Bictegravir

Clinical treatment of AIDS always requires the support of integrase inhibitors with higher barrier to drug resistance and lower adverse reactions, and the advent of bictegravir provides a better option for long-term medication for such patients. As a second-generation HIV integrase strand transfer inhibitor, it inhibits viral replication by blocking the integration of viral DNA into the host cell genome. It is often formulated into a fixed-dose combination with emtricitabine and tenofovir alafenamide for the treatment of HIV-1 infection in adults and adolescents aged over 12 years, delivering clear clinical benefits to both treatment-naïve patients and treatment-experienced patients with drug resistance.

The global anti-HIV drug market continues to expand, among which integrase inhibitors have become the first-line clinical regimen, accounting for more than 40% of the overall market share of antiretroviral drugs. Since its launch, the annual global sales peak of bictegravir-based fixed-dose combination has exceeded 7 billion US dollars, making it one of the single-tablet anti-HIV regimens with the highest global sales volume at present. The domestic market is still dominated by the originator product at present. With the improvement of public awareness of HIV infection and the release of demand for long-term management of people living with HIV, the market of relevant active pharmaceutical ingredients (APIs) and generic drugs has clear growth potential.

The originator of bictegravir is Gilead Sciences, and the trade name of its originator fixed-dose combination is Biktarvy. Its core compound patent will expire in 2033 in China, and the core US patent will expire in 2030. The dosage form of the originator product launched is the fixed-dose combination tablet, each containing 50 mg of bictegravir, 200 mg of emtricitabine and 25 mg of tenofovir alafenamide, which has been included in the Chinese Catalogue of Chemical Drugs and the FDA Reference Listed Drug Catalog. As of the retrieval date, no generic bictegravir preparation has been approved for marketing in China, and no validly registered domestic bictegravir API has been published on the CDE API Registration Platform. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for bictegravir, with most products 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 and reliable reference standard support for enterprises in drug research and development, quality research and consistency evaluation.