{"id":58925,"date":"2026-03-06T14:00:39","date_gmt":"2026-03-06T06:00:39","guid":{"rendered":"https:\/\/flcube.com\/?p=58925"},"modified":"2026-03-06T14:00:40","modified_gmt":"2026-03-06T06:00:40","slug":"fosun-pharmas-hlx97-wins-nmpa-phase-i-approval-first-in-class-kat6a-b-inhibitor-targets-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=58925","title":{"rendered":"Fosun Pharma&#8217;s HLX97 Wins NMPA Phase I Approval \u2013 First-in-Class KAT6A\/B Inhibitor Targets Advanced Solid Tumors"},"content":{"rendered":"\n<p><strong>Shanghai Fosun Pharmaceutical (Group) Co., Ltd.<\/strong> (Fosun Pharma, <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>HLX97<\/strong>, a <strong>first-in-class small molecule inhibitor of lysine acetyltransferase 6A\/B (KAT6A\/B)<\/strong>, has received <strong>Phase I clinical trial approval<\/strong> from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for the treatment of <strong>advanced\/metastatic solid tumors<\/strong>. The candidate represents a <strong>novel epigenetic target<\/strong> with no approved inhibitors globally, positioning Fosun Pharma at the forefront of KAT6A\/B drug development.<\/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>Phase I clinical trial authorization<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>HLX97 (small molecule)<\/td><\/tr><tr><td><strong>Target<\/strong><\/td><td>KAT6A\/B (lysine acetyltransferase 6A\/B)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced\/metastatic solid tumors<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Fosun Pharma (SHA: 600196, HKG: 2196)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>6\u202fMar\u202f2026<\/td><\/tr><tr><td><strong>Global Status<\/strong><\/td><td>No KAT6A\/B inhibitor approved worldwide<\/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>HLX97 Profile<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug Class<\/strong><\/td><td>Small molecule epigenetic modulator<\/td><\/tr><tr><td><strong>Molecular Target<\/strong><\/td><td>KAT6A and KAT6B (histone acetyltransferases)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Inhibition of KAT6A\/B-mediated histone acetylation; disruption of oncogenic transcriptional programs<\/td><\/tr><tr><td><strong>Therapeutic Area<\/strong><\/td><td>Oncology (solid tumors)<\/td><\/tr><tr><td><strong>Development Status<\/strong><\/td><td>Phase I-ready; first-in-class globally<\/td><\/tr><tr><td><strong>Competitive Position<\/strong><\/td><td>No approved competitors; potential first-mover advantage in epigenetic space<\/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>KAT6A\/B overexpression linked to multiple solid tumor types (breast, prostate, lung)<\/li>\n\n\n\n<li>Epigenetic modulation offers alternative to kinase-driven oncology paradigms<\/li>\n\n\n\n<li>Preclinical data suggests synthetic lethality opportunities with existing therapies<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-context\">Strategic Context<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factor<\/th><th>Implication<\/th><\/tr><\/thead><tbody><tr><td><strong>First-in-Class Status<\/strong><\/td><td>HLX97 advances Fosun Pharma into novel target space beyond biosimilars and generics<\/td><\/tr><tr><td><strong>Global Opportunity<\/strong><\/td><td>NMPA approval enables China-first development; potential for U.S.\/EU IND submission based on Phase I data<\/td><\/tr><tr><td><strong>Epigenetic Pipeline<\/strong><\/td><td>Complements Fosun&#8217;s existing oncology portfolio (PD-1, ADCs) with differentiated mechanism<\/td><\/tr><tr><td><strong>Investor Impact<\/strong><\/td><td>SHA: 600196 \/ HKG: 2196 shares may benefit from innovation pipeline validation<\/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<ul class=\"wp-block-list\">\n<li><strong>Phase I Design:<\/strong> Dose-escalation study in advanced solid tumor patients with KAT6A\/B biomarker enrichment<\/li>\n\n\n\n<li><strong>Biomarker Strategy:<\/strong> Companion diagnostic development for KAT6A amplification\/overexpression<\/li>\n\n\n\n<li><strong>Combination Potential:<\/strong> Preclinical exploration with immunotherapy and targeted agents<\/li>\n\n\n\n<li><strong>Regulatory Pathway:<\/strong> China Phase I data to support global expansion; Breakthrough Therapy designation potential<\/li>\n<\/ul>\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 commercial potential for HLX97. Actual results may differ due to trial outcomes, competitive dynamics in epigenetic drug development, and regulatory requirements.<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\/2026030501776_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026030501776_c.\"><\/object><a id=\"wp-block-file--media-a4e218b3-7b3d-495e-8638-534bfe09db7d\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026030501776_c.pdf\">2026030501776_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026030501776_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-a4e218b3-7b3d-495e-8638-534bfe09db7d\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196, HKG: 2196) announced that HLX97,&#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":[16,62,159,893,892],"class_list":["post-58925","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-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 HLX97 Wins NMPA Phase I Approval \u2013 First-in-Class KAT6A\/B Inhibitor Targets Advanced Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196, HKG: 2196) announced that HLX97, a first-in-class small molecule inhibitor of lysine acetyltransferase 6A\/B (KAT6A\/B), has received Phase I clinical trial approval from China&#039;s National Medical Products Administration (NMPA) for the treatment of advanced\/metastatic solid tumors. 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(Fosun Pharma, SHA: 600196, HKG: 2196) announced that HLX97, a first-in-class small molecule inhibitor of lysine acetyltransferase 6A\/B (KAT6A\/B), has received Phase I clinical trial approval from China&#039;s National Medical Products Administration (NMPA) for the treatment of advanced\/metastatic solid tumors. 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(Fosun Pharma, SHA: 600196, HKG: 2196) announced that HLX97, a first-in-class small molecule inhibitor of lysine acetyltransferase 6A\/B (KAT6A\/B), has received Phase I clinical trial approval from China's National Medical Products Administration (NMPA) for the treatment of advanced\/metastatic solid tumors. The candidate represents a novel epigenetic target with no approved inhibitors globally, positioning Fosun Pharma at the forefront of KAT6A\/B drug development.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=58925#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=58925"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=58925#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Fosun Pharma&#8217;s HLX97 Wins NMPA Phase I Approval \u2013 First-in-Class KAT6A\/B Inhibitor 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\/58925","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=58925"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/58925\/revisions"}],"predecessor-version":[{"id":58927,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/58925\/revisions\/58927"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=58925"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=58925"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=58925"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}