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 New Drug Application (NDA) for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI), has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, 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.

The NDA acceptance are based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients. Results from an interim analysis of the TRUST-I trial were presented at the European Lung Cancer Congress (ELCC) 2023.[Link]

Professor Caicun Zhou, Principal Investigator and Oncologist at Shanghai Pulmonary Hospital, stated: "We have extremely limited options for our patients with ROS1-positive NSCLC, especially those with brain metastases who represent more than one-third of patients, and those who go on to develop resistant mutations, which is more than half of patients. Once patients progress on the current options, there are no approved treatments. I hope this NDA represents a step towards making another option available to the ROS1-positive NSCLC patient community in China."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are encouraged by the best-in-class efficacy and safety profile that taletrectinib demonstrated in the TRUST-I trial, and are excited about the NDA acceptance in China. Together with our partner AnHeart, we will work closely with the NMPA to bring this precision therapy to NSCLC patients who are in need of novel treatment options, especially those with acquired resistant mutations or with brain metastases."

Bing Yan, MD, Chief Medical Officer of AnHeart, stated: "Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally. We would like to thank all the doctors and patients who participated in the clinical trials that support this submission. We look forward to working with our partner Innovent and the regulatory authorities in China to hopefully make taletrectinib available to patients in need as soon as possible."