Ledipasvir

For a long time, the treatment of chronic hepatitis C relied on the regimen of interferon combined with ribavirin, which had many adverse reactions and a cure rate of less than 50%. The advent of direct-acting antiviral agents has completely rewritten this clinical pathway. As a core component of NS5A inhibitor class anti-hepatitis C drugs, ledipasvir blocks the RNA replication of HCV NS5A protein and the viral assembly process. It forms a fixed-dose compound preparation with sofosbuvir, an NS5B polymerase inhibitor, for the treatment of adult and adolescent patients over 12 years old with chronic hepatitis C of genotypes 1, 4, 5 and 6. Without the combination of interferon, a sustained virological response rate of more than 95% can be achieved, which greatly reduces the risk of hepatitis C progressing to liver cirrhosis and liver cancer, and it has been listed as a first-line treatment regimen by both domestic and foreign hepatitis C guidelines.

The global market of direct-acting antiviral agents for hepatitis C exceeded USD 20 billion in the peak year. With the popularization of pan-genotypic drugs, the overall market has gradually stabilized. As the first core drug for genotype 1 hepatitis C, the ledipasvir compound preparation has accumulated sales of more than USD 70 billion since its launch. At present, the global supply of ledipasvir API is mainly self-produced by the original manufacturer. After the expiration of the patent, a number of Indian generic pharmaceutical companies have launched generic versions, the accessibility of drugs for Chinese hepatitis C patients has been significantly improved, and the popularity of domestic generic drug applications is still rising.

The original research enterprise of ledipasvir is Gilead Sciences, and the original trade name is Harvoni, which is a fixed-dose compound preparation of 90 mg ledipasvir and 400 mg sofosbuvir. Its core compound patent in the United States expires in 2030, and the core compound patent in China expires in 2031. This compound preparation has been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Chemical Drugs*. At present, no domestic ledipasvir API has been approved for marketing in China, nor has any domestic generic ledipasvir and sofosbuvir preparation been approved. The original research compound preparation was approved for marketing in China in 2018. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for ledipasvir API. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They comply with multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the whole process of process research and development, quality research and declaration.