Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Eight Additional European Countries


-- Ritonavir marketing authorization applications have been submitted to Spain, Portugal, Italy, Belgium, Poland, Sweden, the Netherlands and Denmark


Hangzhou and Shaoxing, China, March 1, 2022-- Ascletis Pharma Inc. (HKEX: 1672) today announces that it has submitted marketing authorization applications for ritonavir (100 mg film-coated tablet) in eight additional European countries (Spain, Portugal, Italy, Belgium, Poland, Sweden, the Netherlands and Denmark) through its agent in Europe.


In addition to the above eight European countries, Ascletis had submitted ritonavir marketing authorization applications in Germany, France, Ireland and United Kingdom. It is expected that more marketing authorization applications for ritonavir in other regions, including Euro-Asia, North & South America, Africa and Asian Pacific, will soon be submitted by Ascletis.


Ascletis continues the engagement with both domestic and major multi-national pharmaceutical companies, for the commercial supplies of ritonavir within China and globally.


Oral ritonavir 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 one of the global commercial suppliers of oral ritonavir tablets. To date, Ascletis owns the only authorized oral ritonavir tablet in China, which has passed bioequivalence study. Ascletis’ oral ritonavir tablet was approved in September 2021 by China National Medical Products Administration (国药准字H20213698). Ascletis significantly increased human bioavailability of ritonavir, which has a very poor solubility, by using sophisticated formulation technology, subsequently, successfully achieved human bioequivalence with Norvir®, which is original produced by AbbVie Inc.


On January 3, 2022, Ascletis announced that oral ritonavir tablet annual production capacity had been expanded to 100 million tablets and can further be expanded rapidly based on market demand.

 

 

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.

Contact:

Ascletis Pharma Inc.

+86-181-0650-9129

pr@ascletis.com

ir@ascletis.com