Keymed Biosciences Inc. (HKG: 2162) has announced that its market filing for stapokibart (CM310), a monoclonal antibody targeting the IL-4 receptor alpha (IL-4Rα), has been accepted for priority review by the National Medical Products Administration (NMPA) for the treatment of moderate to severe atopic dermatitis (AD).
The filing is supported by data from a multi-center, randomized, double-blind, placebo-controlled Phase III trial. In this study, participants were divided into two groups, receiving either stapokibart (600mg-300mg Q2W) or a placebo. The co-primary endpoints included the eczema area and severity index (EASI) -75 achievement rate, indicating a reduction of 75% or more from baseline EASI scores at 16 weeks, and the rate of achieving a score of 0 or 1 on the investigator’s global assessment (IGA) with a decrease of at least 2 points from baseline. Results demonstrated that the primary efficacy endpoints were met, with long-term treatment showing sustained benefits and a favorable safety profile.
CM310 is notable as the first drug developed by a China-based biotech company targeting the human IL-4Rα. This innovative molecule selectively binds to IL-4Rα, inhibiting the interaction between IL-4Rα and both IL-4 and IL-13, thereby suppressing their bioactivity. It has exhibited promising safety and efficacy across multiple studies.- Flcube.com
