Results from First Clinical Study Using Danoprevir to Treat Naive and Experienced COVID-19 Patients

Ascletis Pharma Inc. (HKEX code: 1672) announces today the first clinical study using Ganovo®(danoprevir) to treat naive and experienced COVID-19 patients was published in medRxiv.

The data from this small-sample clinical study showed that danoprevir combined with ritonavir is safe and well tolerated in all patients. After 4 to 12-day treatment of danoprevir combined with ritonavir, all eleven moderate COVID-19 patients enrolled, two naive and nine experienced, were discharged from the hospital as they met all four conditions as follows: (1) normal body temperature for at least 3 days; (2) significantly improved respiratory symptoms; (3) lung imaging shows obvious absorption and recovery of acute exudative lesion; and (4) two consecutive RT-PCR negative tests of SARS-CoV-2 nucleotide acid (respiratory track sampling with interval at least one day).

After initiation of danoprevir/ritonavir treatment, the first negative RT-PCR test occurred at a median of 2 days, ranging from 1 to 8 days, and the obvious absorption in CT scans occurred at a median 3 days, ranging from 2 to 4 days. Clinical findings suggest that danoprevir combined with ritonavir is a promising therapeutic option for COVID-19.

Ganovo®(danoprevir), an oral HCV protease inhibitor developed by Ascletis, was approved by the National Medical Products Administration for market launch in June 2018 for the treatment of chronic Hepatitis C.

Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis commented, "We are pleased that the first clinical study using Ganovo®(danoprevir) to treat COVID-19 patients was published in medRxiv. Ascletis is proud of repurposing our HCV drug, danoprevir, as a potential therapeutic option for COVID-19."

About Ascletis

Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong, S.A.R., China 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: one commercial stage product, one near commercial stage drug 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. 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.

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