Nuvation Bio (NUVB) said Monday that China's National Medical Products Administration approved taletrectinib to treat adult patients with advanced ROS1-positive non-small cell lung cancer.
Under an exclusive license agreement, Innovent Biologics will market taletrectinib in China under the brand name Dovbleron.
The approval was based on data from the phase 2 study, which showed the drug's effectiveness in Chinese patients, including those who had and had not been previously treated with ROS1 tyrosine kinase inhibitors.
Taletrectinib previously received breakthrough therapy designation and priority review from China's NMPA, as well as orphan drug designation and breakthrough therapy designation from the US FDA for treating patients with advanced ROS1-positive NSCLC.
Shares of Nuvation Bio were down 0.2% in recent trading.
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