Hangzhou and Shaoxing, China (Oct. 18, 2018) - Ascletis Pharma Inc. (1672.HK) announces today the New Drug Application (NDA) of Ravidasvir is on the List of Proposed Priority Review, according to the public notification by the China Food and Drug Administration (CFDA) on Oct 17th, 2018. Such Priority Review will accelerate Ravidasvir NDA approval process significantly. Ravidasvir is Ascletis’ second category 1 drug for Hepatitis C.
Ravidasvir is a next-generation, best-in-class and pan-genotypic HCV NS5A inhibitor with a high genetic barrier to resistance. Ravidasvir in combination with Ganovo® (RDV/DNV Regimen) is the first all-oral interferon-free HCV regimen developed by a domestic company in China. Phase II/III clinical trial conducted in China has shown that RDV/DNV Regimen demonstrated a cure rate of 99 % (SVR12) with a short treatment duration of 12 weeks in genotype 1 patients. In patients with baseline NS5A resistance mutations, RDV/DNV Regimen demonstrated a cure rate of 100% (SVR12). Ascletis received the acceptance letter from the CFDA for Ravidasvir NDA on Aug. 1, 2018.
”We launched our first breakthrough HCV regimen 3 months ago. Ganovo Regimen has been well recognized and accepted by the doctors and experts,” said Jinzi J. Wu, Ph.D., Ascletis’ founder, Chairman and CEO. ”The Priority Review for Ravidasvir NDA will accelerate the launch of Ascletis’ all-oral regimen. This will enable Ascletis to soon provide two breakthrough HCV treatment regimens for Chinese patients and further strengthen our leadership position as an integrated solution provider in HCV treatment in China.”