China Medical System: NDA for Allergic Rhinitis Drug Accepted in China
China Medical System Holdings Limited (CMS) announced its New Drug Application (NDA) for the seasonal allergic rhinitis indication of MG-K10 has been accepted by China's National Medical Products Administration (NMPA). MG-K10 is an innovative injection treatment.
China Medical System Holdings Limited (CMS) announced on April 23, 2026, that its New Drug Application (NDA) for MG-K10, an innovative drug for seasonal allergic rhinitis (SAR), has been accepted by China's National Medical Products Administration (NMPA). The drug is intended for adult patients with moderate-to-severe SAR whose symptoms are not adequately controlled by intranasal corticosteroids.
MG-K10 (generic name: Comekibart Injection) is a Class 1 innovative drug, a humanized monoclonal antibody targeting IL-4Rα. CMS holds co-development rights (excluding atopic dermatitis indication) and exclusive commercialization rights in China for the drug.
The acceptance of the NDA marks a significant milestone for CMS's ophthalmology business, CMS Vision, as it expands its therapeutic focus from ophthalmology to otolaryngology (ENT). The drug works by blocking the signaling pathways of key type 2 inflammatory cytokines IL-4 and IL-13. It holds potential as the first long-acting IL-4Rα monoclonal antibody, requiring dosing once every four weeks, compared to current treatments administered bi-weekly.
Allergic rhinitis is a significant health issue in China, affecting approximately 250 million people. A substantial portion, 62% of patients with moderate-to-severe disease, experience inadequate symptom control with current standard treatments. MG-K10 offers a new treatment avenue by targeting the core of type 2 inflammation.