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武汉禾元生物植物源重组人血清白蛋白注射液获得美国FDA批准进入临床研究

2019/08/10点击数:2611

2019810日,武汉禾元生物科技股份有限公司(以下简称“禾元生物”)利用水稻胚乳细胞表达平台研发的生物药——植物源重组人血白蛋白注射液获得美国食品药品监督管理局FDA)批准同意在美国进行临床研究。这是中国第一个在美国批准进入临床的血液制品,也是国际上第一个植物体系表达进入临床的血液制品,标志着禾元生物的水稻胚乳细胞表达平台获得美国FDA的认可,禾元生物的创新生物药物研发能力上了一个新台阶。

人血清白蛋白在临床上广泛用于肝硬化腹水、失血性休克、术后血容量补充、各种水肿、烫伤烧伤和癌症放化疗的辅助治疗,还广泛用于医药辅料、细胞治疗辅助成分、培养基添加剂、细胞或胚胎冻存保护剂和美容美肤等。全球市场需求预测3800/年左右,我国需求量预测在700/年左右,目前国际上完全从血浆中提取,受血浆来源限制,至2008年以来我国长期依赖进口,据中检院批签发数据,2018年我国的人血白蛋白为468吨,其中进口约占60%。由于临床使用剂量大,重组人血清白蛋白纯度要求极高,而售价相对较低,安全性和可及性一直是国际上重组人血清白蛋白研发的痛点。

我司利用水稻胚乳细胞技术平台生产的首个产品——植物源重组人血白蛋白一旦进入市场,可以替代血浆提取,将不再受血浆短缺限制,还可完全杜绝艾滋肝炎未知病毒污染风险,可为我国生物制药提供了一条新途径,不仅解决我国人血白蛋白长期依靠进口的局面,还具有巨大国际市场,展示禾元生物水稻胚乳细胞表达技术平台的巨大市场前景。

该项目是禾元生物委托美国药物申请专业咨询公司DATAREVIVE LLC协助完成。



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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