{"id":59149,"date":"2026-03-10T13:41:17","date_gmt":"2026-03-10T05:41:17","guid":{"rendered":"https:\/\/flcube.com\/?p=59149"},"modified":"2026-03-10T13:41:18","modified_gmt":"2026-03-10T05:41:18","slug":"fosun-pharmas-hlx316-wins-nmpa-approval-first-in-class-b7-h3-sialidase-heterodimer-targets-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59149","title":{"rendered":"Fosun Pharma&#8217;s HLX316 Wins NMPA Approval \u2013 First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors"},"content":{"rendered":"\n<p><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 <strong>HLX316<\/strong>, a <strong>novel first-in-class sialidase heterodimer targeting B7-H3<\/strong>, has received <strong>NMPA clinical trial approval<\/strong> for the treatment of <strong>advanced\/metastatic solid tumors<\/strong>. The <strong>sialidase-Fc fusion protein<\/strong>, developed by fusing a <strong>B7-H3-targeting heavy-chain-only antibody variable region (VHH)<\/strong> with a <strong>licensed-in sialidase bifunctional fusion protein<\/strong>, represents Fosun Pharma&#8217;s <strong>innovation pivot<\/strong> into <strong>next-generation immuno-oncology modalities<\/strong> beyond its established biosimilar and PD-1 franchise.<\/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>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Clinical trial authorization (IND)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>HLX316<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>First-in-class sialidase heterodimer (sialidase-Fc fusion protein)<\/td><\/tr><tr><td><strong>Target<\/strong><\/td><td>B7-H3 (CD276) \u2013 immune checkpoint and tumor-associated antigen<\/td><\/tr><tr><td><strong>Format<\/strong><\/td><td>VHH (heavy-chain-only antibody) fused to sialidase + Fc domain<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced\/metastatic solid tumors<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Shanghai Fosun Pharmaceutical (SHA: 600196, HKG: 2196)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>9\u202fMar\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism\">Drug Profile &amp; Mechanism<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>HLX316 Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Architecture<\/strong><\/td><td>Sialidase-Fc fusion protein heterodimer<\/td><\/tr><tr><td><strong>Targeting Domain<\/strong><\/td><td>B7-H3-specific VHH (heavy-chain-only antibody variable region)<\/td><\/tr><tr><td><strong>Effector Domain<\/strong><\/td><td>Sialidase enzyme (licensed-in bifunctional fusion)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>\u2022 <strong>Desialylation:<\/strong> Removes sialic acid from tumor cell glycocalyx<br>\u2022 <strong>Immune Activation:<\/strong> Unmasks tumor antigens; enhances NK cell and T-cell recognition<br>\u2022 <strong>B7-H3 Blockade:<\/strong> Checkpoint inhibition via B7-H3 targeting<\/td><\/tr><tr><td><strong>Innovation Class<\/strong><\/td><td>First-in-class (no approved sialidase-targeting cancer therapeutics globally)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Scientific Rationale:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>B7-H3 Overexpression:<\/strong> Highly expressed in lung, prostate, breast, and pediatric cancers; associated with poor prognosis and immune evasion<\/li>\n\n\n\n<li><strong>Sialic Acid Shield:<\/strong> Tumor cells use hypersialylation to evade immune surveillance; enzymatic removal restores immune recognition<\/li>\n\n\n\n<li><strong>Dual Mechanism:<\/strong> B7-H3 blockade + desialylation provides complementary immune activation pathways<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-context-amp-competitive-landscape\">Strategic Context &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factor<\/th><th>Market Implication<\/th><\/tr><\/thead><tbody><tr><td><strong>B7-H3 Target Validation<\/strong><\/td><td>Multiple ADCs (DS-7300, MGC018) and CAR-Ts in Phase II\/III; sialidase approach novel<\/td><\/tr><tr><td><strong>Sialidase Modality<\/strong><\/td><td>No approved sialidase cancer therapeutics; Palleon Pharma (sialidase-Fc) and other biotechs in early development<\/td><\/tr><tr><td><strong>Fosun Innovation Pivot<\/strong><\/td><td>HLX316 demonstrates R&amp;D capabilities beyond biosimilars; positions as China innovator in immuno-oncology<\/td><\/tr><tr><td><strong>Licensed Component<\/strong><\/td><td>Sialidase technology in-licensed; VHH platform proprietary; balanced IP strategy<\/td><\/tr><tr><td><strong>Global Potential<\/strong><\/td><td>First-in-class status supports U.S.\/EU IND filing; orphan indication potential in B7-H3-high pediatric tumors<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-dynamics\">Competitive Dynamics<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Competitor<\/th><th>Product<\/th><th>Mechanism<\/th><th>Status<\/th><th>HLX316 Differentiation<\/th><\/tr><\/thead><tbody><tr><td><strong>Daiichi Sankyo<\/strong><\/td><td>DS-7300 (ifinatamab deruxtecan)<\/td><td>B7-H3 ADC<\/td><td>Phase II<\/td><td>Sialidase enzymatic activity + checkpoint blockade vs. cytotoxic payload<\/td><\/tr><tr><td><strong>MacroGenics<\/strong><\/td><td>Enoblituzumab<\/td><td>B7-H3 mAb<\/td><td>Phase II<\/td><td>Dual-action desialylation + B7-H3 targeting<\/td><\/tr><tr><td><strong>Palleon Pharma<\/strong><\/td><td>E-602 (sialidase-Fc)<\/td><td>Pan-tumor desialylation<\/td><td>Phase I<\/td><td>HLX316 