Nilotinib

The long-term clinical medication adherence of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) is directly related to the kinase inhibition selectivity of the drug. As a second-generation tyrosine kinase inhibitor (TKI), nilotinib can precisely target the Bcr-Abl fusion protein, block the transduction of downstream tumor proliferation signals by inhibiting its abnormally activated kinase activity. Clinically, it is mainly used to treat adult patients with chronic-phase and accelerated-phase Ph+CML who are resistant or intolerant to previous first-generation TKIs (including imatinib). Meanwhile, it has also been approved as the first-line treatment for pediatric patients over 2 years old with chronic-phase Ph+CML. Compared with first-generation drugs, it reduces the adverse reactions caused by off-target effects and significantly improves the long-term quality of life of patients.

The global nilotinib market size exceeded USD 1.9 billion in 2023. Driven by the increase in the global CML diagnosis rate and the expansion of pediatric indications, it is expected to grow steadily at a compound annual growth rate of 2.1% from 2024 to 2030. After the expiry of the original research patent in 2023, generic drugs from 3 domestic enterprises have been approved for marketing, and have been included in the seventh batch of national centralized drug procurement. The price of the winning products has dropped by more than 80% compared with the original drug. The capacity release of the winning enterprises has directly driven the rapid growth of demand for upstream APIs and related impurity reference standards.

CATO can provide a full set of impurity reference standards for nilotinib API. All products meet the compliance requirements of both Chinese Pharmacopoeia and FDA regulations, with complete structure confirmation and purity data. Sufficient stock is available for core products, which can meet the needs of various scenarios such as generic drug consistency evaluation, quality research and routine release testing of pharmaceutical enterprises.