Ensartinib Drug News

On August 8, 2020, the interim analysis results of the international >multicenter Phase III clinical trial of Ensartinib Hydrochloride were presented by Dr. Leora Horn from Vanderbilt University, USA, at the Presidential Symposium of the IASLC World Conference on Lung Cancer (IASLC WCLC). The results demonstrated that the median progression-free survival (mPFS) of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) treated with ensartinib was significantly longer than that of patients treated with crizotinib.

In November 2020, the National Medical Products Administration (NMPA) approved Ensartinib Hydrochloride Capsules for official marketing, which is indicated for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have progressed after prior treatment with crizotinib or
are intolerant to crizotinib.

In July 2021, the marketing application for the first-line treatment indication of Ensartinib Hydrochloride was accepted.

In December 2021, Ensartinib Hydrochloride was included in the National Medical Insurance Catalogue.

In March 2022, NMPA approved the marketing of Ensartinib Hydrochloride Capsules for the first-line treatment indication.

In December 2024, the U.S. Food and Drug Administration (FDA) approved the marketing of Ensartinib Hydrochloride.