for the candidate in Mainland China, Hong Kong, Macao, Taiwan and Singapore.

The drug has already met primary endpoints in a Phase III trial for moderate-to-severe atopic dermatitis and is in Phase III testing for asthma, prurigo nodularis and seasonal allergic rhinitis in China. It has also received investigational new drug approvals for chronic spontaneous urticaria, eosinophilic oesophagitis and chronic rhinosinusitis with nasal polyps.

COPD affects more than 400 million people globally and about 107.1 million in China as of 2023, with limited innovative therapies available. China Medical System said MG-K10’s once-every-four-weeks regimen could offer COPD patients a new treatment option and expand the group’s respiratory portfolio.

The company’s rights to MG-K10 were secured under a collaboration agreement signed on Jan, 24 2025 with Mabgeek Biotech and its subsidiary.

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