Keymed Biosciences Inc. announced the National Medical Products Administration (the "NMPA") of China has recently approved the supplemental New Drug Application (the "sNDA") of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: 康悦达, R&D codename: CM310), for the treatment of chronic rhinosinusitis with nasal polyposis.

The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III clinical study to confirm the efficacy and safety of Stapokibart injection in treatment of patients with chronic rhinosinusitis with nasal polyposis. The study results showed that the data from the phase III clinical trial was positive. Compared to the placebo, Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks. The differences were highly statistically significant (P<0.0001). Additionally, it effectively relieved rhinosinusitis, restored sense of smell, improved nasal symptoms, and enhanced quality of life. It also demonstrated a favorable safety profile.