Pixantrone

The clinical treatment of relapsed/refractory non-Hodgkin's lymphoma has long been faced with the dilemma of limited effective drug options and poor patient prognosis. Pixantrone, as an aza-anthracenedione topoisomerase Ⅱ inhibitor, blocks nucleic acid synthesis by intercalating into DNA double strands and inhibiting topoisomerase Ⅱ activity, and ultimately induces apoptosis of tumor cells. This drug is mainly indicated for adult patients with relapsed or refractory aggressive non-Hodgkin's lymphoma who have received at least 2 prior systemic therapeutic regimens. Compared with traditional anthracycline drugs, it has lower cardiotoxicity, providing a new treatment option for patients intolerant to conventional chemotherapy.

At present, the global market size of pixantrone is relatively small, which is mainly concentrated in the end-line treatment scenarios of lymphoma in Europe and the United States. In recent years, with the increase in the diagnosis and treatment rate of patients with relapsed lymphoma, the annual compound growth rate of the market has remained at around 6%. There is no generic version of this drug marketed in China yet, leaving the market in a blank state. With the continuous release of domestic clinical demand for the treatment of relapsed/refractory lymphoma, the development of generic versions of this product has certain market potential.

The original developer of pixantrone is Cell Therapeutics, a U.S.-based company, and the original brand name is Pixuvri. Its compound patent in the European Union expired in 2023, and the core patent for the U.S. market will expire in 2027. The dosage form approved for the original product is injection, with a specification of 50 mg per vial, and it has been included in the reference preparation catalog of the European Medicines Agency (EMA). Up to now, there is no A-status registration number for pixantrone API in China, and no related preparation products have been approved for marketing by the National Medical Products Administration. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for pixantrone API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the generic drug R&D and quality research work of relevant pharmaceutical enterprises.