首个重组人白蛋白注射液（水稻）在汉上市

Core Insights - The global first recombinant human albumin injection (rice) named "Aofumin" has been launched by Wuhan Heyuan Biotechnology Co., Ltd, marking a significant milestone in the biopharmaceutical field in China [1][3] - The product addresses the safety supply issues of "life-saving drugs" in clinical settings and aims to ensure the safety of drug supply in the country [3] Company Overview - Wuhan Heyuan Biotechnology has developed an innovative plant-based recombinant protein expression and purification technology platform, overcoming previous challenges related to safety, scalability, and cost in producing recombinant human serum albumin [2] - The company has secured over 80 patents related to its technology platform and recombinant human serum albumin, supported by various national and local government projects [2] Product Details - The recombinant human albumin injection (rice) is derived from rice endosperm cells and has been clinically proven to be as effective as plasma-derived albumin, with excellent safety and tolerability [2] - The product has a domestic market demand of approximately 1,000 tons per year, with 69% of the current supply being imported, highlighting a significant supply gap in the market [1] Regulatory Milestones - The product received acceptance from the National Medical Products Administration (NMPA) in September 2024 and was included in the priority review process, leading to its approval for market launch on July 18, 2025 [2] Future Plans - The company plans to establish an industrialization base to ensure the production of domestically developed alternatives and is initiating international multi-center Phase III clinical trials under FDA regulations to expand its indications [3]