Axitinib

In the field of targeted therapy for advanced renal cell carcinoma, axitinib is a highly representative second-generation small-molecule tyrosine kinase inhibitor. It can highly selectively inhibit the activity of vascular endothelial growth factor receptor (VEGFR) 1, 2 and 3, and control tumor growth and metastasis by blocking the tumor neovascularization pathway. Clinically, it is mainly used for adult patients with advanced renal cell carcinoma who have failed previous treatment with one tyrosine kinase inhibitor or cytokine. It can also be used in the treatment of other advanced solid tumors in some combination drug regimens, providing new survival benefit options for patients with subsequent treatment tolerance.

The global axitinib market size was approximately USD 1.27 billion in 2023, with a compound annual growth rate of 3.2% in the past five years. The growth momentum mainly comes from the improvement of renal cell carcinoma screening rate and the increase of targeted drug penetration rate in emerging markets. The market size in China was approximately RMB 1.12 billion in 2023. After it was included in the National Medical Insurance Catalogue in 2021, the payment threshold for patients has been greatly reduced, and the market compound growth rate in the past three years has reached 8.9%. In the current competitive landscape, the original research product still accounts for about 62% of the market share. There are 3 domestic generic preparations approved for marketing, with the price being only about 30% of that of the original research product, and the market substitution space continues to expand.

The original research enterprise of axitinib is Pfizer, and the original research trade name is "Inlyta". Its core compound patent in the United States expires in 2028, and the Chinese compound patent expired in 2020. The main dosage form approved for the original research is tablet, with specifications of 1mg and 5mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and is also a reference preparation published by the FDA. Up to now, the Center for Drug Evaluation of China has a total of 27 registration entries of axitinib API, among which 17 have been activated to A status and can be supplied for domestic preparation production; 6 axitinib tablet varieties including the original research product 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 provides a full set of impurity reference standards for axitinib API, covering all research dimensions such as process impurities and degradation impurities, which can perfectly meet the needs of different stages including synthetic process R&D, quality research, stability study, etc. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, which can effectively help R&D and manufacturing enterprises shorten the research cycle and reduce compliance risks.