Keymed Biosciences Inc. announced that the Phase III clinical trial of its Class 1 innovative drug CM310 recombinant humanized monoclonal antibody (Stapokibart) injection in patients with chronic rhinosinusitis with nasal polyps (CM310-102208, registered number: CTR20221480) has completed the unblinding of data from the double-blind treatment period and the preliminary statistical analysis, which shows that the primary endpoints are achieved. CM310-102208 is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial to confirm the efficacy and safety of CM310 recombinant humanized Monoclonal antibody injection in treatment of patients with chronic rhinosinus infection with nasal polyps. This trial enrolled 180 eligible participants, who were randomized in a 1:1 ratio to receive 300 mg CM310 or placebo, once every two weeks (Q2W), total 12 doses in the double-blind period.

The co-primary endpoints were the changes from baseline in nasal polyp score (NPS) and nasal congestion score (NCS) at week 24. The results of the Phase III clinical trial are positive with co-primary endpoints both achieved: the CM310 group is superior to placebo group with statistically significant differences (P<0.0001); CM310 also demonstrates a favorable safety profile. The Company plans to submit the new drug application (NDA) of CM310 for the treatment of chronic rhinosinusitis with facial polyps to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China within 2024.