On November 11, 2013, the innovative Chinese medicine Fuzheng Huayu (FZHY) capsule/tablet created by Shanghai Sundise Traditional Chinese Medicine Co., Ltd. had a press conference in Beijing Diaoyutai State Guesthouse. It was the first time that the results of the US FZHY Phase II clinical trial results were announced in China. The study verified FZHY’s therapeutic effects, safety and efficiency on treating chronic hepatitis C with the highest American standards.
Former vice president of the State Administration of Traditional Chinese Medicine of the People’s Republic of China Li Daning, former vice president of the State Administration of Traditional Chinese Medicine of PRC Ren Dequan, president of China Academy of Chinese Medical Sciences, principal of Tianjin University of Traditional Chinese Medicine, vice president of China Association of Chinese Medicine, and vice president of Chinese Association of Integrative Medicine Academician Zhang Boli and other leaders attended the conference, and gave their speeches. Vice director of the State Administration of Traditional Chinese Medicine of PRC Wu Zhedou, a major researcher of the US FZHY Phase II clinical trial and famous liver disease scientist and professor from University of Southern California San Diego Campus Professor Hassanein, and principal of Shanghai University of Traditional Medicine, president of Shanghai Association For Science and Technology and president of Chinese Association of Integrative Medicine Academician Chen Kaixian gave speeches during the conference. Moreover, nearly 200 experts from other scientific research institutes, experts in liver diseases and friends from the news media attended this press conference.
FZHY was approved by the US FDA to start its phase II clinical trial in 2006. The trial was led by Shanghai Sundise Traditional Chinese Medicine Co., Ltd., with the joint efforts of 9 authoritative medical institutes and many worldly known liver disease experts. With FZHY completing this US phase II clinical trial, it further solitudes its leading position in hepatic fibrosis treatment in the world. It will hopefully make FZHY become the first compound Chinese medicine that is approved to enter the mainstream American drug market. And it will definitely lead Chinese medicines created independently by our country into the international stage.
At the same time, FZHY capsule/tablet has created 5 firsts in the world: FZHY capsule/tablet is the first Chinese medicine that explored in a blank area in western medicine (hepatic fibrosis). FZHY was the first to choose patients that western medicine failed to cure, or it was difficult to treat for overseas clinical research. FZHY capsule/tablet was the first Chinese medicine to use “hard finish” – liver biopsy effects. FZHY was the first Chinese medicine to step out of its own country, and show itself on the highest international academic meeting platform. FZHY is the first Chinese medicine that was approved by FDA, and carried out the phase II clinical trail for liver diseases in the US.
During the press conference on November 11, Shanghai Sundise Traditional Chinese Medicine Co., Ltd. announced that it had started drawing up FZHY’s US phase III clinical trial plan. The plan will be jointly completed by liver disease experts from home and abroad, the research team of the US phase II clinical trial and the applicant team of the US phase III clinical trial. FZHY US phase III clinical trial plan is estimated to be finished at the end of 2014.