China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for stapokibart (CM310), an IL-4Rα monoclonal antibody (mAb) drug candidate, for the treatment of seasonal allergic rhinitis (SAR).
The market filing is supported by a Phase III study, which was a multi-center, randomized, double-blinded, placebo-parallel-controlled trial designed to evaluate the efficacy and safety of stapokibart in adults with SAR who have inadequate control with nasal corticosteroids or other treatments. The study successfully met its primary endpoint, with positive results indicating that stapokibart demonstrated significant improvement over placebo and exhibited a favorable safety profile.
Stapokibart is designed to selectively bind to IL-4Rα, thereby blocking the interaction with IL-4 and IL-13, which play a key role in allergic responses. The drug has shown promising safety and efficacy in multiple studies. In addition to SAR, a market filing for stapokibart for the treatment of moderate to severe atopic dermatitis (AD) has also been granted priority review status by the NMPA.- Flcube.com
