{"id":53775,"date":"2026-01-12T21:12:55","date_gmt":"2026-01-12T13:12:55","guid":{"rendered":"https:\/\/flcube.com\/?p=53775"},"modified":"2026-01-12T21:12:58","modified_gmt":"2026-01-12T13:12:58","slug":"hengruis-quadruple-prostate-cancer-combo-wins-nmpa-ind-for-phase-2-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53775","title":{"rendered":"Hengrui&#8217;s Quadruple Prostate Cancer Combo Wins NMPA IND for Phase 2 Study"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG: 1276<\/a>) announced that the <strong>National Medical Products Administration (NMPA)<\/strong> has approved a <strong>multicenter, open\u2011label Phase\u202fII study<\/strong> evaluating the <strong>quadruple combination<\/strong> of <strong>SHR\u20114394, HRS\u20115041 tablets, zeprumetostat (SHR\u20112554)<\/strong>, and <strong>rezvilutamide<\/strong> in patients with <strong>prostate cancer<\/strong>. The novel regimen addresses multiple resistance mechanisms including <strong>AR\u2011PROTAC degradation<\/strong> and <strong>EZH2 inhibition<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-trial-overview\">Clinical Trial Overview<\/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>Jiangsu Hengrui Pharmaceuticals (600276.SH\/1276.HK)<\/td><\/tr><tr><td><strong>Trial Design<\/strong><\/td><td>Multicenter, open\u2011label Phase\u202fII<\/td><\/tr><tr><td><strong>Regimen<\/strong><\/td><td>SHR\u20114394 + HRS\u20115041 + Zeprumetostat + Rezvilutamide<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>Safety, tolerability, efficacy<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>Prostate cancer patients (stage\/specific cohort TBD)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NMPA IND approval granted<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-component-drug-profiles\">Component Drug Profiles<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Drug<\/th><th>Mechanism<\/th><th>Status<\/th><th>Key Differentiation<\/th><\/tr><\/thead><tbody><tr><td><strong>SHR\u20114394<\/strong><\/td><td>Therapeutic biological (prostate cancer)<\/td><td>Self\u2011developed, Phase\u202fII<\/td><td>Novel biologic targeting undisclosed pathway<\/td><\/tr><tr><td><strong>HRS\u20115041<\/strong><\/td><td>AR\u2011PROTAC small molecule<\/td><td>Self\u2011developed<\/td><td><strong>Degrades wild\u2011type &amp; mutant AR<\/strong>; overcomes resistance to 2nd\u2011gen AR inhibitors<\/td><\/tr><tr><td><strong>Zeprumetostat (SHR\u20112554)<\/strong><\/td><td>EZH2 inhibitor<\/td><td><strong>Approved 2025<\/strong> for PTCL<\/td><td>Repurposed for prostate cancer; oral, highly selective<\/td><\/tr><tr><td><strong>Rezvilutamide<\/strong><\/td><td>2nd\u2011gen AR inhibitor<\/td><td><strong>Approved 2022<\/strong> for mHSPC<\/td><td>Stronger AR inhibition, no agonistic effects vs. 1st\u2011gen<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-rationale-quadruple-combo-approach\">Strategic Rationale: Quadruple Combo Approach<\/h2>\n\n\n\n<p><strong>Mechanism Synergy<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>AR Blockade<\/strong>: Rezvilutamide (direct inhibition) + <strong>HRS\u20115041<\/strong> (PROTAC degradation) provides <strong>dual AR pathway suppression<\/strong><\/li>\n\n\n\n<li><strong>Epigenetic Modulation<\/strong>: Zeprumetostat (EZH2 inhibitor) addresses <strong>tumor plasticity<\/strong> and <strong>AR\u2011independent resistance<\/strong><\/li>\n\n\n\n<li><strong>Biologic Component<\/strong>: SHR\u20114394 adds <strong>immune\u2011modulating or novel target<\/strong> engagement (details pending)<\/li>\n<\/ul>\n\n\n\n<p><strong>Resistance Management<\/strong>: Combination targets <strong>AR\u2011dependent and AR\u2011independent mechanisms<\/strong>, critical for late\u2011line prostate cancer where <strong>50\u201160%<\/strong> of patients develop resistance to enzalutamide\/apalutamide.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-prostate-cancer-in-china\">Market Opportunity: Prostate Cancer in China<\/h2>\n\n\n\n<p><strong>Disease Burden<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Incidence<\/strong>: <strong>120,000<\/strong> new cases annually (2025), growing at <strong>8% CAGR<\/strong><\/li>\n\n\n\n<li><strong>Metastatic Disease<\/strong>: <strong>30\u201140%<\/strong> present with metastatic disease \u2192 <strong>~40,000<\/strong> eligible for combination therapy<\/li>\n\n\n\n<li><strong>Resistance Population<\/strong>: <strong>15,000\u201120,000<\/strong> patients progress on 2nd\u2011gen AR inhibitors annually<\/li>\n<\/ul>\n\n\n\n<p><strong>Market Size<\/strong>: China prostate cancer drug market valued at <strong>\u00a518\u202fbillion<\/strong> (2025), projected <strong>\u00a535\u202fbillion<\/strong> by 2030. <strong>Novel combo therapies<\/strong> represent <strong>\u00a58\u201110\u202fbillion<\/strong> opportunity.