Ifosfamide

As a classic representative of broad-spectrum anti-tumor alkylating agents, ifosfamide is a nitrogen mustard derivative. Its mechanism of action is that it is activated by liver enzymes in vivo to generate phosphoramide mustard, which forms cross-links with the DNA of tumor cells, inhibits DNA synthesis and interferes with RNA function, thereby exerting a cytotoxic effect. It is clinically mainly used to treat osteosarcoma, soft tissue sarcoma, malignant lymphoma, lung cancer, breast cancer and other malignant tumors, and is applicable to adult and pediatric patients with solid tumors. It is often used as the core component of combination chemotherapy regimens, and also has clear clinical value for relapsed and refractory tumors.

At present, the global ifosfamide market size is stable at around USD 420 million, with a compound annual growth rate of approximately 2.1%. The growth mainly comes from the improvement of the diagnosis and treatment rate of pediatric tumors and sarcomas in emerging markets. The domestic market size is approximately RMB 270 million, and the competitive landscape is dominated by generic drugs, with the original research product accounting for less than 10%. At present, the generic preparations of 8 domestic enterprises have passed the consistency evaluation, and the winning bid price in centralized procurement is approximately 87% lower than that of the original research product, greatly improving the clinical accessibility.

The original research enterprise of ifosfamide is Baxter Oncology GmbH, and the original research trade name is "Holoxan". Its core compound patent expired globally in 2001. The main dosage form approved for the original research product is injection, with specifications of 0.5g and 1.0g. It has been included in the *Catalogue of Reference Preparations of Chemical Medicines* of China, and is also listed in the FDA Reference Preparations Catalogue. In terms of domestic API registration, there are currently 6 valid A-status registration numbers in total, and the original research enterprise has not submitted API DMF registration in China. On the preparation side, ifosfamide for injection from the original research enterprise and 12 domestic enterprises has been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of ifosfamide impurity reference standards, covering all research needs such as synthesis process impurities, degradation impurities and enantiomers. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support the whole-process work such as API R&D, quality research and consistency evaluation.