Bosutinib

The long-term treatment of chronic myeloid leukemia (CML) is highly dependent on the precise targeted effect of tyrosine kinase inhibitors (TKI). As a second-generation TKI drug, bosutinib specifically inhibits the activities of BCR-ABL kinase and Src family kinases to block downstream abnormal proliferation signaling pathways. It is mainly indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and accelerated phase who are resistant or intolerant to previous TKI therapy, providing an alternative treatment option for patients who cannot tolerate first-generation drugs or develop drug resistance. Meanwhile, it has also demonstrated a superior early molecular response rate in the population of newly diagnosed patients.

The global market size of bosutinib was approximately USD 870 million in 2023, with a compound annual growth rate maintained at around 7%. The growth drivers mainly come from the long-term medication demand of CML patients, the improvement of accessibility in emerging markets, and the advancement of medical insurance coverage for second-line TKIs in some regions. In terms of the competitive landscape, the original research product still accounts for more than 85% of the market share. At present, only a small number of pharmaceutical companies have submitted marketing applications for generic drugs. As the core patents expire successively, the generic drug substitution space is expected to be gradually released. If there is no verifiable data, please refer to the official disclosure.

The original research enterprise of bosutinib is Pfizer, and the original brand name is Bosulif. Its core compound patent in the United States expired in 2027, and the compound patent in China expired in 2024. The main dosage form approved for the original research product is tablet, with three specifications including 100mg, 400mg and 500mg. The original research product has been included in the FDA Reference Listed Drug Catalog, and has also been included in China's Catalog of Reference Preparations for Chemical Drugs. At present, a number of domestic enterprises have submitted DMF registrations for bosutinib API, some of which are in active status. The original research preparation and a number of generic drug preparations have been approved for marketing by China NMPA. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the impurity research needs in the process of bosutinib R&D and quality control, CATO can provide a full set of impurity reference standards for this API, covering all types of research objects such as process impurities and degradation impurities. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet various research needs of drug R&D, consistency evaluation and post-marketing quality supervision.