Zai Lab announced NMPA approval of AUGTYRO (repotrectinib) for adults with NTRK-positive solid tumors in China, expanding treatment options across TKI-naïve and pretreated patients.
Written By: Pharmacally Medical News Desk
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for AUGTYRO (repotrectinib) to treat adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
The approval applies to patients whose disease is locally advanced or metastatic, or when surgery would likely cause significant morbidity. It also covers patients who have progressed after prior therapies or have no suitable alternative treatment options.
Meaningful expansion to a new patient population
“This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population,” said Dr. Rafael G. Amado, President and Head of Global Research and Development at Zai Lab. He noted that the decision will help meet important unmet medical needs for this group of patients.
Evidence from the TRIDENT-1 study
The NMPA decision was supported by data from the pivotal registrational Phase 1/2 TRIDENT-1 study (NCT03093116) The trial showed strong and durable clinical activity for repotrectinib in patients with NTRK fusion–positive solid tumors, along with a manageable safety profile.
Zai Lab participated in the global program and enrolled the first patient in Greater China in May 2021.
Part of a growing oncology portfolio
This approval follows the NMPA’s earlier decision in May 2024 to approve AUGTYRO for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. The U.S. Food and Drug Administration previously approved the drug for ROS1-positive NSCLC in November 2023.
In June 2024, the FDA also granted accelerated approval to AUGTYRO for adult and pediatric patients 12 years and older with NTRK fusion–positive solid tumors that are locally advanced or metastatic, or when surgery is likely to result in significant risk and have progressed after treatment or lack satisfactory alternatives.
Zai Lab holds exclusive rights to develop and commercialize AUGTYRO in Greater China through its agreement with Bristol Myers Squibb, following BMS’s acquisition of Turning Point Therapeutics.
About AUGTYRO (repotrectinib)
AUGTYRO is a next-generation tyrosine kinase inhibitor that targets oncogenic drivers ROS1 and NTRK. While approved targeted therapies have shown benefit, many patients eventually develop resistance mutations that reduce treatment effectiveness and shorten response duration.
Repotrectinib was engineered to help overcome acquired resistance, improve durability of benefit, and provide activity in the brain, where progression commonly occurs.
About NTRK-positive solid tumors
NTRK-positive advanced solid tumors are rare but aggressive and are associated with poor outcomes in both adults and children. Although targeted treatments exist, the emergence of resistance often limits long-term benefit.
The NMPA approval of AUGTYRO represents the first therapy in China that covers both TRK TKI-naïve and TRK TKI-pretreated patients across multiple solid tumor types, offering a new treatment pathway for this underserved population.
Reference
Zai Lab Announces National Medical Products Administration (NMPA) Approval of AUGTYRO™ (repotrectinib) for Patients with NTRK-Positive Solid Tumors, 06 January 2026, https://ir.zailaboratory.com/news-releases/news-release-details/zai-lab-announces-national-medical-products-administration-nmpa
A Study of Repotrectinib (TPX-0005) in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1), ClinicalTrials.gov ID NCT03093116, https://www.clinicaltrials.gov/study/NCT03093116
Alexander Drilon et al, Repotrectinib in ROS1 Fusion–Positive Non–Small-Cell Lung Cancer, N Engl J Med 2024;390:118-131, DOI: 10.1056/NEJMoa2302299