Daunorubicin

In the clinical treatment of hematological malignancies, anthracycline antibiotics have always been one of the core drugs in combination chemotherapy regimens. As a representative first-generation anthracycline, daunorubicin intercalates into the DNA double strands of tumor cells, inhibits the activity of topoisomerase II, blocks the process of nucleic acid synthesis, and induces tumor cell apoptosis. Its clinical indications cover induction of remission and consolidation therapy for adult and pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). It is also selected as a combination drug in the treatment regimens for some lymphoma and neuroblastoma cases, making it a rigid-demand variety for basic leukemia treatment worldwide.

At present, the global market size of daunorubicin is approximately USD 180 million. Driven by the increased coverage of diagnosis and treatment for childhood leukemia and the rising incidence of AML in developing countries, the compound annual growth rate in the past 3 years has remained at 4.2%. Affected by the centralized drug procurement policy in the domestic market, the price of preparations has dropped significantly. The overall market size is approximately RMB 230 million, with steady release of clinical demand. The competitive landscape is dominated by generic drug supply, with overseas original research products accounting for less than 15% of the market share. Domestic enterprises account for more than 80% of the supply on the API side, and part of the production capacity has obtained FDA and CEP certifications to supply the global market.

The original research enterprise of daunorubicin is Pfizer, with the original brand name "Daunorubicin". The core compound patent in the United States expired in 1988, and all relevant compound patents in China have expired their protection periods due to the relatively early launch time. The main dosage form of the original research product is daunorubicin hydrochloride for injection, with a conventional specification of 20 mg per vial. It has been included in the *Catalogue of Chemical Reference Preparations* of China and is also listed in the FDA Reference Preparation Catalogue. Up to now, there have been 12 valid registration numbers of daunorubicin hydrochloride on the API registration platform of China CDE, 7 of which are in A status and can be used in marketed preparations. More than 20 domestic enterprises have obtained marketing approval for daunorubicin hydrochloride for injection. (Data as of October 2025, please refer to the official website of CDE for the latest information)

CATO provides a full range of daunorubicin impurity reference standards, which can cover the whole-process quality control requirements from API synthesis to preparation stability research. Most products are available from stock. In-stock orders placed before 16:00 can be shipped on the same day. All reference standards comply with the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of pharmaceutical enterprises for registration and declaration as well as daily quality testing.