Vandetanib

Medullary thyroid carcinoma is a highly aggressive endocrine malignant tumor with extremely low response rate to traditional radiotherapy and chemotherapy, and clinical treatment options have been very limited for a long time. Vandetanib is a multi-target tyrosine kinase inhibitor that can simultaneously inhibit the activities of VEGFR, EGFR and RET kinases, and exerts anti-tumor effect by blocking the dual pathways of tumor angiogenesis and tumor cell proliferation signal transduction. Currently, it is mainly used for the treatment of unresectable locally advanced or metastatic medullary thyroid carcinoma. It is the first targeted drug approved for this indication, providing the possibility of significantly prolonging survival for patients who lack effective treatment methods.

The current global market size of vandetanib is approximately USD 320 million. Driven by factors such as the improvement of rare disease drug security policies and the rising detection rate of thyroid cancer, the compound annual growth rate in the past three years has maintained at around 7.8%. Due to the relatively segmented indication of this drug, the original research product has long occupied the major market share in the world. At present, a small number of Indian pharmaceutical companies have launched generic drugs, and there are no domestically produced generic preparations on the market in China, and it has not been included in the scope of national centralized volume-based procurement.

The original research enterprise of vandetanib is AstraZeneca, with the trade name Caprelsa. Its core compound patent in the United States expired in 2021, and the compound patent in China expired in 2023. The main dosage form approved by the original research is oral tablet, with two specifications of 100mg and 300mg. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the Chinese *Catalog of Reference Preparations for Chemical Drugs*. There are no approved vandetanib preparations on the market in China, and no enterprise has completed the registration and filing of active pharmaceutical ingredients at CDE for the time being. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for vandetanib. Most products are available from stock. Stock 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 substance use needs of pharmaceutical enterprises in all links of drug research and development, quality research and production quality control.