Dacomitinib

In response to the clinical treatment needs of EGFR mutation-positive non-small cell lung cancer (NSCLC), the second-generation EGFR tyrosine kinase inhibitor (TKI), with its mechanism advantage of irreversible binding to targets, effectively compensates for the shortcoming of rapid drug resistance of the first-generation drugs, and dacomitinib is a representative variety of this type of drugs. It covalently binds to the kinase domains of EGFR, HER2 and HER4 to durably block the conduction of downstream signaling pathways, and is clinically mainly used for the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutation. Compared with the first-generation EGFR-TKI, it can significantly prolong the progression-free survival of patients, and especially brings better long-term survival benefits to Asian mutant populations.

In 2023, the overall market size of EGFR-TKI in China exceeded 18 billion yuan, of which the second-generation products accounted for approximately 12%, with a compound annual growth rate of 22% in the past three years, and the growth rate was significantly higher than that of the mature first-generation varieties. At present, the domestic dacomitinib preparation market is still dominated by the original research drug, and 3 local pharmaceutical companies have submitted marketing applications for generic drugs. As the patent expiration date approaches, it is expected that the launch of generic drugs in the next 2-3 years will rapidly promote the increase of product penetration, and the corresponding API market demand will also be released simultaneously, with the market size expected to exceed 120 million yuan in 2025.

The original research enterprise of dacomitinib is Pfizer, with the trade name Vizimpro®. Its Chinese compound patent expires in 2031, and the indication patent expires in 2024. At present, the main dosage form of the original research marketed product is tablet, with specifications including 15mg, 30mg and 45mg. It has been included in the Catalogue of Marketed Drugs in China as the reference listed drug, and is also included in the FDA Reference Listed Drug Catalog. In terms of API registration, Pfizer's dacomitinib API has completed A-status registration at the CDE. Currently, 6 domestic enterprises have submitted API registration applications, among which 3 are in A status, and 11 other enterprises have obtained marketing approval for dacomitinib tablets. (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 dacomitinib API, covering all categories such as process impurities and degradation impurities, all of which meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA. Most products have sufficient spot inventory, and orders placed before 16:00 can be shipped on the same day, which can fully meet the quality research needs of pharmaceutical enterprises in the process of R&D and production, and effectively shorten the project promotion cycle.