Birth of a Biotech Industry
SHANGHAI, China -- Known for producing low-cost clothes and well-priced toys, China is getting into making inexpensive drugs.
Opening a new frontier of outsourcing, global pharmaceutical companies overwhelmed by the rising costs of producing new drugs increasingly are turning to China to conduct low-cost research and development. They are finding highly educated scientists who work for a fraction of the cost of their Western counterparts, and vibrant and growing biotech businesses. They also are beginning to sink significant amounts of money into investments that will further boost China's capabilities.
"We see the rapid emergence of a Chinese biotech industry," said Daniel Vasella, chief executive of Novartis AG.
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This month, Roche Ltd. unveiled an R&D center on the outskirts of Shanghai, where the drug giant will employ 40 local scientists. Pfizer Inc. is spending $175 million on establishing a new regional headquarters in Shanghai. Although the office will oversee existing manufacturing and marketing operations, Pfizer said last month that it also is considering building its own R&D center in China. Novartis, for its part, is collaborating with one Chinese R&D institute and is seeking to partner with a Chinese biotech company on further projects.
With the expense of bringing a new drug to market sometimes topping $1 billion, major pharmaceutical companies are increasingly desperate for a low-cost edge. Some highly complex R&D, such as studying the biology of how the body responds to disease, must be done in the West. But drug companies have found that China, where a scientist with doctorate in chemistry earns no more than $25,000 a year compared with nearly 10 times that in the West, makes a good place to carry out chemical testing of drug compounds to determine their effectiveness as possible treatments.
The savings are needed as Big Pharma comes under growing pressure to expand its pipeline of potential blockbusters.
"Doing research in a low-cost setting should allow drug companies to deploy the dollars" they spend in the U.S. and Europe more effectively, said Drew Senyei, a health-care venture capitalist at Enterprise Partners.
At Roche's R&D operation in Shanghai, for instance, scientists will focus on medical chemistry -- screening various compounds that have shown promise as possible antiviral treatments or as cancer drugs. The group will have access to R&D conducted at the drug giant's other research centers in Basel, Switzerland, and Nutley, New Jersey -- and will share its findings with scientists in those laboratories.
Roche executives said they didn't build their $11 million facility simply to save money. "There is very good chemistry done in China," said Jonathan Knowles, the company's global head of research, with many Chinese scientists on the same educational footing as their U.S. counterparts. Instead, the laboratory helps Roche establish strong ties with Chinese authorities, something that could prove valuable as the company seeks to expand operations in China.
Novartis recently formed a partnership with the government-run Shanghai Institute for Materia Medica. Scientists there will screen compounds derived from traditional Chinese medicine, which Novartis scientists may be able to develop into new drugs.
Still, conducting R&D from start to finish in China is years away for Big Pharma. Lingering discomfort with intellectual-property-protection standards remains a problem, drug industry executives said. Also, scientists still require training in the West to gain understanding of cutting-edge techniques and equipment. In the past, Novartis has trained Chinese scientists at the company headquarters in Basel and subsequently transferred them back to China to continue R&D efforts. Mr. Vasella, Novartis's CEO, however, observes that Chinese biotech companies rapidly are adopting Western research standards and knowledge. "It is only a matter of time before China catches up," he said.
The China strategy isn't just for Big Pharma -- Western start-ups are moving into China as well. The lower costs buy them more time to prove the viability of their drug prospects between rounds of funding from venture capitalists.
For instance, TargeGen Inc., based in San Diego, is developing small-molecule drugs for treating cardiovascular disease but has shifted chemical screening of various compounds to WuXi PharmaTech Co. of Shanghai. "We pay WuXi to do research on our compounds and then use the results for further development" in the U.S., said Mr. Senyei of Enterprise Partners, a venture-capital investor in TargeGen. Mr. Senyei said he would like to replicate that arrangement at some point with another U.S. biotech company that is developing cancer treatments.
For biotech companies whose research projects have stalled or whose cash has run dry, positive results achieved in China can help persuade venture-capital investors to give them more money. Mologen Inc. of Germany, for example, is collaborating with Starvax Inc., based in Beijing, on a colon-cancer drug undergoing clinical trials in Europe. Rather than spending on expanded R&D in Europe, Mologen is having Starvax do preliminary screening to determine whether the compound might be effective treating other types of cancer.
