China, Taiwan FDAs accept trial applications for IFN-free HCV regimen

The China and Taiwan Food and Drug Administrations have accepted clinical trial applications filed by Ascletis Innovation for its interferon-free regimen to treat chronic hepatitis C virus infection, according to a press release

Ascletis is the first Chinese company to file clinical trial applications in China for an IFN-free regimen, according to the release, and will initiate a phase 2 trial in Taiwan. The trial will include a combination regimen of Danoprevir (ASC08), a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir (ASC16), an NS5A inhibitor.

“All oral IFN-free regimens are breakthrough treatments of [chronic hepatitis C] marketed outside China at the end of 2014. To date, there are no DAAs approved in China,” Zhuang Hui, MD, academician of the Chinese Engineering Academy and the honorary Chairman of the Chinese society of Hepatology at Peking University Health Science Center, said in the release. “We're very pleased that Ascletis is developing the first IFN-free regimen by a domestic company for [chronic hepatitis C] in China. It shows that the domestic pharmaceutical companies are now catching up with the global development for [chronic hepatitis C].”

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