<\/p>\n\n\n\n<p><strong>Revenue Potential<\/strong>: If successful, quadruple combo could generate <strong>\u00a52\u20113\u202fbillion<\/strong> peak sales by 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Regimen<\/th><th>Company<\/th><th>Mechanisms<\/th><th>Stage<\/th><th>Key Limitation<\/th><\/tr><\/thead><tbody><tr><td><strong>Hengrui Quadruple<\/strong><\/td><td><strong>Hengrui<\/strong><\/td><td>AR PROTAC + EZH2 + ARi + Biologic<\/td><td><strong>Phase\u202fII<\/strong><\/td><td><strong>First multi\u2011mechanism combo<\/strong><\/td><\/tr><tr><td><strong>Enzalutamide + Docetaxel<\/strong><\/td><td>Astellas<\/td><td>AR inhibitor + chemo<\/td><td>Marketed<\/td><td>Resistance, toxicity<\/td><\/tr><tr><td><strong>Pluvicto + ARi<\/strong><\/td><td>Novartis<\/td><td>PSMA RLT + AR inhibitor<\/td><td>Phase\u202fIII<\/td><td>Limited to PSMA\u2011positive<\/td><\/tr><tr><td><strong>Talzenna + Xtandi<\/strong><\/td><td>Pfizer\/Astellas<\/td><td>PARP + AR inhibitor<\/td><td>Marketed<\/td><td>HRR\u2011mutated only (~20\u201125%)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Advantage<\/strong>: Hengrui\u2019s combo is the <strong>first to integrate PROTAC + EZH2 inhibition<\/strong>, potentially <strong>overcoming broader resistance mechanisms<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-pathway-amp-financial-impact\">Development Pathway &amp; Financial Impact<\/h2>\n\n\n\n<p><strong>Phase\u202f2 Design<\/strong>: Likely <strong>~100\u2011150 patients<\/strong> with <strong>mCRPC<\/strong> post\u20112nd\u2011gen AR inhibitor failure, with <strong>primary endpoint<\/strong> of <strong>PSA50 response rate<\/strong> and <strong>safety<\/strong>.<\/p>\n\n\n\n<p><strong>Timeline<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Study Initiation<\/strong>: Q1\u202f2026<\/li>\n\n\n\n<li><strong>Data Readout<\/strong>: Q4\u202f2026 (interim), Q3\u202f2027 (final)<\/li>\n\n\n\n<li><strong>Phase\u202fIII Decision<\/strong>: H2\u202f2027 (if \u226540% PSA50 response)<\/li>\n<\/ul>\n\n\n\n<p><strong>Investment<\/strong>: <strong>\u00a5200\u2011300\u202fmillion<\/strong> for Phase\u202fII; <strong>\u00a51.5\u20112.0\u202fbillion<\/strong> for full development (Phase\u202fIII\u202f\u00b1\u202fNDA).<\/p>\n\n\n\n<p><strong>Financial Leverage<\/strong>: Combination leverages <strong>approved drugs<\/strong> (zeprumetostat, rezvilutamide), reducing <strong>risk and development cost<\/strong> vs. de novo combinations.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the quadruple combination\u2019s clinical development, efficacy, regulatory pathway, market opportunity, and competitive positioning. Actual results may differ materially due to clinical trial outcomes, safety signals, competitive dynamics, and regulatory review timelines.<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\/01\/600276_20260110_NV8Q.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20260110_NV8Q.\"><\/object><a id=\"wp-block-file--media-2e93a7da-f097-49e1-bdb5-3487e8d68925\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/600276_20260110_NV8Q.pdf\">600276_20260110_NV8Q<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/600276_20260110_NV8Q.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-2e93a7da-f097-49e1-bdb5-3487e8d68925\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that the National Medical Products&#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":[16,62,2586,4228,852,70],"class_list":["post-53775","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-sha-600276","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>Hengrui&#039;s Quadruple Prostate Cancer Combo Wins NMPA IND for Phase 2 Study - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA) has approved a multicenter, open\u2011label Phase\u202fII study evaluating the quadruple combination of SHR\u20114394, HRS\u20115041 tablets, zeprumetostat (SHR\u20112554), and rezvilutamide in patients with prostate cancer. 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