Starvax, in turn, is typical of a new breed of Chinese biotech companies run by entrepreneurial Chinese returnees. It was started last July by two former classmates at Peking University, Yiyou Chen, 33 years old, and Justin Chen, 34. The like-named friends both spent more than a decade in the U.S. earning graduate degrees and working as a scientist and a patent lawyer, respectively.
Yiyou Chen previously worked on developing vaccines for viruses that cause cervical cancer and hepatitis B at Genencor International Inc., based in Palo Alto, California. Now Starvax is working on discovering vaccines in the same areas.
Another Chinese upstart is moving beyond simply offering research for hire. Crimson Pharmaceutical in Shanghai plans to license Asian sales rights from its Western partners and conduct its own development studies to create proprietary products. Chinese drug companies are eager to secure such exclusive arrangements.
So far, Crimson has purchased the rights to four compounds, aimed at treating HIV, developed by Octamer Inc., based in Tiburon, California. Crimson hopes to develop the compounds into drugs with regulatory approval and then re-license to a Chinese pharmaceutical company with sales and marketing muscle, chief scientist Sam Lou said.
Crimson and Starvax got off the ground with $2 million in seed financing, a pittance compared with the tens of millions of dollars needed in the U.S.
Although it is unclear which Chinese start-ups will hit the jackpot and which will go under, Western scientists see the burgeoning industry as a positive for drug development in China. Johnson & Johnson and Pfizer, for instance, recently visited the "incubator building" in Beijing's Life Sciences Park, where Starvax is located, to find out what the new biotechs are doing.
Kenneth Chien , director of the Institute of Molecular Medicine at the University of California, San Diego, also thinks a homegrown biotech industry in China will spur progress in intellectual-property protection. Scientists trained in the U.S. generally should have greater understanding of patent rights, he said, and local companies will begin to demand regulatory cover for their breakthroughs. "Without [intellectual property] protection, you have no industry," Mr. Chien said.
西方制药公司将研发外包中国
以制造低成本服装及廉价玩具而闻名的中国现在正把兴趣转向低价药品的研发上。
那些受到新药研制成本不断上升困扰的全球制药企业正越来越多地把目光投向中国，寻求当地研发的低成本优势。选择把研发工作外包给中国是因为中国拥有受过良好教育的科学家，而他们的薪金待遇只是西方同行很小的一部分。而且，中国的生物科技产业也在欣欣向荣地快速发展。这些全球制药企业将大量资金投向中国的做法也会提高中国的实力。
