{"id":69929,"date":"2026-07-14T14:26:38","date_gmt":"2026-07-14T06:26:38","guid":{"rendered":"https:\/\/flcube.com\/?p=69929"},"modified":"2026-07-14T14:26:39","modified_gmt":"2026-07-14T06:26:39","slug":"fosun-pharma-secures-nmpa-approval-for-phase-1-trial-of-hlx37-bispecific-antibody-in-combination-therapies-for-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=69929","title":{"rendered":"Fosun Pharma Secures NMPA Approval for Phase 1 Trial of HLX37 Bispecific Antibody in Combination Therapies for Advanced Solid Tumors"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Shanghai Fosun Pharmaceutical (Group) Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600196:SHA\">SHA: 600196<\/a>; <a href=\"https:\/\/www.google.com\/finance\/quote\/2196:HKG\">HKG: 2196<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has approved a <strong>Phase 1 clinical trial<\/strong> evaluating <strong>HLX37<\/strong> in combination with chemotherapy or <strong>HLX43<\/strong> for the treatment of <strong>advanced\/metastatic solid tumors<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">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>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Phase 1 clinical trial authorization<\/td><\/tr><tr><td><strong>Lead Compound<\/strong><\/td><td>HLX37 \u2013 recombinant humanized anti-PD-L1\/anti-VEGF bispecific antibody<\/td><\/tr><tr><td><strong>Combination Partners<\/strong><\/td><td>Standard chemotherapy regimens and HLX43 (PD-L1-targeting ADC)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced\/metastatic solid tumors<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Henlius (wholly-owned subsidiary of Fosun Pharma)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>14 Jul 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profiles-amp-mechanisms-of-action\" class=\"wp-block-heading\">Drug Profiles &amp; Mechanisms of Action<\/h2>\n\n\n\n<h3 id=\"h-hlx37-dual-targeting-bispecific-antibody\" class=\"wp-block-heading\">HLX37 \u2013 Dual-Targeting Bispecific Antibody<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule Type:<\/strong> Recombinant humanized IgG bispecific antibody<\/li>\n\n\n\n<li><strong>Targets:<\/strong> PD-L1 (immune checkpoint) and VEGF (angiogenesis factor)<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Simultaneously blocks tumor immune evasion and angiogenesis pathways<\/li>\n\n\n\n<li><strong>Development Status:<\/strong> Phase 1 initiation approved<\/li>\n\n\n\n<li><strong>Intellectual Property:<\/strong> Independently developed by Henlius with full IP rights<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-hlx43-next-generation-antibody-drug-conjugate\" class=\"wp-block-heading\">HLX43 \u2013 Next-Generation Antibody-Drug Conjugate<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule Type:<\/strong> PD-L1-targeting antibody-drug conjugate (ADC)<\/li>\n\n\n\n<li><strong>Antibody Component:<\/strong> Independently developed PD-L1-targeting antibody (Henlius)<\/li>\n\n\n\n<li><strong>Payload:<\/strong> Novel DNA topoisomerase I inhibitor small-molecule toxin<\/li>\n\n\n\n<li><strong>Linker Technology:<\/strong> Proprietary peptide linker (licensed technology)<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Targeted delivery of cytotoxic payload to PD-L1-expressing tumor cells<\/li>\n\n\n\n<li><strong>Indication:<\/strong> Advanced\/metastatic solid tumors<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-development-strategy\" class=\"wp-block-heading\">Clinical Development Strategy<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Trial Arm<\/th><th>Combination<\/th><th>Rationale<\/th><\/tr><\/thead><tbody><tr><td><strong>Arm A<\/strong><\/td><td>HLX37 + Chemotherapy<\/td><td>Dual pathway inhibition enhances chemo sensitivity<\/td><\/tr><tr><td><strong>Arm B<\/strong><\/td><td>HLX37 + HLX43<\/td><td>Triple mechanism: immune activation + angiogenesis inhibition + targeted cytotoxicity<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>Safety, tolerability, maximum tolerated dose (MTD)<\/td><td>Establish foundation for Phase 2 expansion<\/td><\/tr><tr><td><strong>Secondary Endpoints<\/strong><\/td><td>Preliminary efficacy, pharmacokinetics, biomarker analysis<\/td><td>Identify optimal patient populations<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The combination approach represents a sophisticated strategy to overcome resistance mechanisms commonly observed with single-agent immunotherapies and targeted therapies in advanced solid tumors.<\/p>\n\n\n\n<h2 id=\"h-market-impact-amp-strategic-implications\" class=\"wp-block-heading\">Market Impact &amp; Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Landscape:<\/strong> The bispecific + ADC combination positions Fosun\/Henlius at the forefront of next-generation immuno-oncology combinations, competing with global leaders like Roche, Merck, and AstraZeneca<\/li>\n\n\n\n<li><strong>Addressable Market:<\/strong> Advanced\/metastatic solid tumors represent a $75+ billion global market opportunity, with combination therapies commanding premium pricing<\/li>\n\n\n\n<li><strong>Pipeline Synergy:<\/strong> Leverages Henlius&#8217; established capabilities in both bispecific antibodies and ADC development, creating operational efficiencies<\/li>\n\n\n\n<li><strong>Global Potential:<\/strong> Successful clinical data could support international regulatory filings, particularly in markets with high solid tumor burden<\/li>\n\n\n\n<li><strong>Strategic Positioning:<\/strong> Demonstrates Fosun Pharma&#8217;s commitment to innovative oncology therapeutics beyond biosimilars, supporting premium valuation multiples<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development, regulatory approvals, and market opportunities for HLX37 and HLX43. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, competitive dynamics, and market adoption rates.<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\/07\/600196_20260711_G46J.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600196_20260711_G46J.\"><\/object><a id=\"wp-block-file--media-8d86b9ab-836a-4a54-b0bf-48b6fdb07d7f\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/600196_20260711_G46J.pdf\">600196_20260711_G46J<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/600196_20260711_G46J.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-8d86b9ab-836a-4a54-b0bf-48b6fdb07d7f\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196; HKG: 2196) announced that China&#8217;s National Medical&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[35,62,159,893,28,892],"class_list":["post-69929","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-clinical-trial-approval-initiation","tag-fosun-pharmaceutical","tag-hkg-2196","tag-multi-specific-antibodies","tag-sha-600196"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Fosun Pharma Secures NMPA Approval for Phase 1 Trial of HLX37 Bispecific Antibody in Combination Therapies for Advanced Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. 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