Keymed Biosciences' Stapokibart Approved for Seasonal Allergic Rhinitis

In a significant development in the field of allergy treatment, KeyMed Biosciences (HKEX: 02162), based in CHENGDU, China, has announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for Stapokibart, also known by its trade name Kangyueda (康悦达). This innovative anti-IL-4Rα monoclonal antibody is now authorized for the treatment of seasonal allergic rhinitis, a condition characterized by severe nasal symptoms due to allergens like pollen.

This approval follows a comprehensive multi-center, randomized, double-blind, placebo-controlled phase III clinical study. The trial was designed to evaluate the efficacy and safety of Stapokibart injections in adults suffering from seasonal allergic rhinitis who have not responded adequately to nasal corticosteroids or other therapeutic measures. The results of the study were compelling, showing that Stapokibart, when administered over a two-week period, significantly mitigated nasal allergy symptoms such as runny nose, congestion, itching, and sneezing during the pollen season. This was in comparison to a control group receiving standard treatment with nasal spray hormones and antihistamines.

The clinical trial revealed a least-squares mean (LSMean) inter-group difference of -1.3, with a 95% confidence interval of -1.3, reflecting a highly significant statistical distinction (P = 0.0008). This outcome exceeds the minimal clinically important difference (MCID) of 0.23, underscoring the substantial clinical benefits of the drug. Additionally, Stapokibart was shown to alleviate ocular symptoms associated with allergies, such as itching or burning of the eyes, tearing, and redness, thus improving the overall quality of life for patients. The safety profile of Stapokibart was also affirmed, making it a promising option for individuals with seasonal allergic rhinitis.

Stapokibart operates by targeting the interleukin-4 receptor alpha subunit (IL-4Rα). It is the first domestically produced IL-4Rα antibody drug in China to receive marketing authorization from the NMPA. By blocking IL-4Rα, Stapokibart effectively inhibits both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways, which are pivotal in initiating type II inflammation. Previous clinical trials have already demonstrated the drug's safety and effectiveness across various indications, including moderate-to-severe atopic dermatitis in adults and chronic rhinosinusitis with nasal polyposis, for which it received marketing approval in September 2024 and December 2024, respectively.

KeyMed Biosciences Inc. has established its reputation by addressing unmet clinical needs with innovative and affordable therapies in both domestic and international markets. Founded by experts with vast experience in translating scientific research into commercial success, KeyMed continues to advance medical treatments that significantly impact patient care.

The recent approval of Stapokibart marks another milestone for KeyMed Biosciences, reinforcing its commitment to enhancing patient outcomes through cutting-edge biotechnology solutions. This significant achievement not only broadens the therapeutic options available for individuals with seasonal allergic rhinitis but also emphasizes KeyMed's role as a leader in the biopharmaceutical industry.