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Fuzheng Huayu (FZHY) Develop A Phase Ⅲ Clinical Trial for Treatment of Liver Fibrosis in Patients with Chronic Hepatitis C
2017-11-09

Washington DC – October 22nd, 2017, Shanghai Sundise Traditional Chinese Medicine Co. Ltd today hold an Advisory Board Meeting during the annual liver meeting to discuss the protocol design of Fuzheng Huayu (FZHY) tablet phase 3 clinical trial in US.

Fuzheng Huayu (FZHY) is a botanical medicine approved in China for HBV liver fibrosis. The protocol of Fuzheng Huayu Phase 3 clinical trial is based on the results of Fuzheng Huayu Phase 2 clinical trial in US, which is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study and proves the Safety, Tolerability, and Efficacy of Fuzheng Huayu Tablet in the Treatment of Liver Fibrosis in HCV Patients.

Sundise applied for a pre-IND meeting with FDA to discuss further clinical trial of Fuzheng Huayu Tablet in United States. At the pre-IND meeting, the protocol design of Fuzheng Huayu Phase 3 clinical trial and further research strategy will be well discussed for the purpose of IND submission and NDA application.

Shanghai Sundise Traditional Chinese Medicine, Co., Ltd. is a technology corporation specialized in the modernization of Traditional Chinese Medicine, based in Shanghai, China. Sundise works closely with universities and research institutes across China and the United States to conduct studies on therapeutic compounds based on the Chinese traditional medicine. Learn more about Sundise and its products at http://www.sundise.com.

 

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