Mabwell(SH:688062) Ge Long Hui A P P·2025-08-31 08:37Core Viewpoint - Maiwei Biotech has received the acceptance notice from the National Medical Products Administration (NMPA) for the Phase II clinical trial application of 9MW3811 injection for pathological scars, marking a significant step in its development pipeline [1][2] Group 1: Product Development - 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 drug effectively inhibits the abnormal activation of the IL-11/IL-11Rα signaling pathway, intervening in the pathological progression of fibrotic diseases [1] - Preclinical studies have shown significant efficacy of 9MW3811 in various models, including pulmonary fibrosis, and potential applications in fibrotic diseases such as hypertrophic scars and abnormal uterine bleeding [1] Group 2: Clinical Trials and Market Position - 9MW3811 has been approved globally for clinical research in advanced malignant tumors and idiopathic pulmonary fibrosis, with Phase I trials completed in Australia and China showing good safety and a half-life exceeding one month [2] - The company plans to initiate Phase II clinical trials for pathological scars by the end of 2025, positioning itself as one of the first IL-11 targeted drugs to enter clinical stages in this indication [2]