Analysis of the pharmacological mechanism and principle of Quizartinib

Quizartinib (Quizartinib) is a targeted therapy drug targeting FLT3 mutations. It is mainly used to treat acute myeloid leukemia (AML) patients. FLT3 is one of the most common gene mutations in AML. About 25%-30% of AML patients carry FLT3 internal tandem duplication (ITD) mutations. Targeted drugs targeting this mutation, especially quizartinib, have received widespread attention and clinical application in many countries and regions around the world.

However, although quizartinib has been clinically approved and has made certain clinical progress in Europe and the United States, its launch in the Chinese market is still in the review stage. As of January 2026, the original drug Quizartinib has not yet been officially launched in the Chinese market. According to public information, the manufacturer of quizartinib has submitted a drug registration application to the China Food and Drug Administration (NMPA), and the drug’s clinical data has proven that it has significant efficacy in patients with FLT3 mutation-positive AML. However, due to the complexity of China's drug approval process and market access challenges, the launch of Quizartinib has been relatively slow.

As a country with a high incidence of AML in the worldChina is in urgent need of innovative drugs to improve the shortcomings of existing treatment options. Although existing treatments include chemotherapy and hematopoietic stem cell transplantation, many AML patients, especially FLT3 mutation-positive patients, still face problems of high relapse and drug resistance. Quizartinib, as a targeted therapy, is expected to fill this treatment gap and provide more precise and efficient treatment options.

According to existing information, the clinical trial data of Quizartinib also shows good therapeutic effects in Chinese patients. Especially after combined with chemotherapy, quizartinib can further improve the patient's response rate and survival period, which brings new hope to Chinese AML patients. Nonetheless, the specific launch time still needs to wait for the final approval results from the Chinese Food and Drug Administration.

Keyword tags: Quizartinib,AML, FLT3 mutation, Chinese market, drug registration, treatment progress

References：https://www.drugs.com/mtm/quizartinib.html