China Medical System Holdings (CMS) has submitted a New Drug Application (NDA) to China's National Medical Products Administration (NMPA) for Comekibart (MG-K10), a long-acting anti-IL-4Rα humanized monoclonal antibody, seeking approval for the treatment of adult patients with moderate-to-severe seasonal allergic rhinitis (SAR) whose symptoms remain inadequately controlled following intranasal corticosteroid therapy. The NMPA accepted the application on 23 April 2026, marking the second NDA acceptance for MG-K10 in China, following an earlier filing for atopic dermatitis accepted in October 2025.
The filing targets a specific and difficult-to-treat patient segment: adults with moderate-to-severe SAR who have already failed standard-of-care intranasal corticosteroids. MG-K10 is administered by injection on a once-every-four-weeks schedule, a dosing interval that distinguishes it from the only currently approved biologic in this class, dupilumab (Dupixent, Regeneron/Sanofi), which requires administration every two weeks. No PDUFA-equivalent review timeline has been disclosed by CMS under NMPA procedures.
The clinical evidence supporting the submission comes from a multicenter, randomized, double-blind, placebo-controlled Phase III trial in adults with moderate-to-severe SAR. CMS reported that the study met its primary endpoint with statistical significance, demonstrating efficacy over placebo, alongside what the company described as a favorable safety profile. Detailed endpoint data, including the magnitude of symptom score changes and adverse event rates, have not been publicly disclosed in the filing announcement.
The submission enters a nascent but no longer uncontested biologic landscape for SAR in China. Stapokibart (CM310), another anti-IL-4Rα monoclonal antibody developed by Keymed Biosciences, received NMPA approval for seasonal allergic rhinitis in February 2025, becoming the first biologic globally approved specifically for this indication. MG-K10, if approved, would join a field currently defined by a single approved agent sharing its mechanistic class.