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国产抗癌新药入选医保目录 救命药每月仅花1千元

2017-09-01 01:19:42   央视财经

深圳微芯生物科技有限责任公司总裁鲁先平,是这支海归研发团队的带头人。2015年5月22日,一则新闻引起社会的关注,中国自主知识产权的原创抗癌新药,西达本胺获准在中国上市,并成为首个在美国等发达国家开展临床研究的化学原创新药,首批适应症为复发或难治的外周T细胞淋巴瘤,中国成功自主研发抗癌药的消息一经发布就吸引了全世界的目光,《时代周刊》《福布斯》等杂志,用大量篇幅进行报道,引起了轰动。这不仅意味着我国有了自己原创的抗癌新药,同时,深圳微芯生物科技有限公司将西达本胺的海外专利开发权授权给一家美国企业,这是我国原创新药首个海外专利授权的案例

鲁先平:T淋巴瘤在中国是没有药的,非常恶性,进展非常快,而西达本胺业带来了在整个这个领域最好获益,和最好的安全性,所以我们实现了。

中国抗淋巴瘤联盟主席马军告诉记者,从2014年的临床研究至今,中国共有1700多人次使用了西达本胺,他本人会诊的300多位淋巴瘤患者使用了这种国产创新药之后,产生了很好的疗效

中国抗淋巴瘤联盟主席马军:我们总结了768例病人,完全缓解率大约是32%左右,如果要是加上它的,我们所说的部分缓解,它可能能达到58%—62%之间,所以它是很少的一个单药就能获得这么好的疗效。

上个世纪90年代,鲁先平在中国协和医科大学读完分子生物学与肿瘤生物学的博士之后,远赴美国加州大学药理系做博士后研究,1998年,年仅36岁的鲁先平担任了一家大型跨国生物医药企业Galderma(高德美实验室)北美中心的研发主任,虽然身居美国企业高管,鲁先平却时刻关注祖国医药行业的发展。

鲁先平:当我回来创业的时候,其实中国的医药市场,大概98%都是仿制药,创新的肿瘤药是特别的缺乏

研制出百姓用得起的创新药,这在是鲁先平心中一直是一个结。2000年,鲁先平放弃在美国的高薪工作和优越生活,把妻子和两个年幼的孩子留在美国,独自回国,联合宁志强、程京等5位资深留美的跨国药企高管和大学教授,在深圳成立微芯生物科技有限责任公司。这个海归研发团队唯一的目标,就是做出中国真正的原创新药。

原创新药的开发,绝对不是一件简单的事情,国际医药界有个通行的说法:研制一款创新药很难逃出“双十”的魔咒,耗时10年时间,投入10亿美金,过程异常艰辛。高风险、高投入、投资期长,使大部分药企都望而却步。

2001年成立之初,微芯生物拿到了一笔5000万元的风险投资,开始研发。但研发团队很快发现,这对于不断投入的巨大的研发成本而言,只是杯水车薪。创新药的研发投入像“无底黑洞”一样,越来越大,面对市场和政策上的压力,一方面融不到资,另一方面老股东也不敢继续投资,?2005年微芯生物已经是举步维艰了,这个20多人的海归研发团队几乎陷入了绝境。

为了节省研发的开支,这支海归团队的领头人鲁先平当即做出了一个惊人的决定,海归团队的工资砍去60%,这个决定使公司的研发成本降低不少,但同时也意味着海归团队中的不少科学家很难以这样的工资水平在海外养家糊口。几位海归创始人不得不遗憾地选择退出,离开了这个创业团队。从2004年到2006年,由于资金短缺,微芯公司的运营非常困难,但是与此同时,团队在创新研发的推进上却取得了成功,在中国首次对两个原创新药都进行了首次进入人体实验的申请。

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