Ascletis Announces Submission 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 (100 mg film-coated tablet) in the Hong Kong Special Administrative Region of 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 therapy. Recently, Ascletis has further expanded its ritonavir oral tablet production capacity to approximately 530 million tablets per year, to meet the potential escalation in the domestic and global demand.

Ascletis aims to be a global commercial supplier of ritonavir oral tablets. To date, Ascletis owns the only authorized ritonavir oral tablet in China, which has passed 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 marketing authorization applications for ritonavir (100 mg film-coated tablet) in 12 European countries (Germany, France, Ireland, the United Kingdom, Spain, Portugal, Italy, Belgium, Poland, Sweden, the Netherlands and Denmark) through its agent in Europe.

Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, said, "With recent significant increases of COVID-19 cases in Hong Kong, there are more urgent needs for COVID-19 oral drugs. 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 novel oral drug candidates against COVID-19."

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.