{"id":40552,"date":"2025-09-02T13:59:14","date_gmt":"2025-09-02T05:59:14","guid":{"rendered":"https:\/\/flcube.com\/?p=40552"},"modified":"2025-09-02T13:59:15","modified_gmt":"2025-09-02T05:59:15","slug":"haisco-secures-fda-clinical-trial-approval-for-first%e2%80%91in%e2%80%91class-bcl6-protac-hsk47977","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40552","title":{"rendered":"Haisco Secures FDA Clinical Trial Approval for First\u2011In\u2011Class BCL6 PROTAC HSK47977"},"content":{"rendered":"\n<p><strong>Haisco Pharmaceutical Group Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/002653:SHE\">SHE: 002653<\/a>)<\/strong> announced that the <strong>U.S. Food and Drug Administration (FDA)<\/strong> has granted clinical\u2011trial approval for its investigational drug <strong>HSK47977 tablets<\/strong>. The approval marks a significant milestone for the company\u2019s first\u2011in\u2011class oral BCL6 PROTAC platform, designed to target and degrade the BCL6 protein in lymphoma cells.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approval-highlights\">FDA Approval Highlights<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory Milestone<\/strong> \u2013 The FDA\u2019s Investigational New Drug (IND) clearance authorizes Phase 1\/2 trials in the United States.<\/li>\n\n\n\n<li><strong>Global Impact<\/strong> \u2013 Haisco will be the first Chinese developer to obtain FDA approval for a BCL6\u2011targeting PROTAC, positioning it as a global leader in next\u2011generation protein degradation therapies.<\/li>\n\n\n\n<li><strong>Speed to Market<\/strong> \u2013 The dual approval\u2014NMPA clearance in August 2025 and FDA IND in March 2025\u2014accelerates the drug\u2019s potential for international commercialization.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-hsk47977-a-novel-bcl6-protac\">HSK47977: A Novel BCL6 PROTAC<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug Class<\/strong><\/td><td>Proteolysis\u2011Targeting Chimera (PROTAC)<\/td><\/tr><tr><td><strong>Target<\/strong><\/td><td>BCL6 (human B\u2011cell lymphoma factor 6)<\/td><\/tr><tr><td><strong>Route<\/strong><\/td><td>Oral tablets<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Treatment of B\u2011cell lymphoma (clinical development)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>BCL6\u2011binding moiety recruits E3 ubiquitin ligase, leading to selective proteasomal degradation of BCL6.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-pre-clinical-efficacy-amp-safety\">Pre\u2011clinical Efficacy &amp; Safety<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Potent Tumor Suppression<\/strong> \u2013 In xenograft models, HSK47977 achieved >80\u202f% tumor growth inhibition at sub\u2011milligram doses.<\/li>\n\n\n\n<li><strong>Target Selectivity<\/strong> \u2013 Proteomic profiling confirmed selective degradation of BCL6 with minimal off\u2011target activity.<\/li>\n\n\n\n<li><strong>Safety Profile<\/strong> \u2013 No dose\u2011limiting toxicities observed up to 200\u202fmg\/kg in rodent and non\u2011human primate studies; no ocular, cardiac, or renal adverse effects reported.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-significance\">Market Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011In\u2011Class Gap<\/strong> \u2013 No other BCL6 PROTAC has entered clinical trials in China, giving Haisco a clear competitive advantage.<\/li>\n\n\n\n<li><strong>Growing Lymphoma Landscape<\/strong> \u2013 Global lymphoma market projected to exceed $20\u202fbillion by 2030; targeted protein\u2011degradation agents represent a high\u2011growth sub\u2011segment.<\/li>\n\n\n\n<li><strong>Strategic Partnerships<\/strong> \u2013 Haisco is actively pursuing collaborations with U.S. biotechs and academic centers to expand the drug\u2019s development portfolio.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-next-steps\">Next Steps<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Phase 1\/2 Trial Initiation<\/strong> \u2013 Enrollment currently underway in the U.S.; first patient dose expected in Q3\u202f2025.<\/li>\n\n\n\n<li><strong>Biomarker Development<\/strong> \u2013 Companion diagnostics for BCL6 expression will be co\u2011developed to identify responsive patient cohorts.<\/li>\n\n\n\n<li><strong>Regulatory Synchronization<\/strong> \u2013 Parallel submissions to EMA and other global regulators are planned to align with FDA timelines.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ol>\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\/2025\/09\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK47977\u7247\u83b7\u5f97FDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK47977\u7247\u83b7\u5f97FDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-dc8325b5-d6be-4202-8484-2bd4c4a75c86\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK47977\u7247\u83b7\u5f97FDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u7684\u516c\u544a.pdf\">\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK47977\u7247\u83b7\u5f97FDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u521b\u65b0\u836fHSK47977\u7247\u83b7\u5f97FDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-dc8325b5-d6be-4202-8484-2bd4c4a75c86\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that the U.S. Food and Drug Administration&#8230;<\/p>\n","protected":false},"author":1,"featured_media":40555,"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":[62,139,929,70],"class_list":["post-40552","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-haisco-pharmaceutical","tag-she-002653","tag-tpd"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Haisco Secures FDA Clinical Trial Approval for First\u2011In\u2011Class BCL6 PROTAC HSK47977 - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2019s Haisco Pharmaceutical Group has gained FDA clearance for its investigational BCL6 PROTAC, HSK47977, an oral lymphoma therapy that selectively degrades the BCL6 protein. 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