Mitoxantrone

Among clinical chemotherapy regimens for malignant tumors, anthracyclines are one of the basic medications, but the cardiotoxicity of traditional anthracyclines has long limited their clinical application scope. Mitoxantrone, a synthetic anthracycline antineoplastic drug, blocks nucleic acid synthesis by intercalating into the DNA strands of tumor cells and inhibiting the activity of topoisomerase II. Meanwhile, compared with traditional anthracyclines such as doxorubicin, its cardiotoxicity is significantly reduced. At present, this drug has been widely used in the treatment of various malignant tumors such as acute leukemia, malignant lymphoma, breast cancer and prostate cancer, and can also be used as salvage therapy for some patients with relapsed and refractory hematological diseases, making it an important clinical choice for balancing antineoplastic efficacy and medication safety.

Driven by the rising prevalence of indications such as hematological tumors and breast cancer, the global mitoxantrone market size has maintained steady growth in recent years. The overall market size in 2023 was approximately USD 120 million, of which the generic drug market accounted for more than 90%. In terms of the domestic market, mitoxantrone has been included in the National Medical Insurance Catalog (Class B). In 2022, the terminal sales of domestic public medical institutions exceeded RMB 210 million. Currently, there are more than 10 domestic enterprises approved to produce the preparation, and the overall API supply is dominated by domestic manufacturers, with an import substitution rate of more than 95%. The accessibility of terminal medication has been further improved after the implementation of the centralized procurement policy.

The original developer of mitoxantrone is Wyeth-Ayerst Laboratories of the United States, with the original brand name Novantrone, and its core compound patent in the United States expired in 1999. The originally approved dosage form is mainly injection, with specifications of 20mg/10ml and 25mg/12.5ml, and the original injection has been included in the FDA Reference Listed Drug Catalog. Up to now, more than 8 enterprises have obtained A-status registration numbers for mitoxantrone API on the domestic CDE API registration platform. There are two dosage forms of mitoxantrone hydrochloride injection and mitoxantrone hydrochloride for injection approved for marketing in China, and the number of enterprises that have passed the consistency evaluation for both dosage forms exceeds 5. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for mitoxantrone API. Most products are available from stock, and in-stock products ordered before 16:00 can be shipped on the same day. All products meet the requirements of multi-dimensional regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference material use needs of drug R&D, quality research and production quality control links.