China Approves Zai Lab's AUGTYRO for NTRK-Positive Solid Tumors

Reuters01-06

China Approves <a href="https://laohu8.com/S/ZAILF">Zai Lab</a>'s AUGTYRO for NTRK-Positive Solid Tumors

Zai Lab Ltd. has announced that China's National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for AUGTYRO™ (repotrectinib) for the treatment of adult patients with NTRK-positive solid tumors. This approval covers patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options. The decision was based on results from the pivotal Phase 1/2 TRIDENT-1 study, which demonstrated robust efficacy and a manageable safety profile. AUGTYRO previously received NMPA approval in May 2024 for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Zai Lab holds an exclusive license agreement with Bristol Myers Squibb to develop and commercialize AUGTYRO in Greater China.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zai Lab Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260106154296) on January 06, 2026, and is solely responsible for the information contained therein.

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This approval covers patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options. The decision was based on results from the pivotal Phase 1/2 TRIDENT-1 study, which demonstrated robust efficacy and a manageable safety profile. AUGTYRO previously received NMPA approval in May 2024 for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Zai Lab holds an exclusive license agreement with Bristol Myers Squibb to develop and commercialize AUGTYRO in Greater China.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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This approval covers patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options. The decision was based on results from the pivotal Phase 1/2 TRIDENT-1 study, which demonstrated robust efficacy and a manageable safety profile. AUGTYRO previously received NMPA approval in May 2024 for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Zai Lab holds an exclusive license agreement with Bristol Myers Squibb to develop and commercialize AUGTYRO in Greater China.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zai Lab Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260106154296) on January 06, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0267386448.USD","symbol_name":"FIDELITY FIRST ALL COUNTRY WORLD \"A\" (USD) INC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260106:nNDLbM9YdY:1","article_id":"2601925558","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2601925558","pubTimestamp":1767702647,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Zai Lab Ltd. has announced that China's National Medical Products Administration  has approved the supplemental New Drug Application  for AUGTYRO  for the treatment of adult patients with NTRK-positive solid tumors. 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This approval covers patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options. The decision was based on results from the pivotal Phase 1/2 TRIDENT-1 study, which demonstrated robust efficacy and a manageable safety profile. AUGTYRO previously received NMPA approval in May 2024 for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Zai Lab holds an exclusive license agreement with Bristol Myers Squibb to develop and commercialize AUGTYRO in Greater China.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zai Lab Ltd. published the original content used to generate this news brief via Business Wire (Ref. 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