Ascletis Filed NDA for Its All-oral HCV Treatment
HANGZHOU and SHAOXING, China, July 31, 2018 /PRNewswire/ -- Ascletis announced today that it has filed the new drug application (NDA) for its second Category 1 HCV drug - Ravidasvir (RDV, ASC16). The company expects to receive feedback from the China Food and Drug Administration (CFDA) within five business days. Ravidasvir in combination with Ganovo® (RDV/DNV Regimen) is the first all-oral interferon-free HCV regimen developed by a domestic company in China. Ravidasvir has been selected as a National Science and Technology Major Project for "Innovative Drug Development" program and its investigational new drug (IND) application was designated as Priority Review by the CFDA.
Ravidasvir is a next generation, best-in-class and pan-genotypic HCV NS5A inhibitor with a high genetic barrier to resistance. Phase II/III clinical trial has shown that RDV/DNV Regimen demonstrated a cure rate of 99% (SVR12) with a short treatment duration of 12 weeks in genotype 1 non-cirrhotic patients. In patients with baseline NS5A resistance mutations, RDV/DNV Regimen demonstrated a cure rate of 100% (SVR12).
"Congratulations for Ascletis' great achievement in the field of HCV treatment!" 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, "The clinical results of RDV/DNV Regimen are very exciting. As the first breakthrough all-oral HCV regimen developed by a domestic company in China, RDV/DNV Regimen will help improve diagnosis, treatment and cure rate and bring significant impact to the elimination of HCV in China."
"Shortly after successful launch of Ganovo® with overwhelming recognition from the key opinion leaders and physicians, we filed an NDA for our all-oral HCV regimen. These reflect Ascletis' unremitting efforts to provide high cure rate regimens to the Chinese HCV patients." Commented Jinzi J. Wu, Ph.D., Ascletis' founder, President and CEO. "Ascletis has 3 direct-acting antiviral agents (DAAs) including Ganovo®, Ravidasvir and ASC21 and will continuously deliver more affordable and effective HCV cures to the patients."