Ascletis Files Clinical Trial Applications for Hepatitis C Drugs in China, Taiwan

Ascletis today announced that clinical trial applications for its interferon (IFN)-free regimen to treat chronic hepatitis C (CHC) have been filed and accepted by both China Food and Drug Administration (CFDA) and Taiwan Food and Drug Administration (TFDA). Ascletis is now the first Chinese company to file clinical trial applications in China for an IFN-free regimen. This is a significant milestone following the completion of the successful IFN-containing phase II trial in Taiwan region with ASC08, the Company’s leading direct-acting antiviral agent (DAA). This IFN-free regimen contains the NS3/4A inhibitor ASC08 and the NS5A inhibitor ASC16.

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

“Following the recognition of ASC08 triple therapy for CHC at the Asian Pacific Association for the Study of Liver (APASL) annual meeting in March this year, Ascletis is now taking another big step toward development of a highly effective, IFN-free CHC treatment for Chinese patients ,” said Jinzi J. Wu, Ph.D., Ascletis’ founder, President and CEO.

Ascletis is planning several clinical studies to evaluate the combination of ASC08 and ASC16 to treat CHC in mainland China and Taiwan region in the near future.

Source: Ascletis