Innovent wins another approval in China for Dovbleron

China’s National Medical Products Administration (NMPA) has approved the second 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).

The approval was granted to China-based Innovent Biologics (HKEX: 01801), whose shares edged up 2.3% to $4.82 on Friday following the announcement.

The approval is based on positive results from the pivotal Phase II TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated the safety, tolerability and efficiency of 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 that taletrectinib continued to show high and durable overall responses and robust activity against intracranial lesions.