Cabozantinib

For the treatment of solid tumors such as advanced renal cell carcinoma and hepatocellular carcinoma, multi-target tyrosine kinase inhibitors have always been a core component of clinical regimens. As a representative drug in this category, cabozantinib can simultaneously inhibit 9 key kinase targets including MET, VEGFR2 and RET, and exert multiple anti-tumor effects by blocking tumor angiogenesis and inhibiting tumor cell proliferation and metastasis pathways. It has currently been approved for indications such as advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy, unresectable hepatocellular carcinoma, and metastatic medullary thyroid carcinoma carrying RET mutations, covering the adult solid tumor patient population, especially refractory cases with drug resistance after multiple lines of treatment. It has been listed as a recommended medication by multiple domestic and foreign clinical guidelines.

According to public data, the global market size of cabozantinib in 2023 was approximately USD 1.68 billion, with a compound annual growth rate of around 8.2% in the recent three years. The growth momentum mainly comes from the expansion of the patient population with hepatocellular carcinoma and renal cell carcinoma indications, as well as the improvement of drug accessibility in emerging markets. The domestic market is still dominated by the original research product at present, and multiple local pharmaceutical companies have submitted marketing applications for generic drugs. As the patent expiration window approaches, it is expected that the launch of generic drugs after 2026 will drive the rapid expansion of the overall market size, and at the same time drive the continuous growth of demand for upstream API.

The original research enterprise of cabozantinib is Exelixis, and the original research brand name is "Cabometyx". Its core compound patent in the United States will expire in 2026, and the core compound patent in China will expire in 2025. The main dosage form approved for the original research product is tablet, covering three specifications of 20mg, 40mg and 60mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, more than 10 domestic enterprises have submitted registration applications for cabozantinib API, some of the registration numbers have been converted to A status, and 5 approved domestic preparation varieties have been launched, covering the tablet dosage form. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cabozantinib impurity reference standards. Most products are available from stock, and in-stock products ordered 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 various usage needs in the stages of API R&D, quality research and declaration.