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Innovent/AnHeart File China NDA for ROS1 Inhibitor to Treat NSCLC

publication date: Mar 5, 2024

Suzhou Innovent and AnHeart Therapeutics of Hangzhou have filed a second NDA of their partnered next-gen ROS1 TKI in China. The new NDA, which has been accepted for review by China’s CDE, is for use of taletrectinib as a first-line therapy for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have not previously been treated with a ROS1 TKI. The first NDA filing was for NSCLC patients who have been previously treated with ROS1 TKIs. In 2021, Innovent entered a $189 million agreement with AnHeart to commercialize taletrectinib in Greater China. More details....

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