China Medical System Holdings Limited announced that on Apr, 23 2026 China’s National Medical Products Administration accepted the new drug application for MG-K10 (Comekibart Injection) to treat adult patients with moderate-to-severe seasonal allergic rhinitis whose symptoms remain inadequately controlled after intranasal corticosteroid therapy.

MG-K10 is a long-acting anti-IL-4Rα humanized monoclonal antibody that blocks IL-4 and IL-13 signaling and is administered once every four weeks. The drug met its primary endpoint in a multicenter Phase III trial, showing superior efficacy versus placebo with a favorable safety profile.

The regulatory milestone broadens the company’s CMS Vision unit from ophthalmology into otolaryngology and advances its pipeline in type 2 inflammatory diseases.

Under a collaboration signed on Jan, 24 2025 with Hunan Mabgeek Biotech Co., Ltd., China Medical System holds co-development rights (excluding atopic dermatitis) and exclusive commercialization rights for MG-K10 in Mainland China, Hong Kong, Macao, Taiwan and Singapore.