Ritonavir Oral Tablets
On September 7, 2021, Ritonavir Oral Tablets was approved by China National Medical Products Administration (NMPA).
Ascletis owns the 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 (100 mg) is a component of oral direct-acting antiviral drug Paxlovid (Nirmatrelvir+ritonavir). The Company applied the sophisticated formulation technology to significantly increase the human bioavailability of ritonavir which has a very poor solubility and successfully achieved human bioequivalence with the ritonavir oral tablets produced by the Originator, AbbVie.
On July 29, 2020, Ascletis' all-oral HCV therapy has been approved for marketing in China by National Medical Products Administration (NMPA). The Company’s all-oral HCV therapy (RDV/DNV Regimen) is Ravidasvir (ASCLEVIR®) in combination with Danoprevir (GANOVO®).
Our second marketed HCV drug , ASCLEVIR® is a best-in-class, NS5A inhibitor with pan-genotypic anti-viral activity, has completed a phase II/III clinical trial. RDV/DNV Regimen (ravidasvir in combination with danoprevir and ribavirin) is an all-oral, interferon-free HCV therapy ，demonstrates a 99% cure rate (SVR12) and a superior safety profile with a short treatment duration of 12 weeks. RDV/DNV Regimen displays a higher genetic barrier to resistance than the approved regimens, Daklinza/Sunvepra. The Phase II/III clincal trial showed RDV/DNV Regimen demomstrated a cure rate of 100% (SVR12) for the patients with baseline NS5A resistance-associated substitutions (RASs).
On June 8, 2018, the NDA approval for danoprevir was granted by the NMPA and we have begun to commercialize GANOVO®(danoprevir) in China.
GANOVO® is an NS3/4A protease inhibitor, which, when administered in combination with pegylated interferon and ribavirin (Ganovo Regimen), demonstrates a 97% cure rate (SVR12) and superior safety profile with a short treatment duration of 12 weeks.
Pegasys® is licensed from Shanghai Roche Pharmaceuticals Ltd. for the exclusive rights in the Mainland China.