#China #Chengdu #Keymed Biosciences #Stapokibart #Allergic Rhinitis

Keymed Biosciences Achieves Milestone with Stapokibart Approval

Keymed Biosciences, a leading biopharmaceutical company based in Chengdu, China, has announced a significant achievement with the approval of Stapokibart (known locally as Kangyueda). This revolutionary drug has been sanctioned by China’s National Medical Products Administration (NMPA) for the treatment of seasonal allergic rhinitis (SAR), providing a new option for patients who experience inadequate relief with current treatments.

About Stapokibart

Stapokibart is a humanized monoclonal antibody designed to inhibit the interleukin-4 receptor alpha (IL-4Rα). By blocking this receptor, the medication effectively counters the actions of key cytokines, interleukin-4 (IL-4) and interleukin-13 (IL-13), both of which play crucial roles in type II inflammation associated with allergic reactions. Notably, Stapokibart is the first antibody targeting the IL-4Rα to receive marketing approval from the NMPA.

Clinical Study Highlights

The approval of Stapokibart is backed by a rigorous phase III clinical trial that meticulously evaluated its safety and efficacy. This study, which was conducted in a randomized, double-blind, placebo-controlled manner across multiple centers, involved adult patients who struggled with seasonal allergic rhinitis despite treatment with nasal corticosteroids or other medications. The results were promising: when compared to conventional therapies that include nasal hormone sprays and antihistamines, patients treated with Stapokibart showed marked improvement in managing symptoms such as nasal congestion, sneezing, and runny nose.

The least-squares mean difference in symptom relief was -1.3, with a 95% confidence interval indicating a statistically significant result (P = 0.0008). This outcome not only surpassed the minimal clinically important difference (MCID) threshold of 0.23 but also highlighted the drug’s substantial impact on patient quality of life. Furthermore, Stapokibart proved effective against ocular symptoms commonly associated with allergic rhinitis, including eye itching and redness, improving overall patient experiences.

Previous Approvals and Future Potential

Stapokibart's approval is not its first milestone; it has previously been sanctioned for the treatment of moderate-to-severe atopic dermatitis and chronic rhinosinusitis with nasal polyposis, with approvals granted in September and December of 2024, respectively. These successes reflect Keymed Biosciences' commitment to addressing critical unmet clinical needs in the therapeutic landscape.

About Keymed Biosciences

Founded by a team of medical and scientific experts, Keymed Biosciences Inc. operates in the dynamic intersection of healthcare and innovation. The company is dedicated to developing advanced therapies that respond to significant health challenges facing patients in China and beyond. Their mission emphasizes delivering high-quality and cost-effective treatment options, ensuring accessibility for a broader patient population.

This recent approval marks an essential step forward, not just for Keymed, but for thousands of individuals suffering from seasonal allergic rhinitis, potentially transforming their experience when faced with this common yet troublesome condition.

As Keymed continues to expand its pipeline of therapies, the healthcare community eagerly anticipates the impact that Stapokibart and future innovations will have on patient care in the realm of allergic diseases.