09 August 2018 | News
Ravidasvir is a next-generation, best-in-class and pan-genotypic HCV NS5A inhibitor with a high genetic barrier to resistance
Ascletis Pharma Inc announced Ravidasvir is recommended by the World Health Organization (WHO) Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection (July 2018) as a future pan-genotypic direct-acting antivirals agent (DAA).
Ascletis received the acceptance letter for Ravidasvir new drug application (NDA) from the China Food and Drug Administration (CFDA) on August 1.
Ravidasvir is a next-generation, best-in-class and pan-genotypic HCV NS5A inhibitor with a high genetic barrier to resistance.
Globally, Ravidasvir has completed three phase III clinical trials with more than 1000 patients enrolled. Ravidasvir in combination with Ganovo® (RDV/DNV Regimen) is the first all-oral interferon-free HCV regimen developed by a domestic company in China.
A phase II/III clinical trial 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).
"We are so excited that Ravidasvir is recommended as a pan-genotypic DAA by the WHO HCV guidelines." Jinzi J. Wu, Ph.D., Ascletis' founder, President and CEO, commented, "Ravidasvir is not only recognized by international academic communities, but also recognized by an internationally renowned public health organization.