Midostaurin

For FLT3-mutated positive acute myeloid leukemia, a hematological malignancy with poor clinical prognosis, midostaurin, the world's first approved multi-target kinase inhibitor, simultaneously inhibits the activities of multiple kinases such as FLT3, KIT and PDGFR to block the key signaling pathways for tumor cell proliferation and survival. In clinical practice, in addition to being combined with standard induction and consolidation chemotherapy for newly diagnosed adult patients with FLT3-mutated positive acute myeloid leukemia, it can also be used as monotherapy for aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, and mast cell leukemia, filling the previous gap of effective targeted therapy for the above indications.

The global market size of midostaurin had exceeded USD 870 million by 2023, and is expected to grow steadily at a compound annual growth rate of 5.2% from 2024 to 2030. The growth drivers mainly come from the increased penetration rate of FLT3 mutation testing in patients with acute myeloid leukemia and the improved clinical diagnosis rate of systemic mastocytosis. The current market is still dominated by the original research product, whose core patents have successively expired in multiple major markets. At present, no generic drug has been approved for marketing in China. In the future, with the gradual improvement of API supply supporting facilities, the launch of generic drugs is expected to further improve drug accessibility.

The original research enterprise of midostaurin is Novartis, with the original trade name Rydapt. Its core compound patent in the United States expired in 2021, and the core compound patent in China expired in 2022. The dosage form approved for the original research product is capsule, with two specifications of 25mg and 100mg. The 25mg specification has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *Catalog of Reference Listed Drugs for Chemical Drugs* of China. Up to now, no midostaurin API has been approved for registration in China. The original preparation was approved for marketing in China by the NMPA in 2021, and it is only indicated for adult patients with FLT3-mutated positive acute myeloid leukemia. (Data as of October 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for midostaurin API, covering all known degradation products and process impurities, which can meet the needs of the whole process of API research, preparation quality control and registration declaration. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can be directly used for relevant compliance research.