HCV Drug Ravidasvir is on the List of Proposed Priority Review by the Chinese Food and Drug Administration

Ascletis’Ravidasvir NDA Proposed for Priority Review by the CFDA
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.” 

http://www.ascletis.com/news_detail/157/id/239.html

Of Interest

April 12, 2018

Liver Congress™ 2018 Affordable hepatitis C combination treatment - Target price of US$300 for a 12-week treatment 

An affordable hepatitis C combination treatment including the new drug candidate ravidasvir has been shown to be safe and effective, with extremely high cure rates for patients, including hard-to-treat cases, according to interim results from the Phase II/III STORM-C-1 trial presented by the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) at the International Liver Conference in Paris.  The results indicate that the sofosbuvir/ravidasvir combination is comparable to the very best hepatitis C therapies available today, but it is priced affordably and could allow an alternative option in countries excluded from pharmaceutical company access programmes,” said Dr Bernard Pécoul, Executive Director, DNDi….