China Medical System: NDA for Atopic Dermatitis Indication of Long-acting Anti-IL-4Rα Humanized Monoclonal Antibody Injection MG-K10 Accepted in China

MG-K10 is expected to become the world’s first long-acting anti-IL-4Rαmonoclonal antibody with a four-week dosing frequency to be launched on the market, and has the potential to become the Best-in-Class   Its Phase III clinical study in adults with moderate-to-severe AD in China has achieved positive results, meeting the primary endpoint, and at 52 weeks of treatment with MG-K10, 76.6% of patients achieved an IGA score of 0/1, with an improvement of ≥2 points from baseline; 94.3% and 79.1% of patients achieved EASI 75 and EASI 90, respectively. The overall safety profile was favorable. The incidence of common adverse reactions (conjunctivitis, injection site reactions, etc.) of drugs with the same target is relatively low for MG-K10.   The Product will further enrich Dermavon’s portfolio in the AD field. It will generate synergy with ruxolitinib cream(for mild to moderate AD), the oral small molecule TYK2 inhibitor CMS-D001 (for moderate to severe AD), and the […]