AnHeart Therapeutics and Innovent Biologics have reported that the Center for Drug Evaluation (CDE) within China’s National Medical Products Administration (NMPA) has granted acceptance to a new drug application (NDA) for taletrectinib.

The next-generation ROS1 tyrosine kinase inhibitor (TKI) is intended for use in adult patients dealing with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), particularly those who have undergone prior treatment with ROS1 TKIs.

The approval of the NDA in China is grounded in favourable outcomes derived from the Phase 2 TRUST-I trial (NCT04395677). This multi-centre, open-label, single-arm trial focused on assessing taletrectinib among Chinese patients with ROS1-positive NSCLC. The interim analysis results from TRUST-I were disclosed at the European Lung Cancer Congress (ELCC) 2023.

AnHeart chief medical officer Bing Yan said: “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.”

Innovent senior vice president Dr Hui Zhou said: “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.”

In June 2021, AnHeart and Innovent forged an exclusive license agreement for the collaborative development and commercialisation of taletrectinib in Greater China, encompassing mainland China, Hong Kong, Macau, and Taiwan.

Taletrectinib received a Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) in 2022.

This designation is specifically for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have undergone prior treatment with a ROS1 tyrosine kinase inhibitor (TKI) and those who have not previously been treated with a ROS1 TKI (TKI-naïve).

Shanghai Pulmonary Hospital principal investigator and oncologist Caicun Zhou said: “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.”