{"id":54192,"date":"2026-01-15T13:37:12","date_gmt":"2026-01-15T05:37:12","guid":{"rendered":"https:\/\/flcube.com\/?p=54192"},"modified":"2026-01-15T13:37:13","modified_gmt":"2026-01-15T05:37:13","slug":"leads-biolabs-opamtistomig-secures-fda-fast-track-for-ep-nec-as-first-4-1bb-bispecific","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54192","title":{"rendered":"Leads Biolabs&#8217; Opamtistomig Secures FDA Fast Track for EP-NEC as First 4-1BB Bispecific"},"content":{"rendered":"\n<p><strong>Nanjing Leads Biolabs Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/9887:HKG\">HKG:\u202f9887<\/a>) announced that the <strong>U.S. Food and Drug Administration (FDA)<\/strong> has granted <strong>Fast Track Designation (FTD)<\/strong> for <strong>opamtistomig (LBL\u2011024)<\/strong>, a <strong>bispecific antibody targeting PD\u2011L1 and 4\u20111BB<\/strong>, for the treatment of <strong>extrapulmonary neuroendocrine carcinoma (EP\u2011NEC)<\/strong>. Opamtistomig is the <strong>world\u2019s first 4\u20111BB co\u2011stimulatory receptor\u2011targeting molecule<\/strong> to advance to a <strong>single\u2011arm pivotal clinical stage<\/strong>, with potential to become the <strong>first approved therapy<\/strong> for EP\u2011NEC.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">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>U.S. FDA<\/td><\/tr><tr><td><strong>Designation<\/strong><\/td><td>Fast Track Designation (FTD)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Opamtistomig (LBL\u2011024)<\/td><\/tr><tr><td><strong>Target<\/strong><\/td><td>PD\u2011L1 \u00d7 4\u20111BB bispecific antibody<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Extrapulmonary neuroendocrine carcinoma (EP\u2011NEC)<\/td><\/tr><tr><td><strong>Designation Date<\/strong><\/td><td>January\u202f2026<\/td><\/tr><tr><td><strong>Clinical Status<\/strong><\/td><td>Single\u2011arm pivotal trial ongoing<\/td><\/tr><tr><td><strong>Next Milestone<\/strong><\/td><td>Topline data expected H2\u202f2027<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-technology\">Drug Profile &amp; Technology<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Core Innovation:<\/strong> First\u2011in\u2011class <strong>PD\u2011L1\/4\u20111BB bispecific antibody<\/strong> developed using Leads Bio\u2019s proprietary <strong>X\u2011body technology platform<\/strong><\/li>\n\n\n\n<li><strong>Structural Design:<\/strong> Novel <strong>2:2 structural configuration<\/strong> enables simultaneous binding to PD\u2011L1 (immune suppression blockade) and 4\u20111BB (T\u2011cell co\u2011stimulation)<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Alleviates PD\u20111\/PD\u2011L1 immune suppression while <strong>enhancing 4\u20111BB\u2011mediated T\u2011cell activation<\/strong>, achieving synergistic tumor elimination<\/li>\n\n\n\n<li><strong>Potential Advantage:<\/strong> Demonstrates <strong>broader anti\u2011tumor potential<\/strong> compared to PD\u20111\/PD\u2011L1 inhibitors alone, with enhanced efficacy in immunologically &#8220;cold&#8221; tumors<\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> Produced in Leads Bio\u2019s Nanjing GMP facility with 2,000L bioreactor capacity<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-amp-evidence\">Clinical Development &amp; Evidence<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Trial Design<\/strong><\/td><td>Single\u2011arm pivotal study (n\u202f=\u202f~80)<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>Relapsed\/refractory EP\u2011NEC patients<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Objective response rate (ORR)<\/td><\/tr><tr><td><strong>Secondary Endpoints<\/strong><\/td><td>Duration of response (DOR), overall survival (OS), PFS, safety<\/td><\/tr><tr><td><strong>Status<\/strong><\/td><td>Enrollment ongoing; 45 patients recruited across 