A traditional Chinese medicine developed in Shanghai has received a permit from the United States Food and Drug Administration to conduct clinical tests on American hepatitis C patients who have developed fibrosis of the liver.
The development was seen as a primary step toward entering the North American market, experts told a medical forum in the city yesterday.
If it passes all clinical tests, the Fuzheng Huayu capsule developed by Shanghai University of Traditional Chinese Medicine will become China's first TCM to be officially recognized by the US FDA.
No drug in the US has so far been successful in treating liver fibrosis. About 20 to 30 percent of patients with chronic hepatitis C develop liver fibrosis, which can lead to cirrhosis, the sixth leading cause of deaths in the world.
Fuzheng Huayu, a compound containing six herbs, was formulated after long-term Chinese research in treating liver fibrosis and was approved by China's FDA for public use in 2002.
Domestic clinical tests have shown the medicine can protect liver cells and slow down or even reverse liver fibrosis in more than 52 percent of patients.
"The medicine is widely available in the nation and has received a national scientific award," said Dr Liu Chenghai from Shuguang Traditional Chinese Medicine Hospital, who is also a Fuzheng Huayu researcher.
"The clinical tests in the US are to study the effects on Americans, a different race with a different cultural background and different metabolism."
It was approved for Phase II clinical tests last month.
Five US hospitals will be involved in the tests, with 100 patients participating.
"Phase II is expected to be completed in 2011 and then we will apply for Phase III, the last step for drug approval, and finish it in 2016," said Bian Huashi, director of Shanghai Sundise Chinese Medicine Technology Development Co, the producer.
He said the medicine was in a TCM globalization project under the Ministry of Science and Technology and received ministry sponsorship.
The Phase II tests would cost US$10 million and the Phase III tests US$70 million for a 1,000-patient coverage, he said.
"The success of Fuzheng Huayu also can better TCM's position in international medical field," Bian said.
(Shanghai Daily August 18, 2009)