Abacavir

In the clinical pathway for long-term management of HIV infection, nucleoside reverse transcriptase inhibitors (NRTIs) have always been the core component of combination antiretroviral therapy (cART), and abacavir is one of the varieties in this category with high clinical recognition. It blocks viral replication by competitively inhibiting the activity of HIV reverse transcriptase and inserting into the viral DNA chain to terminate its extension. It is often clinically used in combination with other antiretroviral drugs to treat HIV-1 infection in adults and children over 3 months of age. Due to fewer central nervous system adverse reactions and less impact on blood lipids, it is particularly suitable for patients with comorbid underlying diseases who cannot tolerate other NRTIs. HLA-B*5701 gene screening is required before medication to avoid the risk of severe hypersensitivity reactions.

In 2023, the global anti-HIV drug market size exceeded 38 billion US dollars, of which nucleoside reverse transcriptase inhibitors accounted for approximately 12%, and the combined annual sales of abacavir single-tablet and compound preparations exceeded 1.8 billion US dollars, with a compound annual growth rate of 2.1% in the past three years. As abacavir is the core component of multiple free treatment regimens, the demand in the generic drug market is stable. At present, abacavir preparations in the Chinese market are mainly supplied by imported original research drugs and 3 domestic generic drug enterprises. After being included in the National Medical Insurance Catalog (Class B) in 2021, the accessibility of medication for patients has been significantly improved.

The original research enterprise of abacavir is GlaxoSmithKline, with the original trade name "Ziagen". Its core compound patent expired globally in 2014, and the compound patent in China also expired in 2014. The original dosage form is tablet with a specification of 300mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also included in the FDA Reference Preparations Catalogue. Up to now, the China NMPA has approved the import and marketing of the original abacavir tablets. There are a total of 6 abacavir API registration information on the CDE API registration platform, including 4 registrations from domestic enterprises and 2 registrations from imported enterprises, all of which have obtained the qualification for use in marketed preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of abacavir, CATO provides a full set of impurity reference standards for this API, covering all categories such as synthetic impurities and degradation impurities. Most products are available from stock, and in-stock products ordered before 16:00 can be shipped on the same day. All impurities meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can be directly used in API quality research, stability study and generic drug consistency evaluation related tests.