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該項目是禾元生物委托美國藥物申請專業咨詢公司DATAREVIVE LLC協助完成。

On August 10, 2019, Wuhan Healthgen Biotechnology Corp. received approval from the FDA of the United States for clinical trials on OsrHSA injection that was produced from rice expression platform. This is the first blood product from China which was approved for clinical trial in the United States and the first blood product expressed by plant system in the world. It strongly implies that the rice expression platform of Healthgen Biotech has been recognized to be safe by the FDA of the United States, thus a crucial milestone for the research and development ability of Healthgen Biotech's innovative biological drugs.

Human serum albumin (HSA) is widely used in clinical therapy of cirrhosis ascites, hemorrhagic shock, and blood volume supplementation after operation, various kinds of edema, burns and cancer, radiotherapy and chemotherapy. It is also widely used in pharmaceutical adjuvants, adjuvant components of cell therapy, media additives, cell or embryo cryoprotectants and cosmetic skin. The global market demand is about 3800 tons/year, and China's share about 700 tons/year. At present, it is entirely derived from human plasma in the world, and supply is severely limited by the source of plasma. China has relied on imports since 2008. In 2018, 468 tons HSA was used in China, which include imports about 60% (this data issued by the Chinese government). Because of the high amounts used clinically, extremely high purity of recombinant human serum albumin is required. However, achieving such high purity in other bioreactors are not cost-effective. Safety and cost have been the key hurdles of international research and development of recombinant human serum albumin.

The first product from Wuhan Healthgen Biotechnology Corp. OsrHSA, produced from OryzoHiExp platform, can replace plasma extracted HSA. Once it is on the market, global supply will no longer be limited by plasma shortage. The use of OsrHSA can also completely eliminate the risk of HIV, hepatitis and unknown virus contamination. It can provide a new platform to produce biologic pharmaceuticals in China. Not only OsrHSA solves the long-term dependence on imports of HSA in China, but also has a huge oversea market. In conclusion, Healthgen Biotech will have huge market prospects with wide application of rice expression technology platform.

The IND application in the US was assisted by DATAREVIVE LLC, an American pharmaceutical application consulting firm. Corp.Corp.

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