Tepotinib

For MET exon 14 skipping mutations, which occur in approximately 3% to 5% of patients with non-small cell lung cancer (NSCLC), there has been a long-term lack of targeted treatment options in clinical practice until the advent of tepotinib, a highly selective MET tyrosine kinase inhibitor, filled this gap. As an oral small-molecule targeted drug, tepotinib can precisely bind to the MET kinase domain, inhibit MET phosphorylation and the activation of downstream signaling pathways, thereby blocking the proliferation, migration and invasion of tumor cells. It has currently been approved for the first-line and post-line treatment of patients with advanced NSCLC carrying MET exon 14 skipping mutations, providing the possibility of longer survival benefits for such patients with poor prognosis.

The global market size related to tepotinib was approximately USD 320 million in 2023. With the improvement of the penetration rate of MET mutation detection and the expansion of indication scope, it is expected that the compound annual growth rate will remain around 12% by 2028. In the current market landscape, the originator product occupies a dominant position. No generic drug has been approved in China, and only multiple pharmaceutical companies are in the stages of generic drug research and development and bioequivalence trials. With the subsequent expiration of patents and the advancement of domestic pharmaceutical companies' declaration, market accessibility is expected to be further improved.

The originator enterprise of tepotinib is Merck Serono, and the original brand name is Tepmetko. The core compound patent will expire in 2032 in the United States, the European Union and China. The main dosage form approved for the originator product is tablet, with specifications of 250 mg and 220 mg (calculated based on tepotinib). It has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs (Fifth Batch)*. Up to now, 3 enterprises in China have submitted DMF registrations for tepotinib API, which are in the public notice state. The originator product and 2 domestic tepotinib tablets have been approved for marketing by the NMPA. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for tepotinib API. Most products are in stock. For in-stock products, orders 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 standard use needs of pharmaceutical enterprises in the process of API R&D, quality research and production.