Human blood protein completes 3rd-phase trial

The plant-made recombinant human serum albumin (HSA) developed by Wuhan Healthgen Biotechnology Co. [Photo/WeChat account of Optics Valley of China]

Recently, Wuhan Healthgen Biotechnology Co successfully completed the Phase III clinical trial of plant-made recombinant human serum albumin (HSA) in patients with hypoalbuminemia due to liver cirrhosis. The company is now advancing the new drug application, marking a significant milestone in the industrialization and commercialization of the world's first commercial plant-made recombinant human serum albumin.

Currently, the clinical use of human serum albumin drugs is derived from the isolation and extraction of human plasma, leading to shortages in resources and risks of pathogen transmission. Statistics show that China's annual demand for human serum albumin exceeds 1,000 metric tons, with over 60 percent reliant on imports, resulting in a substantial supply-demand gap for human serum albumin.

Following the mass production of Healthgen Biotech's plant-made recombinant human serum albumin injection, it will effectively alleviate the tight supply of human serum albumin in China.

To date, there are no recombinant human serum albumin drugs globally. Healthgen Biotech's innovative product is the first blood product approved for clinical use in the United States.

The company's production workshop has achieved basic unmanned operation, enabling the entire production process, from material storage to product manufacturing and inspection release, to be automated, intelligent, digitalized, and paperless, which significantly enhances production efficiency and ensures product quality.

Healthgen Biotech is one of the earliest companies to settle in the Biolake of the East Lake High-tech Development Zone (also known as Optics Valley of China, or OVC), and has been selected as one of Hubei's fourth batch of provincial-level specialized and sophisticated "little giant" enterprises for 2022.