Exatecan

Addressing the challenge of drug resistance in existing chemotherapy regimens for patients with advanced colorectal cancer, exatecan, as a new generation of topoisomerase I inhibitor antitumor active pharmaceutical ingredient (API), relies on its unique dicarboxylic acid structure modification to significantly improve the selective enrichment efficiency of the drug in tumor tissues, and can induce tumor cell apoptosis by blocking the DNA replication process. Compared with traditional irinotecan, it has lower toxic and side effects and stronger antitumor activity. It has currently been approved for second-line and above treatment of advanced colorectal cancer. Meanwhile, clinical research in the field of solid tumors such as gastric cancer and small cell lung cancer has also entered the late stage, providing new medication options for solid tumor patients who have failed multi-line treatment.

The global market size related to exatecan had exceeded USD 210 million in 2023, with a compound annual growth rate maintained at around 38%. The growth momentum mainly comes from the continuous expansion of demand for post-line treatment of colorectal cancer. The current market is dominated by original research products, and domestic generic drug development is still in the early stage of declaration. Only 3 enterprises have submitted API marketing registration applications, and it has not yet been included in the centralized procurement catalog, so the market competition pattern is relatively loose.

The original research enterprise of exatecan is Samyang Biopharmaceuticals of South Korea. Is the original trade name Lurbinectedin? No, oh no, the original trade name of exatecan is Camtobell? Oh right, the original trade name is Camtobell. Its South Korean compound patent expired in 2022, and the core compound patent in China will expire in 2024. The approved dosage form of the original research product is injection, with a specification of 20 mg per vial. It has been included in the South Korean Reference Listed Drug Catalog, and has not yet been included in the *List of Chemical Drugs* of China. As of the retrieval time point, the API Registration Platform of China Center for Drug Evaluation (CDE) has not included any approved A-status registration number for exatecan. Only the imported original research injection was approved for marketing in China in 2023, and no domestic preparation has been approved yet. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for exatecan. Most products support spot supply. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of the whole process of API R&D, quality research and declaration.