Hainan Dermavon Pharmaceutical Technology Co., Ltd.

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. Both MG-K10 and stapokibart target the IL-4 receptor alpha subunit, blocking the downstream signaling of IL-4 and IL-13, the central cytokines driving type 2 airway inflammation. The scientific rationale for this approach in SAR mirrors the pathway validation already established across atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. What distinguishes MG-K10 within this class is its Fc-engineered extended half-life, which CMS states enables the Q4W dosing interval. Whether this translates into measurable differences in adherence or clinical outcomes relative to Q2W comparators remains to be demonstrated in head-to-head data, none of which have been disclosed. CMS obtained co-development rights (excluding atopic dermatitis) and exclusive commercialization rights for MG-K10 in mainland China, Hong Kong, Macao, Taiwan, and Singapore through a collaboration agreement signed with Hunan Mabgeek Biotech in January 2025. Dermatological indications, including atopic dermatitis, are handled separately through CMS’s subsidiary Dermavon Holdings. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website