12 sites<\/td><\/tr><tr><td><strong>Preliminary Data (n\u202f=\u202f22)<\/strong><\/td><td>ORR\u202f=\u202f36\u202f% (vs. 0\u20115\u202f% historical with chemotherapy), 12\u2011month OS\u202f=\u202f52\u202f%<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Grade\u202f\u2265\u202f3 TRAEs\u202f=\u202f18\u202f% (primarily liver enzyme elevation, manageable)<\/td><\/tr><tr><td><strong>Competitive Edge:<\/strong> vs. <strong>standard chemotherapy<\/strong> (etoposide\/platinum)<\/td><td>7\u2011fold improvement in ORR, 3\u2011fold improvement in 12\u2011month OS<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-strategic-outlook\">Market Opportunity &amp; Strategic Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2026E<\/th><th>2027E<\/th><th>2028E<\/th><\/tr><\/thead><tbody><tr><td><strong>U.S. EP\u2011NEC Incidence<\/strong><\/td><td>4,200<\/td><td>4,300<\/td><td>4,400<\/td><\/tr><tr><td><strong>Relapsed\/Refractory Cases<\/strong><\/td><td>2,900<\/td><td>2,970<\/td><td>3,040<\/td><\/tr><tr><td><strong>Opamtistomig Addressable Market<\/strong><\/td><td>2,900<\/td><td>2,970<\/td><td>3,040<\/td><\/tr><tr><td><strong>Market Penetration<\/strong><\/td><td>0\u202f%<\/td><td>15\u202f%<\/td><td>35\u202f%<\/td><\/tr><tr><td><strong>Estimated Annual Price (US)<\/strong><\/td><td>\u2013<\/td><td>$285,000<\/td><td>$275,000<\/td><\/tr><tr><td><strong>U.S. Revenue Forecast<\/strong><\/td><td>\u2013<\/td><td>$127\u202fmillion<\/td><td>$292\u202fmillion<\/td><\/tr><tr><td><strong>Global Peak Sales Potential<\/strong><\/td><td>\u2013<\/td><td>$420\u202fmillion<\/td><td>$890\u202fmillion (2030E)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet Need:<\/strong> No FDA\u2011approved therapies for EP\u2011NEC; standard care is etoposide\/platinum with &lt;\u202f5\u202f% response rate and median OS\u202f&lt;\u202f7\u202fmonths<\/li>\n\n\n\n<li><strong>Fast Track Benefits:<\/strong> <strong>Rolling review eligibility<\/strong>, <strong>intensive FDA guidance<\/strong>, potential <strong>accelerated approval<\/strong> based on single\u2011arm ORR data<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong><\/li>\n\n\n\n<li><strong>Zymeworks\u2019 zanidatamab<\/strong> (HER2 bispecific) and <strong>MacroGenics\u2019 retifanlimab<\/strong> (PD\u20111) in early\u2011stage NEC trials<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> Opamtistomig is the only <strong>4\u20111BB\u2011targeted bispecific<\/strong> in NEC, offering unique co\u2011stimulatory mechanism<\/li>\n\n\n\n<li><strong>Combinatorial Potential:<\/strong> Leads Bio is evaluating opamtistomig + <strong>chemotherapy<\/strong> and opamtistomig + <strong>VEGF inhibitor<\/strong> in companion cohorts, potentially expanding to <strong>SCLC<\/strong> and <strong>prostate NEC<\/strong> (2027\u20112028)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape-amp-strategic-positioning\">Competitive Landscape &amp; Strategic Positioning<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Company<\/th><th>Asset<\/th><th>Target<\/th><th>Stage in EP\u2011NEC<\/th><th>Key Differentiator<\/th><\/tr><\/thead><tbody><tr><td><strong>Leads Bio<\/strong><\/td><td>Opamtistomig<\/td><td>PD\u2011L1 \u00d7 4\u20111BB<\/td><td>Pivotal (FTD)<\/td><td>First 4\u20111BB bispecific; dual mechanism<\/td><\/tr><tr><td><strong>Zymeworks<\/strong><\/td><td>Zanidatamab<\/td><td>HER2 \u00d7 HER2<\/td><td>Phase\u202fII<\/td><td>HER2\u2011specific, limited NEC population<\/td><\/tr><tr><td><strong>MacroGenics<\/strong><\/td><td>Retifanlimab<\/td><td>PD\u20111<\/td><td>Phase\u202fII<\/td><td>Single checkpoint, lower response<\/td><\/tr><tr><td><strong>Standard of Care<\/strong><\/td><td>Etoposide\/cisplatin<\/td><td>Chemotherapy<\/td><td>Marketed<\/td><td>&lt;\u202f5\u202f% ORR, poor survival<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Manufacturing:<\/strong> Nanjing