Keymed Biosciences Gains Approval for Stapokibart to Treat Chronic Rhinosinusitis

Keymed Biosciences has received approval from China’s National Medical Products Administration (NMPA) for a supplemental New Drug Application (sNDA) of Stapokibart.

Stapokibart is a domestically developed humanized monoclonal antibody. It targets IL-4Rα, effectively blocking interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling pathways. These cytokines are linked to type II inflammation, which underpins conditions such as chronic rhinosinusitis with nasal polyposis.

This treatment is the first IL-4Rα antibody manufactured domestically to gain marketing approval in China. Stapokibart had previously been approved for moderate-to-severe atopic dermatitis in adults in September 2024. Furthermore, its application for the treatment of seasonal allergic rhinitis is currently under review by the NMPA.

This monoclonal antibody, targeting interleukin-4 receptor alpha (IL-4Rα), is intended for the treatment of chronic rhinosinusitis with nasal polyposis.

The approval follows a phase III clinical trial that demonstrated the drug’s effectiveness and safety. Conducted as a multi-centre, randomized, double-blind, and placebo-controlled study, the trial showed positive results. 

After 24 weeks of treatment, patients experienced significant reductions in nasal polyps and nasal congestion, with improvements of 2.3 and 0.7 points from baseline, respectively. 
Additional benefits included relief from rhinosinusitis, restoration of the sense of smell, better nasal symptoms, and enhanced quality of life. 

The results showed statistical significance (P<0.0001), and the safety profile of the treatment was favourable.

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