Ascletis Pharma announces the expansion of 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 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).

The company plans to file generic drug applications for registrations in multiple countries in the world. Ritonavir oral tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand.

ASC10 is an oral direct-acting antiviral drug candidate targeting RdRp. 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.

According to the company release, compared to RdRp-targeted molnupiravir which was approved by US Food and Drug Administration (FDA), ASC10 has a new and differentiated chemical structure. The company has filed multiple compound and use patent applications. The data from animal studies demonstrated that ASC10 has higher bioavailability when compared to Molnupiravir. The company plans to submit investigational drug applications (INDs) for clinical trials in China, USA etc. in the first half of 2022.

"At the beginning of Covid-19 in 2020, based on its antiviral platform and R&D experience, the company made the firm and rapid decision to invest in oral direct-acting antivirals R&D against RdRp and 3CLpro of SARS-CoV-2. Meanwhile, the company accelerated the development effort to obtain the approval of ritonavir oral tablets in China and successfully achieved the authorization by China NMPA for ritonavir oral tablets," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.