Idarubicin

In the treatment of hematological malignancies, anthracyclines are the core components of basic chemotherapy regimens. As a second-generation anthracycline antineoplastic drug, idarubicin acts by intercalating into DNA double strands and inhibiting the activity of topoisomerase II, which can effectively block the cell cycle progression of tumor cells and induce apoptosis. Compared with traditional anthracyclines, it has higher lipophilicity, higher cell penetration efficiency and relatively lower cardiotoxicity. At present, it has been recommended by guidelines as a first-line induction therapy for adult acute myeloid leukemia (AML), and can also be used as a second-line treatment for relapsed and refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma, especially suitable for elderly patients and patient groups with weak basal cardiac function.

The global idarubicin market size has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 420 million, with a compound annual growth rate of around 3.8%. From the perspective of competitive landscape, the original research product still accounts for nearly 60% of the share in the high-end markets of Europe and the United States, while generic drugs are mainly concentrated in major generic drug manufacturing countries such as China and India. In terms of the domestic market, 3 enterprises have currently passed the consistency evaluation of generic drugs for idarubicin preparations. In the 2022 provincial-level centralized procurement, the average price reduction of this variety reached 57%. With the further release of clinical demand, the domestic market demand for its API is expected to continue to rise in the future.

The original research enterprise of idarubicin is Pfizer, and the original trade name is Zavedos. The core compound patents of idarubicin expired in Europe and the United States in 2007 and 2008 respectively, and the compound patent in China expired in 2006. The main dosage form approved for the original research product is idarubicin hydrochloride for injection, with specifications of 5mg and 10mg. The original research product has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. As of now, there are a total of 6 idarubicin API registration entries on the China CDE API Registration Platform, of which 3 are in activated status and can be used for associated declaration. There are 9 domestic marketing approvals for idarubicin hydrochloride for injection that have been granted. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and production quality control requirements for idarubicin, CATO can provide a full set of impurity reference standards for this API, covering all categories such as synthesis process impurities and degradation impurities. Most of the products are available from stock, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as drug declaration and quality research.