Chinese drug passes US clinical trials for first time

BEIJING - A traditional Chinese medicine for treating cardiovascular diseases has been tested safe and effective by the US Food and Drug Administration (FDA), and would be marketed there by 2013, Xinhua reported Saturday.

With domestic sales of over one billion yuan (about $148 million) last year, the drug was the first Chinese patent traditional medicine to pass the phase II trials of the FDA.

The Compound Danshen Dripping Pill, composed of herbal extracts and developed by Tianjin-based Tasly Pharmaceutical, passed the phase II clinical trials in July, one step closer to getting into the US and European drug market, company’s president Yan Xijun told a press conference here.

Clinical trials of the drug were conducted in 15 test centres in the US over the last three years and had “generated positive results”, said Yan.

The FDA has also approved the drug to enter phase III trials, he said.

The phase II trials gauge effectiveness of a drug and its risks, while phase III trials are more extensive.

Once phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug in the US.

Yan said Tasly would build 50 to 70 clinical trial centres worldwide in the next 12 to 18 months for phase III trials, and he expected the pills to enter global markets within three years.

The pill is mainly used to treat angina and coronary heart diseases. The company said over 10 million people worldwide have used the pill annually.

Earlier, drug watchdogs in Canada, Russia, South Korea, Vietnam, Singapore and some African countries had approved the pill.