TAIPEI, Taiwan, April 23, 2019 /PRNewswire/ — TaiGen Biotechnology Company, Limited ("TaiGen") announced today that Phase III trial of the combination therapy Furaprevir – Yimitasvir for the treatment of chronic hepatitis C patients has been initiated. The combination regimen of Furaprevir and Yimitasvir was developed by Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd, a joint venture established in 2016 by TaiGen Beijing and YiChang HEC ChangJiang Pharmaceuticals. Co., Ltd (HEC). The trial protocol has been approved by CDE, Center for Drug Evaluation of NMPA. Effort was put into study design to reduce trial cost and shorten trial timeline.
The kick off investigator meeting of the phase III trial was held by Dongguan HEC TaiGen on Saturday, April 20th, in Beijing with more than 200 researchers from 43 clinical sites attending.
The study protocol is a single-arm active treatment design with historical control. It was approved by CDE in March. Three hundred sixty (360) genotype 1 patients (both cirrhotic and non-cirrhotic) will be enrolled with the primary efficacy endpoint of SVR12 (sustained virologic response at 12 weeks). SVR12 is defined as an undetectable HCV RNA level at 12 weeks after stopping antiviral treatment.
Kuo-Lung Huang, Chairman & CEO of TaiGen, indicated that current treatments of HCV in China are imported from abroad. They are expensive and placed a huge economic burden to patient and their family as well as the healthcare system. The Furaprevir – Yimitasvir combination therapy is competitive in the Greater China market. Huang explained that Dongguan HEC TaiGen managed the trial timeline actively in order to bring this novel treatment to patient in need with minimum delay.
The Completion of Phase III trial is projected in 2020. According to the agreement, TaiGen Beijing will receive two milestone payments of five-million USD each after completing phase III trial and NDA filing.
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