{"id":69814,"date":"2026-07-13T15:43:52","date_gmt":"2026-07-13T07:43:52","guid":{"rendered":"https:\/\/flcube.com\/?p=69814"},"modified":"2026-07-13T15:43:53","modified_gmt":"2026-07-13T07:43:53","slug":"transthera-secures-nmpa-approval-for-phase-2-trial-of-tt-00973-in-combination-with-firmonertinib-for-egfr-mutant-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=69814","title":{"rendered":"TransThera Secures NMPA Approval for Phase 2 Trial of TT-00973 in Combination with Firmonertinib for EGFR-Mutant NSCLC"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>TransThera Sciences (Nanjing), Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2617:HKG\">HKG: 2617<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has approved its <strong>Phase 2 clinical trial<\/strong> evaluating <strong>TT-00973 tablets<\/strong> in combination with <strong>firmonertinib mesylate<\/strong> for the treatment of <strong>locally advanced or metastatic non-small cell lung cancer (NSCLC)<\/strong> harboring <strong>EGFR-sensitive mutations<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Phase 2 Clinical Trial<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>TT-00973 tablets + firmonertinib mesylate<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Locally advanced or metastatic NSCLC with EGFR-sensitive mutations<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>13 Jul 2026<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Initiate patient enrollment; evaluate safety and efficacy endpoints<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> Novel dual AXL\/FLT3 inhibitor (oral)<\/li>\n\n\n\n<li><strong>Developer:<\/strong> Independently developed by TransThera<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> First-in-class dual inhibition of AXL and FLT3 pathways, potentially overcoming resistance mechanisms in EGFR-mutant NSCLC<\/li>\n\n\n\n<li><strong>Intellectual Property:<\/strong> Global patents held by TransThera covering the compound and therapeutic use<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-evidence-phase-i-trial\" class=\"wp-block-heading\">Clinical Evidence \u2013 Phase I Trial<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Result (TT-00973)<\/th><\/tr><\/thead><tbody><tr><td><strong>Safety Profile<\/strong><\/td><td>Well tolerated across dose cohorts<\/td><\/tr><tr><td><strong>Maximum Tolerated Dose<\/strong><\/td><td>Not reached at highest tested dose<\/td><\/tr><tr><td><strong>Clinical Efficacy<\/strong><\/td><td>Observed in subset of patients with solid tumors<\/td><\/tr><tr><td><strong>Dose-Limiting Toxicities<\/strong><\/td><td>Minimal; manageable adverse events<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The Phase 1 trial established the safety profile and preliminary efficacy signals that supported advancement to Phase 2 testing in the specific NSCLC population.<\/p>\n\n\n\n<h2 id=\"h-strategic-collaboration\" class=\"wp-block-heading\">Strategic Collaboration<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Partner:<\/strong> Shanghai Allist Pharmaceuticals Co., Ltd.<\/li>\n\n\n\n<li><strong>Agreement Type:<\/strong> Clinical collaboration and drug supply agreement<\/li>\n\n\n\n<li><strong>Trial Design:<\/strong> Jointly conducted Phase 2 study of TT-00973 + firmonertinib mesylate<\/li>\n\n\n\n<li><strong>Patient Population:<\/strong> Locally advanced or metastatic NSCLC with EGFR-sensitive mutations<\/li>\n\n\n\n<li><strong>Future Plans:<\/strong> Potential Phase 3 trial based on Phase 2 results<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This strategic alliance combines TransThera&#8217;s expertise in kinase inhibitor development with Allist&#8217;s experience in EGFR-targeted therapies, creating a complementary approach to address treatment resistance in NSCLC.<\/p>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NSCLC Landscape:<\/strong> EGFR-mutant NSCLC represents approximately 40-50% of Asian NSCLC cases, with significant unmet need for patients who develop resistance to current EGFR inhibitors<\/li>\n\n\n\n<li><strong>Competitive Advantage:<\/strong> The dual AXL\/FLT3 inhibition mechanism may provide enhanced efficacy compared to monotherapy approaches by targeting multiple resistance pathways simultaneously<\/li>\n\n\n\n<li><strong>Commercial Potential:<\/strong> Successful development could position the combination as a second-line option for EGFR-mutant NSCLC patients who progress on first-generation EGFR inhibitors<\/li>\n\n\n\n<li><strong>Regulatory Pathway:<\/strong> Positive Phase 2 results would support accelerated approval discussions with NMPA and potential international regulatory filings<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development timelines, regulatory approvals, and commercial expectations for TT-00973. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\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\/2026\/07\/2026071001464_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026071001464_c.\"><\/object><a id=\"wp-block-file--media-df46c0b3-5c6a-416a-9f51-fc663534a4f2\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2026071001464_c.pdf\">2026071001464_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2026071001464_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-df46c0b3-5c6a-416a-9f51-fc663534a4f2\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced that China&#8217;s National Medical Products Administration (NMPA) has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[62,4181,601],"class_list":["post-69814","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","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 v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>TransThera Secures NMPA Approval for Phase 2 Trial of TT-00973 in Combination with Firmonertinib for EGFR-Mutant NSCLC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"TransThera (Nanjing) Technology Co., Ltd. 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