Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced that its drug candidate stapokibart (CM310) has been granted priority review status by China’s Center for Drug Evaluation (CDE) for its potential as a treatment for chronic sinusitis with nasal polyps (CRSwNP). The IL-4Rα monoclonal antibody (mAb) has previously been awarded priority review status for the treatment of moderate-to-severe atopic dermatitis (AD) in China.
CM310 is the first drug developed by a Chinese biotech company to target the human IL-4 receptor alpha subunit (IL-4Rα). It selectively binds to IL-4Rα, blocking the interaction with IL-4 and IL-13, thereby suppressing its bioactivity. A market filing for the drug in seasonal allergic rhinitis (SAR) has been accepted for review by the National Medical Products Administration (NMPA). The Phase III study for the drug in CRSwNP has met co-primary endpoints, demonstrating that stapokibart is superior to the placebo group with highly significant statistical differences and exhibiting a good safety profile.- Flcube.com
