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.
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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.
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.
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, It 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.