As the first of its kind in the world, plant-derived recombinant human serum albumin developed by a Chinese biotechnology company is set to be industrialized and commercialized, bringing new hope to patients.

In February, Wuhan Healthgen Biotechnology Corp announced that it had successfully completed phase III clinical trials for plant-derived recombinant human serum albumin for hypoalbuminemia patients. According to the results, its curative efficacy was not inferior to plasma-derived human serum albumin in terms of safety and tolerance.

Human serum albumin is among several indispensable therapeutic biologics for various diseases, an essential emergency medicine for hospitals, and a key excipient for biopharmaceuticals. It is also widely used in vaccine production, supplements for cell culture media and other fields.

At present, human serum albumin drugs used in clinical practice are all prepared from human plasma, as has been the case since World War II. Nowadays, there is an increasing public health concern with plasma-derived HSA (pHSA) with its potential risk for transmission of blood-derived infectious pathogens such as hepatitis and HIV, as well as amid plasma resource shortages. Data from industry research company ChinaIRN.com showed that China's annual demand for human serum albumin was between 1,500 and 1,800 tons, among which over 60 percent had to be imported from outside China. Once the plant-derived recombinant human serum albumin is launched in the market, the supply and demand imbalance of human serum albumin in China will be effectively relieved.

Healthgen Biotechnology said it plans to submit a new drug application this year, and the product is expected to be approved and launched in the market as early as next year. So far, the company has gained a drug manufacturing certificate issued by the Hubei medical products administration, and its intelligent manufacturing is capable of producing 10 tons of plant-derived recombinant human serum albumin and 1 million doses of formulations annually. It is planning on building an industrial base capable of producing 120 tons of plant-derived recombinant human serum albumin and 12 million doses of formulations annually, which will guarantee supply once the product is launched.

Healthgen Biotech's plant-derived recombinant human serum albumin project was approved as a National Science and Technology Major Project for New Drug Development. The Center for Drug Evaluation (CDE) in China said that the technology developed by the company is an original innovative technology and has promising application prospects, offering a new path for medicine production.

Yang Daichang, chairman of Healthgen Biotech, began research and development of plant-derived recombinant human serum albumin in 2005.

"Rice has been a staple food consumed by humans for thousands of years. Humans have a high tolerance to proteins in rice. Meanwhile, it can prevent the transmission risk of various viruses or pathogens carried by plasma. Through genetic engineering, we introduced the human serum albumin gene into the rice genome, making the rice a 'bioreactor' or 'protein production plant'. During the process of rice grain filling and maturation, human serum albumin is continuously synthesized and accumulated in rice grains. Finally, human serum albumin is extracted and purified from rice grain," Yang said.

You Xi, co-founder of Beijing-based consultancy Communication Planet, said: "Plant-derived recombinant human serum albumin has broad application prospects, and the success in its phase III clinical trial showcased the progress that China's biotechnology companies have made in R&D capability and independent innovation. Prior to that, there had been no breakthroughs in solving high clinical dosages, high requirements for safety, costs, large-scale production and environmental protection problems of human serum albumin."

You said: "Currently, Chinese biotechnology companies' innovative capabilities are gradually improving, and are taking a leading role in the world in some fields. Yet efforts are still needed to bridge the gap between China and the world in the overall biotech sector."

The National Medical Products Administration said that in 2023, 82 innovative medicines were approved, among which 39 were developed by domestic companies, setting a record high.

Healthgen Biotech said that in the future, it plans to step up efforts to promote the global commercialization of plant-derived recombinant human serum albumin products, as well as the expansion of indications for core pipelines and the R&D progress of other pipelines under development.