CHENGDU, China I September 12, 2024 I Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the “NMPA”) of China has recently approved the new drug application for Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), for the indication of moderate-to-severe atopic dermatitis in adults.
The marketing approval of Stapokibart is based on a multi-center, randomized, double-blind, placebo-controlled Phase III study, with the co-primary endpoints being the achievement of at least a 75% improvement in Eczema Area and Severity Index (EASI-75) from baseline and an Investigator’s Global Assessment (IGA) score of 0 or 1 with a reduction of ≥2 points from baseline at week 16. The results showed that this trial reached the co-primary endpoints at week 16 with long-term treatment achieving sustained clinical benefits with a good safety profile.
The study showed that at week 52, the rates of achieving EASI-75 for the Stapokibart group and the placebo-to-Stapokibart group were 92.5% and 88.7%, respectively. The EASI-90 response rates were 77.1% and 65.6%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline were 67.3% and 64.2%, respectively. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. During the maintenance period, only one subject (0.9%) experienced a relapse. In terms of safety, Stapokibart was safe and well-tolerated after 52 weeks of administration, with safety profiles consistent with those observed at week 16 and no new safety signals identified.
About Stapokibart
Stapokibart (trade name: Kangyueda, R&D codename: CM310) is a humanized and highly potent antibody against the interleukin-4 receptor a-subunit (IL-4Rα). It is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can lead to dual-blockade of interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two critical cytokines for initiating type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials. As of the date of this announcement, its new drug application for the treatments of seasonal allergic rhinitis and chronic rhinosinusitis with nasal polyposis have been accepted by the NMPA.
SOURCE: Keymed Biosciences
Post Views: 2,003
CHENGDU, China I September 12, 2024 I Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the “NMPA”) of China has recently approved the new drug application for Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), for the indication of moderate-to-severe atopic dermatitis in adults.
The marketing approval of Stapokibart is based on a multi-center, randomized, double-blind, placebo-controlled Phase III study, with the co-primary endpoints being the achievement of at least a 75% improvement in Eczema Area and Severity Index (EASI-75) from baseline and an Investigator’s Global Assessment (IGA) score of 0 or 1 with a reduction of ≥2 points from baseline at week 16. The results showed that this trial reached the co-primary endpoints at week 16 with long-term treatment achieving sustained clinical benefits with a good safety profile.
The study showed that at week 52, the rates of achieving EASI-75 for the Stapokibart group and the placebo-to-Stapokibart group were 92.5% and 88.7%, respectively. The EASI-90 response rates were 77.1% and 65.6%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline were 67.3% and 64.2%, respectively. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. During the maintenance period, only one subject (0.9%) experienced a relapse. In terms of safety, Stapokibart was safe and well-tolerated after 52 weeks of administration, with safety profiles consistent with those observed at week 16 and no new safety signals identified.
About Stapokibart
Stapokibart (trade name: Kangyueda, R&D codename: CM310) is a humanized and highly potent antibody against the interleukin-4 receptor a-subunit (IL-4Rα). It is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can lead to dual-blockade of interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two critical cytokines for initiating type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials. As of the date of this announcement, its new drug application for the treatments of seasonal allergic rhinitis and chronic rhinosinusitis with nasal polyposis have been accepted by the NMPA.
SOURCE: Keymed Biosciences
Post Views: 2,003
