Velpatasvir

Hepatitis C virus infection is a global public health challenge. Its complex genotypic characteristics once restricted clinical medication. As a second-generation NS5A inhibitor, velpatasvir targets and binds to the N-terminal domain of the viral NS5A protein to block the replication and assembly process of HCV, and is a core component of pan-genotypic hepatitis C treatment regimens. In clinical practice, it is often formulated as a fixed-dose combination preparation with sofosbuvir, which covers all 6 HCV genotypes and is used for the treatment of adult hepatitis C patients without cirrhosis or with compensated cirrhosis. When combined with ribavirin, it can also be used for people with decompensated cirrhosis, with a sustained virological response rate of over 95%, which greatly reduces the risk of hepatitis C progressing to liver fibrosis and liver cancer.

At present, the global hepatitis C treatment market has entered a stage dominated by pan-genotypic regimens. According to public data, the overall market size of pan-genotypic hepatitis C drugs in 2023 was approximately USD 18.7 billion, among which velpatasvir-related combination preparations contributed nearly 32% of the market share. The patent expiry effect is driving the restructuring of the market landscape. In the terminal hepatitis C medication market of public medical institutions in China in 2023, the proportion of generic drugs had risen to 72%, and the annual growth rate of domestic demand for velpatasvir API remains at around 19%. Currently, India and China are the major suppliers of velpatasvir for generic drugs worldwide.

The original research enterprise of velpatasvir is Gilead Sciences, and the trade name of its original research combination product is Epclusa (sofosbuvir and velpatasvir tablets). The expiry date of its core compound patent in the United States is 2031, and the expiry date of the core compound patent in China is 2024. The main dosage form approved for the original research product is tablet, with a specification of 400 mg sofosbuvir and 100 mg velpatasvir per tablet. This original research product has been included in the *Catalogue of Chemical Reference Preparations* of China, and is also listed in the FDA Reference Preparation Catalogue. As of the retrieval time point, more than 10 enterprises in China have obtained CDE registration numbers (status A) for velpatasvir API, and the generic versions of sofosbuvir and velpatasvir tablets from multiple domestic pharmaceutical companies have been approved for marketing. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for velpatasvir, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and generic drug consistency evaluation.