Cheap drug and stem cell trials in China

"Leaders and laggards in the stem cell enterprise," in the 30 June 05 issue of Nature Biotechnology, describes the global distribution of policy and science of stem cell research.  The story notes that;

The wild cards in all this are China and South Korea. Both have extremely talented scientists, but both are (perhaps unfairly) singled out for lax ethical standards and an uninformed public. With fewer shackles on the momentum of ES cell research, the two countries could potentially accelerate products into clinical trials much faster than the rest of the world.

But just because progress might be made in the clinic, it isn't clear that drugs (including cell-based therapies) produced in China will find an easy time in U.S. and European markets.

In "China beckons to clinical trial sponsors", Hepeng Jia writes that;

The clinical trials market is opening up in China...Low cost and ease of access to patients are the main incentives for clinical trial outsourcing...Ying Zhang, marketing director at Beijing-based clinical trial contract research organization (CRO) Excel Medical Technology, estimates that the cost of a clinical trial for a new drug in China is only half of the amount in the United States or Western Europe owing to lower labor and infrastructure costs.

There are, however, a few challenges, including, "poor data standardization, delays in gaining trial authorization from regulators and questionable ethical standards," and a, "poor level of compliance with Western standards."

Despite the harmonization of standards at some clinical trials facilities, it remains to be seen whether the US Food and Drug Administration or European Medicines Agency will accept data obtained from clinical trials carried out in China. Already foreign organizations like Quintiles, CCBR and Canadian company MDS of Toronto, have been seeking endorsement of agencies like the American College of Pathologists to gain recognition for their work there.

Large pharmaceutical corporations are moving into the Chinese market via acquisition.  Alla Katsnelson reports (Nature Biotechnology 23, 765 (2005)) that the Israeli generic manufacturer Teva Pharmaceuticals is buying Tianjin Hualida Biotechnology Pharmaceutical Co, in part because of "regulatory purgatory" in the United States.  "By tackling less strictly regulated markets first, Teva could gain more expertise in manufacturing biogenerics and profit from those markets directly."

Writes Katznelson;

The first problem is that products made in China are arguably unlikely to be approvable in Western countries [by the FDA and EMEA].  'Standards in the US are so much higher that there's just no comparison'.
    Getting non-Western facilities up to production standards is a long and expensive process...  For example, requirements for manufacturing specific such as water purity may not be important clinically, but the FDA is likely to insist on them.

Yet Teva is evidently pursuing a long-term strategy, because while the FDA has for several years been issuing assurances that, "creating a regulatory pathway for biogenerics is a top priority...its reactionary approach has not inspired confidence in the generics industry of late;"

RA used to mean regulatory affairs, but now it means risk aversion," says Alan Liss, senior director of biotech at Duramed Research in Pennsylvania. "While we're talking, China and India will be supplying the rest of the world with products," he adds.

But the story concludes that this same sort of transition occurred in India, that Indian drug development and manufacturing efforts were "eventually folded in the Western regulatory framework," and that "in ten years, companies will use China not only as a local market but as a springboard for global opportunities -- providing talent and infrastructure at a good price."

Gong Yidong, writing in the 29 July issue of Science, notes the many motivations for operating in China;

China's growing appetite for Western drugs--the current $15 billion market is expected to quadruple by 2010, and then double again by 2020--has certainly caught the attention of every drug company. So has its cheap but skilled scientific labor force. Not only do Ph.D.s receive annual salaries of $10,000 or less, but the most expensive aspect of drug development--clinical trials--costs an estimated 30% less in China than in the United States or Europe. And then there is its growing prowess in science. "I'd say that setting up our own research lab there is only a matter of time," Novartis CEO Dan Vasella remarked this spring. "It's not so much a need as it is a hunger to take advantage of the opportunities."

With many companies opening R&D labs in country, combined with the increasing level of education and the desire to take a larger role on the world state, we're likely to see remarkable ferment developing new treatments in China.