迈威生物：9MW3811注射液用于病理性瘢痕适应症的II期临床试验申请获得批准

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]