{"id":67214,"date":"2026-06-03T19:04:23","date_gmt":"2026-06-03T11:04:23","guid":{"rendered":"https:\/\/flcube.com\/?p=67214"},"modified":"2026-06-03T19:04:24","modified_gmt":"2026-06-03T11:04:24","slug":"kelun-biotechs-novel-b7-h3-adc-skb500-shows-42-7-response-rate-across-multiple-solid-tumors-in-first-in-human-asco-2026-presentation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=67214","title":{"rendered":"Kelun-Biotech&#8217;s Novel B7-H3 ADC SKB500 Shows 42.7% Response Rate Across Multiple Solid Tumors in First-in-Human ASCO 2026 Presentation"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/6990:HKG\">HKG: 6990<\/a>) unveiled <strong>first-in-human clinical data<\/strong> for its investigational <strong>B7-H3-targeting antibody-drug conjugate (ADC) SKB500<\/strong> at the <strong>2026 American Society of Clinical Oncology (ASCO) Annual Meeting<\/strong>, demonstrating <strong>robust antitumor activity<\/strong> across six distinct solid tumor types with a <strong>favorable safety profile<\/strong> at the 12 mg\/kg dose level.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The novel ADC achieved an <strong>objective response rate (ORR) of 42.7%<\/strong> and <strong>disease control rate (DCR) of 83.9%<\/strong> among 124 patients with advanced solid tumors, positioning SKB500 as a promising addition to the competitive B7-H3 therapeutic landscape.<\/p>\n\n\n\n<h2 id=\"h-clinical-trial-overview-amp-patient-population\" class=\"wp-block-heading\">Clinical Trial Overview &amp; Patient Population<\/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 Type<\/strong><\/td><td>First-in-human Phase I<\/td><\/tr><tr><td><strong>Presentation Venue<\/strong><\/td><td>ASCO Annual Meeting 2026<\/td><\/tr><tr><td><strong>Total Patients (12 mg\/kg cohort)<\/strong><\/td><td>124 patients<\/td><\/tr><tr><td><strong>Minimum Follow-up<\/strong><\/td><td>6 weeks<\/td><\/tr><tr><td><strong>Tumor Types Evaluated<\/strong><\/td><td>Small cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), nasopharyngeal carcinoma (NPC)<\/td><\/tr><tr><td><strong>Optimal Dose Identified<\/strong><\/td><td>12 mg\/kg (superior safety vs. 16 mg\/kg)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-adc-engineering-features\" class=\"wp-block-heading\">ADC Engineering Features<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Antibody Properties<\/strong>: High affinity, high hydrophilicity, enhanced endocytosis capability<\/li>\n\n\n\n<li><strong>Fc Engineering<\/strong>: Silenced Fc effector function in constant region to reduce off-target toxicity<\/li>\n\n\n\n<li><strong>Payload<\/strong>: Moderately toxic cytotoxic agent optimized for therapeutic index<\/li>\n\n\n\n<li><strong>Linker Technology<\/strong>: Cleavable hydrophilic linker for controlled payload release<\/li>\n\n\n\n<li><strong>Drug-to-Antibody Ratio (DAR)<\/strong>: Approximately 8 (high DAR for enhanced potency)<\/li>\n\n\n\n<li><strong>Target<\/strong>: B7-H3 (tumor-associated antigen overexpressed across multiple solid tumors)<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-efficacy-results-12-mg-kg-cohort-n-124\" class=\"wp-block-heading\">Efficacy Results \u2013 12 mg\/kg Cohort (n=124)<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Result<\/th><\/tr><\/thead><tbody><tr><td><strong>Objective Response Rate (ORR)<\/strong><\/td><td>42.7%<\/td><\/tr><tr><td><strong>Disease Control Rate (DCR)<\/strong><\/td><td>83.9%<\/td><\/tr><tr><td><strong>Tumor Types with Activity<\/strong><\/td><td>SCLC, ESCC, HNSCC, PDAC, NSCLC, NPC<\/td><\/tr><tr><td><strong>Response Breadth<\/strong><\/td><td>Activity observed across histologically diverse tumor types<\/td><\/tr><tr><td><strong>Clinical Significance<\/strong><\/td><td>Robust responses in traditionally difficult-to-treat cancers including pancreatic and SCLC<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-safety-profile-amp-dose-optimization\" class=\"wp-block-heading\">Safety Profile &amp; Dose Optimization<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Recommended Dose<\/strong>: 12 mg\/kg selected based on superior safety profile<\/li>\n\n\n\n<li><strong>Dose Comparison<\/strong>: 12 mg\/kg demonstrated more favorable tolerability than 16 mg\/kg cohort<\/li>\n\n\n\n<li><strong>Therapeutic Index<\/strong>: High efficacy coupled with manageable safety supports continued development<\/li>\n\n\n\n<li><strong>ADC-Specific Toxicities<\/strong>: No significant off-target