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商业 - 医药

生物技术大国梦:美国苦苦挣扎,中国跃跃欲试

David Ewing Duncan 2011年08月18日

经过多年的高额投入之后,美国的生物技术产业仍然在苦苦挣扎,试图将研究成果转化为经济效益。而在太平洋彼岸,意气风发的中国也瞄准了这个领域,计划投入数以10亿计的资金,大力发展本国的生物技术产业。前事不忘后事之师,如果能够绕开美国“重科研,轻开发”的老路,中国或许能够率先从生物技术产业这块富矿里淘出真金。

    现在轮到中国投入大量资金用于药物研发了。

    10多年来,为了将大量的生物学突破性研究成果转化为实际的治疗方法和经济效益,美国已经投入了大量资金。自2000年以来,对生物技术产业的公共和私人投资已经接近万亿美元。但在最近几年里,生物技术和制药行业平均每年仅推出约21种新药,数量只相当于1996年至2004年间的三分之二。如今,药物的试验和审批需要耗费十几年时间,而在进入人类临床试验阶段的药物中,有90%都以失败告终。

    菲薄的回报导致投资者逃离,商业模式备受质疑。去年,仅有1/9的美国风险资金投资于生物技术产业,大大低于2009年的近1/6。营收也出现下滑,安进(Amgen)等少数几个大型生物技术公司掳走了大部分资金,而其他绝大多数的生物技术公司则面临着筹资困难,处于早期阶段的项目更是如此。

    与此同时,在太平洋彼岸,中国认为现在是从其大量储备中拿出部分资金,对生物医学进行大力投资的时候了——今后5年内将投入3,080亿美元。据《中国日报》(China Daily)报道,中国国务委员刘延东在近期举行的一次会议上说:“十二五计划的发展重点——生物制药、生物工程、生物农业和生物制造——将造福中国人民。”这家政府出资的报纸在该文中还报道了这一投资的宏伟目标:“从2011年到2015年,预计将新增100万个工作岗位,人均期望寿命提高1年,婴儿死亡率下降至12%,常规污染物排放减少10%。”

    这种巨额投入与美国在1998年经济繁荣时期的做法如出一辙。当时,美国总统克林顿与国会领袖合作,将美国国立卫生研究院(NIH)的5年预算增加了一倍。此次大规模扩大生物医学研究投入之时,正是“人类基因组计划”驶入快车道之际(在2000年完成了人类基因组草图)。那时科学家们相信,在21世纪前10年,迅速发展的分子生物学将很快产生大量的新药物和新疗法。

避免重蹈底特律的覆辙

    显然,对中国而言,美国的经历既是警示也是机遇。

    警示在于,政府——此处是私有大型制药公司——投入了研究资金,却没有切实可行的计划来将研究成果转化为实际的产品,尽管这些成果作为科学项目而言光彩夺目。在美国国立卫生研究院的预算中,仅有4%用于所谓的“转化医学”。去年底,该研究院院长弗朗西斯•科林斯在匆忙宣布成立转化医学与治疗学研究所( Institute for Translational Medicine and Therapeutics)的计划时承认,这是他们的疏忽。成立转化医学与治疗学研究所是个不错的主意,但这个新机构必须处理好转化医学投入总体上没有增加的问题。

    机遇在于,中国——当然还有美国——可以吸取教训,避免在“研发”过程中过分强调“研”(研究),转而更多地关注“发”(开发)。中国(和其他国家)还可以借鉴美国万亿美元投资所带来的大量基础研究成果(在杂志和数据库中可以轻易获得),并将之转化为产品,经济效益就会随之而来。

    与上世纪70年代向底特律发起挑战的日本一样,现在的中国既有资金,又没有被生物技术行业里的固有做法所束缚,这使得他们可以走出不同的路子。同样,如同40年前的日本,如今的中国将其优秀学子和年轻研究人员送到美国的大学里就读,或者到美国的公司里工作,了解美国的得失。

    包括中国在内,没有哪个国家能够在生物技术领域里对美国发起真正的挑战,至少目前如此。美国的生物技术产业也不像在上世纪70年代处于萧条时期的底特律那般僵化,生物科研界依然走在创新前沿和并具有全球眼界。美国生命科学企业,从默克(Merck)和辉瑞(Pfizer)等大型制药公司到艾迪克(Biogen-Idec)等生物技术公司,都渴望与中国同行展开合作。

    然而,就长期来看,美国能否维持其作为生物技术大国的优势地位呢?我认为不会。但是,正如“新底特律”所发现的那样,这对消费者或者企业利润来说未必是件坏事,但从旧到新的转变可能是个同样痛苦的过程。

    译者:千牛絮

    Now it's China's turn to fling lots of cash at trying to come up with cures.

