中國藥企發力研發創新藥 徵募病患參加研究

Amid daily updates from the pharmaceuticals industry on the latest clinical trials, last week’s announcement by Hutchison China MediTech that it had enrolled patients for a study of colorectal cancer was hardly cause for excitement.

在製藥業每天都宣佈最新臨牀試驗的大背景下，和黃中國醫藥科技(Hutchison China MediTech)上週宣佈已徵募病患參加結直腸癌研究的消息，算不上令人振奮。

But it represented another step forward for one of several experimental medicines that the company – backed by Li Ka-shing, Asia’s richest man – is developing in China.

但這個消息反映出，亞洲首富李嘉誠(Li Ka-shing)支持的這家醫藥公司正在中國開發的幾種試驗藥物之一又取得新進展。

With a market capitalisation of just ￡550m, London-listed China MediTech – known as Chi-Med – is not going to shake up “big pharma” overnight. However, it is part of a growing Chinese life science sector that the authorities in Beijing hope will become a force in drug development.

在倫敦上市的和黃中國醫藥市值僅5.5億英鎊，不會在一夜之間撼動大型製藥商。然而，和黃中國醫藥是中國生命科學行業的一部分，而北京方面希望該行業能成爲藥物開發領域的一支力量。

“China realises that innovation is what matters in pharma,” says Christian Hogg, Chi-Med chief executive. “There are already some big Chinese drug companies, but to get to the next level they have to innovate.”

“中國意識到，在製藥業中，重要的是創新。”和黃中國醫藥首席執行官賀雋(Christian Hogg)表示，“中國已經有一些大型製藥商，但要提升一個層次，它們就必須創新。”

Beijing has made faster development of research-based pharmaceuticals a national priority – both to serve the growing health demands of Chinese society, and to challenge the dominance of western drugmakers globally. In the government’s latest five-year plan, launched in 2011, the sector was identified as one of seven “pillar” industries to be promoted.

北京方面已經將加快研發創新藥列爲國家重點工作，一方面是爲了滿足中國社會不斷增長的健康需求，另一方面是爲了挑戰西方製藥商在全球的主導地位。在2011年出臺的“十二五”規劃中，生物產業被列爲要大力發展的七大“支柱”產業之一。

To the outside world, signs of progress have so far been limited. Several big foreign drugmakers have opened research and development centres in China, or are planning to do so – including Novartis, Pfizer and Johnson & Johnson. But most home-grown Chinese companies are yet to move beyond low-value generic medicines or ingredients for innovative drugs made in the US and Europe.

在外界看來，迄今沒有多少跡象顯示情況有重大進展。多家大型外資製藥商在中國開設了研發中心，或是有這樣做的計劃，其中包括諾華(Novartis)、輝瑞(Pfizer)和強生(Johnson & Johnson)。但大多數中國本土製藥商仍在生產低附加值的仿製藥，或在爲歐美生產的創新藥供應配料。

This puts China in a similar position to India, where companies such as Lupin and Ranbaxy have become big generic manufacturers but show little sign of developing their own high-value medicines. Where the two countries differ, however, is in their approach to the patent system underpinning the global pharma industry.

這將中國置於類似印度的地位上，印度的魯賓(Lupin)和蘭伯西(Ranbaxy)已成爲大型仿製藥生產商，但似乎沒有自行研發高價值藥物的跡象。然而，兩國對待支撐全球製藥行業的專利制度態度不同。

Whereas India is battling with US and European drugmakers over the intellectual property rights that allow them to charge premium prices, China has shown less dissent. This, say analysts and industry executives, reflects Beijing’s hope that it will eventually become a beneficiary of the patent system when its companies start developing drugs of their own.

歐美製藥商的產品之所以能開出高價，就是因爲有知識產權。印度在知識產權上正在與美國和歐洲製藥商展開較量，而中國沒有對知識產權制度表現出多少異議。分析師和行業高管表示，從這一點上可以看出，北京方面希望當中國製藥商開始自行研發創新藥時，中國能成爲專利制度的受益者。

For several groups, the first step has been to strike partnerships with multinational companies.

多家中國製藥商的第一步，都是與跨國製藥商達成合作。

Chi-Med, for example, is developing its colorectal cancer drug, fruquintinib, with Eli Lilly of the US and is working with AstraZeneca of the UK on another, called volitinib, for renal cell cancer. Beijing-based BeiGene, meanwhile, is developing cancer drugs with Merck of Germany.

例如，和黃中國醫藥正在與美國製藥商禮來(Eli Lilly)合作，開發用於治療結直腸癌的藥物——呋喹替尼(Fruquintinib)；它還在與英國製藥商阿斯利康(AstraZeneca)合作，研發用於治療腎細胞癌的藥物——沃利替尼(Volitinib)。與此同時，總部位於北京的製藥商百濟神州(BeiGene)正在與德國製藥商默克(Merck)合作開發癌症藥物。

George Baeder, an adviser to local and multinational pharma companies, predicts more than a dozen Chinese-originated products will enter the clinic in the next three years. “Then the industry will have to recognise China’s role as a drug innovator,” he said.

