China Approves Rice-Derived Albumin Injection, Offering New Treatment Option

The National Medical Products Administration granted marketing approval for a rice-derived recombinant human albumin injection on Friday. This decision followed a priority review process, as announced on the administration's website.

The approved product, developed by Wuhan Healthgen Biotechnology, is intended to treat hypoalbuminemia, a condition characterized by low albumin levels in the blood (≤30g/L), often caused by liver cirrhosis. This approval provides a new treatment option for patients suffering from this condition.

The approval is a result of a significant advancement in large-scale production technology. The company successfully utilized rice as a bioreactor to produce human serum albumin (HSA).

HSA is a crucial blood product used in treating various medical conditions, including hemorrhage and cancers. Historically, its production has been limited by the availability of human blood.

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

Yang Daichang, chairman of Healthgen Biotechnology, explained that the company uses rice as a protein production platform, introducing human genes into the rice plant to produce HSA and other proteins.

The company currently has an annual production capacity of 10 tons of HSA stock solution. With a new facility scheduled to open in 2026, the total capacity will increase to 130 tons. This expansion is projected to replace approximately 25 percent of the HSA currently imported from other countries.

In 2024, China produced and imported over 1,000 tons of HSA, with imports accounting for more than 69 percent of the total supply.