Ascletis Announces Further Expansion of Ritonavir Oral Tablet Production Capacity to 530 Million Tablets Per Year

HANGZHOU, China and SHAOXING, China, March 13, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (Ascletis, HKEX: 1672) today announces that it 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 demands. Ascletis has taken multiple measures for expansion of the annual ritonavir production capacity, including adding additional key equipment at the manufacturing facilities of Ascletis Pharmaceuticals Co., Ltd., a wholly-owned subsidiary of Ascletis.

Ritonavir oral tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of the approved oral antiviral drug PAXLOVID (Nirmatrelvir 300 mg tablet + ritonavir 100 mg tablet co-administration package).

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). Furthermore, 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 rapid global spread of the Omicron variant, there are more urgent needs for COVID-19 oral drugs. In addition to further expansion of annual ritonavir oral tablet production capacity, we are accelerating the development of ASC10 (targeting RdRp) and ASC11 (targeting 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.

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SOURCE Ascletis Pharma Inc.