AnHeart Therapeutics and Innovent Biologics, Inc. announced that the Center for Drug Evaluation (CDE) of China?s National Medical Products Administration (NMPA) has accepted a second New Drug Application (NDA) for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI). This NDA is for taletrectinib as a first-line treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have not previously been treated with ROS1 TKIs. In 2023, China?s NMPA accepted taletrectinib?s first NDA and granted Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have been previously treated with ROS1 TKIs.

Both NDAs in China are based on positive results from the Phase 2 TRUST-I (NCT04395677) trial. Data from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023 and additional data from TRUST-I is planned to be presented at an upcoming medical meeting in 2024.