#China #Chengdu #Stapokibart #Keymed #Allergy Treatment

Keymed Biosciences Announces Approval of Stapokibart

In a significant development, Keymed Biosciences (HKEX: 02162) has recently announced that the National Medical Products Administration (NMPA) of China has approved Stapokibart, a monoclonal antibody designed to treat seasonal allergic rhinitis. This groundbreaking news was shared on February 10, 2025, following a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study that validates the efficacy and safety of Stapokibart in adults suffering from this condition.

Study Highlights

The Phase III clinical study involved patients whose seasonal allergic rhinitis was not adequately controlled by existing nasal corticosteroids or other therapies. During the pollen season, the administration of Stapokibart for a duration of two weeks demonstrated remarkable effectiveness. It effectively controlled typical allergic nasal symptoms such as runny nose, nasal congestion, itching, and sneezing. The treatment group showed a mean difference of -1.3 in symptoms compared to the standard treatment group, which included nasal sprays combined with antihistamines. With a statistically significant p-value of 0.0008, the findings indicate substantial clinical benefits that significantly exceed the minimum clinically important difference (MCID) of 0.23.

Moreover, Stapokibart's efficacy extends beyond nasal symptoms. It has also been shown to alleviate ocular allergic symptoms such as itching, burning, tearing, and redness, thereby enhancing the overall quality of life for patients while exhibiting an excellent safety profile.

About Stapokibart

Stapokibart is an innovative, highly effective humanized antibody targeting the alpha subunit of the interleukin-4 receptor (IL-4Rα). It is recognized as the first domestically produced IL-4Rα antibody to receive marketing approval from the NMPA. By targeting IL-4Rα, Stapokibart serves to inhibit signaling pathways activated by interleukin-4 (IL-4) and interleukin-13 (IL-13), both critical cytokines that contribute to type II inflammation.

Prior to this approval, Stapokibart had undergone several clinical trials, demonstrating a promising safety and efficacy profile. Key indications for Stapokibart include moderate to severe atopic dermatitis in adults, as well as chronic rhinosinusitis with nasal polyps, both of which received marketing authorization in September and December of 2024 respectively.

About Keymed Biosciences

Keymed Biosciences Inc. (HKEX 02162) was founded to address pressing clinical needs that remain unmet. The company is dedicated to providing innovative, affordable, and high-quality therapies to patients both in China and abroad. Founded by a team of medical experts and scientists, Keymed focuses on transforming scientific and technological advancements into commercialized products, enhancing patient care through its innovative solutions.

In conclusion, the approval of Stapokibart not only marks a milestone for Keymed Biosciences but also offers hope for millions of patients suffering from seasonal allergic rhinitis, providing them with an effective treatment option that significantly improves their quality of life.