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武漢禾元生物植物源重組人血清白蛋白注射液獲得美國FDA批準進入臨床研究

2019/08/10點擊數:6614

2019810日,武漢禾元生物科技股份有限公司(以下簡稱“禾元生物”)利用水稻胚乳細胞表達平臺研發的生物藥——植物源重組人血白蛋白注射液獲得美國食品藥品監督管理局FDA)批準,同意在美國進行臨床研究。這是中國第一個在美國批準進入臨床的血液制品,也是國際上第一個植物體系表達進入臨床的血液制品,標志著禾元生物的水稻胚乳細胞表達平臺獲得美國FDA的認可,禾元生物的創新生物藥物研發能力上了一個新臺階。

人血清白蛋白在臨床上廣泛用于肝硬化腹水、失血性休克、術后血容量補充、各種水腫、燙傷燒傷和癌癥放化療的輔助治療,還廣泛用于醫藥輔料、細胞治療輔助成分、培養基添加劑、細胞或胚胎凍存?;ぜ梁兔廊菝婪艫?。全球市場需求預測3800/年左右,我國需求量預測在700/年左右,目前國際上完全從血漿中提取,受血漿來源限制,至2008年以來我國長期依賴進口,據中檢院批簽發數據,2018年我國的人血白蛋白為468噸,其中進口約占60%。由于臨床使用劑量大,重組人血清白蛋白純度要求極高,而售價相對較低,安全性和可及性一直是國際上重組人血清白蛋白研發的痛點。

我司利用水稻胚乳細胞技術平臺生產的首個產品——植物源重組人血白蛋白一旦進入市場,可以替代血漿提取,將不再受血漿短缺限制,還可完全杜絕艾滋、肝炎未知病毒污染風險,可為我國生物制藥提供了一條新途徑,不僅解決我國人血白蛋白長期依靠進口的局面,還具有巨大國際市場,展示禾元生物水稻胚乳細胞表達技術平臺的巨大市場前景。

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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