Vinblastine

As a natural indole alkaloid extracted from Catharanthus roseus, vinblastine is a classic antitumor drug of the tubulin inhibitor class. Its mechanism of action is to bind to the β-subunit of tubulin, inhibit microtubule polymerization, arrest cell mitosis in the M phase, and thereby induce apoptosis of tumor cells. It is often used in combination with other chemotherapeutic drugs in clinical practice, mainly for the treatment of malignant tumors such as Hodgkin lymphoma, non-Hodgkin lymphoma, testicular cancer, breast cancer and Kaposi's sarcoma. It is a basic drug in the combination chemotherapy regimens for a variety of hematological tumors and solid tumors, and is suitable for adult and pediatric tumor patients who meet the indications for chemotherapy.

The expansion of the global antitumor drug market coupled with the continuous rise in the incidence of hematological tumors has driven the market of vinblastine drugs to maintain steady growth. In 2023, the global market size of vinblastine and its preparations was approximately USD 270 million, with a compound annual growth rate maintained at around 4.2%. In terms of the competitive landscape, due to the high difficulty and low yield of vinblastine extraction processes, the global production capacity is mainly concentrated in a small number of enterprises with technical advantages in the extraction and purification of natural drugs. The domestic market is currently dominated by generic drug supplies. In recent years, with the implementation of the centralized procurement policy, the price of preparations has dropped significantly, clinical accessibility has been significantly improved, and the supply stability of upstream API has become the core concern of the industrial chain.

The original developer of vinblastine is Teva Pharmaceutical Industries of Israel, with the original brand name Velban. The core compound patent in the US market expired in 1997. The current mainstream dosage form is injection, with a conventional specification of 10 mg per vial. The original vinblastine for injection has been included in the FDA Reference Listed Drug Catalog, and no original preparation has been approved for import in China yet. As of now, there are a total of 3 registration entries for vinblastine API on the CDE API Registration Platform, among which 2 are in the status of "A", which can be used in association with domestic preparation declarations. (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 vinblastine, CATO provides a full set of impurity reference standards for this API, which fully covers process impurities and degradation impurities. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support the usage needs in different scenarios such as API R&D, quality research and routine release testing.