Innovent Announces Second New Drug Application of DOVBLERON ® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) was Approved by China's National Medical Products Administration

Core Viewpoint - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor, for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) [1][6]. Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing, manufacturing, and commercializing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [1][9]. - The company has launched 13 products and has multiple new drug applications under regulatory review, showcasing its commitment to innovative therapies [9]. Product Details - DOVBLERON® is an oral, potent, central nervous system-active, selective next-generation ROS1 inhibitor, currently evaluated in pivotal studies TRUST-I and TRUST-II for advanced ROS1-positive NSCLC [5][7]. - The approval of DOVBLERON® is based on positive results from the TRUST-I trial, which demonstrated a confirmed objective response rate (cORR) of 91% in ROS1 TKI-naïve patients [2][3]. Clinical Trial Insights - The TRUST-I trial showed high and durable overall responses, with a median follow-up of 23.5 months, indicating that the median duration of response and median progression-free survival were not reached [2][3]. - The trial results were presented at the 2024 ASCO Annual Meeting and published in the Journal of Clinical Oncology, reinforcing the efficacy of DOVBLERON® compared to first-generation TKIs [2][3]. Market Context - Lung cancer has a high global incidence and mortality rate, with NSCLC accounting for approximately 85% of all cases. In China, about 2.6% of NSCLC patients are ROS1-positive [4]. - There is a significant need for more effective and tolerable treatment options for patients with metastatic ROS1-positive NSCLC, particularly those with brain metastases or resistance mutations [4]. Regulatory and Developmental Milestones - DOVBLERON® has received Orphan Drug Designation and Breakthrough Therapy Designations from the U.S. FDA and China's NMPA, highlighting its potential in treating ROS1-positive NSCLC [7]. - Innovent has partnered with AnHeart Therapeutics for the co-development and commercialization of taletrectinib in Greater China, indicating strategic collaborations to enhance market reach [8].