China’s National Medical Products Administration’s (NMPA) Center for Drug Evaluation has accepted a new drug application (NDA) for AnHeart Therapeutics and Innovent Biologics’ taletrectinib to treat locally advanced or metastatic ROS1 (proto-oncogene 1)-positive non-small cell lung cancer (NSCLC).

NSCLC, the most common type of lung cancer, is diagnosed in more than a million people globally each year. 3% of individuals with NSCLC in China are ROS1-positive.

Taletrectinib, an oral, brain penetrant, selective and next-generation ROS1 tyrosine kinase inhibitor (TKI), is intended for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who were previously treated with ROS1 TKIs.

The NDA has been accepted based on positive data from the Phase II TRUST-I open-label, single-arm, multi-centre study, which assessed the therapy in NSCLC patients in China.

AnHeart chief medical officer Bing Yan stated: “Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally.

“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.”

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By GlobalData

In June 2021, AnHeart signed an exclusive licence agreement with Innovent to co-develop and commercialise taletrectinib in Greater China, including mainland China, Macau, Hong Kong and Taiwan.

The therapy obtained breakthrough therapy designation from the CDE in 2022 to treat adult patients with advanced or metastatic ROS1-positive NSCLC, whether or not they had previously received treatment with a ROS1 TKI.

It also secured breakthrough therapy designation from the US Food and Drug Administration to treat ROS1-positive NSCLC.

In October 2023, AnHeart Therapeutics signed an exclusive agreement with Nippon Kayaku for taletrectinib. Nippon Kayaku agreed to market and distribute the ROS1 inhibitor in Japan.