Stapokibart Was Granted Marketing Approval From National Medical Products Administration For The Treatment Of Moderate-to-severe Atopic Dermatitis in Adults

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.

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.

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