#China #Chengdu #Keymed Biosciences #Stapokibart #Chronic Rhinosinusitis

Keymed Biosciences Achieves Milestone in Rhinosinusitis Treatment

In a significant advancement for patients suffering from chronic rhinosinusitis with nasal polyposis, Keymed Biosciences Inc. has announced the approval of its drug Stapokibart by the National Medical Products Administration (NMPA) in China. This innovative treatment, which is also known by its trade name Kangyueda (康悦达), has been developed as an anti-IL-4Rα monoclonal antibody and is designated with the research and development code CM310.

Background of the Approval

The recent approval follows a rigorous multi-center, randomized, double-blind, placebo-controlled phase III clinical trial aimed at establishing the efficacy and safety of Stapokibart for patients afflicted with chronic rhinosinusitis characterized by nasal polyps. The findings from this extensive trial were promising, demonstrating that Stapokibart significantly reduced the severity of nasal polyps, achieving a nasal polyp score (NPS) improvement of 2.3 from the baseline after 24 weeks—a statistically significant result (P<0.0001). Notably, participants also experienced an average improvement of 0.7 in nasal congestion scores (NCS).

Alongside reducing nasal polyps and alleviating congestion, Stapokibart markedly improved overall symptoms associated with rhinosinusitis, helped restore patients' sense of smell, and enhanced their quality of life while maintaining a favorable safety profile.

What is Stapokibart?

Stapokibart is notable for being the first domestically produced IL-4Rα antibody approved for marketing by the NMPA. By specifically targeting the interleukin-4 receptor alpha subunit (IL-4Rα), this drug effectively interferes with the signaling pathways of two critical cytokines—interleukin-4 (IL-4) and interleukin-13 (IL-13)—which are instrumental in initiating type II inflammation responsible for various allergic conditions.

Prior to this approval, Stapokibart has already shown noteworthy results in other clinical trials, including its previously granted marketing approval for the treatment of moderate-to-severe atopic dermatitis in adults, which was received in September 2024. The NMPA has also accepted applications for its use in treating seasonal allergic rhinitis.

This remarkable progress underscores Keymed Biosciences' commitment to addressing significant unmet medical needs and providing effective treatments for individuals dealing with chronic inflammatory disorders. The favorable outcomes from clinical trials reflect both the safety and efficacy of Stapokibart's unique formulation, solidifying its role as a crucial option in the management of chronic rhinosinusitis with nasal polyposis.

Conclusion

The approval of Stapokibart marks a pivotal moment for Keymed Biosciences and the healthcare landscape in China. As the company continues to innovate and expand its portfolio, patients can expect improved treatment options that directly target the mechanisms of chronic rhinosinusitis and enhance their overall quality of life. With Stapokibart now available, there is hope for many who have long sought relief from this challenging condition.