Ascletis Announces Submission of Marketing Authorization Application for Ritonavir in Hong Kong

04 April 2022 | Monday | News


Ascletis Pharma Inc. (HKEX: 1672) today announces that it has submitted the marketing authorization application for ritonavir (100 mg film-coated tablet) in the Hong Kong Special Administrative Region of the People's Republic of China ("Hong Kong").
Image Source : Public Domain

Image Source : Public Domain

Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) released on March 15, 2022 by the National Health Commission of the People's Republic of China includes PF-07321332/ritonavir (Paxlovid) as an antiviral therapy. Recently, Ascletis has further expanded its ritonavir oral tablet production capacity to approximately 530 million tablets per year, to meet the potential escalation in the domestic and global demand.

Ascletis aims to be a global commercial supplier of ritonavir oral tablets. To date, Ascletis owns the only authorized ritonavir oral tablet in China, which has passed bioequivalence study. Ascletis' ritonavir oral tablet was approved in September 2021 by China National Medical Products Administration (国药准字H20213698). Ascletis has submitted marketing authorization applications for ritonavir (100 mg film-coated tablet) in 12 European countries (GermanyFranceIreland, the United KingdomSpainPortugalItalyBelgiumPolandSwedenthe Netherlands and Denmark) through its agent in Europe.

Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, said, "With recent significant increases of COVID-19 cases in Hong Kong, there are more urgent needs for COVID-19 oral drugs. In addition to filing marketing authorization applications for ritonavir in multiple countries/regions, we are accelerating the development of ASC10 (targeting RNA dependent RNA polymerase (RdRp)) and ASC11 (targeting 3-chymotrypsin like protease (3CLpro)), two novel oral drug candidates against COVID-19."

Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close