Keymed Biosciences' Stapokibart: A New Hope for Seasonal Allergic Rhinitis Patients

Keymed Biosciences Inc. (HKEX: 02162) has made a significant stride in the treatment of seasonal allergic rhinitis (SAR) with the recent approval of Stapokibart by the National Medical Products Administration (NMPA) of China. This approval marks a new era in the management of SAR, offering patients a more effective and well-tolerated treatment option.

Stapokibart, a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are key cytokines that trigger type II inflammation. This novel mechanism of action sets Stapokibart apart from existing treatments for SAR, such as antihistamine tablets and nasal sprays.

The approval of Stapokibart is based on a multi-center, randomized, double-blind, placebo-controlled phase III study that demonstrated its efficacy and safety in treating adult patients with SAR who were poorly controlled with nasal corticosteroids or other therapies. The study findings showed that Stapokibart effectively controlled typical nasal allergic symptoms, including runny nose, nasal congestion, nasal itching, and sneezing, and alleviated ocular allergic symptoms such as eye itching or burning, eye tearing or watering, and eye redness. The least-squares mean (LSMean) of the inter-group difference in the total nasal symptom score (TNSS) was -1.3, with a 95% confidence interval (CI) of -1.3, indicating a highly significant statistical difference (P = 0.0008). This difference far exceeds the minimal clinically important difference (MCID) of 0.23, clearly demonstrating substantial clinical benefits.

Stapokibart's safety profile was also impressive, with no new safety signals identified after 52 weeks of administration. The safety profile was consistent with that observed at week 16, indicating that Stapokibart is well-tolerated by patients.

The approval of Stapokibart has significant implications for the competitive landscape of the SAR market, particularly in China. Keymed Biosciences becomes a new player in the market, joining established competitors such as Regeneron Pharmaceuticals, Revolo Biotherapeutics, Allergy Therapeutics, Emergo Therapeutics, and ALK-Abelló. As the first domestically manufactured IL-4Rα antibody drug, Stapokibart offers a locally produced alternative to imported products, giving Keymed Biosciences a competitive edge in the Chinese market.

In conclusion, the approval of Stapokibart by the NMPA of China is a game-changer in the treatment of seasonal allergic rhinitis. With its novel mechanism of action, proven efficacy, and excellent safety profile, Stapokibart offers patients a more effective and well-tolerated treatment option. The approval also has significant implications for the competitive landscape of the SAR market, with Keymed Biosciences emerging as a new player with a locally produced alternative to imported products. As the prevalence of allergies continues to rise, the demand for innovative and effective treatments like Stapokibart is expected to grow, driving the market's expansion and contributing to better patient outcomes.