effects reported due to Fc silencing design<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-implications-for-kelun-biotech\" class=\"wp-block-heading\">Strategic Implications for Kelun-Biotech<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ADC Platform Validation<\/strong>: Success validates Kelun-Biotech&#8217;s proprietary ADC engineering capabilities<\/li>\n\n\n\n<li><strong>B7-H3 Competitive Position<\/strong>: Enters crowded but promising B7-H3 field with differentiated high-DAR approach<\/li>\n\n\n\n<li><strong>Global Development Potential<\/strong>: Strong ASCO presentation facilitates international partnership opportunities<\/li>\n\n\n\n<li><strong>Pipeline Diversification<\/strong>: Expands beyond traditional small molecules into advanced biotherapeutics<\/li>\n\n\n\n<li><strong>Market Opportunity<\/strong>: Addresses significant unmet needs in multiple solid tumor indications with limited treatment options<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-competitive-landscape-analysis\" class=\"wp-block-heading\">Competitive Landscape Analysis<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>B7-H3 Field<\/strong>: Growing interest from major pharma companies with multiple ADCs in development<\/li>\n\n\n\n<li><strong>Differentiation Factors<\/strong>: High DAR (8), hydrophilic linker, Fc-silenced antibody, broad tumor activity<\/li>\n\n\n\n<li><strong>Clinical Benchmark<\/strong>: 42.7% ORR compares favorably to other early-stage B7-H3 ADCs<\/li>\n\n\n\n<li><strong>Development Stage<\/strong>: First-in-human data positions Kelun-Biotech competitively in race to market<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-considerations\" class=\"wp-block-heading\">Market Impact Considerations<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Treatment Paradigm<\/strong>: Potential new option for patients with B7-H3-positive solid tumors failing standard therapies<\/li>\n\n\n\n<li><strong>Commercial Strategy<\/strong>: Likely focus on tumor types with highest unmet need (pancreatic, SCLC, HNSCC)<\/li>\n\n\n\n<li><strong>Pricing Premium<\/strong>: Advanced ADC technology supports premium pricing in oncology market<\/li>\n\n\n\n<li><strong>Global Ambitions<\/strong>: Data supports potential regulatory filings beyond China in major markets<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory pathways, and commercial potential for SKB500. Actual results may differ due to clinical trial outcomes, competitive dynamics, and regulatory decisions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) unveiled first-in-human clinical data for its investigational B7-H3-targeting&#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":[106,35,17,971,1832],"class_list":["post-67214","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-academic-conference","tag-adc-xdc","tag-clinical-trial-results","tag-hkg-6990","tag-kelun-biotech-biopharmaceutical"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Kelun-Biotech&#039;s Novel B7-H3 ADC SKB500 Shows 42.7% Response Rate Across Multiple Solid Tumors in First-in-Human ASCO 2026 Presentation - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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(HKG: 6990) unveiled first-in-human clinical data for its investigational B7-H3-targeting antibody-drug conjugate (ADC) SKB500 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating robust antitumor activity across six distinct solid tumor types with a favorable safety profile at the 12 mg\/kg dose level.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=67214#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=67214"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=67214#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Kelun-Biotech&#8217;s Novel B7-H3 ADC SKB500 Shows 42.7% Response Rate Across Multiple Solid Tumors in First-in-Human ASCO 2026 Presentation"}]},{"@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\/67214","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=67214"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/67214\/revisions"}],"predecessor-version":[{"id":67215,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/67214\/revisions\/67215"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=67214"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=67214"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=67214"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}