Commercial Ascletis' ritonavir eyes marketing authorisation in Europe

Ascletis’ ritonavir eyes marketing authorisation in Europe


Ascletis Pharma is aiming to enter the European market with its antiviral drug ritonavir. 

Applications have been sent through the company’s agents to gain marketing authorisation for eight European countries; Portugal, Spain, Poland, Italy, Sweden, Denmark, the Netherlands and Belgium.

In the preceding month Ascletis aimed to gain marketing authorization in Germany, Ireland, the UK and France for the same drug by making similar applications.

Ritonavir is an antiviral tablet, taken orally, which targets various viruses in the body. At the start of 2022, Ascletis pharma expanded the ritonavir treatment mandate to help treat COVID-19 infection caused by the coronavirus. 

Ascletis does not plan to stop at the European market but also aims to gain ritonavir’s marketing authorization across other continents, namely Asia, North & South America and Africa. 

In fact, the company is the only authorized seller of oral ritonavir in China, after the China National Medical Products Administration approved the tablets for use last year. Presently, the supply of ritonavir internationally from Chinese multi-national pharmas is being pursued by the company.

Ascletis’ ritonavir is able to accomplish human bioequivalence with  AbbVie’s Norvir. This increased human bioavailability is made possible due to the company’s drug formulation technology which increases its solubility.

Ascletis Pharma has been expanding into China through other drugs as well. In 2019, Ascletis exclusively partnered with the company Suzhou Alphamab to develop a treatment for viral illnesses, named KN035 for use in China.

The exclusive license allows the company to commercially develop KN035 and combat such viral ailments, such as hepatitis B.

Ritonavir is also a component of pharmaceutical giant Pfizer’s COVID-19 oral drug- Paxlovid.

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