Sunitinib

In the clinical treatment of solid tumors such as renal cell carcinoma and gastrointestinal stromal tumors, small molecule tyrosine kinase inhibitors are one of the core medications for prolonging the survival of patients. As a representative variety of multi-target inhibitors, sunitinib can simultaneously inhibit multiple targets including platelet-derived growth factor receptor, vascular endothelial growth factor receptor, and stem cell factor receptor, and exerts anti-tumor effects by blocking the dual pathways of tumor cell proliferation and neovascularization. At present, its clinical indications cover gastrointestinal stromal tumors with imatinib treatment failure or intolerance, inoperable advanced renal cell carcinoma, and unresectable metastatic well-differentiated progressive pancreatic neuroendocrine tumors. It is a first-line medication recommended by multiple clinical guidelines in the above fields, covering adult patients with advanced solid tumors.

In 2023, the global market size of sunitinib was approximately USD 820 million. Affected by the increasing penetration rate of generic drugs, the market size has maintained low-speed and stable fluctuations in recent years. In terms of the domestic market, the sales of sunitinib at public medical institution terminals exceeded RMB 210 million in the first half of 2024, among which the market share of generic drugs has exceeded 72%. This variety was included in the National Medical Insurance Class B Catalogue in 2018. In the third batch of national centralized drug procurement in 2020, generic drugs from 3 domestic pharmaceutical enterprises won the bid, with the winning price being reduced by more than 70% compared with the original research drug, and the accessibility of medication for patients has been greatly improved.

The original research enterprise of sunitinib is Pfizer, with the trade name Sutent. Its core compound patent expired in China in 2021, and the crystal form patent will expire in 2027. The main formulation approved for the original research drug is capsules, with specifications including 12.5mg, 25mg, 37.5mg and 50mg. It has been included in the China Listed Medicines Catalogue as a reference preparation, and is also included in the FDA Reference Preparations Catalogue. In terms of domestic API registration, as of now, sunitinib APIs from nearly 20 enterprises have been registered and publicized by CDE with the status of A; on the formulation side, in addition to the original research drug, sunitinib capsules from 6 domestic enterprises have been approved for marketing, which are deemed to have passed the consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the needs of pharmaceutical research and quality control of sunitinib, CATO provides a full set of impurity reference standards for this API, supporting the full-process use requirements from early method development to routine release testing. Most products are in stock. In-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide complete research data such as structure confirmation and purity calibration, helping R&D and production enterprises efficiently advance the project process.