adds B7-H3 targeting for tumor-specific delivery<\/td><\/tr><tr><td><strong>Fosun Pharma<\/strong><\/td><td><strong>HLX316<\/strong><\/td><td><strong>B7-H3-targeted sialidase heterodimer<\/strong><\/td><td><strong>Phase I-ready<\/strong><\/td><td><strong>First-in-class bifunctional; China-developed global asset<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-outlook\">Development Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Phase<\/th><th>Timeline<\/th><th>Objectives<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase I<\/strong><\/td><td>2026-2027<\/td><td>Safety, tolerability, MTD; biomarker validation (sialylation levels, B7-H3 expression)<\/td><\/tr><tr><td><strong>Phase II<\/strong><\/td><td>2027-2029<\/td><td>Expansion in B7-H3-high indications (lung, prostate, neuroblastoma); combination with PD-1<\/td><\/tr><tr><td><strong>Global Expansion<\/strong><\/td><td>2028-2030<\/td><td>U.S.\/EU IND; potential Fast Track for pediatric solid tumors<\/td><\/tr><tr><td><strong>Partnering<\/strong><\/td><td>Ongoing<\/td><td>Licensing discussions for ex-China rights anticipated given first-in-class status<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development timelines, first-in-class positioning, and competitive differentiation for HLX316. Actual results may differ due to novelty of sialidase mechanism, manufacturing complexity, and competitive dynamics in B7-H3-targeted oncology.<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\/03\/2026030900872_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026030900872_c.\"><\/object><a id=\"wp-block-file--media-a592f172-7418-4aa3-95d7-26ca3d1331f1\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026030900872_c.pdf\">2026030900872_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026030900872_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-a592f172-7418-4aa3-95d7-26ca3d1331f1\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel&#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_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":[16,62,159,893,25,892],"class_list":["post-59149","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-fosun-pharmaceutical","tag-hkg-2196","tag-potential-first-in-class","tag-sha-600196"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Fosun Pharma&#039;s HLX316 Wins NMPA Approval \u2013 First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel first-in-class sialidase heterodimer targeting B7-H3, has received NMPA clinical trial approval for the treatment of advanced\/metastatic solid tumors. The sialidase-Fc fusion protein, developed by fusing a B7-H3-targeting heavy-chain-only antibody variable region (VHH) with a licensed-in sialidase bifunctional fusion protein, represents Fosun Pharma&#039;s innovation pivot into next-generation immuno-oncology modalities beyond its established biosimilar and PD-1 franchise.\" \/>\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=59149\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fosun Pharma&#039;s HLX316 Wins NMPA Approval \u2013 First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors\" \/>\n<meta property=\"og:description\" content=\"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel first-in-class sialidase heterodimer targeting B7-H3, has received NMPA clinical trial approval for the treatment of advanced\/metastatic solid tumors. The sialidase-Fc fusion protein, developed by fusing a B7-H3-targeting heavy-chain-only antibody variable region (VHH) with a licensed-in sialidase bifunctional fusion protein, represents Fosun Pharma&#039;s innovation pivot into next-generation immuno-oncology modalities beyond its established biosimilar and PD-1 franchise.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=59149\" \/>\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=\"2026-03-10T05:41:17+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-10T05:41:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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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(SHA: 600196, HKG: 2196) announced that HLX316, a novel first-in-class sialidase heterodimer targeting B7-H3, has received NMPA clinical trial approval for the treatment of advanced\/metastatic solid tumors. The sialidase-Fc fusion protein, developed by fusing a B7-H3-targeting heavy-chain-only antibody variable region (VHH) with a licensed-in sialidase bifunctional fusion protein, represents Fosun Pharma's innovation pivot into next-generation immuno-oncology modalities beyond its established biosimilar and PD-1 franchise.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=59149#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=59149"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=59149#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Fosun Pharma&#8217;s HLX316 Wins NMPA Approval \u2013 First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59149","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=59149"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59149\/revisions"}],"predecessor-version":[{"id":59151,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59149\/revisions\/59151"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=59149"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=59149"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=59149"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}