Innovent Biologics, a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that China’s National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) of DOVBLERON (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.

DOVBLERON marks the 13th addition to Innovent’s commercial portfolio, representing an innovative precision therapy expected to benefit more lung cancer patients alongside our strong TKI franchise.

Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive.

The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated the potential of DOVBLERON to address unmet needs, particularly in patients with limited therapeutic options after treatment with prior ROS1-targeted therapies.

In addition, a second NDA for DOVBLERON was accepted and granted Priority Review Designation by China’s NMPA in March 2024 for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have not previously been treated with ROS1 TKIs.