Camptothecin

As a natural alkaloid isolated from Camptotheca acuminata of the Nyssaceae family, camptothecin is a topoisomerase I inhibitor antineoplastic drug. Its mechanism of action is to specifically bind to the covalent complex formed by topoisomerase I and DNA, prevent the re-ligation of DNA strands, trigger DNA double-strand breaks, and ultimately induce tumor cell apoptosis. In clinical practice, camptothecin and its derivatives are widely used in the treatment of various malignant tumors such as gastric cancer, colorectal cancer, bladder cancer and leukemia. They are one of the important options in the chemotherapy regimens for patients with advanced digestive system tumors, and also provide a new treatment path for patients with relapsed and refractory hematological tumors.

The global market size of camptothecin drugs had exceeded USD 2.8 billion in 2023, with a compound annual growth rate of 7.2% in the past five years. The growth momentum mainly comes from the expansion of clinical demand for solid tumors and the expansion of indications of new derivatives. In terms of the domestic market, with the maturity of local generic drug processes, the clinical penetration rate of camptothecin series preparations has increased year by year. At present, local enterprises have occupied more than 65% of the API supply share, and the product impurity control level of leading enterprises has met the international pharmacopoeia standards.

The original research of camptothecin was developed by Merck & Co., Inc. in the United States, and the first original research brand name is Camptosar. The core compound patent was obtained in 1966, and all patents in major global markets have expired. The main dosage forms currently on the market include injections, with the main specification of 2ml:20mg. Relevant preparations have been included in the FDA Reference Listed Drug Catalog, and camptothecin derivative preparations such as irinotecan and topotecan have also been included in the *Collection of Chemical Drug Catalogs* in China. According to the domestic API registration platform, 12 enterprises have obtained A-status registration numbers for camptothecin APIs, and a total of 27 camptothecin preparation varieties have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of camptothecin APIs, CATO can provide a full set of impurity reference standards for this API. Most products are available from stock, and in-stock products ordered before 16:00 can 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 cover the whole-process R&D scenarios such as process research, quality standard establishment and stability study.