The marketing application for the indication of moderate to severe atopic dermatitis of MG-K10, the world's first long-acting IL-4Rα monoclonal antibody, has been accepted.

The marketing authorization application for the innovative drug of Class 1, Kemeiqibai Monoclonal Antibody Injection (Research Code: MG-K10), submitted by Mabgeek Biotech, has been accepted by the National Medical Products Administration (NMPA) of China. The acceptance number is CXSS2500116. The product is intended for the treatment of moderate to severe atopic dermatitis in adults.

MG-K10

MG-K10 is an innovative long-acting anti-IL-4Rα humanized monoclonal antibody independently developed by Mabwell Biopharmaceuticals. It can simultaneously block the signal transduction of key type 2 inflammatory factors IL-4 and IL-13. With a longer half-life, the product can be administered at a frequency of 300mg every four weeks (while currently marketed anti-IL-4Rα drugs are administered at a frequency of 300mg every two weeks), improving patient compliance and has the potential to become the world's first long-acting anti-IL-4Rα monoclonal antibody, with the potential to be the best-in-class. MG-K10 has achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical study in adult patients with moderate to severe atopic dermatitis, reaching the primary endpoint of the clinical trial as designed. At the 52nd week of treatment with 300mg every four weeks, 76.6% of the subjects had an Investigator's Global Assessment (IGA) score of 0 or 1 and an improvement of ≥2 points from baseline; 94.3% of the subjects achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI 75) from baseline; and 79.1% of the subjects achieved at least a 90% improvement in the Eczema Area and Severity Index (EASI 90) from baseline. In terms of safety, most of the treatment-emergent adverse events (TEAE) during the 52-week treatment period were grade 1-2, and the incidence of common adverse reactions of drugs targeting the same target (such as conjunctivitis and injection site reactions) was lower in MG-K10. MG-K10 has entered Phase III clinical trials for asthma, prurigo nodularis and seasonal allergic rhinitis.

Mabgeek Biotech

Mabgeek Biotech was established in 2016 and has always adhered to the R&D philosophy of "innovation, efficiency, and safety", focusing on allergic inflammatory diseases and autoimmune diseases. Mabgeek Biotech has a research and development team composed of top experts in the industry. With outstanding R&D capabilities and profound industry accumulation, it utilizes its unique TEADA high-throughput antibody screening platform to develop innovative antibody drugs with high biological activity, high drugability, and differentiation, aiming to bring safer, more effective, and more convenient treatment options to patients worldwide. Besides MG-K10, Mabgeek Biotech's TSLP monoclonal antibody (with a half-life exceeding 80 days) has entered the Phase II clinical trial for asthma, and the MASP-2 monoclonal antibody with extended half-life has obtained the IND approval.