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January 7, 2026

Zai Lab’s Augtyro receives NMPA approval for solid tumours in China

Zai Lab has received approval from China’s National Medical Products Administration (NMPA) for the supplemental new drug application (sNDA) for Augtyro (repotrectinib) to treat adult patients with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

The regulatory decision was based on results from the pivotal Phase I/II TRIDENT-1 study. Credit: Premreuthai / Shutterstock.com.