FDA approves new biotechnology

A Wuhan-based biotechnology company in central China's Hubei province received approval by the US Food and Drug Administration for clinical trials of its OsrHSA, a recombinant human serum albumin derived from rice grains.

The clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. Approval was announced Aug 10.

It is the first time for a Chinese product of this kind to get the approval, paving the way for the company to enter the US market, according to a report from Hubei Daily.

The human serum albumin is the most abundant protein in human plasma. It can transport hormones, lipids and other molecules while maintaining osmotic pressure, according to the company's official website.

Statistics show in the next few years, the global market demand for human serum albumin is expected to reach 3,800 tons per year, and China's annual demand is forecast to be 700 tons,.

Currently, human serum albumin can only be derived from plasma. In 2018, the consumption of serum albumin in China was 468 tons.

According to Healthgen Biotechnology Corp, OsrHSA provides an excellent solution for an animal-free medium, has higher purity and excellent batch consistency, compared with FBS, pHSA and BSA.

OsrHSA is widely used as excipient, stabilizer and embedding agent in bio-pharmaceutical applications, per the company's website.

Yang Daichang, chairman of the company, was quoted by Hubei Daily saying after more than a decade of research and development, the technology has large-scale application value and is expected to replace plasma extraction.

In 2017, OsrHSA entered the human clinical trial stage in China. Previously, researchers completed experiments in rats, monkeys, rabbits and other animals. The results show human serum albumin extracted from rice has no significant difference from human plasma extraction, and by some measures is even better.

Jiang Peijin in Beijing contributed to this story.