Ascletis Announces Filing of Marketing Authorization Application for Ritonavir in Hong Kong

HANGZHOU and SHAOXING, China, April 3, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX:1672) today announces that it has submitted the Marketing Authorization Application for ritonavir (100mg film-coated tablet) in Hong Kong Special Administrative Region Kong the People’s Republic of China (“hong kong“).

Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) released on March 15, 2022 by the National Health Commission of the People’s Republic of China includes PF-07321332/ritonavir (Paxlovid) as an antiviral treatment. Recently, Ascletis further expanded its production capacity for oral ritonavir tablets to approximately 530 million tablets per year, to meet the potential escalation in domestic and global demand.

Ascletis aims to be a global commercial supplier of oral ritonavir tablets. To date, Ascletis has the only oral ritonavir tablet authorized in China, which has passed the bioequivalence study. Ascletis’ ritonavir oral tablet was approved in September 2021 by China National Medical Products Administration (国药准字H20213698). Ascletis has submitted MA applications for ritonavir (100 mg film-coated tablet) in 12 European countries (Germany, France, Irelandthe UK, Spain, Portugal, Italy, Belgium, Poland, Sweden, the Netherlands and Denmark) through its agent in Europe.

dr. Jinzi J. WuFounder, President and CEO of Ascletis, said, “With the recent significant increase in COVID-19 cases in hong kong, there are more urgent needs for oral COVID-19 medications. In addition to filing marketing authorization applications for ritonavir in multiple countries/regions, we are accelerating the development of ASC10 (targeting RNA-dependent RNA polymerase (RdRp)) and ASC11 (targeting 3-chymotrypsin like protease (3CLpro)), two new oral drug candidates against COVID-19.”

About Ascletis

Ascletis is an innovative, R&D-focused biotechnology company listed on the Hong Kong Stock Exchange (1672.HK), a global platform covering the entire value chain, from discovery and development to manufacturing and marketing. Ascletis is committed to developing and commercializing innovative medicines in the areas of viral diseases, NASH/PBC and cancer (oral cancer metabolic and immune checkpoint inhibitors) to address unmet medical needs both in China and globally. Led by a management team with deep expertise and proven track record, Ascletis targets therapeutic areas with unmet medical needs from a global perspective and effectively advances pipeline development with the goal of dominating global competition. . To date, Ascletis has three commercialized products and 20 robust R&D pipelines of globally competitive drug candidates, and is actively exploring new therapeutic areas.

1. Viral Diseases: (1) Hepatitis B Virus (Functional Cure): Focus on Breakthrough Therapies for Hepatitis B Functional Cure with Subcutaneously Injected PD-L1 Antibody – ASC22 and Pegasys ® as basic drugs. (2) COVID-19 pipeline: currently includes (i) ritonavir oral tablet (100mg), an authorized product, (ii) ASC10, an oral RNA-dependent RNA polymerase (RdRp) inhibitor, and ( iii) ASC11, a 3-inhibitor of chymotrypsin like protease (3CLpro). (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to functional cure of HIV-infected patients. (4) Hepatitis C: successful launch of an all-oral regimen combining ASCLEVIR® and GANOVO® (RDV/DNV regimen).
2. Non-alcoholic steatohepatitis/primary biliary cholangitis: Gannex, a 100% Ascletis company, 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 a 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 small molecule PD-L1 next-generation immune checkpoint inhibitors.
4. Exploratory indications: Acne: After NASH and recurrent GBM, the third indication for ASC40 has been approved to enter the phase 2 clinical trial. For more information, visit www.ascletis. com.

SOURCEAscletis Pharma Inc.

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