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

Ascletis Pharma Inc. 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. 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.