Maraviroc

As the world's first approved CCR5 receptor antagonist, maraviroc belongs to the entry inhibitor category of antiretroviral drugs. Its mechanism of action is different from that of traditional nucleoside/non-nucleoside reverse transcriptase inhibitors. By blocking the binding of HIV virus to the CCR5 co-receptor on the surface of CD4 cells, it prevents the virus from invading host cells, and is an important component of the current AIDS cocktail therapy. It is clinically mainly used to treat adult patients with human immunodeficiency virus type 1 (HIV-1) infection who have failed treatment with other antiretroviral drugs and whose virus strains are CCR5-tropic, providing a new treatment option for drug-resistant HIV-infected patients.

At present, the global market size of anti-AIDS drugs has exceeded 40 billion US dollars, among which the proportion of innovative targeted drugs entering the patent expiration period is increasing year by year, and the annual compound growth rate of the entry inhibitor细分 market where maraviroc belongs remains around 7.8%. In terms of the domestic market, with the expansion of the free AIDS treatment catalog and the expansion of the drug-resistant patient group, the clinical demand for maraviroc is rising steadily. At present, the original research product still occupies a dominant position. A number of local pharmaceutical companies have laid out generic drug research and development, the number of consistency evaluation declarations related to centralized procurement continues to increase, and the demand for domestic substitution of related API continues to release.

The original research enterprise of maraviroc is GlaxoSmithKline, and the original research trade name is "善瑞" (Selzentry/Celsentri). Its core compound patent expires in China in August 2023. The main dosage form approved by the original research is tablet, with specifications including 150mg and 300mg. The original research tablet has been included in the *Reference Preparations Catalogue of Chemical Drugs* issued by NMPA, and is also included in the FDA Reference Preparations Catalogue. Up to now, 2 domestic enterprises have submitted maraviroc API registration applications on the CDE API registration platform, which are in the public review stage. Imported original research preparations have been approved for marketing in China, and no domestic generic preparations have been approved yet. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for maraviroc API, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the needs of pharmaceutical enterprises in generic drug consistency evaluation, quality research and impurity control in the production process.