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UPDATED: Booming China poised to take a top position in global drug R&D

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Determined to emerge as a leading force in the global drug development business, China has invested a total of more than $160 billion in building its biotech industry, according to a new assessment from Lux Research. And with 15 clusters--including 5 fast-growing "super" clusters--the huge Asian market is poised to leap past Japan and take the number two spot in terms of overall R&D spending on drug development.

Taking a distinctly bullish tone, Lux reports that the fast-growing biotech sector is evolving from basic research toward late-stage efforts and commercialization as more drugs are approved for use in China. Over the past four years China's native R&D industry--distinct from the Big Pharma operations that have been growing there--has produced more than 3,000 patents and 12 new drugs. And the country's economic czars plan to see that number of innovative new drugs swell to 100 by 2020.

That approval pace would average about 12 new drugs a year for the next 8 years, compared to 39 new chemical entities OK'd by the FDA last year.

Most of these new drugs should be for cancer. Fifty-six of China's 127 "Major New Drug Innovation Program" projects seek to develop drugs to treat cancer. Biologics outnumber small molecule drugs by a large margin--34 for biologics versus only 22 for small molecule drugs. And it's only a matter of time before China's biotech industry looks abroad.

"While the Chinese domestic market provides ample room for all players now, Chinese pharmaceutical companies will naturally look outside to lucrative markets in North America and Japan over time," said Lux Research Director Kevin Pang.

"The thing that's quite interesting is how they are targeting clusters of innovation," Pang tells FierceBiotech. The U.S. primarily relies on the private sector to foment innovation clusters, he adds, while "in China it's top down." The national committees that create 5-year plans often include many university staffers. They've helped create clusters around the universities and the spinouts have multiplied. There's been a big national focus on monoclonal antibodies, vaccines and biosimilars.

As China's biotech industry grows, however, it also faces some major challenges. GlaxoSmithKline's ($GSK) recent decision to fire its R&D chief in Shanghai for manipulating data underscores the country's growing ethics crisis. That crisis has become the fodder for international headlines in recent days as GSK and other multinationals find themselves squirming in the spotlight of accusations that they routinely bribe physicians and others to use their products.

Back in 2007 China executed the head of its drug watchdog agency, Zheng Xiaoyu, after accusing him of taking bribes for approving a lethal antibiotic. But China's political leaders continue to figure prominently in rumors about rampant corruption.  For China to take a leading place in the global R&D industry, it's going to need to clean up its reputation, or any new drugs that come from the country will face intense scrutiny by wary regulators and consumers in the West.

- here's the press release

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