Bendamustine

As a purine analog anti-tumor drug with dual effects of alkylating agent and antimetabolite, bendamustine causes cross-breakage of DNA strands through alkylation, while interfering with the purine metabolism process and inducing apoptosis of tumor cells. Its clinical advantages lie in relatively mild toxic and side effects and low incidence of drug resistance. At present, it is a first-line or second-line treatment option for chronic lymphocytic leukemia, non-Hodgkin's lymphoma and multiple myeloma, especially suitable for elderly patients and patients with relapsed and refractory hematological tumors who are resistant to other alkylating agents.

The global market size of bendamustine was approximately USD 1.28 billion in 2023, with a compound annual growth rate of 4.2% from 2019 to 2023. The core growth drivers are the continuous rise in the prevalence of hematological tumors and the expansion of medical insurance coverage in emerging markets. In terms of the competitive landscape, the original research product still accounts for about 45% of the share in mature markets such as Europe, the United States and Japan. Generic drugs from China and India have entered regions such as Southeast Asia and Latin America with their cost advantages. After the domestic market was included in the centralized procurement in 2022, the terminal price has dropped by more than 80%, and the overall accessibility of medication has been greatly improved.

The original research enterprise of bendamustine is Mundipharma (Germany), and the original brand name is Treanda. Its US compound patent expired in 2019, and the core compound patent in China expired in 2016. At present, the main dosage form approved for the original research product is injection, with specifications including 25mg/vial and 100mg/vial, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (29th Batch)*. In terms of domestic API registration, 6 enterprises including Mundipharma have completed the CDE registration of bendamustine API (status A), and 8 domestic enterprises have obtained marketing approval for bendamustine for injection. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of bendamustine impurity reference standards. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day, fully meeting the efficient supply needs of pharmaceutical enterprises in R&D and quality control links.