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生物技術大國夢:美國苦苦掙扎,中國躍躍欲試

生物技術大國夢:美國苦苦掙扎,中國躍躍欲試

David Ewing Duncan 2011-08-18
經過多年的高額投入之后,美國的生物技術產業仍然在苦苦掙扎,試圖將研究成果轉化為經濟效益。而在太平洋彼岸,意氣風發的中國也瞄準了這個領域,計劃投入數以10億計的資金,大力發展本國的生物技術產業。前事不忘后事之師,如果能夠繞開美國“重科研,輕開發”的老路,中國或許能夠率先從生物技術產業這塊富礦里淘出真金。

????現在輪到中國投入大量資金用于藥物研發了。

????10多年來,為了將大量的生物學突破性研究成果轉化為實際的治療方法和經濟效益,美國已經投入了大量資金。自2000年以來,對生物技術產業的公共和私人投資已經接近萬億美元。但在最近幾年里,生物技術和制藥行業平均每年僅推出約21種新藥,數量只相當于1996年至2004年間的三分之二。如今,藥物的試驗和審批需要耗費十幾年時間,而在進入人類臨床試驗階段的藥物中,有90%都以失敗告終。

????菲薄的回報導致投資者逃離,商業模式備受質疑。去年,僅有1/9的美國風險資金投資于生物技術產業,大大低于2009年的近1/6。營收也出現下滑,安進(Amgen)等少數幾個大型生物技術公司擄走了大部分資金,而其他絕大多數的生物技術公司則面臨著籌資困難,處于早期階段的項目更是如此。

????與此同時,在太平洋彼岸,中國認為現在是從其大量儲備中拿出部分資金,對生物醫學進行大力投資的時候了——今后5年內將投入3,080億美元。據《中國日報》(China Daily)報道,中國國務委員劉延東在近期舉行的一次會議上說:“十二五計劃的發展重點——生物制藥、生物工程、生物農業和生物制造——將造福中國人民?!边@家政府出資的報紙在該文中還報道了這一投資的宏偉目標:“從2011年到2015年,預計將新增100萬個工作崗位,人均期望壽命提高1年,嬰兒死亡率下降至12%,常規污染物排放減少10%。”

????這種巨額投入與美國在1998年經濟繁榮時期的做法如出一轍。當時,美國總統克林頓與國會領袖合作,將美國國立衛生研究院(NIH)的5年預算增加了一倍。此次大規模擴大生物醫學研究投入之時,正是“人類基因組計劃”駛入快車道之際(在2000年完成了人類基因組草圖)。那時科學家們相信,在21世紀前10年,迅速發展的分子生物學將很快產生大量的新藥物和新療法。

避免重蹈底特律的覆轍

????顯然,對中國而言,美國的經歷既是警示也是機遇。

????警示在于,政府——此處是私有大型制藥公司——投入了研究資金,卻沒有切實可行的計劃來將研究成果轉化為實際的產品,盡管這些成果作為科學項目而言光彩奪目。在美國國立衛生研究院的預算中,僅有4%用于所謂的“轉化醫學”。去年底,該研究院院長弗朗西斯?科林斯在匆忙宣布成立轉化醫學與治療學研究所( Institute for Translational Medicine and Therapeutics)的計劃時承認,這是他們的疏忽。成立轉化醫學與治療學研究所是個不錯的主意,但這個新機構必須處理好轉化醫學投入總體上沒有增加的問題。

????機遇在于,中國——當然還有美國——可以吸取教訓,避免在“研發”過程中過分強調“研”(研究),轉而更多地關注“發”(開發)。中國(和其他國家)還可以借鑒美國萬億美元投資所帶來的大量基礎研究成果(在雜志和數據庫中可以輕易獲得),并將之轉化為產品,經濟效益就會隨之而來。

????與上世紀70年代向底特律發起挑戰的日本一樣,現在的中國既有資金,又沒有被生物技術行業里的固有做法所束縛,這使得他們可以走出不同的路子。同樣,如同40年前的日本,如今的中國將其優秀學子和年輕研究人員送到美國的大學里就讀,或者到美國的公司里工作,了解美國的得失。

????包括中國在內,沒有哪個國家能夠在生物技術領域里對美國發起真正的挑戰,至少目前如此。美國的生物技術產業也不像在上世紀70年代處于蕭條時期的底特律那般僵化,生物科研界依然走在創新前沿和并具有全球眼界。美國生命科學企業,從默克(Merck)和輝瑞(Pfizer)等大型制藥公司到艾迪克(Biogen-Idec)等生物技術公司,都渴望與中國同行展開合作。

????然而,就長期來看,美國能否維持其作為生物技術大國的優勢地位呢?我認為不會。但是,正如“新底特律”所發現的那樣,這對消費者或者企業利潤來說未必是件壞事,但從舊到新的轉變可能是個同樣痛苦的過程。

????譯者: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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