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]
友芝友生物-B(02496.HK)：Y225“艾美赛珠单抗注射液”取得NMPA的IND批准