Fruquintinib

In response to the unmet clinical demand for third-line and above treatment for patients with metastatic colorectal cancer, fruquintinib, as a highly selective inhibitor of vascular endothelial growth factor receptor (VEGFR) 1/2/3, blocks the nutrient supply to tumors by potently inhibiting tumor angiogenesis, and belongs to the category of small molecule targeted anti-tumor drugs. Compared with drugs targeting the same target, it has higher kinase selectivity and lower off-target toxicity, and is indicated for patients with metastatic colorectal cancer who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and who have previously received or are unsuitable for anti-vascular endothelial growth factor therapy and anti-epidermal growth factor receptor therapy (RAS wild type). Subsequent clinical exploration has also been expanded to solid tumors such as gastric cancer and non-small cell lung cancer, providing a better tolerable option for patients with advanced solid tumors.

The annual number of new cases of colorectal cancer in China is approximately 408,000, among which 30% are already at advanced stage at the time of diagnosis, and the size of the patient population receiving third-line and above treatment exceeds 100,000. The domestic market size of fruquintinib was approximately RMB 1.8 billion in 2023, with a compound annual growth rate of 27% in the past three years. As a Class 1 innovative drug independently developed in China, its competitive landscape is relatively concentrated. At present, only the original research enterprise holds the preparation approval, and no generic drug has been launched. After being included in the National Medical Insurance Catalog in 2021, the payment threshold for patients has been greatly reduced, and the market penetration rate continues to increase.

Fruquintinib was originally developed by Hutchison MediPharma (Shanghai) Co., Ltd., with the trade name Elunate®. The core compound patent expires in September 2031. The domestically approved dosage form is hard capsule, with specifications including 1mg and 5mg. This product has been included in the Reference Listed Drugs of the China Listed Drug Catalog, and is also included in the FDA Orange Book. As of June 2024, the CDE API Registration Platform has not yet published the registration information of other enterprises except the original research enterprise, and only the preparation of the original research enterprise has been approved for marketing in China. (Data as of June 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for fruquintinib API. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in all stages of R&D, quality research and registration declaration.