{"id":46420,"date":"2025-11-11T16:56:19","date_gmt":"2025-11-11T08:56:19","guid":{"rendered":"https:\/\/flcube.com\/?p=46420"},"modified":"2025-11-11T16:56:20","modified_gmt":"2025-11-11T08:56:20","slug":"lepu-biopharma-secures-fda-ind-clearance-for-cdh17%e2%80%91targeted-adc-mrg007","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46420","title":{"rendered":"Lepu Biopharma Secures FDA IND Clearance for CDH17\u2011Targeted ADC MRG007"},"content":{"rendered":"\n<p><strong>Lepu Biopharma Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2157:HKG\">HKG: 2157<\/a>) announced that the U.S. Food and Drug Administration (FDA) has granted an <strong>Investigational New Drug (IND) approval<\/strong> for its antibody\u2011drug conjugate (ADC) <strong>MRG007<\/strong>, an innovative CDH17\u2011directed therapy now entering first\u2011in\u2011human studies in the United States.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-deal-amp-development-overview\">Deal &amp; Development Overview<\/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>Company<\/strong><\/td><td>Lepu Biopharma Co., Ltd. (2157.HK)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>MRG007 \u2013 CDH17\u2011targeted ADC<\/td><\/tr><tr><td><strong>Regulatory Milestone<\/strong><\/td><td>FDA <strong>IND approval<\/strong> (Nov\u202f2025)<\/td><\/tr><tr><td><strong>Current Trial Phase<\/strong><\/td><td>Dose\u2011escalation (Phase\u202f1) \u2013 first patient enrolled in China on <strong>25\u202fJul\u202f2025<\/strong><\/td><\/tr><tr><td><strong>Licensing Partner<\/strong><\/td><td><strong>ArriVent<\/strong> \u2013 exclusive global rights outside Greater China<\/td><\/tr><tr><td><strong>Agreement Date<\/strong><\/td><td>22\u202fJan\u202f2025 \u2013 exclusive development, manufacturing, and commercialization license<\/td><\/tr><tr><td><strong>Collaboration Model<\/strong><\/td><td>Joint global clinical development; Lepu provides Chinese regulatory support and early\u2011stage data<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-scientific-rationale\">Scientific Rationale<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Target:<\/strong> <strong>CDH17<\/strong> (Cadherin\u201117) \u2013 over\u2011expressed in gastrointestinal malignancies, particularly gastric and colorectal cancers.<\/li>\n\n\n\n<li><strong>ADC Architecture:<\/strong> Humanized anti\u2011CDH17 monoclonal antibody linked to a potent cytotoxic payload via a cleavable linker, designed for selective tumor cell killing while sparing normal tissue.<\/li>\n\n\n\n<li><strong>Pre\u2011clinical Highlights:<\/strong> In xenograft models, MRG007 achieved <strong>>85\u202f% tumor regression<\/strong> with a favorable safety margin compared with non\u2011targeted chemotherapy.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-timeline\">Clinical Development Timeline<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Expected Date<\/th><\/tr><\/thead><tbody><tr><td><strong>IND filing (US)<\/strong><\/td><td>10\u202fNov\u202f2025 (approved)<\/td><\/tr><tr><td><strong>First US patient dosing<\/strong><\/td><td>Q1\u202f2026<\/td><\/tr><tr><td><strong>Dose\u2011escalation completion<\/strong><\/td><td>Mid\u20112027<\/td><\/tr><tr><td><strong>Phase\u202f1b expansion (selected tumor types)<\/strong><\/td><td>Late\u202f2027<\/td><\/tr><tr><td><strong>Pivotal Phase\u202f2\/3 initiation<\/strong><\/td><td>2028 (contingent on Phase\u202f1 data)<\/td><\/tr><tr><td><strong>Potential US NDA submission<\/strong><\/td><td>2029\u20112030<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-potential-amp-financial-outlook\">Market Potential &amp; Financial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Addressable Market:<\/strong> CDH17\u2011positive gastric and colorectal cancers represent an estimated <strong>$4.2\u202fbillion<\/strong> global market in 2025, with a high unmet\u2011need segment of patients refractory to standard chemotherapy and immunotherapy.<\/li>\n\n\n\n<li><strong>Revenue Forecast (ArriVent):<\/strong> Assuming a 5\u202f% market share post\u2011approval, projected <strong>U.S. sales of $150\u202fM\u2013$220\u202fM<\/strong> by 2032.<\/li>\n\n\n\n<li><strong>Strategic Fit:<\/strong> The IND clearance positions Lepu and ArriVent to be first\u2011to\u2011market with a CDH17\u2011directed ADC, differentiating from existing HER2 or EGFR ADC pipelines.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory timelines, clinical development, and commercial expectations for MRG007. Actual results may differ due to risks including clinical trial outcomes, regulatory approvals, manufacturing scale\u2011up, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lepu Biopharma Co., Ltd. (HKG: 2157) announced that the U.S. Food and Drug Administration (FDA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":46423,"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":[35,62,1207,3609],"class_list":["post-46420","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-clinical-trial-approval-initiation","tag-hkg-2157","tag-lepu-biopharma"],"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>Lepu Biopharma Secures FDA IND Clearance for CDH17\u2011Targeted ADC MRG007 - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Lepu Biopharma Co., Ltd. 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