Cabotegravir

As a core variety of long-acting antiretroviral drugs of the integrase inhibitor class, cabotegravir inhibits viral replication at the source by blocking the key step of integration of HIV viral DNA into the host cell genome. Its unique molecular structure endows it with an ultra-long half-life, which can significantly reduce the frequency of medication. Currently, it is used not only in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and adolescents over 12 years old, but also in combination with rilpivirine as a post-exposure prophylaxis medication, providing a brand-new clinical solution for improving patients' medication compliance and reducing the risk of viral drug resistance.

In 2023, the global market size related to cabotegravir has exceeded USD 4.2 billion, with a compound annual growth rate of over 37%, making it one of the fastest-growing categories in the current anti-AIDS drug market. At present, only the original research enterprise has achieved commercial supply worldwide, no generic drug has been approved for marketing in China, and this variety has not been included in the relevant centralized procurement catalog for the time being. With the upgrading of domestic HIV prevention and control needs and the increase in the penetration rate of long-acting treatment regimens, it is expected that the domestic market size of cabotegravir will exceed RMB 1.5 billion in 2028, and the supply gap of API is relatively significant.

The original research enterprise of cabotegravir is ViiV Healthcare, and the original research trade name is Vocabria. Its core compound patent will expire in China in 2026. The original research dosage forms that have been approved in China include injection (600mg/3ml) and tablet (30mg), both of which have been included in the *Reference Listed Drug Catalog of Chemical Drugs* issued by the National Medical Products Administration. Up to now, the domestic API registration platform has not yet announced the approved API registration number of cabotegravir. Only the original research imported preparations have obtained marketing approval, and all domestic preparations are in the clinical research and development stage. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cabotegravir impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API research and development, quality research and generic drug declaration.