Cabazitaxel

In response to the unmet demand after docetaxel resistance in the clinical treatment of castration-resistant prostate cancer, cabazitaxel, as a new generation of taxane tubulin inhibitor, exerts its anti-tumor effect by binding to tubulin subunits with high affinity, promoting microtubule polymerization, inhibiting depolymerization, and blocking the process of cell mitosis. Its clinical indication is mainly used in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel treatment. Compared with similar drugs, cabazitaxel has lower affinity for P-glycoprotein and can effectively break through the limitation of docetaxel resistance, providing an important later-line treatment option for patients with advanced prostate cancer.

The global cabazitaxel market size was approximately USD 820 million in 2023, with a compound annual growth rate of 7.8% from 2019 to 2023. The core growth drivers are the increasing incidence of advanced prostate cancer and the rising penetration rate of later-line treatment. In terms of the competitive landscape, the original research product still accounts for about 62% of the global market at present. With the approval of generic drugs in the Chinese market, the proportion of generic drugs had increased to 38% in 2023, and 3 domestic enterprises have obtained preparation approvals, with the demand for localized supply of API continuing to release.

The original research enterprise of cabazitaxel is Sanofi, and the original trade name is Jevtana. Its core compound patent in the United States expired in 2024, and the core compound patent in China expired in 2020. The main dosage form of the original product is injection, with two specifications of 60mg/1.5mL and 20mg/0.5mL, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. Up to now, there are 6 cabazitaxel API registration numbers on the API registration platform of China CDE, among which 3 are in A status, and 6 generic cabazitaxel injections have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cabazitaxel impurity reference standards. Most 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 Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs in each stage of API R&D, quality research and registration declaration.