#China #Chengdu #Keymed Biosciences #Stapokibart #Chronic Rhinosinusitis

Keymed Biosciences Secures NMPA Approval for Stapokibart

On December 24, 2024, Keymed Biosciences Inc. (stock code: HKEX 02162) announced a significant milestone: the National Medical Products Administration (NMPA) of China has approved its supplemental New Drug Application (sNDA) for Stapokibart, a monoclonal antibody targeting IL-4Rα. This development is particularly exciting as it opens new avenues in the treatment of chronic rhinosinusitis with nasal polyposis.

The approval is founded on the results of a Phase III clinical trial that assessed the efficacy and safety of Stapokibart injections. Conducted as a multicentric, randomized, double-blind, placebo-controlled study, the trial yielded positive outcomes indicating that Stapokibart significantly improves nasal polyp size and alleviates nasal congestion. Specifically, after 24 weeks of treatment, Stapokibart demonstrated an average improvement of 2.3 in nasal polyps (NPS) and 0.7 in nasal congestion severity compared to placebo. The results were statistically significant (P<0.0001), showcasing Marked differences in efficacy.

Moreover, patients reported enhanced quality of life, with Stapokibart effectively relieving rhinosinusitis symptoms and restoring sense of smell. Importantly, the drug exhibited a favorable safety profile, further supporting its use for this condition.

Stapokibart, marketed under the brand name Kangyueda (康悦达), is a humanized antibody designed to block the IL-4Rα unit, which plays a crucial role in the inflammatory processes associated with chronic rhinosinusitis. The inhibition of IL-4 and IL-13 signaling pathways, known to trigger type II inflammation, positions Stapokibart as a groundbreaking option for managing not only chronic rhinosinusitis but also other allergic conditions.

In September 2024, Stapokibart also gained approval for the treatment of moderate to severe atopic dermatitis in adults, marking its versatility and potential in treating various allergic disorders. Currently, there is an ongoing review of the application for Stapokibart aimed at treating seasonal allergic rhinitis, indicating the company's commitment to expanding therapeutic options for allergic conditions.

Keymed Biosciences continues to innovate in the biotechnology sector, focusing on developing advanced therapies that leverage mechanisms in immune modulation to address chronic and complex diseases. The approval of Stapokibart reinforces Keymed's dedication to improving patient outcomes and enhancing the quality of life for those suffering from chronic rhinosinusitis and other related diseases.

As the landscape of treatment for chronic conditions evolves, the approval of Stapokibart represents a significant step forward, offering new hope to patients and healthcare providers alike. The scientific community eagerly anticipates more data from ongoing and future studies to fully understand the implications of Stapokibart's role in chronic and allergic conditions, while Keymed Biosciences stands poised as a key player in this transformative phase in medicine.