Canertinib

For the clinical treatment of EGFR mutation-positive non-small cell lung cancer, targeted tyrosine kinase inhibitors are the current core medication regimen. Canertinib, as an irreversible pan-EGFR inhibitor, can simultaneously target multiple targets including EGFR, HER2 and HER4, and block the phosphorylation process of receptor tyrosine kinases through covalent binding. Compared with the first-generation reversible EGFR inhibitors, it can better overcome the T790M resistance mutation and reduce the risk of drug resistance. It is clinically mainly used for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 19 deletion or exon 21 L858R substitution mutation. There are also studies exploring its therapeutic potential in HER2-positive breast cancer, providing a new medication option for patients who have developed drug resistance after previous treatment with first-generation EGFR-TKIs.

At present, the global market size of pan-EGFR inhibitors has exceeded 12 billion US dollars, with a compound annual growth rate maintained at around 8.2%, among which the third-generation and subsequent iterative irreversible EGFR inhibitors account for more than 60%. In the domestic lung cancer targeted drug market, canertinib is still in the market introduction stage. Due to the limited number of marketed products with the same target currently approved, and the unmet clinical needs of the T790M resistant population, its market growth space is considerable. There is no publicly verifiable data on the segmented market size and share.

The original developer of canertinib is Pfizer, with the original brand name "Campto". The core compound patent will expire in China in 2030. At present, the main formulation approved for the original drug is tablet, with three specifications of 150mg, 200mg and 300mg, which has been included in the FDA Reference Listed Drug Catalog. As of the retrieval time point, no domestic enterprise has submitted the marketing registration application (Status A) for canertinib active pharmaceutical ingredient, no canertinib preparations produced by domestic enterprises have been approved for marketing, and the original product has not been officially launched in the Chinese market. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of canertinib impurity reference standards. Most products have sufficient spot inventory. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for drug R&D, quality research and declaration processes, fully meeting the R&D needs of different stages.