HANGZHOU, China and SHAOXING, China, April 4, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672) today announces that the first sale of its ritonavir tablets in Zhejiang Province has been completed.
On April 3, 2022, Ascletis’ distributor, Zhejiang Int’l Medicine Co., Ltd. (“Zhejiang Int’l”), completed the first sale of Ascletis’ ritonavir tablets in Zhejiang Province. Zhejiang Int’l is a major company engaged in the wholesale and retail of pharmaceuticals and medical equipment in Zhejiang Province.
As a leading antiviral company in China, to date, Ascletis owns the only authorized ritonavir tablet in China, which has passed bioequivalence study. Ascletis’ ritonavir tablet was approved in September 2021 by China National Medical Products Administration (国药准字 H20213698).
Ritonavir tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases. 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 for COVID-19.
Ascletis has further expanded its ritonavir tablet production capacity to approximately 530 million tablets per year to secure the supplies. 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) and Hong Kong, China.
Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, said, “It’s a great pleasure that the first sale of Ascletis’ ritonavir tablets in Zhejiang Province has been completed. Ascletis’ antiviral pipeline includes two novel oral drug candidates against COVID-19, ASC10 (targeting RNA dependent RNA polymerase (RdRp)) and ASC11 (targeting 3-chymotrypsin like protease (3CLpro)), with global intellectual property. We hope to contribute to ‘Healthy Zhejiang’ and ‘Healthy China’ as well as the fights against COVID-19 and other infectious diseases.”
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.