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

Approval of Stapokibart for Chronic Rhinosinusitis

In a significant advancement in the field of biotechnology, Keymed Biosciences Inc. has announced that China's National Medical Products Administration (NMPA) has granted approval for Stapokibart (康悦达, RD codename: CM310). This innovative treatment is specifically designed for patients suffering from chronic rhinosinusitis with nasal polyposis, a condition that adversely affects nasal health and quality of life.

The approval was achieved after a comprehensive multi-center, randomized, double-blind, placebo-controlled phase III clinical trial. This critical study aimed to substantiate the efficacy and safety of Stapokibart in treating patients with this debilitating condition. The results were overwhelmingly positive, indicating significant improvements when compared to a placebo. Patients receiving Stapokibart demonstrated a notable reduction in nasal polyp size, with a nasal polyps score (NPS) improvement of 2.3 from baseline measurements after 24 weeks of treatment. Furthermore, nasal congestion scores improved by 0.7, highlighting the drug's effectiveness in alleviating symptoms of chronic rhinosinusitis.

The statistical significance of these findings is remarkable, with a p-value of less than 0.0001, confirming that the improvements observed are unlikely to have occurred by chance. In addition to reducing the size of nasal polyps and alleviating congestion, Stapokibart also exhibited a strong ability to restore the sense of smell and enhance overall nasal symptoms, significantly improving patients' quality of life. Importantly, the safety profile of Stapokibart was favorable, with no severe side effects reported in the clinical trials.

Understanding Stapokibart

Stapokibart (康悦达, RD codename CM310) is a humanized monoclonal antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα). This mechanism is vital as it blocks the pathways of both interleukin-4 (IL-4) and interleukin-13 (IL-13), which are crucial cytokines involved in triggering type II inflammation—a primary driver of conditions like atopic dermatitis and chronic rhinosinusitis. The introduction of Stapokibart marks a new era in the management of these conditions, being the first domestically manufactured drug of its kind approved by the NMPA.

Previously, Stapokibart had already received marketing approval for the treatment of moderate-to-severe atopic dermatitis in adults in September 2024, indicating the broad applicability and potential of this innovative therapy. Moreover, the NMPA has accepted its application for the treatment of seasonal allergic rhinitis, further expanding its impactful role in allergy-related therapies.

About Keymed Biosciences

Keymed Biosciences Inc. is a company renowned for addressing urgent clinical needs and delivering high-quality, affordable therapies to both Chinese and international patients. Its fully integrated development platform streamlines antibody drug discovery, from target validation to clinical development and manufacturing. The company's commitment to innovation and patient care is evident in its diverse pipeline of antibody-based therapies, which continue to push the boundaries of what is possible in medical science.

For more information about Keymed Biosciences and its groundbreaking therapies, please visit Keymed Biosciences. Stay tuned for more updates on Stapokibart and its impacts on chronic rhinosinusitis and other conditions in the near future.