Is Midostaurin available in China? 2025 Marketing Progress and Drug Purchasing Guide

Midostaurin is a drug used to treat acute myeloid leukemia (AML) and other hematological malignancies. The original drug Rydapt is produced by Novartis. The main mechanism of action of midostaurin is to inhibit the proliferation of leukemia cells by inhibiting the activity of FLT3 and other tyrosine kinases. It has important therapeutic value especially for AML patients with FLT3 mutations.

目前，米哚妥林的原研药尚未在中国市场上市。国内AML治疗仍以化疗、造血干细胞移植及其他靶向治疗为主，米哚妥林的批准进展相对缓慢。然而，随着中国对新药审批流程的逐步优化，预计米哚妥林将在不久的未来进入中国市场。

According tothe market forecast for 2025, the progress of midostaurin's launch in China is relatively positive, especially under the accelerated approval policy of the China National Medical Products Administration, the approval application of midostaurin has entered the review stage. In 2024, midostaurin submitted a marketing application and entered the accelerated approval process.预计在2025年，米哚妥林有望正式在中国上市，进一步扩大AML及其他血液系统恶性疾病的治疗选择。

对于患者来说，在米哚妥林未上市之前，可能需要依赖进口药物。根据现有政策，患者可以通过“特殊病种申请”或“境外购药”渠道获取米哚妥林。 In some top tertiary hospitals in big cities, patients can apply for overseas drug purchase under the guidance of a doctor, and usually need to provide the doctor's prescription and relevant supporting documents. At the same time, patients can also consider purchasing midostaurin from other countries through international drug purchase platforms, but they need to pay attention to the legality and authenticity verification of the drug.

Reference materials:https://medlineplus.gov/druginfo/meds/a617033.html