China approves rice-derived recombinant human albumin injection

The National Medical Products Administration approved the marketing of a rice-derived recombinant human albumin injection on Friday after the priority review and approval process, according to a statement released on its website.

The product, developed by Wuhan Healthgen Biotechnology, is for the treatment of hypoalbuminemia (≤30g/L) caused by liver cirrhosis, it said, adding that the approval marks a new treatment option for patients with the condition.

The approval follows a major breakthrough in large-scale production technology, in which the company successfully harnessed rice as a bioreactor to produce human serum albumin (HSA).

HSA is a blood product vital in the treatment of a number of medical conditions, including hemorrhage and cancers, but its production has long been hampered by the limited supply of healthy people's blood.

According to an April report by Xinhua News Agency, the company stated that through genetic engineering, a 25-kilogram bag of rice can yield an amount of HSA equivalent to that found in five liters of human plasma.

"We use the rice as a bioreactor, or more plainly, a protein production workshop. We implant human genes into the rice plant to produce HSA and other proteins," said Yang Daichang, chairman of Healthgen Biotechnology, in the April report.

According to Yang, the company's current annual production capacity is 10 tons of HSA stock solution. With a new facility set to begin operations in 2026, total capacity will rise to 130 tons, which is expected to replace about 25 percent of the HSA imported from abroad, Xinhua reported.

China produced and imported more than 1,000 tons of HSA in 2024, with imports accounting for over 69 percent, he added.