Vincristine

For the clinical treatment of malignant hematological tumors such as childhood acute lymphoblastic leukemia and lymphoma, vincristine is an indispensable basic chemotherapeutic drug, which belongs to the vinca alkaloid class of antineoplastic agents. Its mechanism of action is to bind to tubulin, inhibit the formation of spindle microtubules, and arrest cell division in the metaphase of mitosis, thereby blocking the proliferation of tumor cells. At present, it is widely used in the clinical treatment of a variety of malignant tumors such as Hodgkin lymphoma, non-Hodgkin lymphoma, acute leukemia, neuroblastoma, etc. It is a core component in the combination chemotherapy regimens for pediatric tumors, and is also one of the first-choice chemotherapeutic drugs in the combination treatment of some adult malignant tumors.

As a classic antineoplastic drug that has been in clinical use for more than 60 years, the global market size of vincristine has stabilized in the range of USD 120 million to 150 million in recent years, with the Chinese market accounting for approximately 32%. Due to its rigid clinical demand and high difficulty in production process, the current global supply pattern is highly concentrated, with only 5 enterprises holding compliant production qualifications. The domestic market was previously long dependent on imports. After 2 domestic API enterprises obtained approval in 2021, the import dependence has dropped to below 40%. At present, the winning bid price in the centralized procurement at the terminal of public medical institutions has decreased by 89% compared with the price of the original research drug, and the accessibility for patients has been significantly improved.

The original research enterprise of vincristine is Eli Lilly and Company, and the original research trade name is Oncovin®. The core compound patent in the United States expired in 1984. The main dosage form approved for the original research product is injection, with a specification of 1 mg per vial, which has been included in the FDA Reference Listed Drug Catalog and the *Catalogue of Reference Preparations for Chemical Drugs (11th Batch)* of China. In terms of domestic API registration, a total of 3 enterprises have obtained CDE registration numbers for vincristine API, among which 2 are in status A (approved for associated use). In addition, vincristine for injection produced by 6 enterprises has been approved for marketing in China, all of which have passed the consistency evaluation of generic drugs. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for vincristine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable impurity reference standard supply support for API manufacturers, preparation R&D institutions and testing platforms, effectively meeting the full-process requirements of process research, quality research and compliance declaration.