AnHeart Therapeutics and Innovent Announce China NMPA Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation

AnHeart Therapeutics a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, and Innovent Biologics, Inc. 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, today announced the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review Designation for the New Drug Application (NDA) of taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI), 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 CDE accepted the NDA in November 2023.

“Taletrectinib’s Priority Review Designation reinforces the urgent need for patients with ROS1-positive NSCLC who were previously treated with ROS1 TKIs in China and the significant clinical advance that taletrectinib may represent for these patients,” said Bing Yan, MD, Chief Medical Officer, AnHeart. “We look forward to working with the regulatory authorities as they conduct their review of taletrectinib to hopefully bring this breakthrough investigational therapy to patients as soon as possible.”

“Taletrectinib’s potential as a best-in-class precision therapy is further underscored by the Priority Review Designation,” said Dr. Hui Zhou, Senior Vice President of Innovent. “We will continue to work with the regulatory authorities to support the review of taletrectinib with the goal of bringing this next-generation option to address unmet needs for ROS1-positive NSCLC patients in China.”

The NDA and Priority Review Designation in China are based on data from the Phase 2 TRUST-I trial (NCT04395677). Data from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023.

Priority Review Designation was established in China to accelerate the research and development of innovative drugs that have significant clinical advantages and for diseases where there is urgent clinical need. Priority Review Designation allows the CDE to prioritize the review process and evaluation resources for NDAs, which helps accelerate the market access of innovative drugs.

About Taletrectinib

Taletrectinib is an oral, potent, brain penetrant, selective, next-generation potential best-in-class ROS1 inhibitor.

Taletrectinib is being evaluated for the treatment of ROS1-positive NSCLC patients in two Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial.

In March 2022, taletrectinib was granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs as well as those who have not previously been treated by ROS1 TKIs (TKI-naïve).

Taletrectinib has also been granted Breakthrough Therapy Designation in the United States for the treatment of ROS1-positive NSCLC by the U.S. Food and Drug Administration (FDA).

In June 2021, AnHeart and Innovent 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.

About ROS1-Positive NSCLC in China

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 two 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 tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment.

About AnHeart Therapeutics

AnHeart Therapeutics (“AnHeart”) is a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer. Our lead investigational therapy, taletrectinib, is a next-generation ROS1-inhibitor currently in pivotal Phase 2 trials for ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration and the China National Medical Products Administration. AnHeart’s second investigational therapy, safusidenib, is a mIDH1-inhibitor being evaluated in Phase 2 trials for IDH1-mutant glioma.

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