China Approves Plant-Derived Recombinant Albumin Produced from Rice

China's drug regulator has approved the country's first plant-derived recombinant human serum albumin injection, produced using genetically modified rice endosperm as a bioreactor. Developed by Wuhan University professor Yang Daichang and commercialized by Wuhan Healthgen Biotechnology, the biopharmaceutical provides a non-plasma alternative to plasma-extracted albumin, a critical medical protein long constrained by plasma supply shortages and import dependency. With commercial facilities completed in Wuhan's East Lake High-tech Development Zone, the extraction process yields the equivalent of one liter of human plasma albumin from five kilograms of rice.

Human serum albumin is essential in critical care, but global supply has historically relied strictly on donated human plasma. Successfully scaling recombinant albumin from rice demonstrates the practical viability of plant-based biomanufacturing for critical injectables, providing a non-plasma route to ease structural blood product shortages.

Chinese regulators have granted market approval to a plant-derived recombinant human serum albumin injection, marking a significant milestone in plant-based biomanufacturing, according to a report by People's Daily. The therapeutic was cleared in July 2025 by the National Medical Products Administration under a priority review procedure, establishing a non-plasma production route for one of the medical sector's most widely used emergency and critical-care injectables. Human serum albumin is a critical protein found in blood plasma, used clinically to rapidly restore blood volume and maintain oncotic pressure. Historically, global supply has been strictly dependent on human blood plasma collection, leading to persistent domestic supply shortfalls and heavy reliance on overseas imports in China. The bioengineered alternative was developed by a team led by Yang Daichang, a professor at Wuhan University who began working on the technology in 2005 alongside four doctoral students. The manufacturing platform introduces the human protein gene into rice endosperm cells, leveraging the cereal crop's eukaryotic protein processing mechanisms to translate, fold, and modify complex recombinant proteins. Following harvest, the grain undergoes dehusking, milling, chromatography, and purification. According to Yang, five kilograms of processed rice yields an amount of purified recombinant albumin equivalent to the yield extracted from one liter of human blood plasma. Development required dozens of iterations before reaching human testing. In 2017, after 37 successive formulation designs, the therapy advanced to clinical trials, during which Yang received a 10-gram injection of the experimental protein to demonstrate confidence in its safety profile. Commercial production is centered at Wuhan Healthgen Biotechnology Co., Ltd., based in the Wuhan East Lake High-tech Development Zone. The company has completed construction of its Phase II industrialization base, which is designed to scale output and support diversified product lines. While regulatory clearance validates the technical platform, long-term commercial impact will depend on cost parity with plasma-derived products and hospital procurement uptake.