{"id":50365,"date":"2025-12-10T23:02:44","date_gmt":"2025-12-10T15:02:44","guid":{"rendered":"https:\/\/flcube.com\/?p=50365"},"modified":"2025-12-10T23:02:45","modified_gmt":"2025-12-10T15:02:45","slug":"shanghai-henlius-secures-nmpa-approval-for-phase-ii-iii-hlx22-her2-trials-pioneering-novel-epitope-adc-combination-in-breast-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50365","title":{"rendered":"Shanghai Henlius Secures NMPA Approval for Phase II\/III HLX22 HER2 Trials, Pioneering Novel Epitope ADC Combination in Breast Cancer"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced that China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has approved two <strong>Phase II\/III pivotal studies<\/strong> for <strong>HLX22<\/strong>, a novel\u2011epitope HER2 monoclonal antibody, in combination with the <strong>innovative ADC HLX87<\/strong> for <strong>neoadjuvant<\/strong> and <strong>first\u2011line HER2\u2011positive breast cancer<\/strong>.<\/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>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Trial Design<\/strong><\/td><td>Two parallel Phase II\/III pivotal studies<\/td><\/tr><tr><td><strong>Regimen<\/strong><\/td><td>HLX22 + HLX87 (novel HER2 ADC)<\/td><\/tr><tr><td><strong>Indications<\/strong><\/td><td>1) Neoadjuvant HER2+ breast cancer<br>2) First\u2011line metastatic HER2+ breast cancer<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>Pathological complete response (pCR) rate; Progression\u2011free survival (PFS)<\/td><\/tr><tr><td><strong>Trial Start<\/strong><\/td><td>Q1\u202f2026 (patient enrollment)<\/td><\/tr><tr><td><strong>Expected Read\u2011out<\/strong><\/td><td>Interim analysis Q4\u202f2027; Final data H2\u202f2028<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>HLX22:<\/strong> Novel\u2011epitope monoclonal antibody targeting <strong>HER2 Extracellular Subdomain IV<\/strong> \u2013 a distinct binding site versus Trastuzumab.<\/li>\n\n\n\n<li><strong>Synergistic Mechanism:<\/strong> Enables <strong>non\u2011overlapping epitope binding<\/strong> when paired with Trastuzumab\u2011based ADCs, amplifying <strong>HER2 internalization and receptor degradation<\/strong>.<\/li>\n\n\n\n<li><strong>Combination Rationale:<\/strong> Preclinical data (HLX22\u202f+\u202ftrastuzumab deruxtecan analog) and clinical precedents demonstrate <strong>enhanced tumor cell kill<\/strong> versus single\u2011agent HER2 blockade, with a <strong>manageable safety profile<\/strong> (neutropenia, GI toxicity Grade\u202f\u2264\u202f2).<\/li>\n\n\n\n<li><strong>Pipeline Position:<\/strong> HLX87 (Henlius\u2019 proprietary HER2 ADC) complements HLX22, creating a <strong>dual HER2 blockade + payload<\/strong> platform.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-expected-phase-ii-iii-profile\">Clinical Evidence \u2013 Expected Phase II\/III Profile<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>HLX22\u202f+\u202fHLX87 (Projected)<\/th><th>Standard of Care (T-DM1\/Pyrotinib)<\/th><th>Strategic Advantage<\/th><\/tr><\/thead><tbody><tr><td><strong>pCR Rate (Neoadjuvant)<\/strong><\/td><td>65\u201170%<\/td><td>45\u201150%<\/td><td>+15\u201125\u202fppt improvement<\/td><\/tr><tr><td><strong>Median PFS (1L Metastatic)<\/strong><\/td><td>24\u201126\u202fmonths<\/td><td>18\u201120\u202fmonths<\/td><td>6\u2011month extension<\/td><\/tr><tr><td><strong>ORR (Objective Response)<\/strong><\/td><td>80\u201185%<\/td><td>65\u201170%<\/td><td>Higher depth of response<\/td><\/tr><tr><td><strong>Safety (Grade\u202f\u2265\u202f3 AEs)<\/strong><\/td><td>&lt;\u202f15%<\/td><td>20\u201125%<\/td><td>Improved tolerability<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The trial will enroll <strong>~800 patients<\/strong> across <strong>35 centers<\/strong> in China, with a possible <strong>global expansion<\/strong> cohort (U.S.\/EU) contingent on early data.<\/p>\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 HER2+ Breast Cancer Market:<\/strong> ~\u202f120,000 new cases annually; neoadjuvant and first\u2011line segments represent <strong>$850\u202fmillion<\/strong> in addressable drug sales (2025).<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong> Dominated by <strong>Roche\u2019s Perjeta\u202f+\u202fHerceptin<\/strong> and <strong>AstraZeneca\/Daiichi Sankyo\u2019s Enhertu<\/strong>; HLX22\u2019s <strong>novel epitope<\/strong> may circumvent prior resistance mechanisms.<\/li>\n\n\n\n<li><strong>Revenue Forecast:<\/strong> Henlius estimates <strong>\u00a52.8\u202fbillion<\/strong> (\u2248\u202fUS$390\u202fmillion) peak China sales by 2032, assuming <strong>15% market share<\/strong> in second\u2011line neoadjuvant use.<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> Successful data could support <strong>BLA submission<\/strong> in the U.S. under FDA\u2019s <strong>ORP<\/strong> (Oncology Reform Pathway), given the unmet need in Trastuzumab\u2011refractory populations.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding trial timelines, clinical outcomes, and commercial projections for HLX22 and HLX87. Actual results may differ due to regulatory delays, competitive responses, and unforeseen safety signals.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China\u2019s National Medical Products Administration (NMPA) has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":50367,"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":[35,16,62,270,862],"class_list":["post-50365","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-henlius-biotech","tag-hkg-2696"],"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 Secures NMPA Approval for Phase II\/III HLX22 HER2 Trials, Pioneering Novel Epitope ADC Combination in Breast Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. 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