Lenvatinib

For highly prevalent malignant tumors such as unresectable hepatocellular carcinoma and differentiated thyroid cancer, the clinical application of multi-target tyrosine kinase inhibitors has greatly prolonged the survival benefit of patients with advanced-stage diseases. Lenvatinib is an oral multi-receptor tyrosine kinase inhibitor that can simultaneously inhibit multiple signaling pathways including VEGFR1-3, FGFR1-4, and PDGFRα, exerting the dual effects of anti-angiogenesis and tumor proliferation inhibition. Its currently clinically approved indications cover unresectable hepatocellular carcinoma in treatment-naïve patients who have not received prior systemic therapy, radioiodine-refractory differentiated thyroid cancer, and combination therapy with everolimus for advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy, covering multiple treatment scenarios in solid tumor therapy where a large number of unmet needs exist.

The global market size of lenvatinib exceeded USD 4 billion in 2022. After entering the Chinese market in 2018, its volume growth rate was remarkable, and the domestic market size exceeded RMB 3.5 billion in 2023. With the expiration of the compound patent, the popularity of generic drug applications has continued to rise. At present, lenvatinib generics from more than 15 domestic enterprises have been approved for marketing, and the drug has been included in multiple rounds of national centralized drug procurement. The winning price has dropped by more than 90% compared with the peak price of the originator drug, and its accessibility has been greatly improved. Globally, China is the core production and supply base of lenvatinib API, with a production capacity accounting for more than 60%. In addition to supplying domestic preparation enterprises, a large volume of products are exported to Europe, America, Southeast Asia and other markets.

The originator enterprise of lenvatinib is Eisai Co., Ltd., with the originator brand name Lenvima. Its Chinese compound patent expired in October 2021. The main dosage form approved for the originator drug is capsule, with specifications of 4mg and 10mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. At present, there are more than 30 lenvatinib API registration records on the Chinese API Registration Platform, among which more than 20 have been publicized with A status, which can meet the domestic preparation production needs. In addition, lenvatinib capsules from dozens of enterprises have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In the process of lenvatinib generic drug R&D and consistency evaluation, impurity research is the core link to ensure product quality. CATO provides a full set of impurity reference standards for this API. Most products are in stock, in-stock products ordered before 16:00 will be shipped on the same day, and the products comply with multiple regulations such as Chinese Pharmacopoeia and FDA. They can directly support enterprises in quality research, stability investigation and application document preparation, and reduce supply chain uncertainty in the R&D process.