I already know the news! Detailed time for gilitinib to be launched

Gilteritinib, branded as It was developed by Astellas Pharma. In April 2018, Astellas submitted a new drug application to the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML).

Subsequently, the FDA accelerated approval of gilitinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have FLT3 mutations detected byan FDA-approved test. Giritinib has been granted orphan drug status by the US FDA, the European Commission (EC) and the Japanese Ministry of Health, Labor and Welfare for use in some AML patients. Giritinib was approved for medical use in Australia in March 2020. In January 2022, giritinib was approved by the National Medical Products Administration and was launched in China under the name of giritinib fumarate tablets/segatan.

The domestically marketed original drug Giritinib has not yet been included in medical insurance. The price of each box of 40mg*42 tablets may be more than 20,000 yuan. The price of the Hong Kong version of the original drug is about 90,000 yuan per box. The price of the European version of the original drug, 40mg*84 tablets, per box listed overseas is around RMB 210,000 (the price may fluctuate due to exchange rates), which is very expensive. Generic drugs of giritinib are currently produced and sold overseas, and their drug ingredients are basically the same as those of the original drugs sold domestically and abroad. For example, the price of 40mg*84 tablets per box produced by a Laos pharmaceutical factory is more than 4,000 yuan (the price may fluctuate due to the exchange rate).