#China #Chengdu #Keymed Biosciences #Stapokibart #IL-4Rα

Keymed Biosciences Secures Approval for Stapokibart

Keymed Biosciences, listed as HKEX: 02162, has announced a significant development in the realm of allergy treatment with the recent approval of Stapokibart (commercially known as Kangyueda) by China's National Medical Products Administration (NMPA). This approval marks Stapokibart as the first locally developed monoclonal antibody targeting IL-4Rα that has been authorized for the treatment of seasonal allergic rhinitis.

Study Highlights

This pivotal approval is rooted in the findings from a Phase III study characterized as multicentric, randomized, double-blind, and placebo-controlled, aiming to assess the safety and efficacy of Stapokibart in managing seasonal allergic rhinitis in adults who have had inadequate control of their symptoms through traditional therapies, such as nasal corticosteroids. The results emerged as quite promising. Patients who received Stapokibart over a two-week period during peak pollen seasons exhibited a marked reduction in classic nasal allergic symptoms compared to those who underwent standard treatments involving hormonal nasal sprays and antihistamines.

The average least squares mean (LSMean) difference between the two groups stood at -1.3, with a 95% confidence interval also reflecting -1.3, indicating a statistically significant difference (P = 0.0008). This figure robustly exceeds the minimal clinically important difference (MCID) benchmark of 0.23, illustrating substantial clinical benefits for patients. Additionally, Stapokibart showed effectiveness in alleviating ocular allergic symptoms which typically include itching, burning, tearing, and redness, enhancing the overall quality of life for individuals affected by these allergies.

Mechanism of Action

Stapokibart functions as a humanized monoclonal antibody targeting the alpha subunit of the interleukin-4 receptor, IL-4Rα. This innovative treatment blocks the signaling pathways of key inflammatory cytokines, interleukin-4 (IL-4) and interleukin-13 (IL-13), which are pivotal in promoting type II inflammation. Data from earlier clinical trials have demonstrated Stapokibart's good safety profile and encouraging efficacy for several indications, including moderate to severe atopic dermatitis and chronic rhinosinusitis with nasal polyps, the latter two receiving market approval in September and December of 2024, respectively.

A Commitment to Innovation

Keymed Biosciences is dedicated to addressing critical unmet clinical needs and is steadfast in its mission to deliver innovative, affordable, and high-quality therapies to patients, both within China and globally. With a foundation built by seasoned medical and scientific experts, Keymed is well-positioned to transform advancements in scientific research into therapeutic realities.

Overall, the introduction of Stapokibart represents a promising avenue in the treatment landscape for seasonal allergic rhinitis, providing hope to those who struggle with the daily challenges posed by this condition.