China Medical System Holdings Limited said that China’s National Medical Products Administration accepted the marketing authorisation application on Oct, 30 2025 for Comekibart Injection (MG-K10), a long-acting anti-IL-4Rα humanised monoclonal antibody intended to treat adults with moderate-to-severe atopic dermatitis who are inadequately controlled with topical therapies or for whom such therapies are unsuitable.

MG-K10 blocks the signalling of IL-4 and IL-13 and is designed for dose administration once every four weeks, compared with the bi-weekly schedule of currently marketed anti-IL-4Rα drugs. In a randomised, double-blind, placebo-controlled Phase III trial, 52-week treatment with MG-K10 yielded an Investigator Global Assessment score of 0 or 1 with at least a two-point improvement in 76.6% of participants; EASI-75 in 94.3% and EASI-90 in 79.1%. Most treatment-emergent adverse events were Grade 1–2 and no adverse events of special interest or fatal events were reported.

The product is being co-developed by the Group’s dermatology subsidiary Dermavon Holdings Limited, which holds exclusive commercialisation rights in Mainland China, Hong Kong, Macao, Taiwan and Singapore. China Medical System said approval would expand its dermatology franchise and create synergies with Dermavon’s prescription drugs and skincare lines.

The company advised shareholders and investors to exercise caution when dealing in its securities.