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武漢AG亚洲官网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:2583

2019810日,武漢AG亚洲官网生物科技股份有限公司(以下簡稱“AG亚洲官网生物”)利用水稻胚乳細胞表達平台研發的生物藥——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製品,也是國際上第一個植物體係表達進入臨床的血液製品,標誌著AG亚洲官网生物的水稻胚乳細胞表達平台獲得美國FDA的認可,AG亚洲官网生物的創新生物藥物研發能力上了一個新台階。

人血清白蛋白在臨床上廣泛用於肝硬化腹水、失血性休克、術後血容量補充、各種水腫、燙傷燒傷和癌症放化療的輔助治療,還廣泛用於醫藥輔料、細胞治療輔助成分、培養基添加劑、細胞或胚胎凍存保護劑和美容美膚等。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,受血漿來源限製,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%。由於臨床使用劑量大,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台生產的首個產品——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製,還可完全杜絕艾滋肝炎未知病毒汙染風險,可為我國生物製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麵,還具有巨大國際市場,展示AG亚洲官网生物水稻胚乳細胞表達技術平台的巨大市場前景。

該項目是AG亚洲官网生物委托美國藥物申請專業谘詢公司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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