HANGZHOU and SHAOXING, China, March 15, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672) today announces the business update on its oral double prodrug ASC10 against Coronavirus Disease 2019 (COVID-19):

By taking measures below, the manufacturing cost of ASC10 reduced significantly, which is critical to accessibility of COVID-19 drugs.

1. The synthesis process of the key intermediate of ASC10 active pharmaceutical ingredient (API) has been optimized. Under the premise of ensuring quality, by introducing biological enzyme catalyzed green synthesis, the key intermediate yield is improved and the amount of organic solvents used is reduced, which is more environmentally friendly;

2. Improvement of overall equipment efficiency (OEE) of key production equipment for ASC10 has been planned; yield of ASC10 formulation will be increased by adopting a continuous production mode; and

3. ASC10 API intermediate and other material suppliers have been expanded.

New experimental data indicated that ASC10-A showed potent cellular antiviral activity against Omicron variant (EC50 = 0.3µM), Delta variant (EC50 = 0.5µM) and wildtype virus (EC50 = 0.7µM). New experimental data also suggested that there were no drug-drug interactions between ASC10 and other common medicines.

ASC10 is an oral double prodrug of the antiviral nucleoside analog ASC10-A, which potently inhibits RNA dependent RNA polymerase (RdRp) of SARS-CoV-2 virus.ASC10 oral tablet formulation is developed with in-house proprietary technology.

To date, Ascletis has filed multiple patent applications for ASC10 and its use globally.

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), a global platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors) to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 20 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

1. Viral Diseases: (1) Hepatitis B Virus (functional cure): focus on breakthrough therapies for CHB functional cure with a subcutaneously-injected PD-L1 antibody – ASC22 and Pegasys® as cornerstone drugs. (2) COVID-19 pipeline: currently includes (i) ritonavir oral tablet (100 mg), an authorized product, (ii) ASC10, an oral RNA dependent RNA polymerase (RdRp) inhibitor and (iii) ASC11, an oral 3-chymotrypsin like protease (3CLpro) inhibitor. (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients. (4) Hepatitis C: successfully launched an all-oral regimen of combining ASCLEVIR® and GANOVO® (RDV/DNV regimen).

2. Non-alcoholic Steatohepatitis/Primary Biliary Cholangitis: Gannex, a wholly-owned company of Ascletis, is dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THRβ and FXR, three fixed-dose combinations for NASH and one PBC program targeting FXR.

3. Cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors): a pipeline of oral inhibitors targeting FASN, which plays a key role in cancer lipid metabolism, and a pipeline of oral PD-L1 small molecule next generation immune checkpoint inhibitors.

4. Exploratory Indications: Acne: Following NASH and recurrent GBM, the third indication for ASC40 has been approved to enter Phase 2 clinical trial. For more information, please visit www.ascletis.com.

Source: Ascletis Pharma Inc.