Adefovir

Long-term management of chronic hepatitis B has always relied on the viral inhibitory effect of nucleos(t)ide analogues. As a classic variety of nucleoside reverse transcriptase inhibitors, adefovir competitively inhibits the activity of hepatitis B virus DNA polymerase and terminates the extension of viral DNA chains, thereby achieving sustained viral load control. It is clinically indicated mainly for the treatment of adult patients with chronic hepatitis B and compensated liver function who have evidence of active replication of hepatitis B virus, accompanied by persistent elevation of serum aminotransferase (ALT or AST) or active histological lesions of the liver. It is especially suitable for the patient group with lamivudine resistance, and is an important component of the sequential treatment regimen for chronic hepatitis B.

The global base of chronic hepatitis B patients exceeds 250 million, among which Chinese patients account for approximately one-third, driving long-term stable market demand for adefovir-related preparations. In 2023, the domestic market size of adefovir dipivoxil preparations was approximately RMB 420 million. With the improvement of the coverage of diagnosis and treatment of chronic hepatitis B at the primary level, the compound annual growth rate of the market in the past three years has remained at 2.1%. At present, the domestic market has formed a pattern of full competition between original research drugs and generic drugs, and generic drugs from more than 30 enterprises have been approved for marketing. After the centralized procurement, the price of preparations has dropped by more than 90%, which further reduces the medication burden of patients and also drives the continuous release of demand for upstream API.

The original research enterprise of adefovir is GlaxoSmithKline, and the original trade name is "Hepsera". Its core compound patent expired in 2016 in major global markets, and the compound patent in China also terminated in 2016. The main dosage form approved for the original research drug is adefovir dipivoxil tablets with a specification of 10mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and also included in the FDA Reference Preparation Catalogue. Up to now, more than 20 domestic enterprises in China have obtained CDE registration numbers (status A) for adefovir dipivoxil API, and both the original research and domestic generic preparations have been approved for marketing in China, with sufficient clinical accessibility. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of adefovir impurity reference standards, covering the full-path research needs such as synthesis process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of impurity reference standards for pharmaceutical enterprises in API R&D, quality research and production processes.