Daclatasvir

The global prevention and control of chronic hepatitis C has long been limited by the accessibility of pan-genotypic treatment regimens, and the advent of daclatasvir has broken this limitation. As a second-generation NS5A inhibitor class of direct-acting antiviral agents, it binds to the N-terminal domain of the hepatitis C virus NS5A protein to block the assembly of viral replication complexes and the release of progeny viruses, enabling potent antiviral effects without the need for combination with interferon. It can be clinically used in combination with asunaprevir, sofosbuvir and other drugs, covering patients with genotype 1-6 hepatitis C. In particular, it has good safety and response rate in special populations such as those with hepatic and renal function impairment and liver cirrhosis, and is one of the core recommended drugs for the global hepatitis C elimination initiative.

The global market size related to daclatasvir was approximately USD 430 million in 2022. Driven by the popularization of generic drugs and the improvement of hepatitis C screening coverage, the annual compound growth rate of the market remains at around 3.2%. The competitive landscape shows obvious stratification: the European and American markets are dominated by original research products, while generic drugs account for more than 85% in low- and middle-income countries. Since relevant drugs were included in the medical insurance catalog in 2019 in the Chinese market, the treatment burden of patients has decreased significantly, and the annual growth rate of drug demand has reached 18%. At present, more than 10 domestic enterprises have submitted marketing applications for generic drugs, and the market penetration rate is expected to further increase after the implementation of centralized procurement.

The original research enterprise of daclatasvir is Bristol-Myers Squibb, and the original research brand name is "Daklinza". The expiration time of its core compound patent in China is 2026. The main dosage form approved for the original research product is tablet, with specifications of 30mg and 60mg. It has been included in the *Catalogue of Chemical Reference Preparations (29th Batch)* of China, and is also listed in the FDA Reference Preparations Catalogue. Up to now, there are more than 20 registration numbers of daclatasvir active pharmaceutical ingredients (APIs) in China, most of which are in status A (approved for use in marketed preparations). In addition, 8 domestic daclatasvir tablets have been approved for marketing, and the original research preparation has also completed import registration. (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 daclatasvir API. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API R&D, quality research and generic drug declaration.