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), has been approved by the National Medical Products Administration (NMPA) of China [1] - Y225 is designed to treat Hemophilia A, a condition caused by a deficiency of coagulation factor VIII, which leads to bleeding disorders [1] - The original drug Shuyou Lile is the only bispecific antibody available for preventive treatment in patients with or without factor VIII inhibitors, but its high cost limits accessibility for patients [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 in the domestic market [1] - The existing patents for the original drug extend its protection until 2038, creating a high barrier to entry for competitors [1] Group 3: Strategic Collaborations - A strategic cooperation agreement was signed with Hubei Jiangxia Laboratory to leverage their research capabilities alongside the company's experience in antibody drug development [2] - The collaboration will focus on innovative antibody molecular 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]

Core Viewpoint - Youzhiyou Biotech-B (02496.HK) has received approval from the National Medical Products Administration (NMPA) of China for the clinical trial application of its biosimilar Y225, aimed at treating Hemophilia A [1][2] Group 1: Product and Market Potential - Y225 is a biosimilar of the dual-specific antibody Shuyou Lile® (Emicizumab injection), which targets FIX and FX for the treatment of Hemophilia A [1] - The original drug Shuyou Lile® is the only dual antibody medication available for preventive treatment in patients with or without factor VIII inhibitors, offering advantages such as once every four weeks dosing and subcutaneous injection [1] - The high cost of Shuyou Lile® limits patient access, and over 20% of Hemophilia A patients develop inhibitors that affect treatment efficacy [1] - The original drug has a patent protection period extended to 2038, but the company has innovatively overcome the formulation patent, allowing Y225 to potentially launch seven years earlier, filling a gap in the domestic market for high-barrier biosimilars [1] Group 2: Clinical Trial Details - The approved clinical trial is a randomized, double-blind, single-dose, parallel-comparison study assessing the bioequivalence of Shuyou Lile® and Y225 in healthy male subjects [2] - The trial is led by Dr. Huang Chaolin from Wuhan Jinyintan Hospital as the principal investigator [2]