Keymed Biosciences Gains Approval for Stapokibart, a New Drug for Seasonal Allergic Rhinitis
On February 7, 2025, Keymed Biosciences (HKEX: 02162) announced that it has received approval from China's National Medical Products Administration (NMPA) for its supplemental New Drug Application (sNDA) concerning Stapokibart (known as Kangyueda in China) for the treatment of seasonal allergic rhinitis. This approval is a significant milestone for the company and its efforts to address unmet clinical needs in allergy treatments.
The approval process was underpinned by a comprehensive phase III clinical trial that was multi-center, randomized, double-blind, and placebo-controlled, designed to assess the efficacy and safety of Stapokibart in patients suffering from seasonal allergic rhinitis who do not have satisfactory control with nasal corticosteroids or alternative therapies. The findings from the study were compelling. During the pollen season, patients treated with Stapokibart showed a statistically significant improvement in managing their nasal allergy symptoms compared to those receiving standard treatments, which included nasal corticosteroids and antihistamines. The least-squares mean (LSMean) difference between groups was -1.3, with a confidence interval of -1.3, reaching statistical significance (P = 0.0008). This outcome surpasses the minimal clinically important difference (MCID) of 0.23, indicating clear clinical benefits for users of Stapokibart.
In addition to nasal symptoms such as runny nose, nasal congestion, and sneezing, Stapokibart was also shown to alleviate ocular symptoms associated with allergic reactions—providing relief from eye itching, tearing, or redness. This multifaceted efficacy of Stapokibart aims to significantly improve the quality of life for its patients while maintaining a favorable safety profile.
Stapokibart is a humanized monoclonal antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), a key player in type II inflammation. This makes Stapokibart the first domestically produced IL-4Rα-targeting drug authorized for sale by the NMPA. By inhibiting the signaling of both interleukin-4 (IL-4) and interleukin-13 (IL-13), the drug effectively tackles the underlying pathophysiology of allergic diseases.
The path to this approval reflects Keymed Biosciences’ dedication to addressing crucial health needs. The company was founded by medical professionals and scientists dedicated to developing innovative and accessible therapies for patients in China and beyond. Keymed has already seen previous successes, obtaining marketing approvals for Stapokibart for other conditions like moderate-to-severe atopic dermatitis and chronic rhinosinusitis with nasal polyposis in late 2024, showcasing its commitment to transforming scientific advancements into practical therapies.
The launch of Stapokibart could herald a new era for patients suffering from seasonal allergic rhinitis, as it brings a promising option to those who have struggled to manage their conditions effectively. Given the substantial data supporting its efficacy and safety, it is anticipated that Stapokibart will play a pivotal role in the future of allergy management in the Chinese market and possibly beyond in the years to come.
The approval process was underpinned by a comprehensive phase III clinical trial that was multi-center, randomized, double-blind, and placebo-controlled, designed to assess the efficacy and safety of Stapokibart in patients suffering from seasonal allergic rhinitis who do not have satisfactory control with nasal corticosteroids or alternative therapies. The findings from the study were compelling. During the pollen season, patients treated with Stapokibart showed a statistically significant improvement in managing their nasal allergy symptoms compared to those receiving standard treatments, which included nasal corticosteroids and antihistamines. The least-squares mean (LSMean) difference between groups was -1.3, with a confidence interval of -1.3, reaching statistical significance (P = 0.0008). This outcome surpasses the minimal clinically important difference (MCID) of 0.23, indicating clear clinical benefits for users of Stapokibart.
In addition to nasal symptoms such as runny nose, nasal congestion, and sneezing, Stapokibart was also shown to alleviate ocular symptoms associated with allergic reactions—providing relief from eye itching, tearing, or redness. This multifaceted efficacy of Stapokibart aims to significantly improve the quality of life for its patients while maintaining a favorable safety profile.
Stapokibart is a humanized monoclonal antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), a key player in type II inflammation. This makes Stapokibart the first domestically produced IL-4Rα-targeting drug authorized for sale by the NMPA. By inhibiting the signaling of both interleukin-4 (IL-4) and interleukin-13 (IL-13), the drug effectively tackles the underlying pathophysiology of allergic diseases.
The path to this approval reflects Keymed Biosciences’ dedication to addressing crucial health needs. The company was founded by medical professionals and scientists dedicated to developing innovative and accessible therapies for patients in China and beyond. Keymed has already seen previous successes, obtaining marketing approvals for Stapokibart for other conditions like moderate-to-severe atopic dermatitis and chronic rhinosinusitis with nasal polyposis in late 2024, showcasing its commitment to transforming scientific advancements into practical therapies.
The launch of Stapokibart could herald a new era for patients suffering from seasonal allergic rhinitis, as it brings a promising option to those who have struggled to manage their conditions effectively. Given the substantial data supporting its efficacy and safety, it is anticipated that Stapokibart will play a pivotal role in the future of allergy management in the Chinese market and possibly beyond in the years to come.
Topics Health）
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