ROCKVILLE, Md. and SUZHOU, China, Nov. 22, 2023 /PRNewswire/ -- 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 NSCLCROS1-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 NSCLCROS1-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."
, 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."
More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 3% of people with NSCLC in China are ROS1-positive. There are approved first-generation TKIs for people with newly diagnosed advanced or metastatic ROS1-positive NSCLCROS1-positive NSCLC and no approved therapies for people whose ROS1-positive NSCLC has progressed following treatment with these medicines. Up to 35% of people newly diagnosed with metastatic ROS1-positiveNSCLC have tumors that have spread to their brain (brain metastases), the number increases to approximately 55% for those whose cancer has progressed following initial treatment.
Taletrectinib was evaluated in ROS1-positive NSCLC patients in two Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial. Positive interim results from TRUST-II trial were reported at the ELCC 2023, and positive interim results from TRUST-II trial were reported at the European Society of Medical Oncology Congress 2023.[Link]
Taletrectinib was granted Breakthrough Therapy Designation (BTD) by the CDE of NMPA in 2022 for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLCROS1-positive NSCLC who have previously been treated with a ROS1 TKI as well as those who have not previously been treated by a ROS1 TKI (TKI-naïve). In addition, taletrectinib has also been granted BTD for the treatment of ROS1-positive NSCLC by the U.S. Food and Drug Administration in the United States in 2022.
Innovent has also entered into 30 strategic collaborations with EliLilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer CenterCancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.
Our mission is to improve the lives of people with cancer. We are supported by leading life sciences investors and have built an organization with deep oncology drug discovery and development expertise, with offices in New York and Shanghai. For more information, visit https://www.anhearttherapeutics.com/ or follow us on LinkedIn at https://www.linkedin.com/company/anheart-therapeutics-official/.
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
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