Tenofovir alafenamide

The long-term treatment of chronic hepatitis B and AIDS has always faced the balanced demand of "potent antiviral efficacy" and "long-term medication safety". The advent of tenofovir alafenamide provides a better solution to this clinical pain point. As a novel nucleoside reverse transcriptase inhibitor, it achieves targeted liver enrichment through structural optimization. It can exert the same antiviral activity at a dose less than one-tenth of that of tenofovir disoproxil fumarate, while greatly reducing the risk of adverse reactions associated with long-term medication, such as renal function impairment and decreased bone mineral density. At present, it has been preferentially recommended by domestic and foreign guidelines for the treatment of chronic hepatitis B in adults and adolescents, and is also one of the core components of HIV pre-exposure prophylaxis and combined antiviral therapy.

The global market size of tenofovir alafenamide had exceeded USD 7 billion in 2022. Driven by factors such as the increase in the coverage rate of standardized hepatitis B treatment and the expansion of HIV prevention demand, the compound annual growth rate from 2025 to 2030 is expected to remain at approximately 8%. In terms of the domestic market, after the product was included in the national centralized drug procurement in 2021, the penetration rate of generic drugs has rapidly increased to over 75%, and the market share of the original research drug has been gradually diverted by local enterprises. Driven by the volume expansion of preparations, the demand for upstream API has achieved an average annual growth rate of more than 22% in the past three years.

The original research enterprise of tenofovir alafenamide is Gilead Sciences, and the original brand name is "Vemlidy". Its core compound patent expires in 2021 in China, and the crystal form patent expires in 2027. The main dosage form of the original marketed product is tablet with a specification of 25mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and is also a reference preparation recognized by the FDA. As of September 2024, more than 20 domestic enterprises in China have obtained A status for their tenofovir alafenamide APIs through CDE registration, and nearly 30 domestic enterprises have obtained marketing approval for their 25mg tenofovir alafenamide tablets. (Data as of September 2024, please refer to the official CDE website for the latest information)

In response to the demand for quality research and consistency evaluation of this API, CATO provides a full set of impurity reference standards for tenofovir alafenamide, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can directly support the full-process R&D scenarios such as structure confirmation, impurity quantification and stability studies.