    For more than a decade, the U.S. has lavished funding on efforts to transform a wealth of biological breakthroughs in the lab into actual therapies and profits. After spending nearly a trillion dollars in public and private investments since 2000, however, the biotech and pharma industries have produced an average of only about 21 new drugs a year in recent years -- only two-thirds of the output from 1996 to 2004. Drugs now take a dozen years to be tested and approved, and 90% of meds that reach human clinical trial fail.

    This meager yield is causing investors to abscond and business models to be questioned, with only one in nine venture dollars in the U.S. last year going to biotech, down from a ratio of nearly one in six in 2009. Revenues are also down, with a handful of large biotechs like Amgen (AMGN) making the lion's share of money while the majority of biotechs struggle to raise funds, especially for early stage projects.

    Meanwhile, across the Pacific Ocean, the Chinese government has decided that now is the time to take some of its massive national reserves of cash and launch a spending spree on biomedicine -- $308 billion over the next five years. "The development priorities of the 12th Five-Year Plan – biopharmacy, bioengineering, bioagriculture, and biomanufacturing – will bring benefits to Chinese people," said Chinese State Councilor Liu Yandong at a recent meeting, according to China Daily. The article in this state-funded newspaper goes on to report the ambitious goals of this investment: "From 2011 to 2015, it is expected to generate 1 million jobs, extend people's life expectancies by one year and reduce the infant mortality rate to 12 percent, as well as reduce emissions of the most common pollutants by 10 percent, Ma elaborated."

    This commitment mirrors the attitude in the U.S. in our giddier days of 1998, when President Bill Clinton joined with Congressional leaders to champion a doubling of the NIH's budget over five years. This major bump up in biomedical research came as the Human Genome Project – which completed a draft "map" of human DNA in 2000 - kicked into high gear and scientists believed that the burgeoning field of molecular biology soon would be producing a plethora of new drugs and treatments during the decade of the aughts.

Avoiding a Detroit analogy

    What happened in the U.S. is both a cautionary tale and an opportunity – neither apparently lost on the Chinese.

    The cautionary tale is what happens when governments -- and in this case the private sector in Big Pharma -- throw money into research without a real plan to translate all of the discoveries, which can be dazzling as science projects, into tangible products. A mere 4% of the NIH's budget goes to so-called "translational medicine," an oversight acknowledged by NIH Director Francis Collins late last year when he hastily announced plans to form a new Institute for Translational Medicine and Therapeutics (ITMAT). This is great idea, although this new entity is having to make due with no overall increase in translational funding.

    The opportunity for the Chinese – and, of course, for the U.S. – is to learn from this overemphasis on the "R" (research) in the "R&D" equation, and to focus more on the "D" (development). The other opening for China (and others) is to take the mass of basic research bought by America's trillion-dollar investment, which is readily available in journals and databases, and turn it into products – and into gold.

    Like Japan vis-à-vis Detroit in the 1970s, China finds itself with cash and without an ingrained way of doing things in biotechnology, allowing them to come up with fresh approaches. Also like the Japanese 40 years ago, China has sent its brain trust of students and young researchers to our universities and to work in our companies to learn what's gone right – and wrong.

    No one, including China, is even close to truly challenging the U.S. in biotechnology – not yet. Nor is this industry in the U.S. as calcified as Detroit during its heavy-metal doldrums of the 1970s, with American "R" still highly innovative and globally focused. U.S. life science companies, ranging from big pharmas such as Merck (MRK) and Pfizer (PFE) to biotechs such as Biogen-Idec (BIIB) are also eagerly collaborating with Chinese counterparts.

    Yet there is a question of whether America in the long run can maintain its edge as the biotech colossus. I suspect that it won't – though as the "New Detroit" is discovering, this may not necessarily be a bad thing for consumers, or for the company's bottom line, even if it may be equally painful to make a transition from the old to the new.

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