Zai Lab Limited (NASDAQ:ZLAB) announced on January 6, 2026, that China’s National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for AUGTYRO™ (repotrectinib).
This approval targets adult patients with advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
This marks the second NMPA approval for AUGTYRO in China, following its May 2024 green light for ROS1-positive non-small cell lung cancer (NSCLC).
Repotrectinib is now the first therapy in China approved to treat both TKI-naïve (those who haven't received a tyrosine kinase inhibitor) and TKI-pretreated patients in this population, addressing a significant "resistance" gap in the current standard of care.
The approval is backed by the pivotal TRIDENT-1 study, which demonstrated that AUGTYRO’s unique, compact macrocyclic structure allows it to bind effectively even when tumors have developed common "solvent-front" mutations that typically block first-generation inhibitors like larotrectinib or entrectinib.