Core Insights - Lung cancer, particularly non-small cell lung cancer (NSCLC), has high global incidence and mortality rates, with NSCLC accounting for about 85% of all cases. In China, approximately 2.6% of NSCLC patients are ROS1-positive [1][3] - DOVBLERON® (taletrectinib) has been approved by China's National Medical Products Administration (NMPA) for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs, marking it as the 13th addition to Innovent's commercial portfolio [10][14] - The approval is based on positive results from the TRUST-I trial, which demonstrated DOVBLERON®'s efficacy, particularly in patients with brain metastases and those who have developed resistance to prior therapies [11][12] Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing high-quality medicines for oncology and other major diseases, with a strong pipeline of targeted therapies [10][16] - The company has established partnerships with over 30 global healthcare companies, enhancing its capabilities in drug development and commercialization [16] Product Details - DOVBLERON® is a next-generation ROS1 inhibitor designed for advanced ROS1-positive NSCLC, with a favorable safety profile and low rates of dose reduction due to adverse events [4][11] - Taletrectinib has received Orphan Drug Designation and Breakthrough Therapy Designations from the U.S. FDA and China's NMPA, indicating its potential to address unmet medical needs in this patient population [5][14]
Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China's National Medical Products Administration