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March 2, 2022

Ascletis seeks marketing authorisation for ritonavir in eight European countries

The company sought marketing authorisation for the antiviral in the UK, France, Germany and Ireland in February.

Ascletis Pharma has submitted applications seeking marketing authorisation for ritonavir in eight European countries, namely the Netherlands, Portugal, Spain, Denmark, Belgium, Poland, Sweden and Italy.

The company submitted the applications through its agent in the region.

In January, Ascletis expanded the production of ritonavir tablets and oral direct-acting antiviral research and development (R&D) pipeline to treat SARS-CoV-2 infection.

A 100mg film-coated oral tablet, ritonavir is a pharmacokinetic booster of various oral antiviral therapies that act on viral proteases. 

It is also a component of Pfizer’s oral antiviral Covid-19 drug, Paxlovid.

Last month, the company sought marketing authorisation for ritonavir in the UK, France, Germany and Ireland.

The company also anticipates submitting additional marketing authorization applications for the oral tablet in various other regions, including North and South America, Euro-Asia, Asian Pacific and Africa.

Currently, Ascletis possesses the only authorised oral ritonavir tablet in China, which has also passed bioequivalence study.

The China National Medical Products Administration granted approval to ritonavir in September last year.

By leveraging complex formulation technology, the company substantially boosted ritonavir’s human bioavailability which otherwise has a reduced solubility.

It thereby attained human bioequivalence with Norvir produced originally by AbbVie.

Ascletis is presently holding talks with various multi-national pharmaceutical firms for commercially supplying ritonavir in China and across the globe.

In January 2019, Ascletis entered an exclusive licensing agreement with Suzhou Alphamab for developing an investigational candidate, KN035, to treat viral diseases such as hepatitis B in Greater China.

Under the deal, Ascletis obtained an exclusive licence for developing and commercialising ASC22 (KN035) to treat viral diseases in the region.

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