Pibrentasvir

In the clinical treatment of chronic hepatitis C, NS5A inhibitors are one of the core components of direct-acting antiviral (DAA) regimens. As a representative member of this class of drugs, pibrentasvir potently binds to the NS5A protein of hepatitis C virus, blocks the assembly of viral replication complexes and the release of progeny viruses, and exhibits high antiviral activity against genotype 1, 2 and 4 HCV infections. It is often clinically used in combination with other DAA drugs for the treatment of adult patients with chronic hepatitis C, including those without cirrhosis or with compensated cirrhosis, and the overall sustained virological response rate can reach more than 95%, which greatly reduces the risk of chronic hepatitis C progressing to liver fibrosis and hepatocellular carcinoma.

After the popularization of DAA drugs, the global anti-HCV drug market has gradually entered a stage of stable adjustment. Among them, the pan-genotypic DAA segment market, to which pibrentasvir belongs, had a size of approximately USD 2.8 billion in 2023, with a compound annual growth rate remaining at 4.2%. For the domestic market, with the advancement of the hepatitis C elimination initiative, the market size of domestic pibrentasvir-related preparations exceeded RMB 120 million in 2023, an increase of 18% over the previous year. At present, the competitive landscape is dominated by domestic generic preparations, with the market share of original research products being less than 10%, and they have not been included in the scope of national centralized volume-based procurement. The supply of APIs is characterized by domestic enterprises as the mainstay and imports as the supplement.

The original research enterprise of pibrentasvir is Shionogi Pharmaceutical of Japan, and pibrentasvir is a component of the original research compound preparation with the trade name "Grazoprevir/Pibrentasvir". The original research monotherapy has not been independently launched, and its core compound patent expired in China in 2024. The main dosage form of the original research compound preparation is tablet, each containing 40 mg of pibrentasvir. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *List of Chemical Drugs* of China. At present, 3 domestic enterprises have obtained Class A status for their pibrentasvir APIs through CDE registration, and another 6 are in the review and approval stage. Domestic compound preparations composed of domestically produced pibrentasvir and other DAAs have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the research and development and quality control needs of pibrentasvir, CATO can provide a full set of impurity reference standards for this API. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and most impurities are in stock. Spot orders submitted before 16:00 can be shipped on the same day, fully meeting the R&D and production quality control needs of pharmaceutical enterprises in the whole process of impurity research, quality standard establishment, consistency evaluation, etc.