China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving an additional marketing approval from the National Medical Products Administration (NMPA) for its drug taletrectinib. This second-generation ROS1 tyrosine kinase inhibitor is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The recent endorsement follows an earlier NMPA approval in December 2024 for the drug to treat adult patients with ROS1 positive locally advanced or metastatic NSCLC that has progressed after ROS1-TKI therapy.
Co-Development and Global Reach of Taletrectinib
Taletrectinib, which is co-developed and commercialized by AnHeart Therapeutics Inc. (acquired by US firm Nuvation Bio Inc. earlier last year), was licensed in June 2021. The drug’s market filing was accepted for review by the US FDA with priority review status in December of last year. Having previously been awarded Orphan Drug Designation (ODD) by the agency, a decision on taletrectinib is expected by June 23, 2025.
Expanding Access to Taletrectinib for NSCLC Patients
The additional marketing approval from the NMPA further expands access to taletrectinib for patients with ROS1 positive NSCLC in China. This development is a significant step forward in providing more treatment options for patients battling this aggressive form of lung cancer and highlights Innovent Biologics’ commitment to advancing oncology treatments.-Fineline Info & Tech
