Recently, Wuhan Heyuan Biotechnology Co., Ltd. (hereinafter referred to as "Heyuan Bio") has successfully completed the phase clinical study of plant-derived recombinant human serum albumin in patients with hypoalbuminemia with liver cirrhosis, and the company is comprehensively promoting the new drug application, which means that the commercialization of the company's world's first plant-derived recombinant human serum albumin is about to usher in an important node of industrialization and commercialization.
At present, the human serum albumin drugs used in clinical practice are all isolated and extracted from human plasma, which has a shortage of resources and the risk of pathogen transmission. According to statistics, China's annual demand for human serum albumin is more than 1,000 tons, of which more than 60% rely on imports, and there is still a large supply and demand gap for human serum albumin. After the mass production of Heyuan Bio's plant-derived recombinant human serum albumin injection, it will effectively alleviate the tension of human serum albumin in China.
The project has been supported by the national "major new drug creation" science and technology major special project, and the major new drug creation special expert group commented: "This technology is an original innovative technology with a wide range of application prospects and opens up a new way for pharmaceutical production." ”
At present, there are no recombinant human serum albumin drugs in the world, and Heyuan Bio's "plant-derived recombinant human serum albumin injection" is the first blood product approved for clinical practice in the United States in China, and the first blood product in the world to be expressed in the plant system into the clinic. The production workshop of the enterprise has basically realized unmanned, starting from the storage of materials, to the production and inspection and release of products, to realize the automation, intelligence, digitization and paperless of the whole production process, which can greatly improve production efficiency and ensure product quality. Heyuan Biotech is one of the first enterprises to settle in Optics Valley Bio-City, and is also a typical representative of the "small and beautiful" enterprises independently cultivated by Optics Valley, and was selected as the fourth batch of provincial-level specialized, special and new "little giant" enterprises in Hubei Province in 2022 and Wuhan City's 2023 Specialized, Specialized and New Growth Award Small and Medium-sized Enterprises.
At present, Optics Valley is actively building an innovative drug industry cluster with global influence, building a global life and health innovation center, with more than 400 Class 1 new drug pipelines under development, more than 50 into clinical trials, and 2 new drugs included in the "breakthrough **" innovative drug industry of the State Food and Drug Administration.
*: China Optics Valley).
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