诺华制药(Novartis AG)的首席执行长魏思乐(Daniel Vasella)表示，“我们认为中国的生物科技产业将迅速崛起。”
这些全球制药企业纷纷在中国设立研发中心。例如，罗氏(Roche Ltd)本月在上海郊区的研发中心开始投入使用，该研发中心将雇佣40名中国科研人员。辉瑞(Pfizer Inc.)将斥资1.75亿美元在上海兴建地区总部，这个地区总部将负责监管现有的制造及营销业务。不过，辉瑞上个月表示还有意在中国设立研发中心。诺华制药也在同中国一个研究机构协商合作事宜，同时还准备和一家中国生物科技企业结成合作伙伴，以深化二者的合作关系。
由于新药研发需要巨大的投入，有时甚至超过10亿美元，因此大型制药企业越来越迫切希望尽可能地降低成本。一些高度复杂的研发项目，如观察人体如何对疾病做出反应的研究项目只能在西方国家进行。但制药公司发现，不妨把新药疗效的化学测试交给中国的科学家来完成，因为他们的年薪不超过25,000美元，约是西方同行的十分之一。
人力成本上的节省对于这些大型制药商来说非常必要，因为它们可以把节约下来的资金用于开发有可能成为畅销药潜质的药品，而在这个方面它们正承受著越来越大的竞争压力。
Enterprise Partners的保健业风险投资专家德鲁?谢涅伊(Drew Senyei)表示，与在美国和欧洲搞研发相比，在低成本环境中从事药品研发使得这些全球制药商能够更有效地调配资金。
例如，在罗氏位于上海的研发中心，科研人员将主要从事医学化学工作，即从各种化合物中筛选出具有成为抗病毒药物或者抗癌药潜质的药品。上海的科研人员可以接触到罗氏全球其他研发中心的研究成果，并和其他研发中心的同行们一道分享取得的成就。
罗氏管理人士表示，该公司斥资1,100万美元在上海建立研发中心并不只是为了节省资金。罗氏负责研发的全球主管约翰森?诺里斯(Jonathan Knowles)表示，中国的医疗化学工作取得了卓有成效的成果，而且许多中国科学家的教育背景不亚于美国同行。在中国开设研发中心还有助于该公司同中国政府建立良好的关系，而这对于该公司今后拓展中国业务将是非常有帮助的。
诺华制药近期同中国科学院上海药物研究所(Shanghai Institute for Materia Medica)结成了合作伙伴关系。上海的科研人员将从传统中药中筛选出可能有助于诺华制药科学家开发新药有帮助的化合物。
不过，对于大型制药商来说，把研发工作全面转移到中国还需要数年的时间。制药界管理人士表示，中国知识产权保护标准令他们感到不安，这个问题仍然存在。另外，科学家还需在西方接受培训才能对最尖端的科技和设备有所了解。诺华制药曾在公司总部巴塞尔培训中国的科研人员，然后把他们送回中国继续从事研发工作。不过，魏思乐认为，中国的生物科技公司在研发标准及知识储备方面正在和西方企业迅速看齐。他认为，中国企业的迎头赶上只是个时间早晚的问题。
不但是大型制药商，就连西方国家那些刚刚起步的企业也在纷纷把研发工作转向中国。成本的降低使得他们有更充裕的时间来改进药品的疗效，从而为进一步争取风险投资创造了条件。
例如，开发用于治疗心血管疾病的小分子药物的制药商TargeGen Inc.已经把化合物的筛选工作转交给了无锡药明康德新药开发有限公司(WuXi PharmaTech Co.)。谢涅伊表示，“我们聘请这家公司对我们的化合物进行研发，然后把研发结果送到美国进行进一步的研究。”谢涅伊表示，他希望能在将来某个时候在另一家研发抗癌药的美国生物科技公司身上沿用这种研发模式。
对于那些研发项目陷入停滞以及现金储备已经告罄的生物科技企业来说，在中国的研发工作取得积极成果将有助于风险投资为它们提供更多的资金。例如，德国制药企业Mologen Inc.正在和北京斯泰康生物科技(Starvax Inc.)就一种正在欧洲进行临床测试的结肠癌药物进行合作。Mologen并未把全部研发工作放在欧洲，而是选择了斯泰康生物科技来做一些初步的筛选工作，以决定该药品对于治疗其他种类的癌症是否具有疗效。
斯泰康生物科技是由归国留学生创办的新一代中国生物科技企业的典型代表。该公司于今年7月由两位归国留学生陈亦工和陈一友创办。
另一家中国初创企业已经不满足于只是替别人做研发工作了。上海富海科申药业有限公司(Crimson Pharmaceutical)计划获得其西方合作伙伴的产品在亚洲的销售权，并准备进行自主研发，研制出具有自主知识产权的产品。中国的制药企业往往渴望获得这种独家的代理协议。
目前为止，上海富海科申药业有限公司购买了由Octamer Inc.开发的4种治疗艾滋病的化合物的代理权。该公司首席营运长娄实(Sam Lou)希望公司能把这4种化合物开发成获得监管部门批准的药品，然后再通过授权的形式交给一家具有销售实力的中国制药企业来进行生产。
北京斯泰康生物科技和上海富海科申药业有限公司两家公司成立时都只有200万美元的起步资金，而美国初创制药企业的初始资金动辄达到上千万美元。
尽管目前尚不清楚哪些中国初创生物科技企业将大红大紫，哪些将难逃破产厄运，但西方科研人员认为生物科技产业在中国的崛起将推动中国的药品研发事业。例如，强生(Johnson & Johnson)和辉瑞近期均走访了北京生命科学园内的孵化科研基地大厦，察看那里的生物科技研究有什么最新的进展。北京斯泰康生物科技的总部就设在生命科学园中。
加州大学(University of California)分子医学研究所(Institute of Molecular Medicine)所长钱肯(Kenneth Chien)也认为，中国本土生物科技产业将推动保护知识产权的进程。他表示，在美国接受过培训的科研人员普遍对专利权有比较清楚的了解；中国国内企业也将要求监管部门对他们所取得科研突破提供立法保护。钱肯表示，知识产权如果得不到保护，任何产业的健康发展就无从谈起。