爲中國本地和跨國製藥企業提供服務的諮詢顧問喬治•貝德(George Baeder)預測，未來3年內，將有逾12種中國發明的新藥投入臨牀使用。他說：“屆時，製藥業將不得不承認中國在創新藥研發中的地位。”

China’s potential to become a force in pharmaceutical R&D has been evident since the 1960s when Mao Zedong ordered the Chinese army to find a treatment for malaria, which was ravaging North Vietnamese soldiers in their jungle battles with US-backed South Vietnam.

中國在醫藥研發方面的潛力在上世紀60年代就表現出來了，當時，北越在跟美國支持的南越打叢林戰，而瘧疾在北越士兵中肆虐，於是毛澤東命令中國軍隊尋找治療瘧疾的藥方。

This programme discovered artemisinin, which remains one of the most important weapons against malaria. It was derived from the sweet wormwood plant – a herb used in Chinese medicine for centuries – highlighting the potential to marry the country’s traditional medical practices with modern science.

經過努力，中國人發現了青蒿素——至今仍然是對付瘧疾最重要的武器之一。青蒿素是從黃花蒿莖葉中提取的，這種植物幾個世紀以來一直是一味中藥，顯示出中國傳統中醫在與現代科技結合方面存在巨大潛力。

However, it was not until the 1990s, when an artemisinin-based drug was commercialised by Novartis of Switzerland, that this Chinese innovation was made available to the wider world. Beijing wants to make sure future discoveries reach the global market more quickly – and with domestic companies taking them all the way.

然而，直到上世紀90年代、瑞士諾華將一種基於青蒿素的藥物商業化以後，這項中國的創新才得以造福世界。北京方面希望確保未來的發明能更快推向全球市場，而且由中國本土企業全程研發和製造。

One of those trying to make the leap from generic to innovative medicines is Simcere Pharmaceuticals, which recently opened an R&D hub in Nanjing. Ren Jinsheng, the company’s founder and chairman, says funding remains a challenge. “Compared to the $30bn invested by the US government each year in fundamental drug research, the Chinese government invests less than Rmb10bn [$1.6bn] and, at the company level, the gap is even larger.”

一些中國製藥商正在嘗試完成從仿製藥到創新藥的飛躍，先聲藥業(Simcere Pharmaceuticals)就是其中一家，它最近在南京成立了研發中心。先聲藥業創始人兼董事會主席任晉生表示，資金仍然是個難題。“相比美國政府每年300億美元的基礎藥物研究投入，中國政府每年的投入還不到100億元人民幣（合16億美元），在企業層面上，兩國的差距更大。”

There are signs, however, that the gap is beginning to narrow.

然而，有跡象顯示，這種差異已開始縮小。

Between 2007 and 2012, Chinese investment in biomedical R&D grew at a compound annual rate of 33 per cent, compared with an average 7 per cent in the rest of Asia-Pacific, according to McKinsey, the consultant. This increased spending is beginning to produce results: the number of Chinese papers in respected life science journals rose more than sixfold between 2001 and 2013, says Fangning Zhang of McKinsey in Shanghai.

諮詢公司麥肯錫(McKinsey)的數據顯示，2007年至2012年期間，中國的生物研發投資規模以每年33%的複合增長率增長，而亞太其他國家的平均增長率是7%。麥肯錫駐香港的張芳寧表示，增加投入已初見成效：中國人在權威生命科學期刊上發表的論文數量，在2001年至2013年之間增長了5倍。

Skills shortages are another obstacle being gradually overcome, as China’s universities churn out young scientists and those trained in the west return home.

技能短缺的障礙也逐漸被克服，中國的大學輸送着一批接一批的年輕科學家，還有許多在西方接受了訓練的中國科學家返回中國。

Even so, the regulatory environment remains difficult, according to Carl Firth, a former AstraZeneca executive in China who is now chief executive of Aslan Pharmaceuticals, an Asia-focused drug developer. He says early-stage trials are easier to carry out elsewhere in Asia.

即便如此，曾任阿斯利康駐中國高管、現任聚焦亞洲的藥物開發商Aslan Pharmaceuticals首席執行官的卡爾•弗思(Carl Firth)表示，監管環境仍然嚴峻。他說，在亞洲其他地方，開展早期試驗的難度比中國更低。

“If there was a serious push by regulators to speed up the process, the biggest beneficiaries would be multinationals because Chinese companies are not ready,” Mr Firth argues. “China is going to be a major player in pharma R&D, but they are not about to overtake the US and Europe. One day maybe, but not yet.”

“如果監管機構真正着手推動流程加速，那麼最大的受益者將會是跨國製藥商，因爲中國製藥商還沒準備好。”弗思指出，“中國將成爲醫藥研發中的重要力量，但中國還不至於很快超越美國和歐洲。未來或許可以，但現在還不行。”