CHENGDU, China I December 23, 2024 I Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the “NMPA”) of China has recently approved the supplemental New Drug Application (the “sNDA”) of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), R&D codename: CM310), for the treatment of chronic rhinosinusitis with nasal polyposis.
The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III clinical study to confirm the efficacy and safety of Stapokibart injection in treatment of patients with chronic rhinosinusitis with nasal polyposis. The study results showed that the data from the phase III clinical trial was positive. Compared to the placebo, Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks. The differences were highly statistically significant (P<0.0001). Additionally, it effectively relieved rhinosinusitis, restored sense of smell, improved nasal symptoms, and enhanced quality of life. It also demonstrated a favorable safety profile.
About Stapokibart
Stapokibart (trade name: Kangyueda, R&D codename: CM310) is a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), and 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. IL-4 and IL-13 are two key cytokines that trigger type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials, and its treatment of the indication of moderate-to-severe atopic dermatitis in adults has been approved for marketing in September 2024. As of the date of this announcement, the new drug application of Stapokibart for the treatment of seasonal allergic rhinitis has been accepted by the NMPA.
SOURCE: Keymed Biosciences
Post Views: 186
CHENGDU, China I December 23, 2024 I Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the “NMPA”) of China has recently approved the supplemental New Drug Application (the “sNDA”) of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), R&D codename: CM310), for the treatment of chronic rhinosinusitis with nasal polyposis.
The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III clinical study to confirm the efficacy and safety of Stapokibart injection in treatment of patients with chronic rhinosinusitis with nasal polyposis. The study results showed that the data from the phase III clinical trial was positive. Compared to the placebo, Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks. The differences were highly statistically significant (P<0.0001). Additionally, it effectively relieved rhinosinusitis, restored sense of smell, improved nasal symptoms, and enhanced quality of life. It also demonstrated a favorable safety profile.
About Stapokibart
Stapokibart (trade name: Kangyueda, R&D codename: CM310) is a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), and 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. IL-4 and IL-13 are two key cytokines that trigger type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials, and its treatment of the indication of moderate-to-severe atopic dermatitis in adults has been approved for marketing in September 2024. As of the date of this announcement, the new drug application of Stapokibart for the treatment of seasonal allergic rhinitis has been accepted by the NMPA.
SOURCE: Keymed Biosciences
Post Views: 186
