{"id":41152,"date":"2025-09-11T13:35:33","date_gmt":"2025-09-11T05:35:33","guid":{"rendered":"https:\/\/flcube.com\/?p=41152"},"modified":"2025-09-11T13:35:34","modified_gmt":"2025-09-11T05:35:34","slug":"transthera-sciences-secures-china-phase-ii-trial-approval-for-tinengotinib%e2%80%91fulvestrant-combination","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41152","title":{"rendered":"TransThera Sciences Secures China Phase\u202fII Trial Approval for Tinengotinib\u2011Fulvestrant Combination"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>TransThera Sciences (Nanjing) Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/2617:HKG\">HKG: 2617<\/a>)<\/strong> announced that the China National Medical Products Administration has approved a Phase\u202fII clinical trial for its oral small\u2011molecule kinase inhibitor <strong>tinengotinib<\/strong> in combination with the endocrine agent <strong>fulvestrant<\/strong>. The study targets patients with previously treated hormone\u2011receptor positive (HR\u207a) and HER2\u2011negative (HER2\u207b) recurrent or metastatic breast cancer.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-tinengotinib-a-multi-kinase-inhibitor\">Tinengotinib: A Multi\u2011Kinase Inhibitor<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Targets<\/strong> \u2013 Fibroblast growth factor receptor (FGFR)\/Vascular endothelial growth factor receptor (VEGFR), Janus kinase (JAK), and Aurora kinases.<\/li>\n\n\n\n<li><strong>Clinical Status<\/strong> \u2013 Global Phase\u202fIII registration, with encouraging monotherapy activity in heavily pre\u2011treated HR\u207a\/HER2\u207b breast\u2011cancer cohorts.<\/li>\n\n\n\n<li><strong>Rationale for Combination<\/strong> \u2013 Preclinical data demonstrate synergistic inhibition of endocrine\u2011therapy\u2011resistant tumor cells when tinengotinib is paired with fulvestrant, a selective estrogen\u2011receptor degrader.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-trial-design-and-patient-population\">Trial Design and Patient Population<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase<\/strong> \u2013 II, multi\u2011center, open\u2011label.<\/li>\n\n\n\n<li><strong>Eligibility<\/strong> \u2013 Adults with HR\u207a\/HER2\u207b metastatic breast cancer who have progressed after endocrine therapy, CDK4\/6 inhibition, and chemotherapy.<\/li>\n\n\n\n<li><strong>Endpoints<\/strong> \u2013 Progression\u2011free survival (PFS), overall response rate (ORR), and safety profile of the tinengotinib\u2011fulvestrant regimen.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>For TransThera<\/strong> \u2013 The trial represents a pivotal step toward regulatory approval in a high\u2011need market segment, potentially positioning tinengotinib as a first\u2011line combination for endocrine\u2011resistant disease.<\/li>\n\n\n\n<li><strong>For Patients<\/strong> \u2013 Offers a novel therapeutic option that may delay disease progression and improve quality of life after standard therapies fail.<\/li>\n\n\n\n<li><strong>For the Market<\/strong> \u2013 Could stimulate further investment in FGFR\/VEGFR\u2011targeted agents and expand the therapeutic landscape for HR\u207a\/HER2\u207b breast cancer.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025091001214_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025091001214_c.\"><\/object><a id=\"wp-block-file--media-0810fcad-6c6c-402c-a901-56edad89380a\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025091001214_c.pdf\">2025091001214_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025091001214_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-0810fcad-6c6c-402c-a901-56edad89380a\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>TransThera Sciences (Nanjing) Inc. (HKG: 2617) announced that the China National Medical Products Administration has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41153,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[16,62,4181,601],"class_list":["post-41152","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-hkg-2617","tag-transthera-sciences"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>TransThera Sciences Secures China Phase\u202fII Trial Approval for Tinengotinib\u2011Fulvestrant Combination - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"TransThera Sciences (Nanjing) Inc. (HKG: 2617) announced that the China National Medical Products Administration has approved a Phase\u202fII clinical trial for its oral small\u2011molecule kinase inhibitor tinengotinib in combination with the endocrine agent fulvestrant. The study targets patients with previously treated hormone\u2011receptor positive (HR\u207a) and HER2\u2011negative (HER2\u207b) recurrent or metastatic breast cancer.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=41152\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TransThera Sciences Secures China Phase\u202fII Trial Approval for Tinengotinib\u2011Fulvestrant Combination\" \/>\n<meta property=\"og:description\" content=\"TransThera Sciences (Nanjing) Inc. (HKG: 2617) announced that the China National Medical Products Administration has approved a Phase\u202fII clinical trial for its oral small\u2011molecule kinase inhibitor tinengotinib in combination with the endocrine agent fulvestrant. 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