Core Viewpoint - The company Maiwei Biotech has developed a unique targeted monoclonal antibody, 9MW3011, for the treatment of Polycythemia Vera (PV), which is the only one of its kind globally [1] Group 1: Product Development - The 9MW3011 antibody has received external licensing for collaboration, with the company responsible for development and commercialization in Greater China and Southeast Asia [1] - The partner DISCMEDICINE, INC. is advancing the product in other regions and has obtained "Fast Track Designation" (FTD) and "Orphan Drug Designation" (ODD) from the FDA [1] Group 2: Clinical Trials - The Phase II clinical study targeting PV patients is set to complete its first dosing in the United States by September 2025, marking a significant milestone in the collaboration [1] - PV has been included in the second batch of rare disease catalog published by the National Health Commission in September 2023, indicating ongoing efforts to advance clinical enrollment in both China and the U.S. [1]
迈威生物:公司负责大中华区和东南亚区域的开发及商业化