Ascletis Pharma Inc. is expanding the production of ritonavir oral tablets and oral direct-acting antiviral R&D pipeline for the treatment of SARS-CoV-2 infection. The company’s COVID-19 pipeline currently includes (i) ritonavir oral tablet (100mg), an authorized product, (ii) ASC10, an oral RNA dependent RNA polymerase (RdRp) inhibitor and (iii) ASC11, an oral 3-chymotrypsin like protease (3CLpro) inhibitor.
 
The company owns the only authorized ritonavir oral tablet in China, which passed bioequivalence study. The company’s ritonavir oral tablet was approved in September 2021 by China’s National Medical Products Administration (NMPA). As a pharmacokinetic booster of multiple antiviral protease inhibitors, a low dose ritonavir oral tablet (100mg) is a component of oral direct-acting antiviral drug Paxlovid (Nirmatrelvir+ritonavir).
 
Through new formulation technology, the company says it has increased the human bioavailability of ritonavir and successfully achieved human bioequivalence with the ritonavir oral tablets produced by the originator, AbbVie. The company is planning to file generic drug applications for registrations in multiple countries around the world. Ritonavir oral tablet annual production capacity has been expanded to 100 million tablets and can be further expanded based on market demand.
 
ASC10 is an oral direct-acting antiviral drug candidate targeting RdRp and in vitro data showed significant activity against SARS-CoV-2. ASC10 is an in-house discovered drug candidate with the global intellectual property and commercial rights. Compared to RdRp-targeted Molnupiravir which was approved by U.S. FDA, ASC10 has a new and differentiated chemical structure. The company said data from animal studies demonstrated that ASC10 has higher bioavailability when compared to Molnupiravir. It company plans to submit investigational drug applications (INDs) for clinical trials in China, the U.S. and other countries in the first half of 2022.
 
ASC11 is an oral direct-acting antiviral drug candidate targeting 3CLpro, in combination with the authorized ritonavir oral tablets produced by the company to treat SARS-CoV-2 infection. ASC11 is also an in-house discovered drug candidate with the global intellectual property and commercial rights. Compared to 3CLpro-targeted Nirmatrelvir which was approved by U.S. FDA, ASC11 has a new and differentiated chemical structure. The company plans to submit INDs for clinical trials in China and the U.S. in the second half of 2022. The company has extensive R&D experience in viral protease inhibitors and successfully developed and commercialized oral HCV protease inhibitor GANOVO in combination with ritonavir oral tablets for the treatment of chronic hepatitis C.