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成都高新区将建成国际化蛋白质药物生产研发中心--亲稳舆论引导监测室
2013-01-22

  中新网成都1月21日电 (周迪迪)21日,跨国企业瑞华药业集团与成都高新区管委会签署投资合作协议,将在成都高新区西部园区成立子公司瑞华药业(成都)有限公司并投资建立国际化的蛋白质药物生产及研发中心。该项目总投资为1.5亿美元,投产后年产值将不低于10亿人民币。

Beijing on January 21, chengdu (ZhouDiDi)21,The multinational enterprise ruihua pharmaceutical group and chengdu high-tech zone the ac signed investment cooperation agreement,Will be in chengdu high-tech zone west park established subsidiary ruihua pharmaceutical(chengdu)Co., LTD and investment to establish international protein drug production and research and development center.The project total investment of usd 150 million,After put into production the annual output will not less than 1 billion yuan.

  该项目用地面积为65亩,预期5年内分两期完成。项目总建筑面积约4.6万平方米,包括新药研发中心,以及符合国际GMP标准的蛋白质药物生产基地,预计2018年开始独家生产自行研发并拥有自主产权的抗癌新药供应全球市场。

The project land area of 65 mu,5 years is expected to complete in two phase.The project total construction area of about 46000 square meters,Including new drug research and development center,And in line with international GMP standard production base of protein drugs,Began in 2018 is expected to sole production to develop with independent property rights and the cancer drug supply global market.

  据了解,瑞华药业主要研发项目为抗癌新药为ADI-PEG20,是一种利用肿瘤细胞自身在氨基酸新陈代谢上的重大差异而设计的靶向药物。“癌细胞与正常细胞在代谢上有很多不同,癌细胞没有精氨酸则无法合成。通过将药物注入体内,如同切断‘食物’,而‘饿死’癌细胞。”瑞华药业集团董事长吴伯文表示,该药可完全取代化疗、放疗,减轻患者痛苦。目前已在全球针对16种不同的肿瘤、600多名患者进行治疗,疗效明确而且副作用极轻微。

It is understood,Ruihua pharmaceutical research projects for the anticancer drugs for ADI - PEG20,Is a use of tumor cells themselves in amino acid metabolism of the major differences of the design of targeted drugs."Cancer cells and normal cells in metabolism has many different,Cancer cells without arginine cannot synthesis.Through the use of drugs into the body,As cut off‘food’,and‘Starve to death’Cancer cells."Ruihua pharmaceutical group chairman of the board of directors WuBoWen said,The drug can totally replace chemotherapy/radiation,Reduce pain in patients with.At present has set up a file in the global for 16 different tumors/More than 600 patients for treatment,Curative effect and side effects clear very mild.

  瑞华药业于2011年7月启动ADI-PEG20的全球多国多中心第三期肝癌临床试验,现阶段在美国、英国、意大利、韩国、台湾已有48家医学中心加入,并已有180多名晚期肝癌患者参加临床试验。预期于2014年完成本试验,并于2015年起陆续通过美国、台湾、欧洲、韩国及中国大陆等地审批,取得上市许可。瑞华药业将拥有本项目在大中华区的所有研发、生产及销售权利,并已从关系企业北极星药业集团取得了全球除大中华区以外所有区域的独家制造权。未来其成都厂所生产的抗癌新药ADI-PEG20将通过世界各先进国家的GMP认证,供应全球市场。

Ruihua pharmaceutical in July 2011 start ADI - PEG20 global multinational many center of the third stage liver cancer clinical trials,At present in the United States/British/Italy/South Korea/Taiwan has been home to join and medical center,And more than 180 advanced liver cancer patients in clinical trials.Expected to be completed in 2014 this test,And in 2015 by the United States in the/Taiwan/The European/South Korea and China, the examination and approval,Obtain authorisation.Ruihua pharmaceutical will have this project in greater China all research and development/Production and sales rights,And has set up a file from the relationship between enterprise Polaris pharmaceutical group made global except outside the greater China region in all areas of the exclusive right to manufacture.In the chengdu plant the production of anti-cancer drugs ADI - PEG20 will through the advanced countries in the world of the GMP certification,Supply global market.

  近年来,成都高新区已逐步成为国内外著名生物医药企业在中国西部落户的首选地。截至2012年底,成都高新区聚集生物医药企业264家,其中,生产企业117家,研发及服务外包企业46家,医药流通企业91家,管理咨询等其他服务型企业10家。共有195个药品和医疗器械方面的研发和产业化项目,其中,临床前研究阶段100个,临床试验阶段48个,申报注册和产业化阶段47个。

In recent years,Chengdu high-tech zone has gradually become the domestic and international famous biological pharmaceutical enterprise in western China in the first.By the end of 2012,Chengdu high-tech zone gathered biological medicine 264 enterprises,the,Production enterprise 117,Research and development and service outsourcing enterprises and home,Medicine circulation enterprises 91,Management consulting and other service enterprise 10.A total of 195 drugs and medical devices research and development and industrialization of project,the,Clinical research stage before 100,Clinical trial stage and a,Declaration registration and industrialization phase 47.

  该区已初步形成了包括地奥药物筛选中心、医药化学研究测试公共服务平台、华西医院GCP中心、成都生物医药GMP中试生产中心等,涵盖药物发现、药物开发、临床前评价、临床试验、中试生产等全过程的新药研发体系,以及现代中药、化学药、生物制剂、医疗器械、研发外包五大产业领域。(完)

The area has been initially formed including mondial drug screening center/Pharmaceutical chemistry research test public service platform/West China hospital GCP center/Chengdu biological medicine GMP pilot production center, etc,Covers drug discovery/Drug development/Preclinical evaluation/Clinical trials/Pilot production of new medicine r&d system process,And modern traditional Chinese medicine/Chemical medicine/Biological agents/Medical devices/Research and development outsourcing five industries.(finish)


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