2010-08-09 09:11

BEIJING -?A government-backed industry-university alliance was launched here on Saturday to further promote the traditional Chinese medicine (TCM) in the global market.

Members of the alliance include Peking University, Beijing University of Chinese Medicine, the health ministry's development center for medical science and technology, and 12 domestic pharmaceutical corporations.

"The alliance marks a new stage in the development of TCM's entering the global market," said Wang Guoqiang, vice minister of the health ministry, also director of the TCM State Administration.

The alliance's launch came as Tianjin-based Tasly Pharmaceutical Co announced Saturday that the company's Compound Danshen Dripping Pill had been tested safe and effective during the US Food and Drug Administration (FDA)'s Phase II clinical trials.

The FDA had also approved the drug to enter the Phase III trials, said Tasly chairman Yan Xijun, also a board member of the TMC promotion alliance.

He added that he expected the drug to enter US and global drug markets in 2013.

FDA Phase II trials gauge the effectiveness of a drug and its side effects and risks, while Phase III trials are more extensive. Once Phase III is complete, a pharmaceutical company can request the FDA approval for marketing the drug in the US.

The Compound Danshen Dripping Pill is mainly used to treat angina and coronary heart diseases. More than 10 million people worldwide take the pills annually, according to Tasly.

With domestic sales of more than one billion yuan ($148 million) last year, the drug was the first Chinese patent traditional medicine to pass the FDA's Phase II trials.

Despite 2,000-years of use on home turf, Chinese traditional medicines often find it tough to enter markets dominated by Western pharmaceuticals.

None of the Chinese patent medicines has so far been approved for marketing in the mainstream US and European drug markets.

Previously, the Compound Danshen Dripping Pill had only been approved by drug watchdogs in Canada, Russia, Republic of Korea, Vietnam, Singapore and some African countries.

One major obstacle Chinese drug firms face when obtaining market approvals in the US and European countries is how to explain the ways traditional Chinese medicines work in a scientific language that appeals to Western ears.

Many traditional Chinese medicines are mixtures of a number of ingredients, which makes them much more difficult to explain than western drugs in a quantitative sense.

The huge expense of conducting the FDA's marathon-like three-phase clinical trials, often mounting to hundreds of millions of dollars, and unfamiliarity with laws and regulations in Western countries made things even more complicated.

Hopefully, the TCM promotion alliance might change the current situation for the good.

"With support from the government and collaboration among its members, the alliance will enhance our research capabilities, and could invite more overseas experts to provide guidance for us to promote TCMs in the global market," said Zhang Boli, president of Tianjin University of Traditional Chinese Medicine.

Tasly's success in passing the FDA Phase II clinical trials was also of great help for Chinese firms undergoing similar drug trials, said Zhang, who is also a member of the Chinese Academy of Engineering.

"It is a breakthrough in the globalization of traditional Chinese medicines," he said.

Vice Health Minister Wang Guoqiang also said that Tasly's progress in FDA clinical trials could play an exemplary role for other Chinese patent traditional medicine.

Yan Xijun said Tasly was willing to share with the alliance's members its experience in passing the FDA's clinical trials.

"It should be a long-term strategy for Chinese patent traditional drugs to seek FDA recognition in order to be further promoted in the global market," he said.

He said the newly launched TCM promotion alliance hopes to see at least one Chinese patent traditional medicine entering the US and European drug market by 2015, one to two drugs undergoing FDA Phase III clinical trials and at least three undergoing Phase II trials by that time.