Chinese biotechnology company Keymed Biosciences Inc (HKEX: 02162) announced on Monday that it has received approval from the National Medical Products Administration (NMPA) of China for the supplemental New Drug Application (sNDA) for Stapokibart, a humanised antibody targeting the interleukin-4 receptor alpha subunit, intended for the treatment of chronic rhinosinusitis with nasal polyposis.

This approval is based on a multi-centre, randomised, double-blind, placebo-controlled phase III clinical study.

Compared to placebo, Stapokibart significantly reduced nasal polyps and alleviated nasal congestion after 24 weeks. It also helped in effectively relieving rhinosinusitis, restoring sense of smell, improving nasal symptoms and enhancing quality of life, with a favourable safety profile.

Stapokibart is the first domestically manufactured IL-4Rα antibody drug to receive marketing approval from the NMPA.