Pirarubicin

As an iterative variety of anthracycline antineoplastic drugs, pirarubicin blocks nucleic acid synthesis by embedding into DNA double strands and inhibiting the activity of topoisomerase II. Meanwhile, its chemical structure modification reduces cardiotoxicity. Clinically, it is mainly used for the treatment of various malignant tumors such as breast cancer, malignant lymphoma, acute leukemia and bladder cancer, covering the patient population of adult solid tumors and hematological tumors. It is a core medication component of multiple chemotherapy regimens, and bladder perfusion administration also provides an efficient option for the prevention of postoperative recurrence of superficial bladder cancer.

In China's current antineoplastic chemotherapy drug market, the annual market size of anthracycline drugs is approximately RMB 3.2 billion. With lower toxic and side effects, pirarubicin accounts for about 28% of the anthracycline drug market, and its compound annual growth rate has remained at 4.2% in the past three years. Affected by the volume-based procurement policy, the price of pirarubicin for injection preparations has dropped by more than 60%, the domestic generic drug market share has exceeded 90%, and the top 3 generic pharmaceutical enterprises account for nearly 75% of the overall market share. The demand for active pharmaceutical ingredients continues to be released steadily with the implementation of volume-based procurement, and there is no verifiable global market size data.

The original research enterprise of pirarubicin is Meiji Seika Kaisha, Ltd. of Japan, and the original research brand name is "Pirarubicin Hydrochloride for Injection". Its core compound patent in Japan expired in 2004, and the compound patent protection period in China ended in 2002. The main dosage form approved for the original research product is injection, with specifications including 10mg and 20mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. Up to now, the API Registration Platform of China National Medical Products Administration Center for Drug Evaluation (CDE) has recorded a total of 6 pirarubicin API registration numbers, of which 3 are in status A (already used in marketed preparations). 12 domestic enterprises have obtained approval to produce pirarubicin for injection preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of pirarubicin impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in all stages of API R&D, quality research and registration declaration.