Regorafenib

The treatment of advanced metastatic solid tumors has always been a clinical challenge, and the emergence of multi-target tyrosine kinase inhibitors has brought the possibility of prolonging survival for such patients. Regorafenib is an oral multi-kinase inhibitor that can act on multiple targets such as VEGFR, RAF, KIT, etc. It can not only inhibit tumor angiogenesis, but also directly inhibit tumor cell proliferation. The currently approved indications include previously treated metastatic colorectal cancer, gastrointestinal stromal tumor and hepatocellular carcinoma. Liver cancer patients who have failed sorafenib treatment, and gastrointestinal stromal tumor patients who are resistant to imatinib and sunitinib can all obtain clinical benefits from this drug.On a global scale, the global market size of regorafenib exceeded 1.2 billion US dollars in 2022. Driven by the continuous release of clinical demand for indications such as liver cancer and gastrointestinal stromal tumors, the compound annual growth rate from 2023 to 2029 is expected to remain at around 3.2%. In terms of the domestic market, with the access of medical insurance negotiations and the launch of generic drugs, its market penetration rate has increased year by year. The domestic market size was nearly 1.8 billion yuan in 2024. At present, more than 10 domestic enterprises have submitted marketing applications for generic drugs. After the implementation of centralized procurement, the price has dropped by more than 70%, further expanding the drug accessibility for grassroots patients.The original developer of regorafenib is Bayer Pharma, and the original trade name is Stivarga. Its compound patent in China expires in 2023, and the formulation patent expires in 2030. The main dosage form approved for the original drug is tablet, with a specification of 40mg. This product has been included in the China Listed Drug Catalog, and is listed as a reference preparation by both NMPA and FDA. At present, regorafenib APIs from more than 15 domestic enterprises have completed registration with CDE and obtained Class A status, which can be directly associated with formulation review. Generic formulations from 6 enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)CATO can provide a full set of impurity reference standards for regorafenib API, which support multiple specifications and are traceable. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in API R&D, quality control and generic drug consistency evaluation.

作为全球范围内瑞戈非尼全球市场规模在2022年突破12亿美元，受肝癌、胃肠道间质瘤等适应症临床需求持续释放，2023-2029年复合增长率预计维持在3.2%左右。国内市场方面，随着医保谈判准入和仿制药上市，其市场渗透率逐年提升，2024年国内市场规模已接近18亿元人民币，目前已有超过10家国内企业提交仿制药上市申请，集采落地后价格降幅超过70%，进一步拓宽了基层患者的用药可及性。

瑞戈非尼原研企业为拜耳医药，原研商品名为拜万戈，其中国化合物专利到期时间为2023年，制剂专利到期时间为2030年。原研获批的主要剂型为片剂，规格包括40mg。该品种已列入中国上市药品目录集，同时被NMPA和FDA均列为参比制剂。目前国内已有超过15家企业的瑞戈非尼原料药已在CDE完成登记获A状态，可直接关联制剂审评，已有6家企业的仿制药制剂已获批上市。（数据截至2025年6月，最新请以CDE官网为准）

CATO/佳途科技可提供瑞戈非尼API全套杂质标准品，支持多种规格可溯源，大部分产品现货供应、现货产品16:00前下单当天发货，全面符合中国药典、FDA等多法规要求，能够为药企的原料药研发、质量控制及仿制药一致性评价工作提供稳定可靠的对照品支持。