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中国药审改革激发全行业活力 先声安进结盟布局生物类似药

2017-10-13 09:37:53   

安进-先声生物类似药战略联盟发布会

10月8日,中办、国办联合发布《关于深化审评审批制度改革,鼓励药品医疗器械创新的意见》。这意味着2015年以来的药审改革新政,以两办发文的高规格形式得以延续和升级。这一被誉为建国以来医药行业力度最大的改革政策,将决定未来相当长时期中国医药行业发展的基本格局。

10月12日,南京,安进(ANGEN)和先声药业生物类似药战略联盟启动。借助药审改革新政的战略机遇,中国生物类似药大市场可望迎来重大突破。

先声药业董事长、CEO 任晋生

先声药业董事长、CEO任晋生表示,一切为了患者,为了让更多患者用得起高标准的抗体药物,这是我们合作之旅的开始。近二年来国家食药监总局出台了一系列加快审评审批的新政,强化了安进等跨国公司对生物药和生物类似药进入中国市场的信心,也激发了国内制药企业看齐国际最高标准和创新转型的动力。他说:“安进和先声愿意用实际行动回应政府这样一个政策的改变,把更多的资源投入到创新和研发方面,以此表明我们对这一改革的拥护和信心。”

安进公司副总裁兼日本及亚太区总经理 温陈佩茜

安进公司副总裁兼日本及亚太区总经理温陈佩茜说:“我们对这一刻期待已久。对安进来说,中国是特别重要的市场,有巨大的患者群体和高度未满足的临床需求,但对患者有重要治疗意义的生物药物并不是总是容易获得,安进的高质量生物类似药能为他们的生活带来改变。”

中美药企间具开创性意义的跨境战略合作

生物类似药也被称为生物仿制药,和原研药相比,其质量、安全性和疗效具有极高的相似性,但价格更低,因此极大地增加了患者对高品质生物药的可及性。

生物类似药在全球范围内还属于起步阶段。目前,欧美国家批准的抗体类生物类似药不超过10个,在中国,几近空白。

此次安进和先声药业联手一次性将多个单抗品种的生物类似药引进中国,共同研究开发和商业化,这是中美药企在生物类似药领域第一次展开较大规模的合作。

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