Entecavir

Chronic hepatitis B remains a key long-term prevention and control priority in the global public health field, and the core goal of clinical treatment is to long-term inhibit the replication of hepatitis B virus and delay disease progression. Nucleoside reverse transcriptase inhibitors are the cornerstone category of anti-hepatitis B virus therapy. Among them, entecavir can specifically target the hepatitis B virus polymerase, exert a potent inhibitory effect by terminating the synthesis of viral DNA strands, and is currently a first-line medication for adult patients with chronic hepatitis B and child patients aged over 2 years. It is also applicable to the combined antiviral treatment regimen for hepatitis B patients co-infected with HIV, with low incidence of drug resistance and good long-term medication safety.

The global entecavir-related market size exceeded USD 1.8 billion in 2023. As a country with a large burden of hepatitis B, China accounts for nearly 42% of the market. With the expansion of medical insurance coverage and the increase of primary diagnosis and treatment penetration rate, the domestic entecavir preparation market maintains a compound annual growth rate of 3.2%. In terms of the competitive landscape, this variety has entered multiple rounds of national centralized procurement. The price of preparations has dropped by more than 90%, and generic drugs account for more than 95% of the domestic market share. The supply of upstream API is dominated by local enterprises. Driven by the centralized procurement policy, the market concentration of API manufacturers with strong impurity control capabilities and outstanding cost advantages continues to increase.

The original research enterprise of entecavir is Bristol-Myers Squibb, and the original research brand name is "Baraclude". Its core compound patent was approved in the United States in 2005 and expired in 2015, and the Chinese compound patent expired in 2017. The main dosage forms approved for the original research include oral tablets and oral solutions. The tablet specifications cover 0.5mg and 1mg, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, entecavir APIs of more than 30 domestic enterprises have obtained Class A status through CDE registration, and entecavir oral preparations of more than 60 enterprises have been approved for marketing, all of which have passed or are deemed to have passed the consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of entecavir, CATO provides a full set of impurity reference standards for this API, which can cover all key impurities in the synthesis process and degradation pathways. All products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA. Most products are in stock, and stock products ordered before 16:00 can be shipped on the same day, which can effectively shorten the R&D cycle of enterprises and reduce the cost of quality research.