{"id":48656,"date":"2025-11-19T21:04:58","date_gmt":"2025-11-19T13:04:58","guid":{"rendered":"https:\/\/flcube.com\/?p=48656"},"modified":"2025-11-19T21:05:00","modified_gmt":"2025-11-19T13:05:00","slug":"sino-biopharms-lm-350-cdh17-adc-wins-nmpa-nod-for-clinical-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48656","title":{"rendered":"Sino Biopharm&#8217;s LM-350 CDH17-ADC Wins NMPA Nod for Clinical Trials"},"content":{"rendered":"\n<p><strong>Sino Biopharmaceutical Limited<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1177:HKG\">HKG: 1177<\/a>) announced that its self\u2011developed <strong>LM\u2011350<\/strong>, a <strong>CDH17\u2011targeting Antibody\u2011Drug Conjugate (ADC)<\/strong>, received <strong>clinical trial approval<\/strong> from China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong>, advancing the first\u2011in\u2011class asset toward human studies.<\/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>Product<\/strong><\/td><td>LM\u2011350 (CDH17\u2011targeting ADC)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Sino Biopharmaceutical Limited (1177.HK)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Phase\u202f1 clinical trial approval<\/td><\/tr><tr><td><strong>Target<\/strong><\/td><td>CDH17 (Cadherin\u201117)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced solid tumors (initial focus: colorectal cancer)<\/td><\/tr><tr><td><strong>Platform<\/strong><\/td><td>LaNova Medicines\u2019 next\u2011generation LM\u2011ADC platform<\/td><\/tr><tr><td><strong>Next Step<\/strong><\/td><td>Initiate Phase\u202f1 dose\u2011escalation trial H1\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile\">Drug Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> High\u2011selectivity binding to CDH17 with strong internalization; delivers cytotoxic payload while retaining <strong>wild\u2011type IgG1 configuration<\/strong> and <strong>Antibody\u2011Dependent Cell\u2011Mediated Cytotoxicity (ADCC)<\/strong> activity for dual\u2011mode tumor killing<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> <strong>First\u2011in\u2011class CDH17\u2011targeting ADC<\/strong> globally; CDH17 is overexpressed in <strong>>90% of colorectal cancers<\/strong> and <strong>70% of gastric cancers<\/strong>, with minimal normal tissue expression<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> ADCC\u2011enhanced ADC may overcome resistance to conventional ADCs; preclinical data show <strong>strong efficacy in MMAE\u2011 and irinotecan\u2011resistant CRC xenograft models<\/strong><\/li>\n\n\n\n<li><strong>Pipeline:<\/strong> Sino Biopharm\u2019s third ADC to enter clinic, strengthening its <strong>oncology\u2011focused biologics portfolio<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-plan\">Clinical Development Plan<\/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>Study Phase<\/strong><\/td><td>Phase\u202f1 (dose escalation &amp; expansion)<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>CDH17\u2011positive advanced solid tumors (CRC, gastric cancer) post\u2011standard therapy<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>Safety, tolerability, MTD, RP2D<\/td><\/tr><tr><td><strong>Secondary Endpoints<\/strong><\/td><td>ORR, DCR, PFS, biomarker analysis (CDH17 expression levels)<\/td><\/tr><tr><td><strong>Competitive Edge<\/strong><\/td><td>First CDH17 ADC; unique ADCC capability may enable lower doses vs. traditional ADCs<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-outlook\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China CRC Market:<\/strong> ~<strong>550,000 new cases<\/strong> annually; CDH17 positivity in >90% creates addressable population of <strong>>500,000 patients<\/strong> .<\/li>\n\n\n\n<li><strong>Gastric Cancer Add\u2011On:<\/strong> Additional <strong>450,000 patients<\/strong> annually with 70% CDH17 expression expands total addressable market to <strong>>800,000 patients<\/strong>.<\/li>\n\n\n\n<li><strong>No Approved CDH17 Therapies:<\/strong> Globally empty competitive landscape; closest rivals are <strong>CLDN18.2 ADCs<\/strong> (e.g., LaNova\u2019s LM\u2011302) but CDH17 offers broader tumor coverage.<\/li>\n\n\n\n<li><strong>Revenue Forecast:<\/strong> Analysts project <strong>\u00a53.5\u20114.5\u202fbillion<\/strong> (~US$480\u2011610\u202fmillion) China peak sales potential by 2033 if Phase\u202f1 data support advancement to pivotal trials.<\/li>\n\n\n\n<li><strong>Partner Leverage:<\/strong> LaNova\u2019s LM\u2011ADC platform provides validated linker\u2011payload technology, de\u2011risking manufacturing and accelerating timeline vs. de\u2011novo ADC development.<\/li>\n\n\n\n<li><strong>Next Catalysts:<\/strong> Phase\u202f1 first\u2011in\u2011human data expected <strong>Q4\u202f2026<\/strong>; fast\u2011track designation likely given unmet need in refractory CRC.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding LM\u2011350\u2019s clinical development, regulatory pathway, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, and competitive dynamics in the ADC space.<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\/2025\/11\/2025111800701_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025111800701_c.\"><\/object><a id=\"wp-block-file--media-7ce8bb3d-c590-463f-9f81-31e500200c46\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111800701_c.pdf\">2025111800701_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111800701_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-7ce8bb3d-c590-463f-9f81-31e500200c46\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sino Biopharmaceutical Limited (HKG: 1177) announced that its self\u2011developed LM\u2011350, a CDH17\u2011targeting Antibody\u2011Drug Conjugate (ADC),&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48658,"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":[35,16,62,313],"class_list":["post-48656","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-clinical-trial-approval-initiation","tag-sino-biopharmaceutical"],"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>Sino Biopharm&#039;s LM-350 CDH17-ADC Wins NMPA Nod for Clinical Trials - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sino Biopharmaceutical Limited (HKG: 1177) announced that its self\u2011developed LM\u2011350, a CDH17\u2011targeting Antibody\u2011Drug Conjugate (ADC), received clinical trial approval from China\u2019s National Medical Products Administration (NMPA), advancing the first\u2011in\u2011class asset toward human studies.\" \/>\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=48656\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sino Biopharm&#039;s LM-350 CDH17-ADC Wins NMPA Nod for Clinical Trials\" \/>\n<meta property=\"og:description\" content=\"Sino Biopharmaceutical Limited (HKG: 1177) announced that its self\u2011developed LM\u2011350, a CDH17\u2011targeting Antibody\u2011Drug Conjugate (ADC), received clinical trial approval from China\u2019s National Medical Products Administration (NMPA), advancing the first\u2011in\u2011class asset toward human studies.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48656\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-19T13:04:58+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-19T13:05:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1905.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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