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迈威生物:9MW3811注射液临床试验申请获得国家药品监督管理局受理

Core Viewpoint - Maiwei Biotech (688062.SH) has received the acceptance notice from the National Medical Products Administration (NMPA) for the Phase II clinical trial application of 9MW3811 injection for pathological scar indications [1] Group 1: Product Information - 9MW3811 is a humanized monoclonal antibody targeting human IL-11, classified as a Class 1 therapeutic biological product with independent intellectual property rights [1] - The mechanism of 9MW3811 involves high-affinity binding to IL-11, effectively inhibiting the abnormal activation of the IL-11/IL-11Rα signaling pathway, thereby intervening in the pathological progression of fibrotic diseases [1] Group 2: Competitive Advantages - The product boasts higher target affinity and signaling blockade capability [1] - It has a half-life of over one month, making it suitable for long-term administration in chronic disease treatment [1]