Core Viewpoint - The approval of the clinical trial for the biosimilar Y225 marks a significant advancement for the company in the treatment of Hemophilia A, potentially filling a gap in the domestic market for high-barrier bispecific monoclonal antibody biosimilars [1][2] Group 1: Product Development - The clinical trial for Y225, a biosimilar to the drug Shuyou Lile® (Emicizumab injection), has been approved by the National Medical Products Administration (NMPA) of China, with the trial set to begin on December 23, 2025 [1] - Y225 is designed to treat Hemophilia A, a condition caused by a deficiency in coagulation factor VIII, which leads to bleeding disorders [1] - The original drug Shuyou Lile® is the only bispecific antibody approved for preventive treatment in patients with or without factor VIII inhibitors, but its high cost limits patient access [1] Group 2: Competitive Advantage - The company has innovatively overcome the formulation patent of the original drug, allowing Y225 to potentially launch seven years earlier than expected, making it the first biosimilar of Shuyou Lile® to enter the domestic market [1] - The existing patents for Shuyou Lile® extend its protection until 2038, creating a significant barrier to entry for competitors [1] Group 3: Strategic Partnerships - A strategic cooperation agreement was signed with Hubei Jiangxia Laboratory on June 17, 2025, to leverage the laboratory's research capabilities alongside the company's experience in antibody drug development [2] - The collaboration will focus on innovative antibody molecule design, efficient production process development, and clinical research, with Y225 as the first project [2] - This partnership aims to enhance the overall research and development efficiency and long-term industrialization potential of the company's pipeline [2]
友芝友生物-B(02496)：Y225(艾美赛珠单抗注射液)取得NMPA的IND批准