Epirubicin

As a classic upgraded variety of anthracycline anti-tumor drugs, epirubicin inhibits nucleic acid synthesis by embedding between DNA base pairs, and induces tumor cell apoptosis by interfering with the activity of topoisomerase II, with cardiotoxicity significantly lower than that of doxorubicin, a drug of the same category. It is mainly used clinically for the first-line treatment of various solid tumors such as breast cancer, malignant lymphoma, lung cancer and ovarian cancer. It can be used as a single agent, or can be combined with other chemotherapeutic drugs to form a regimen. It is a cytotoxic drug that is extremely widely used in the systematic treatment of patients with intermediate and advanced tumors.

The global epirubicin market size is stable at around USD 800 million, and the annual sales in the domestic market exceed RMB 1.5 billion. In recent years, with the increase of tumor early screening coverage and the popularization of combination therapy regimens, the annual compound growth rate has remained at 4.2%. The competition pattern shows a coexistence situation of originator drugs and generic drugs. Domestic generic drug enterprises have occupied nearly 60% of the market share by virtue of cost advantages. After the implementation of centralized procurement, the terminal price has dropped by more than 70%, which further promotes the clinical accessibility of this drug, and the growth rate of usage in primary medical institutions is obvious.

The originator enterprise of epirubicin is Pfizer, and the originator brand name is "Farmorubicin". Its core compound patent expired globally in 1999, and the preparation patent in China also expired in 2011. The main dosage form approved for the originator drug is epirubicin hydrochloride for injection, with conventional specifications including 10mg and 50mg. It has been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA reference preparation catalogue. At present, more than 20 API registration numbers have been activated in China, and the generic epirubicin for injection from more than 30 enterprises has passed the consistency evaluation, with sufficient market supply. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of epirubicin impurity reference standards, which fully meet the needs of the whole process of API R&D, quality research and declaration. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, which can greatly shorten the impurity research cycle of customers and effectively reduce compliance risks.