China Approves Zai Lab's AUGTYRO for NTRK-Positive Solid Tumors
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Zai Lab Ltd. has received approval from China's NMPA for AUGTYRO™ (repotrectinib) to treat adult patients with NTRK-positive solid tumors. This approval is for patients with locally advanced or metastatic disease who have progressed after prior therapies or lack satisfactory alternatives. The decision is based on the Phase 1⁄2 TRIDENT-1 study, showing strong efficacy and safety. Zai Lab previously obtained NMPA approval for AUGTYRO in May 2024 for ROS1-positive NSCLC. Zai Lab has an exclusive license with Bristol Myers Squibb for AUGTYRO in Greater China.
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