#China #Chengdu #Keymed Biosciences #Stapokibart #Kangyueda

Keymed Biosciences Achieves Major Milestone in Rhinosinusitis Treatment

Chengdu, China - On December 24, 2024, Keymed Biosciences Inc. (HKEX: 02162) revealed a significant development in allergy treatment as the National Medical Products Administration (NMPA) of China granted approval for Stapokibart, a monoclonal antibody targeting IL-4Rα. This drug, known commercially as Kangyueda (康悦达) and developed under the auspices of the internal code CM310, is now officially sanctioned to treat chronic rhinosinusitis with nasal polyposis.

The approval is anchored in a rigorously designed Phase III clinical trial, characterized by its multicentric, double-blind, and placebo-controlled methodology. The study's findings demonstrated that Stapokibart notably diminished nasal polyps with an improvement in the Nasal Polyp Score (NPS) averaging a reduction of 2.3 from baseline scores. Additionally, participants experienced a reduction in nasal congestion as measured by the Nasal Congestion Score (NCS), showing an improvement of 0.7.

Statistically, these results are compelling, with a significance level well below 0.0001, suggesting that the drug does not merely offer placebo-level outcomes but an effective intervention worth further investigation.

Beyond the quantifiable benefits in polyp size and nasal congestion, Stapokibart has also been linked to the restoration of the sense of smell, enhancement of overall nasal symptoms, and the upliftment of quality of life for patients suffering from chronic rhinosinusitis.

About Stapokibart

Stapokibart is an innovative humanized monoclonal antibody engineered specifically to inhibit the alpha subunit of the interleukin-4 receptor (IL-4Rα). It represents a pioneering national achievement as the first domestically produced IL-4Rα antibody to secure commercial approval from the NMPA. By effectively blocking the signaling pathways of both interleukin-4 (IL-4) and interleukin-13 (IL-13)—proven cytokines that mediate type II inflammation—Stapokibart offers a robust solution to combat inflammatory conditions.

Prior to this approval, Stapokibart had shown considerable promise in various clinical contexts, and it received market approval in September 2024 for the treatment of moderate to severe atopic dermatitis in adults. The NMPA has also accepted further applications for Stapokibart concerning seasonal allergic rhinitis, indicating a strategic move towards broader therapeutic applications.

In a setting where chronic rhinosinusitis can severely impair life quality, the introduction of Stapokibart stands to revolutionize treatment approaches, offering hope for effective management of this debilitating condition. With its favorable safety profile demonstrated during trials, healthcare professionals and patients alike have reason to anticipate a positive impact.

Keymed Biosciences continues to position itself as a leader in biopharmaceutical advancements within China and globally, as they embark on the next phase of introducing Stapokibart to the healthcare market.

In conclusion, the approval of Stapokibart is a noteworthy advancement for patients suffering from chronic rhinosinusitis with nasal polyposis, underlining Keymed Biosciences' commitment to enhancing healthcare and improving the lives of patients through innovative treatments. The company's ongoing research aims to capitalize on the momentum and scientifically robust foundation established by this landmark approval as they explore additional therapeutic avenues.