China Bets On Homegrown Drugs

TO FOSTER DOMESTIC drug discovery capabilities, China's government is distributing 6.6 billion yuan—nearly $1 billion at current exchange rates—to companies, public research institutes, or universities that promise to engage in world-class drug discovery research. Applicants submitted their proposals to government officials in Beijing in late October. Results will be released within the next few weeks.

Today, many firms in China provide sophisticated drug discovery services on a contract basis to foreign customers. Dozens of Chinese manufacturers produce drug ingredients that meet Western regulatory standards. And Chinese academics routinely publish papers in the world's most prestigious life sciences journals.

But innovative drug discovery is not something China is good at on its own, and the country has not discovered any widely used pharmaceutical so far. China's scientists have performed fundamental research that foreign companies have harnessed to launch new drugs, but a Chinese company or research institute has never been in the driver's seat. The country's new drug discovery program aims to change the status quo.

"It's a very bold program that will help to boost China's drug discovery and development capabilities," says Samantha Du, chief executive officer of Shanghai-based Hutchison MediPharma, probably the country's most sophisticated drug discovery and development company. "One of the most worthwhile results may be that it will encourage a greater number of Chinese scientists now based abroad to return and join the country's research institutes." The return to China of scientists with drug discovery and development experience, Du says, would have a profound impact on the country's drug R&D capabilities.

Kaikun Wei, the biochemistry group leader at the drug discovery lab of Shanghai Hengrui Pharmaceutical, says Chinese scientists are trying to develop drugs that are more affordable than the ones the country now imports. Some of the newer biotech drugs on the international market, he says, cost as much as $3,000 per treatment, a price that is way beyond the reach of most Chinese patients. "We need to develop our own lower cost substitutes to these drugs without infringing on anyone's patents," he says.

Hengrui, a major Chinese producer of generic pharmaceuticals, has been trying to develop its own new drugs for the Chinese market (C&EN, June 30, page 25). Kei traveled to Beijing in October to present Hengrui's requests for money under the new drug discovery program.

Administered by the China National Center for Biotechnology Development, the program is funded directly by the State Council, China's highest decision-making body. It targets 10 major disease areas: malignant tumors, heart disease, cardiovascular system ailments, nervous system diseases, diabetes, psychosis, autoimmune problems, drug-resistant infections, viral infectious diseases, and tuberculosis.

THE FUNDING PROGRAM results from a 2006 Chinese government white paper that called for a national policy to develop the ability to innovate. China has identified 16 areas—pharmaceuticals being one of them—where acquiring the ability to innovate is critical to the country's overall development, according to Wei.

Funding for drug discovery programs is offered only to companies based in China, according to the program guide. To ensure that the research performed is of world-class quality, groups applying for funding are encouraged to employ foreign scientists and discuss their research with foreign organizations, as long as foreigners do not end up retaining control of any new technologies.

The stipulation regarding foreign control is strict. Zelin Sheng, chief operating officer of the Shanghai-based drug discovery firm Egret Pharma, tells C&EN that he was unable to convince government officials that Egret is actually a Chinese company. The problem, he believes, is that, although his company is Chinese, it was founded by Americans who still retain an active role in management.

The program allows companies and public institutions to seek funding for a wide range of projects. On one end of the spectrum, for organizations with established drug discovery infrastructure, China will provide $730,000 for every preclinical drug candidate they develop. It's not much, but the government expects that private companies involved in such programs will provide at least two-thirds of the funding.

For organizations that undertake to establish "comprehensive technology platforms for drug discovery," which includes proving the safety and efficacy of drug candidates, the government will provide as much as $29 million per project. Such integrated projects entail the discovery of drug leads, drug screening, design of new technologies to isolate and purify active substances, development of safety testing capabilities, and related activities.

OFFICIALS want to see fast results for the money they are spending. The government hopes to initiate funding soon for preclinical research on as many as 100 compounds. Within three years, the government expects that several of these compounds will be approved as Investigational New Drugs (IND) and begin to be tested on human patients in China. At least one or two compounds will subsequently become commercial drugs, the government envisions.

The government's schedule is overly ambitious, Hengrui's Wei argues. "It takes more than three years to go from early-stage preclinical research to IND," he says. But he is optimistic that the program will deliver tangible results. "We do big projects well in China, like the Olympics, the Great Wall. This is another one of those."

The cost of launching a new drug in Western countries has exceeded $800 million, according to a study from the Tufts Center for the Study of Drug Development. Even accounting for the lower costs of operating in China, Chinese executives acknowledge that a program funded with barely $1 billion will be hard-pressed to yield new drugs that are both safe and effective. Government officials managing the program declined an interview with C&EN, but Wei believes that more funds will be added if results are encouraging.

A bigger challenge for the program, according to Hutchison's Du, is that few organizations in China, whether private or public, have the sophistication required to undertake world-class drug discovery and development programs. "There aren't that many people in China who have done drug discovery and development in accordance with world standards," she says.

For Wei, the main point is that China has no choice but to develop its R&D capabilities if it is to continue expanding its economy. "We have to export 800 million shirts to pay for just one jumbo jet," he says. The funding program has some flaws, Wei notes, such as poorly defined follow-up mechanisms to ensure that the government's money is well spent. But the plan does address the central issue. "China needs its own ability to innovate," Wei stresses.