Pill closer to US entry
Source: Xinhua |
August 8, 2010, Sunday
|
Print Edition
Print Edition
A China-made pill to treat cardiovascular conditions has been tested as safe and effective by the US Food and Drug Administration, and, hopefully, will be marketed in the United States as early as 2013, its maker said yesterday.
Tianjin-based Tasly Pharmaceutical's Compound Danshen Dripping Pill, had passed the US FDA's Phase II clinical trials in July, one step closer to getting into the US and European drug market, company President Yan Xijun said in Beijing.
Clinical trials of the drug, composed of herbal extracts, were held in 15 test centers in the US over the last three years and had "generated positive results," Yan said.
With domestic sales of more than 1 billion yuan (US$148 million) last year, the drug was the first Chinese patent traditional medicine to pass Phase II trials of the FDA, known for its strictness in approving drugs.
The FDA has also approved the drug to enter the Phase III trials, Yan said. FDA Phase II trials gauge the effectiveness of a drug and its side effects and risks, while Phase III trials are more extensive.
Yan said Shanghai-listed Tasly would build 50-70 clinical trial centers worldwide in the next 12 to 18 months for the Phase III trials, adding that he expected the pills to enter the US and global drug markets within three years.
Compound Danshen Dripping Pill is mainly used to treat angina and coronary heart diseases.
Tianjin-based Tasly Pharmaceutical's Compound Danshen Dripping Pill, had passed the US FDA's Phase II clinical trials in July, one step closer to getting into the US and European drug market, company President Yan Xijun said in Beijing.
Clinical trials of the drug, composed of herbal extracts, were held in 15 test centers in the US over the last three years and had "generated positive results," Yan said.
With domestic sales of more than 1 billion yuan (US$148 million) last year, the drug was the first Chinese patent traditional medicine to pass Phase II trials of the FDA, known for its strictness in approving drugs.
The FDA has also approved the drug to enter the Phase III trials, Yan said. FDA Phase II trials gauge the effectiveness of a drug and its side effects and risks, while Phase III trials are more extensive.
Yan said Shanghai-listed Tasly would build 50-70 clinical trial centers worldwide in the next 12 to 18 months for the Phase III trials, adding that he expected the pills to enter the US and global drug markets within three years.
Compound Danshen Dripping Pill is mainly used to treat angina and coronary heart diseases.
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