Ponatinib

For refractory chronic myeloid leukemia (CML) resistant to tyrosine kinase inhibitors and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), there has been a long-term lack of effective treatment options in clinical practice, until the advent of ponatinib, a third-generation TKI drug, filled this gap. As a multi-target tyrosine kinase inhibitor, it can potently inhibit the wild-type BCR-ABL kinase and all known mutant subtypes including T315I, and suppress the proliferation of tumor cells by blocking abnormal kinase signaling pathways. It is mainly indicated for adult patients with all phases of CML who are resistant or intolerant to prior TKI therapy, as well as patients with Ph+ ALL, providing a critical treatment pathway for the refractory hematopathy population with no available drugs.

At present, the global market size of ponatinib has exceeded 1.2 billion US dollars, with a compound annual growth rate remaining above 9%. The core driving force for the growth comes from the unmet clinical needs of the global refractory hematopathy patient population, as well as the continuous increase in the penetration rate of targeted therapy for hematological malignancies. The domestic market is still in the introduction stage. The original research product was just approved for marketing in 2023, and no generic drug has been approved yet, with a highly concentrated competitive landscape. With the improvement of clinical awareness and the subsequent layout of generic drug enterprises, the market size is expected to enter a rapid growth stage in the next 3 years.

The original research enterprise of ponatinib is ARIAD Pharmaceuticals, a subsidiary of Takeda Pharmaceutical, and the original research trade name is Iclusig. The expiration date of the core compound patent in the United States is 2027, and the expiration date of the core compound patent in China is 2028. The dosage form of the original research marketed product is tablet, with specifications including 15mg, 30mg and 45mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs* issued by China NMPA. Up to now, a number of domestic enterprises have submitted DMF registration applications for ponatinib API, and no generic drug preparation has been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for ponatinib API. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the whole process of API R&D, quality research and registration declaration.