Keymed Biosciences Gains Approval for Stapokibart to Treat Chronic Rhinosinusitis with Nasal Polyposis

CHENGDU, China, Dec. 23, 2024 - Keymed Biosciences Inc. has announced that the National Medical Products Administration (NMPA) of China has approved a supplemental New Drug Application for Stapokibart, a monoclonal antibody marketed under the name Kangyueda. This approval is specifically for the treatment of chronic rhinosinusitis with nasal polyposis.

The decision was based on a phase III clinical trial that was multi-center, randomized, double-blind, and placebo-controlled. This study aimed to evaluate the effectiveness and safety of Stapokibart in treating chronic rhinosinusitis patients who have nasal polyposis. Results from the trial were promising, showing that Stapokibart led to a considerable reduction in nasal polyps, with a 2.3-point improvement from baseline. Additionally, it eased nasal congestion significantly, with a 0.7-point improvement from baseline after 24 weeks. These results were statistically significant with a P-value of less than 0.0001. The treatment also relieved symptoms of rhinosinusitis, improved the sense of smell, and enhanced the overall quality of life, all while maintaining a favorable safety profile.

Stapokibart, known by its trade name Kangyueda and research codename CM310, is a humanized antibody that targets the interleukin-4 receptor alpha subunit (IL-4Rα). It stands out as the first IL-4Rα antibody drug produced domestically in China to receive marketing approval from the NMPA. The mechanism of Stapokibart involves blocking the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are crucial in triggering type II inflammation. Previous clinical trials have shown Stapokibart to have a good safety and efficacy profile. Notably, it was approved for marketing in September 2024 for treating moderate-to-severe atopic dermatitis in adults. Additionally, the application for using Stapokibart in treating seasonal allergic rhinitis is currently under review by the NMPA.

This recent approval marks a significant advancement for Keymed Biosciences Inc. in the field of inflammation treatment, particularly targeting chronic rhinosinusitis, a condition that significantly impairs patients' quality of life. Stapokibart's approval is expected to provide an effective treatment option for patients suffering from this condition, who previously had limited alternatives.

The development and approval of Stapokibart underscore Keymed Biosciences' commitment to advancing medical science and offering innovative solutions for patients with chronic inflammatory conditions. By focusing on targeted therapies that address the underlying mechanisms of diseases, the company aims to improve health outcomes and provide relief to patients who have long awaited better treatment options.

In summary, the approval of Stapokibart for treating chronic rhinosinusitis with nasal polyposis represents a crucial milestone in therapeutic options for this condition. The promising results from clinical trials and the drug's favorable safety profile offer hope for improved management and better quality of life for affected individuals. As Keymed Biosciences continues its research and development efforts, the medical community and patients alike anticipate further advancements in treating chronic inflammatory diseases.