Dasatinib

The clinical treatment of chronic myeloid leukemia (CML) has long relied on tyrosine kinase inhibitors. As a second-generation multi-target tyrosine kinase inhibitor, dasatinib can potently inhibit multiple targets such as BCR-ABL kinase, SRC family kinases and c-KIT, overcoming the mutation problem that causes resistance to some of the first-generation imatinib. It is clinically indicated mainly for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, accelerated phase and blast phase who are resistant or intolerant to prior therapies including imatinib. Meanwhile, it has also been approved for the combination therapy of pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia, providing a better treatment option for patients with refractory hematological diseases of different age groups.

At present, the global dasatinib market size is stably above 2 billion US dollars, and the annual growth rate of the Chinese market maintains at 12%~15%. In 2023, the sales volume in domestic sample hospitals exceeded 900 million yuan. With the expiration of the core patent in 2020, domestic generic drug enterprises have accelerated their layout. Dasatinib preparations from nearly 10 enterprises have been approved for marketing, and this variety has been included in the 7th batch of national centralized volume-based procurement. The bid-winning price has dropped by more than 90% compared with the original research drug, which greatly improves the clinical accessibility, and also drives the continuous expansion of the demand for upstream API. At present, the domestic API supply presents a competitive pattern where original research authorization and local enterprises coexist.

The original research enterprise of dasatinib is Bristol-Myers Squibb, with the original trade name "Sprycel". Its core compound patent expired in the United States in 2020, and the core compound patent in China also expired in 2020. The main dosage form approved for the original research drug is tablet, with specifications including 20mg, 50mg, 70mg and 100mg, which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. In terms of domestic API registration, there have been nearly 10 dasatinib API registration numbers, most of which have obtained Status A through the joint evaluation and approval with preparations, and a number of generic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D and production quality control needs of dasatinib, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises for registration and declaration, quality research and daily production testing.