China’s National Medical Products Administration (NMPA) has approved the world’s first plant-based human albumin, a landmark achievement that promises to revolutionize the treatment of liver cirrhosis. On July 18, 2025, the NMPA officially sanctioned Wuhan Healthgen Biotech’s recombinant human albumin injection (rice), as announced in an official statement. The product is specifically indicated for the treatment of hypoalbuminemia (≤30 g/L) associated with liver cirrhosis.
Innovative Plant-Based Technology
This approval represents the first global endorsement of a plant-based expression system for a large-molecule protein drug. The technology employs rice seeds as the expression platform, utilizing genetic engineering to prompt the rice to produce a recombinant protein. This protein closely mirrors the structure and function of natural human albumin. After meticulous extraction and purification, the protein is formulated into an injectable solution, ready for clinical application.
Advantages and Implications
The innovation eliminates the previous dependency on human plasma, directly addressing historical challenges related to supply limitations and high costs. Additionally, it introduces potential enhancements in safety, batch consistency, and the ability to scale production. Notably, the project has been supported by China’s prestigious “863” Program and the “Major New Drug Innovation” initiative, underscoring its significance as a trailblazing technology.-Fineline Info & Tech
