China’s drug regulator has expanded treatment options for patients with rare, genetically driven cancers by approving Zai Lab Limited’s AUGTYRO™ (repotrectinib) for adult patients with solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions. The National Medical Products Administration (NMPA) granted approval for the supplemental New Drug Application (sNDA), marking a significant milestone for precision oncology in the country.
The approval covers patients whose disease is locally advanced or metastatic, or for whom surgery could lead to severe morbidity. It is specifically intended for adults who have progressed following prior therapies or who lack satisfactory alternative treatment options, addressing a major unmet medical need in this small but clinically challenging patient population.
AUGTYRO’s latest approval represents its second indication in China. In May 2024, the NMPA cleared the drug for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). With the new NTRK fusion indication, AUGTYRO becomes the first therapy in China approved across both tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with NTRK-positive solid tumors.
“This approval marks an important step forward for patients with NTRK-positive cancers,” said Dr. Rafael G. Amado, President and Head of Global Research and Development at Zai Lab. He noted that no prior therapy in China had been approved to treat both newly diagnosed and previously treated patients across this tumor-agnostic population, highlighting the drug’s potential to fill a critical treatment gap.
The regulatory decision was supported by data from the global Phase 1/2 TRIDENT-1 study, which evaluated repotrectinib in patients with NTRK fusion–positive solid tumors. Results from the trial demonstrated strong and durable clinical responses, along with a manageable safety profile. Zai Lab played a role in the global development program and dosed the first patient in Greater China in May 2021, underscoring its contribution to the clinical evidence package.
Repotrectinib is designed to overcome resistance mutations that can limit the effectiveness of earlier-generation TKIs, making it a promising option for patients whose disease has progressed after prior targeted therapies.
Zai Lab holds exclusive rights to develop and commercialize AUGTYRO in Greater China—including mainland China, Hong Kong, Taiwan, and Macau—under a license agreement with Bristol Myers Squibb, following its acquisition of Turning Point Therapeutics. With this latest approval, Zai Lab strengthens its oncology portfolio and reinforces its focus on bringing innovative, globally developed therapies to patients in the region.