Capmatinib

For patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutation, the options of previous clinical treatment regimens are limited, and the overall prognosis is poor. The advent of capmatinib has filled the gap in this细分治疗领域？不对，细分治疗领域是this niche treatment area.哦对，重新来：For patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutation, the options of previous clinical treatment regimens are limited, and the overall prognosis is poor. The advent of capmatinib has filled the gap in this niche treatment area. As a highly selective oral MET tyrosine kinase inhibitor, it can accurately block the conduction of downstream signaling pathways mediated by MET receptors and inhibit the proliferation and migration of tumor cells. It is not only approved for the first-line and post-line treatment of adult patients with locally advanced or metastatic NSCLC carrying METex14 skipping mutation, but also shows clear clinical benefits for targeted drug-resistant populations with MET amplification, and is one of the core targeted drugs for the treatment of tumors with abnormal MET pathway.

The global market size related to capmatinib has maintained a relatively rapid growth trend in recent years, and the market size has exceeded 400 million US dollars in 2023. Since METex14 skipping mutation accounts for about 3%-4% of NSCLC patients, with the improvement of the penetration rate of companion diagnosis and the expansion of combination drug regimens, there is still room for continuous release of market demand. At present, the original research products still occupy the major market share worldwide, and many pharmaceutical enterprises in multiple countries including China have started the R&D and declaration work of generic drugs, and the market competition pattern is expected to be gradually restructured after the patent expires.

The original research enterprise of capmatinib is Novartis, and the original brand name is Tabrecta. The core compound patent of capmatinib expires in 2030 in the United States, and the compound patent expires in 2031 in China. The main dosage form approved for the original research product is tablet, with specifications of 150mg and 200mg, and it has been included in the FDA Reference Listed Drug Catalog. As of now, there is no marketing registration information for the API of the original research capmatinib in mainland China. The original research preparation was approved by the NMPA for import and marketing in 2023, and no generic preparation has been approved in China. (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 capmatinib API. Most products are in regular stock, and spot orders paid before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of reference standards in the stages of API R&D, quality research and declaration.