Ascletis' All-oral HCV Treatment Approved for Marketing in China
HANGZHOU and SHAOXING, China, July 31, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) announces today that its all-oral HCV treatment has been approved for marketing in China by National Medical Products Administration (NMPA). The Company's all-oral HCV treatment (RDV/DNV Regimen) is Ravidasvir (Asclevir®) in combination with Danoprevir (Ganovo®). 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 patients. In patients with baseline NS5A resistance mutations, RDV/DNV Regimen demonstrated a cure rate of 100% (SVR12).
Both Ravidasvir and Danoprevir have been selected as National Science and Technology Major Project for "Innovative Drug Development" programs. Ravidasvir was licensed from Presidio Pharmaceuticals, Inc., a clinical stage pharmaceutical company.
"We are excited about the approval of all-oral HCV treatment and fully committed to curing hepatitis C," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "As an innovative R&D driven biotech, we are also developing curative medicines for chronic hepatis B, such as first-in-class immunotherapy -- subcutaneously injected PDL-1 antibody. The Company aims to be a leader for both hepatitis C and B treatments."
Ascletis is an innovative R&D driven biotech with three commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing antiviral, steatohepatitis, and tumor-related innovative drugs for unmet medical needs in China and Globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis' pipeline is focused primarily on three therapeutic areas: 1. HCV: two commercial stage products and two R&D stage drug candidates. Ganovo® (Danoprevir) is the first direct-acting anti-viral agent for hepatitis C, developed by a domestic firm in China. Asclevir® (Ravidasvir) in combination with Ganovo® (Danoprevir) (RDV/DNV Regimen) is the first all-oral HCV regimen developed by a domestic company in China. 2. HBV: one commercial stage product and three R&D stage drug candidates. Pegasys® (Peginterferon alfa-2a) is a leading marketed pegylated interferon for hepatitis B&C partnered with Roche. 3. NASH (Non-Alcoholic SteatoHepatitis): three R&D stage drug candidates against three different targets for combination treatments. For more information, please visit www.ascletis.com.
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