Nilotinib

The treatment of chronic myeloid leukemia (CML) has long relied on the precise intervention of tyrosine kinase inhibitors. As a second-generation BCR-ABL tyrosine kinase inhibitor, nilotinib binds to the ATP-binding site of ABL protein in a targeted manner, potently inhibiting the autophosphorylation of BCR-ABL and downstream signal transduction. It has remarkable efficacy in adult patients with Philadelphia chromosome-positive CML in chronic phase and accelerated phase who are resistant or intolerant to imatinib, and can also be used as first-line treatment for newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase. It can deeply reduce the molecular response threshold of patients and significantly improve the long-term survival prognosis.

The global nilotinib market size has remained in the range of USD 1.8 to 2.0 billion in recent years. With the increase in the detection rate of CML patients and the release of demand for second-line treatment, the market size is expected to exceed USD 2.4 billion by 2028, with a compound annual growth rate of approximately 3.8%. In terms of the Chinese market, the sales of nilotinib in sample hospitals exceeded RMB 1.2 billion in 2023, with a growth rate of 10.2%. Currently, the original research product still occupies a dominant position. Generic preparations from 3 domestic enterprises have passed the consistency evaluation, and have been included in the National Reimbursement Drug List (Category B), so the accessibility of drugs for patients continues to improve.

The original research enterprise of nilotinib is Novartis, and the original brand name is Tasigna®. Its core compound patent expired in China in 2023, and the crystal form patent will expire in 2027. The main dosage form approved for the original product is capsules, with specifications of 150 mg and 200 mg, 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, 7 enterprises including the original research manufacturer have submitted nilotinib APIs that have passed the CDE review and public notification (status A) so far, and a number of domestic nilotinib capsule preparations have been approved for marketing. (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 nilotinib API, covering degradation impurities, process impurities and corresponding isotope labels. The vast majority of products are available from stock. Stock 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, with complete and traceable impurity purity and structural characterization data, which fully meets the full-process requirements of API R&D, quality research and registration submission stages.