武汉造全球首款 “稻米造血”创新药获准在美开展三期临床试验

Core Viewpoint - Wuhan Heyuan Biotechnology Co., Ltd. has reached a consensus with the FDA on the global multi-center Phase III clinical research design for the world's first "rice-derived" recombinant human albumin injection, marking a significant milestone in the biopharmaceutical field [1][2]. Group 1: Company Developments - Heyuan Biotechnology's recombinant human albumin injection (rice) has been recognized by FDA experts as a "Historical innovation," indicating strong support for its global multi-center clinical trials [1]. - The FDA confirmed that upon successful completion of the international multi-center Phase III clinical study, the product will be eligible for all clinical indications approved for existing human serum albumin, benefiting patients with clinical needs [1]. - The company has initiated preparations for the global multi-center Phase III clinical research, with plans to launch the study soon [2]. Group 2: Industry Context - The approval of Heyuan Biotechnology's recombinant human albumin injection by the National Medical Products Administration in July 2025 will make it the first approved recombinant human albumin product in China, filling a gap in the global biopharmaceutical market [2]. - This development signifies a transition for China from "catching up" to "leading" in the recombinant human albumin sector, providing a solution for global blood product alternatives [2]. - The competitive landscape of the global pharmaceutical market is intensifying, prompting domestic pharmaceutical companies to expand internationally to enhance their global competitiveness and participate in the restructuring of the global pharmaceutical industry [2].