Is Quizartinib already on the market in China?

Quizartinib (Quizartinib) is an innovative FLT3 inhibitor specifically designed to treat patients with acute myeloid leukemia (AML) who carry FLT3-ITD mutations. Such mutations are common molecular features with poor prognosis in AML, so the development of targeted drugs has attracted widespread global attention. Quizartinib is marketed overseas under the trade name Vanflyta and has been approved by the US FDA in 2023 for maintenance treatment after combination with standard chemotherapy. However, as of 2025, the original drug Quizartinib has not been officially approved for marketing in mainland China, nor has it been included in the approval list of the National Medical Products Administration (NMPA).

From a policy perspective, China's drug regulatory authorities have accelerated the introduction and review of tumor-targeted drugs in recent years. For example, Gilteritinib and other similar drugs have entered the domestic market earlier. As a rising star, Quizartinib’s launch pace may be affected by the progress of clinical trials, submission of local registration materials and the progress of cooperation between Chinese and foreign companies. Although there is no official approval information yet, there are signs that some hospitals have started the introduction of overseas clinical data and patient medication registration, showing its potential to enter the Chinese market in the future.

In terms of price, as it has not yet been officially launched in China, the price of quizartinib in China is still uncertain. Currently, in the overseas pharmacy market, its selling price is relatively high, mainly due to research and development costs and the existence of patent protection periods. After it is officially introduced into the country and included in the national medical insurance catalog, its price is expected to drop significantly.

From the perspective of patient treatment, the clinical advantage of quizartinib lies in its highly selective inhibitionFLT3-ITD mutated leukemia cells, providing new treatment ideas for relapsed or drug-resistant patients. Foreign studies have shown that the drug has better disease control capabilities and long-term survival benefits in combination treatment regimens.

Reference materials:https://go.drugbank.com/drugs/DB12874