{"id":32233,"date":"2025-04-22T18:32:47","date_gmt":"2025-04-22T10:32:47","guid":{"rendered":"https:\/\/flcube.com\/?p=32233"},"modified":"2025-04-22T18:32:48","modified_gmt":"2025-04-22T10:32:48","slug":"zai-labs-augtyro-nda-accepted-by-chinas-nmpa-for-ntrk-fusion-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=32233","title":{"rendered":"Zai Lab’s Augtyro NDA Accepted by China’s NMPA for NTRK Fusion Solid Tumors"},"content":{"rendered":"\n

China-based biotech Zai Lab Ltd (NASDAQ: ZLAB<\/a>, HKG: 9688<\/a>) announced that the supplemental New Drug Application (sNDA) for its Augtyro (repotrectinib) has been accepted for review by China’s National Medical Products Administration (NMPA). The application targets adult patients with NTRK gene fusion-positive solid tumors that are locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity. This includes patients who have progressed following prior therapies or have no satisfactory alternative treatment options.<\/p>\n\n\n\n

Repotrectinib: Next-Generation TKI<\/strong>
Augtyro, also known as repotrectinib, is a next-generation tyrosine kinase inhibitor (TKI) targeting ROS1 and NTRK oncogenic drivers. Zai Lab licensed the drug from Turning Point Therapeutics Inc., now a Bristol-Myers Squibb company, for development and commercialization in Greater China. This milestone underscores Zai Lab’s commitment to bringing innovative oncology therapies to patients in the region.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the supplemental New Drug…<\/p>\n","protected":false},"author":1,"featured_media":32234,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[429,428,16,869,38,868,2831],"class_list":["post-32233","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-bms","tag-bristol-myers-squibb","tag-cancer","tag-hkg-9688","tag-market-approval-filings","tag-nasdaq-zlab","tag-turning-point-therapeutics"],"yoast_head":"\nZai Lab's Augtyro NDA Accepted by China's NMPA for NTRK Fusion Solid Tumors - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the supplemental New Drug Application (sNDA) for its Augtyro (repotrectinib) has been accepted for review by China's National Medical Products Administration (NMPA). 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