{"id":43906,"date":"2025-10-20T20:08:13","date_gmt":"2025-10-20T12:08:13","guid":{"rendered":"https:\/\/flcube.com\/?p=43906"},"modified":"2025-10-20T20:08:14","modified_gmt":"2025-10-20T12:08:14","slug":"shanghai-henlius-biotech-secures-fda-orphan-drug-designation-for-hlx43-in-thymic-epithelial-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43906","title":{"rendered":"Shanghai Henlius Biotech Secures FDA Orphan Drug Designation for HLX43 in Thymic Epithelial Tumors"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech, Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>)<\/strong> announced today that the U.S. Food and Drug Administration (FDA) has granted <strong>Orphan Drug Designation (ODD)<\/strong> to its innovative programmed\u2011death\u2011ligand\u20111 (PD\u2011L1)\u2011targeting antibody\u2011drug conjugate (ADC), <strong>HLX43<\/strong>, for the treatment of <strong>thymic epithelial tumors (TETs)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-highlights\">Product Highlights<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Dual\u2011Mechanism ADC<\/strong> \u2013 HLX43 combines immune\u2011checkpoint blockade with a potent cytotoxic payload, delivering a two\u2011pronged attack on tumor cells.<\/li>\n\n\n\n<li><strong>Broad\u2011Spectrum Activity<\/strong> \u2013 In addition to TETs, HLX43 is advancing in non\u2011small\u2011cell lung cancer (NSCLC), demonstrating robust efficacy across patient subgroups.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-2025-wclc-data-snapshot\">2025 WCLC Data Snapshot<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Cohort<\/th><th>Confirmed ORR (cORR)<\/th><th>Dose (mg\/kg)<\/th><th>Safety<\/th><\/tr><\/thead><tbody><tr><td><strong>EGFR wild\u2011type NSCLC<\/strong><\/td><td>46.7\u202f%<\/td><td>\u2013<\/td><td>Favorable<\/td><\/tr><tr><td><strong>EGFR wild\u2011type, 2.5\u202fmg\/kg<\/strong><\/td><td>60.0\u202f%<\/td><td>2.5<\/td><td>Favorable<\/td><\/tr><tr><td><strong>PD\u2011L1 negative (TPS\u202f&lt;\u202f1\u202f%)<\/strong><\/td><td>38.1\u202f%<\/td><td>\u2013<\/td><td>85.7\u202f% Disease\u2011Control Rate (DCR)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Key Insight<\/strong> \u2013 HLX43 maintains high activity even in PD\u2011L1\u2011negative patients, expanding its therapeutic reach beyond traditional biomarkers.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Orphan Designation<\/strong> \u2013 The FDA ODD status provides Henlius with market\u2011exclusivity incentives, expedited review pathways, and potential pricing advantages for TET patients.<\/li>\n\n\n\n<li><strong>Pipeline Expansion<\/strong> \u2013 HLX43\u2019s promising data in NSCLC support parallel development tracks, positioning Henlius as a leader in next\u2011generation ADCs for solid tumors.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech, Inc. (HKG: 2696) announced today that the U.S. Food and Drug Administration&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43908,"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":[35,16,270,862,18],"class_list":["post-43906","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-henlius-biotech","tag-hkg-2696","tag-pd-1-l1"],"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>Shanghai Henlius Biotech Secures FDA Orphan Drug Designation for HLX43 in Thymic Epithelial Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. 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(HKG: 2696) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its innovative programmed\u2011death\u2011ligand\u20111 (PD\u2011L1)\u2011targeting antibody\u2011drug conjugate (ADC), HLX43, for the treatment of thymic epithelial tumors (TETs).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=43906\" \/>\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=\"2025-10-20T12:08:13+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-20T12:08:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2014.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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