Irinotecan

As a highly prevalent malignant gastrointestinal tumor worldwide, the systemic treatment of patients with advanced colorectal cancer has long relied on the iterative upgrading of chemotherapeutic drugs. Irinotecan is a camptothecin topoisomerase I inhibitor, which induces apoptosis of tumor cells by specifically blocking the DNA repair function of topoisomerase I. It is a core first-line chemotherapeutic drug for advanced colorectal cancer, and can also be used in the combination treatment regimens for solid tumors such as small cell lung cancer and pancreatic cancer, covering the applicable population of adult relapsed and refractory solid tumors and some pediatric tumors. Its treatment regimen combined with fluorouracil drugs can increase the median survival of patients with advanced colorectal cancer to more than 20 months.

The global irinotecan market size is stable at around USD 1.8 billion. The Chinese market has maintained a compound annual growth rate of 6.2% in recent years, and the domestic market size exceeded RMB 3.2 billion in 2023. As the compound patent has expired for many years, the domestic generic drug market has sufficient competition. At present, more than 10 enterprises have obtained preparation approval documents, and the winning bid price in centralized procurement has decreased by more than 85% compared with the highest price of the original research drug, which has greatly improved the accessibility for patients. The upstream API supply is dominated by local enterprises, and the top 3 manufacturers account for nearly 70% of the domestic market share.

The original research enterprise of irinotecan is Daiichi Sankyo Co., Ltd. of Japan, and the original trade name is Campto. Its core compound patent expired around 2007 in major markets such as the United States and Europe, and the compound patent in China also expired in 2008. The original dosage form is injection, with mainstream specifications including 2ml:40mg and 5ml:100mg, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and also included in the FDA Reference Preparation Catalogue. As of now, there are a total of 32 irinotecan API registration records on the API registration platform of the Center for Drug Evaluation of China, among which 24 have been activated in A status and can be used for associated preparation declaration. More than 20 domestic enterprises have obtained marketing approval for irinotecan injection. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of irinotecan impurity reference standards, covering synthesis process impurities, degradation impurities and corresponding isotope labeled substances. Most products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of the whole process of API R&D, quality research and declaration.