Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Multiple European Countries
–Ritonavir marketing authorization applications have been submitted to Germany, France, Ireland and United Kingdom
–Ascletis has been in discussion with both domestic and international companies, including major multi-national pharmaceutical companies, for the commercial supplies of ritonavir in China and globally
Ascletis Pharma Inc. announces that it has submitted marketing authorization applications for ritonavir (100 mg film-coated tablet) in Germany, France, Ireland and United Kingdom through its agent in Europe. It is expected that more marketing authorization applications for ritonavir in certain other countries, including the ones in Europe, North America and Asian Pacific will soon be submitted.
Ascletis has been in discussion with both domestic and international companies, including major multi-national pharmaceutical companies, for the commercial supplies of ritonavir in China and globally.
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Oral ritonavir tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of oral antiviral drug Paxlovid (Nirmatrelvir tablet + ritonavir tablet co-package).
Ascletis aims to be one of the global commercial suppliers of oral ritonavir tablets. Ascletis owns the only authorized oral ritonavir tablet in China, which passed bioequivalence study. Ascletis’ oral ritonavir tablet was approved in September 2021 by China National Medical Products Administration (国药准字H20213698). Ascletis has been applying sophisticated formulation technology to significantly increase human bioavailability of ritonavir which has a very poor solubility and successfully achieved human bioequivalence with the oral ritonavir tablets produced by the originator, AbbVie. On January 3, 2022, Ascletis announced that oral ritonavir tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand.