Innovent, AnHeart announce China NMPA accepts NDA for ROS1 Inhibitor, taletrectinib to treat NSCLC

Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical company, and AnHeart Therapeutics (AnHeart), a global clinical-stage biopharmaceutical company, 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.

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.”

In June 2021, Innovent and AnHeart entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

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 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-positive NSCLC have tumours that have spread to their brain (brain metastases), the number increases to approximately 55% for those whose cancer has progressed following initial treatment.

Taletrectinib is an oral, potent, brain penetrant, selective, next-generation potential best-in-class ROS1 inhibitor being evaluated for the treatment of ROS1-positive NSCLC.

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.

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 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 US Food and Drug Administration in the United States in 2022.

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives.

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