Crizotinib

In response to the demand for precise treatment of ALK-positive non-small cell lung cancer (NSCLC), crizotinib, as the world's first approved ALK tyrosine kinase inhibitor, competitively inhibits the ATP binding sites of kinases such as ALK, ROS1 and c-MET, and blocks the abnormal activation of downstream signaling pathways, thereby inhibiting the proliferation and metastasis of tumor cells. It is mainly used clinically to treat patients with ALK-positive locally advanced or metastatic NSCLC and ROS1-positive advanced NSCLC. As a first-line treatment recommended by guidelines for such patients, it significantly prolongs the median progression-free survival of patients, and reverses the treatment dilemma of limited benefit from traditional chemotherapy for such patients.

Data show that the market size of ALK inhibitors in China has exceeded 7.5 billion yuan in 2023, with a compound annual growth rate of more than 22% in the past five years. Among them, the first-generation ALK inhibitors still account for nearly 30% of the market share, with stable clinical demand. In terms of competitive landscape, after the patent expiration of crizotinib, domestic generic drugs have been approved rapidly. At present, more than 10 enterprises have obtained generic drug approvals through consistency evaluation, and the products have been included in multiple batches of national centralized drug procurement. The winning price has dropped by more than 90% compared with the peak price of the original drug, further improving the drug accessibility for primary-level patients.

The original developer of crizotinib is Pfizer, with the original brand name "Xalkori". Its core compound patent in China expires in March 2024, and the crystal form patent expires in September 2028. The main dosage form approved for the original drug is capsules, with specifications of 200mg and 250mg, which have been included in the China Listed Medicines Catalogue and the FDA Reference Preparations Catalogue. Up to now, there are nearly 20 registration numbers of crizotinib API on the API registration platform of the Center for Drug Evaluation of China, most of which are in status A (approved for co-review with preparations), and multiple generic drug preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for crizotinib API. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurities are available from stock. Stock orders submitted before 16:00 can be shipped on the same day, which can fully meet the reference substance use needs of pharmaceutical enterprises in all links such as API R&D, quality research and stability study.