Tivozanib

Renal cell carcinoma is a highly prevalent malignant tumor of the urinary system worldwide, accounting for approximately 2% to 3% of all adult malignant tumors. Among patients with advanced renal cell carcinoma, the five-year survival rate is less than 12%, and there is an urgent clinical demand for targeted therapeutic drugs with high efficacy and low toxicity. Tivozanib is a third-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor. It can highly selectively inhibit the activities of VEGFR-1, 2 and 3, block tumor angiogenesis, and reduce adverse reactions caused by off-target effects. It is mainly used for the treatment of adult patients with relapsed/refractory advanced renal cell carcinoma who have failed previous first-line or second-line systemic therapy, and has demonstrated longer progression-free survival and better tolerance in clinical application.

The global market size related to tivozanib was approximately USD 180 million in 2023, and it is expected to grow at a compound annual growth rate of 12.7% to USD 330 million by 2028. The growth momentum mainly comes from the increase in the penetration rate of later-line treatment for advanced renal cell carcinoma and the expansion of indications. At present, the market is still dominated by the original research product. A number of pharmaceutical companies around the world have laid out generic drug R&D, and no generic drug has been approved for marketing in China. With the subsequent expiration of patents, the entry of generic drugs will further expand the accessibility of drugs and drive the rapid rise in demand for upstream API.

The original research enterprise of tivozanib is Astellas Pharma Inc. of Japan, and the original trade name is Fotivda. The core compound patent of tivozanib expires in 2026 in the United States, and the core patent expires in 2027 in the European Union. The main dosage form approved by the original research is oral capsule, with specifications of 0.894mg and 1.34mg, which has been included in the FDA reference preparation catalog. Up to now, the import of the original preparation has not been approved in China, nor has the domestic tivozanib preparation been approved for marketing. No valid tivozanib API registration number in Status A has been retrieved on the CDE API registration platform. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full range of tivozanib impurity reference standards, which comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in sufficient stock. For in-stock products, orders placed before 16:00 can be shipped on the same day, which can provide stable and reliable reference standard support for pharmaceutical enterprises in API R&D, quality research and declaration work.