Ascletis' All-oral HCV Treatment Approved for Marketing in China

HANGZHOU and SHAOXING,China,July 31,2020 -- 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."

About Ascletis

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.