08:51 AM EDT, 05/13/2024 (MT Newswires) -- Zai Lab ( ZLAB ) said late Sunday the New Drug Application for Augtyro has received approval from China's National Medical Products Administration.

Approval of the application is based on results of a phase 1/2 trial that assessed Augtyro in TKI-naive and TKI-pretreated patients, the company said.

The regulator accepted the application for Augtyro for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer in June 2023.

Zai Lab ( ZLAB ) shares were up 5.6% in recent Monday premarket activity.

Price: 21.21, Change: +1.13, Percent Change: +5.63