Core Insights - Maiwei Biotech has received approval from the National Medical Products Administration for the Phase II clinical trial application of 9MW3811 injection for pathological scars, potentially becoming the first IL-11 targeted drug to enter clinical stages for this indication [1] Group 1: Clinical Development - The Phase II clinical trial for 9MW3811 is planned to start by the end of 2025, marking a significant milestone in the treatment of pathological scars [1] - 9MW3811 has already been approved for clinical research in advanced malignant tumors and idiopathic pulmonary fibrosis globally, having completed Phase I trials in Australia and China [1] Group 2: Licensing Agreement - The company has entered into an exclusive licensing agreement with CALICO Life Sciences LLC, granting CALICO global rights outside of Greater China [1] - CALICO has made an upfront payment of $25 million to the company, with potential milestone payments reaching up to $571 million related to near-term, development, registration, and commercialization [1]

Core Viewpoint - Maiwei Biotech (688062.SH) has received approval from the National Medical Products Administration for the clinical trial of 9MW3811 injection for pathological scar indications, marking a significant advancement in its research and development pipeline [1] Group 1: Clinical Trial Approval - The company announced that it has obtained the Clinical Trial Approval Notice for 9MW3811 injection, which is intended for use in pathological scar indications [1] - The II phase clinical trial for 9MW3811 is planned to start by the end of 2025, making it the first IL-11 targeted drug to enter clinical stages in this indication area [1] Group 2: Global Research and Development Progress - 9MW3811 has already been approved for clinical research in advanced malignant tumors and idiopathic pulmonary fibrosis globally, having completed Phase I trials in Australia and China [1] - The development progress of 9MW3811 is currently leading among global peers targeting similar pathways [1] Group 3: Licensing Agreement - The company has entered into an exclusive licensing agreement with CALICO Life Sciences LLC, granting CALICO global rights outside Greater China [1] - CALICO has made an upfront payment of $25 million to the company, with potential milestone payments reaching up to $571 million for near-term, development, registration, and commercialization milestones [1]

迈威生物公告，近日收到国家药品监督管理局签发的《受理通知书》，9MW3811注射液用于病理性瘢 痕适应症的II期临床试验申请已获正式受理。9MW3811是迈威生物自主研发的一款靶向人IL-11的人源 化单克隆抗体，拥有自主知识产权。临床前研究表明，9MW3811在肺纤维化等多种模型中展现出显著 疗效，并在瘢痕增生、子宫内膜异常出血等纤维化相关疾病中显示出潜在应用价值。公司计划于2025年 底启动其用于病理性瘢痕的II期临床试验，成为该适应症领域首批进入临床阶段的IL-11靶向药物。 ...