Dovitinib

针对肾癌、胃肠道间质瘤等晚期实体瘤的临床治疗中，激酶抑制剂类药物是延长患者生存期的核心方案之一。多韦替尼属于受体酪氨酸激酶抑制剂，可同时作用于FGFR、PDGFR、VEGFR等多个靶点，通过阻断肿瘤细胞增殖信号传导、抑制肿瘤新生血管生成发挥抗肿瘤活性，目前在临床研究中主要用于既往标准治疗失败的晚期肾癌、胃肠道间质瘤以及部分存在FGFR基因变异的实体瘤患者，为后线治疗无药可选的患者提供了新的探索方向。In the clinical treatment of advanced solid tumors such as renal cell carcinoma and gastrointestinal stromal tumors, kinase inhibitor drugs are one of the core regimens to prolong the survival of patients. Dovitinib is a receptor tyrosine kinase inhibitor that can simultaneously act on multiple targets such as FGFR, PDGFR and VEGFR. It exerts anti-tumor activity by blocking the signal transduction of tumor cell proliferation and inhibiting tumor angiogenesis. At present, in clinical research, it is mainly used for patients with advanced renal cell carcinoma, gastrointestinal stromal tumors and some solid tumors with FGFR gene variation who have failed previous standard treatment, providing a new exploration direction for patients who have no drugs available for later-line treatment.

目前全球范围内多韦替尼尚未正式获批上市，整体市场仍处于临床开发阶段，暂无公开可核实的市场规模及增速数据。竞争格局方面，全球仅有少数药企布局该品种的临床研究，仿制药企业的相关开发进度普遍滞后，市场尚未形成规模化竞争，后续若核心适应症获批，有望填补部分实体瘤后线治疗的市场空白。At present, dovitinib has not been officially approved for marketing worldwide, and the overall market is still in the clinical development stage, with no publicly verifiable market size and growth rate data available. In terms of the competitive landscape, only a small number of pharmaceutical companies around the world have arranged clinical research on this variety, and the relevant development progress of generic drug companies is generally lagging behind. Large-scale competition has not yet formed in the market. If the core indications are approved in the future, it is expected to fill the market gap of later-line treatment for some solid tumors.

多韦替尼原研企业为诺华制药，原研商品名为Dovitinib，核心化合物专利在主要市场的到期时间为2027年，目前原研开发的剂型主要为口服片剂，规格包括200mg、300mg等。截至当前，该品种尚未被列入中国《化学药品目录集》及FDA参比制剂目录，国内暂无已获批上市的多韦替尼制剂产品，CDE原料药登记平台也暂未查询到有效在榜的多韦替尼原料药登记号。（数据截至2025年5月，最新请以CDE官网为准）The original developer of dovitinib is Novartis, and the original brand name is Dovitinib. The core compound patent will expire in 2027 in major markets. At present, the dosage form developed by the original manufacturer is mainly oral tablets, with specifications including 200mg and 300mg, etc. Up to now, this variety has not been included in the Chinese *Catalogue of Chemical Drugs* and the FDA Reference Listed Drug Catalogue. There are no approved dovitinib preparation products marketed in China, and no valid and listed API registration number of dovitinib has been found on the CDE API registration platform. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO可提供多韦替尼全套杂质标准品，大部分产品现货供应，现货产品16:00前下单当天发货，所有产品均符合中国药典、FDA等多法规合规要求，可充分满足药物研发、质量研究及生产过程中的对照品使用需求。CATO can provide a full set of impurity reference standards for dovitinib, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs in the process of drug research and development, quality research and production.