Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a market filing for its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), for the treatment of moderate to severe atopic dermatitis (AD). This marks a significant milestone for the company as CM310 is the first drug developed by a Chinese biotech to target the human IL-4 receptor alpha subunit (IL-4Rα).
CM310 is designed to selectively bind to IL-4Rα, thereby blocking the interaction of IL-4Rα with IL-4 and IL-13, which are key drivers of the pathogenesis of AD. This targeted approach aims to suppress the bioactivity of these cytokines, offering a novel treatment option for patients suffering from moderate to severe AD.
The approval decision was supported by a multi-center, randomized, double-blind, placebo-controlled Phase III study, which showed that at week 16, the EASI-75 response rate (66.9% vs 25.8%) and the proportion of patients achieving IGA 0/1 with a decrease of ≥ 2 points from baseline (44.2% vs 16.1%) in the stapokibart group were significantly higher than those in the placebo group (P<0.0001), meeting the co-primary endpoints. The drug also demonstrated a favorable safety profile, adding to its sustainable clinical benefits. – Flcube.com
