China-based YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has announced that the National Medical Products Administration (NMPA) in China has accepted a market approval filing for its Category 1 hepatitis C virus (HCV) drug, yiqibuvir. Yiqibuvir is an NS5B polymerase inhibitor and a pan-HCV direct-acting antiviral agent (DAA) known for its high safety and efficacy rates, offering a potential ‘cure’ for HCV with limited concerns regarding drug resistance. The drug is used in combination with antaitasvir to treat adult chronic HCV infection across genotypes 1, 2, 3, and 6, with or without compensatory cirrhosis.
Phase II/III Study Results Support NMPA Filing
The filing is supported by the positive results of a combined Phase II/III study involving yiqibuvir and antaitasvir, which demonstrated that the primary efficacy endpoint was met with statistical significance. The 12-week sustained virological response rate (SVR12) exceeded 95%, indicating a high success rate in treating HCV. Additionally, the study reported good safety profiles with side effects that were controllable and manageable.-Fineline Info & Tech
