{"id":65263,"date":"2026-05-14T13:04:37","date_gmt":"2026-05-14T05:04:37","guid":{"rendered":"https:\/\/flcube.com\/?p=65263"},"modified":"2026-05-14T13:04:37","modified_gmt":"2026-05-14T05:04:37","slug":"shanghai-henlius-biotech-doses-first-patient-in-phase-i-trial-of-hlx97-novel-kat6a-b-inhibitor-for-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=65263","title":{"rendered":"Shanghai Henlius Biotech Doses First Patient in Phase I Trial of HLX97 \u2013 Novel KAT6A\/B Inhibitor for Advanced Solid Tumors"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced the dosing of the first patient in a <strong>Phase I clinical study<\/strong> evaluating <strong>HLX97<\/strong>, a <strong>small molecule inhibitor of lysine acetyltransferase 6A\/B (KAT6A\/B)<\/strong>, for the treatment of <strong>advanced\/metastatic solid tumors<\/strong> in mainland China.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-milestone\">Clinical Development 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>Company<\/strong><\/td><td>Shanghai Henlius Biotech Inc. (HKG: 2696)<\/td><\/tr><tr><td><strong>Trial Phase<\/strong><\/td><td>Phase I<\/td><\/tr><tr><td><strong>Patient Status<\/strong><\/td><td>First patient dosed<\/td><\/tr><tr><td><strong>Therapeutic Area<\/strong><\/td><td>Advanced\/metastatic solid tumors<\/td><\/tr><tr><td><strong>Geography<\/strong><\/td><td>Mainland China<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Dose escalation and safety assessment<\/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>Molecule:<\/strong> Small molecule inhibitor targeting epigenetic regulators<\/li>\n\n\n\n<li><strong>Target:<\/strong> <strong>Lysine acetyltransferase 6A\/B (KAT6A\/B)<\/strong> enzymes<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> KAT6A\/B work with paralog KAT6B and other chromatin-associated proteins to acetylate lysine residues on histone H3, playing an <strong>oncogenic role<\/strong> across multiple tumor types<\/li>\n\n\n\n<li><strong>Development Stage:<\/strong> Early clinical (Phase I)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-context\">Strategic Context<\/h2>\n\n\n\n<p>Henlius Biotech, primarily known for its biosimilars portfolio, is strategically expanding into novel targeted oncology therapies. The initiation of this Phase I trial represents a significant milestone in the company&#8217;s diversification beyond biosimilars into innovative assets addressing high-unmet medical needs in oncology.<\/p>\n\n\n\n<p>The KAT6A\/B inhibition approach offers a novel epigenetic strategy for cancer treatment, potentially providing new therapeutic options for patients with limited alternatives in advanced solid tumor settings.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-outlook\">Market Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Oncology Landscape:<\/strong> Epigenetic targets like KAT6A\/B represent an emerging frontier in precision oncology with potential applicability across multiple tumor types<\/li>\n\n\n\n<li><strong>Competitive Position:<\/strong> HLX97 joins a limited number of KAT6A\/B inhibitors in clinical development globally<\/li>\n\n\n\n<li><strong>Pipeline Strategy:<\/strong> This program complements Henlius&#8217;s existing oncology pipeline, which includes both biosimilars and novel targeted agents<\/li>\n\n\n\n<li><strong>Development Timeline:<\/strong> Preliminary data from the dose-escalation phase expected within 12-18 months<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development timelines and therapeutic potential of HLX97. Actual results may differ due to risks including clinical trial outcomes, regulatory requirements, and competitive dynamics.<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\/05\/2026051300489_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026051300489_c.\"><\/object><a id=\"wp-block-file--media-ac72d0d3-d836-49b4-8d1a-2e01db1e6dda\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/2026051300489_c.pdf\">2026051300489_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/2026051300489_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-ac72d0d3-d836-49b4-8d1a-2e01db1e6dda\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech Inc. (HKG: 2696) announced the dosing of the first patient in a&#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":[16,62,270,862],"class_list":["post-65263","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","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 v27.5 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Shanghai Henlius Biotech Doses First Patient in Phase I Trial of HLX97 \u2013 Novel KAT6A\/B Inhibitor for Advanced Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech Inc. 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