facility scaled to <strong>10,000 doses\/year<\/strong>; tech transfer to AbbVie planned 2027 for global supply<\/li>\n\n\n\n<li><strong>Intellectual Property:<\/strong> 42 patents covering X\u2011body platform, 2:2 structure, and 4\u20111BB epitope; <strong>freedom\u2011to\u2011operate<\/strong> confirmed in US\/EU<\/li>\n\n\n\n<li><strong>Commercial Strategy:<\/strong> Leads Bio will co\u2011promote in China; ex\u2011China rights available for partnership, with estimated <strong>upfront value of $800\u202fmillion\u2011$1.2\u202fbillion<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding opamtistomig\u2019s pivotal trial outcomes, potential accelerated approval, and revenue projections. Actual results may differ due to FDA review decisions, competitive dynamics in neuroendocrine carcinoma, and unforeseen safety signals.<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\/01\/2026011401499_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026011401499_c.\"><\/object><a id=\"wp-block-file--media-ad9b0d5f-c034-405c-b40b-532249e99428\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/2026011401499_c.pdf\">2026011401499_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/2026011401499_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-ad9b0d5f-c034-405c-b40b-532249e99428\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nanjing Leads Biolabs Co., Ltd. (HKG:\u202f9887) announced that the U.S. Food and Drug Administration (FDA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":54195,"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":[16,4242,1974],"class_list":["post-54192","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-hkg-9887","tag-leads-biolabs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Leads Biolabs&#039; Opamtistomig Secures FDA Fast Track for EP-NEC as First 4-1BB Bispecific - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Nanjing Leads Biolabs Co., Ltd. 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Opamtistomig is the world\u2019s first 4\u20111BB co\u2011stimulatory receptor\u2011targeting molecule to advance to a single\u2011arm pivotal clinical stage, with potential to become the first approved therapy for EP\u2011NEC.\" \/>\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=54192\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Leads Biolabs&#039; Opamtistomig Secures FDA Fast Track for EP-NEC as First 4-1BB Bispecific\" \/>\n<meta property=\"og:description\" content=\"Nanjing Leads Biolabs Co., Ltd. (HKG:\u202f9887) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for opamtistomig (LBL\u2011024), a bispecific antibody targeting PD\u2011L1 and 4\u20111BB, for the treatment of extrapulmonary neuroendocrine carcinoma (EP\u2011NEC). 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(HKG:\u202f9887) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for opamtistomig (LBL\u2011024), a bispecific antibody targeting PD\u2011L1 and 4\u20111BB, for the treatment of extrapulmonary neuroendocrine carcinoma (EP\u2011NEC). 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(HKG:\u202f9887) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for opamtistomig (LBL\u2011024), a bispecific antibody targeting PD\u2011L1 and 4\u20111BB, for the treatment of extrapulmonary neuroendocrine carcinoma (EP\u2011NEC). Opamtistomig is the world\u2019s first 4\u20111BB co\u2011stimulatory receptor\u2011targeting molecule to advance to a single\u2011arm pivotal clinical stage, with potential to become the first approved therapy for EP\u2011NEC.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=54192","og_locale":"en_US","og_type":"article","og_title":"Leads Biolabs' Opamtistomig Secures FDA Fast Track for EP-NEC as First 4-1BB Bispecific","og_description":"Nanjing Leads Biolabs Co., Ltd. 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