中国药企发力研发创新药 征募病患参加研究

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.

在制药业每天都宣布最新临床试验的大背景下，和黄中国医药科技(Hutchison China MediTech)上周宣布已征募病患参加结直肠癌研究的消息，算不上令人振奋。

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.

但这个消息反映出，亚洲首富李嘉诚(Li Ka-shing)支持的这家医药公司正在中国开发的几种试验药物之一又取得新进展。

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.

在伦敦上市的和黄中国医药市值仅5.5亿英镑，不会在一夜之间撼动大型制药商。然而，和黄中国医药是中国生命科学行业的一部分，而北京方面希望该行业能成为药物开发领域的一支力量。

“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.”

“中国意识到，在制药业中，重要的是创新。”和黄中国医药首席执行官贺隽(Christian Hogg)表示，“中国已经有一些大型制药商，但要提升一个层次，它们就必须创新。”

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.

北京方面已经将加快研发创新药列为国家重点工作，一方面是为了满足中国社会不断增长的健康需求，另一方面是为了挑战西方制药商在全球的主导地位。在2011年出台的“十二五”规划中，生物产业被列为要大力发展的七大“支柱”产业之一。

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.

在外界看来，迄今没有多少迹象显示情况有重大进展。多家大型外资制药商在中国开设了研发中心，或是有这样做的计划，其中包括诺华(Novartis)、辉瑞(Pfizer)和强生(Johnson & Johnson)。但大多数中国本土制药商仍在生产低附加值的仿制药，或在为欧美生产的创新药供应配料。

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.

这将中国置于类似印度的地位上，印度的鲁宾(Lupin)和兰伯西(Ranbaxy)已成为大型仿制药生产商，但似乎没有自行研发高价值药物的迹象。然而，两国对待支撑全球制药行业的专利制度态度不同。

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.

欧美制药商的产品之所以能开出高价，就是因为有知识产权。印度在知识产权上正在与美国和欧洲制药商展开较量，而中国没有对知识产权制度表现出多少异议。分析师和行业高管表示，从这一点上可以看出，北京方面希望当中国制药商开始自行研发创新药时，中国能成为专利制度的受益者。

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

多家中国制药商的第一步，都是与跨国制药商达成合作。

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，和黄中国医药正在与美国制药商礼来(Eli Lilly)合作，开发用于治疗结直肠癌的药物——呋喹替尼(Fruquintinib)；它还在与英国制药商阿斯利康(AstraZeneca)合作，研发用于治疗肾细胞癌的药物——沃利替尼(Volitinib)。与此同时，总部位于北京的制药商百济神州(BeiGene)正在与德国制药商默克(Merck)合作开发癌症药物。

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.

为中国本地和跨国制药企业提供服务的咨询顾问乔治•贝德(George Baeder)预测，未来3年内，将有逾12种中国发明的新药投入临床使用。他说：“届时，制药业将不得不承认中国在创新药研发中的地位。”

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.

中国在医药研发方面的潜力在上世纪60年代就表现出来了，当时，北越在跟美国支持的南越打丛林战，而疟疾在北越士兵中肆虐，于是毛泽东命令中国军队寻找治疗疟疾的药方。

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.

经过努力，中国人发现了青蒿素——至今仍然是对付疟疾最重要的武器之一。青蒿素是从黄花蒿茎叶中提取的，这种植物几个世纪以来一直是一味中药，显示出中国传统中医在与现代科技结合方面存在巨大潜力。

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，直到上世纪90年代、瑞士诺华将一种基于青蒿素的药物商业化以后，这项中国的创新才得以造福世界。北京方面希望确保未来的发明能更快推向全球市场，而且由中国本土企业全程研发和制造。

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.”

一些中国制药商正在尝试完成从仿制药到创新药的飞跃，先声药业(Simcere Pharmaceuticals)就是其中一家，它最近在南京成立了研发中心。先声药业创始人兼董事会主席任晋生表示，资金仍然是个难题。“相比美国政府每年300亿美元的基础药物研究投入，中国政府每年的投入还不到100亿元人民币（合16亿美元），在企业层面上，两国的差距更大。”

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

然而，有迹象显示，这种差异已开始缩小。

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.

咨询公司麦肯锡(McKinsey)的数据显示，2007年至2012年期间，中国的生物研发投资规模以每年33%的复合增长率增长，而亚太其他国家的平均增长率是7%。麦肯锡驻香港的张芳宁表示，增加投入已初见成效：中国人在权威生命科学期刊上发表的论文数量，在2001年至2013年之间增长了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.

技能短缺的障碍也逐渐被克服，中国的大学输送着一批接一批的年轻科学家，还有许多在西方接受了训练的中国科学家返回中国。

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，曾任阿斯利康驻中国高管、现任聚焦亚洲的药物开发商Aslan Pharmaceuticals首席执行官的卡尔•弗思(Carl Firth)表示，监管环境仍然严峻。他说，在亚洲其他地方，开展早期试验的难度比中国更低。

“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.”

“如果监管机构真正着手推动流程加速，那么最大的受益者将会是跨国制药商，因为中国制药商还没准备好。”弗思指出，“中国将成为医药研发中的重要力量，但中国还不至于很快超越美国和欧洲。未来或许可以，但现在还不行。”