Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, and AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, announce that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted a second New Drug Application (NDA) for taletrectinib adipate capsule (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI). This NDA is for taletrectinib as a first-line treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have not previously been treated with ROS1 TKIs.

In November 2023, the NMPA accepted taletrectinib's first NDA and granted Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have been previously treated with ROS1 TKIs. Both NDAs in China are based on positive results from the Phase 2 TRUST-I (NCT04395677) trial. Data from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023 and additional data from TRUST-I is planned to be presented at an upcoming medical meeting in 2024.

Professor Caicun Zhou, Principal Investigator and Oncologist at Shanghai Pulmonary Hospital, stated:" I am pleased this second NDA for taletrectinib has been accepted in China. We need additional options for our patients who are newly diagnosed with advanced or metastatic ROS1-positive NSCLC that may improve upon the first-generation medicines"

Dr. Hui Zhou, Senior Vice President of Innovent, stated:"Given the clinically demonstrated benefits of taletrectinib in the TRUST-I trial, we are pleased to see the second NDA accepted by the NMPA of China. We will continue close communications with our partner AnHeart Therapeutics and regulatory authorities in China, hoping to bring this new generation of targeted therapy to all appropriate patients with ROS1-positive NSCLC as a standard initial treatment option."

Bing Yan, MD, President of AnHeart China, stated: "The acceptance of this NDA in China supports our belief in taletrectinib as a first-line treatment for people with advanced or metastatic ROS1-positive NSCLC, and we are excited by the opportunity to bring a potentially transformative medicine to people earlier in their treatment journey. We plan to work closely with our partner Innovent and regulatory authorities in China to continue progressing taletrectinib as part of our mission to improve the lives of people with cancer. "