{"id":45763,"date":"2025-11-04T21:38:08","date_gmt":"2025-11-04T13:38:08","guid":{"rendered":"https:\/\/flcube.com\/?p=45763"},"modified":"2025-11-04T21:38:09","modified_gmt":"2025-11-04T13:38:09","slug":"hengrui-gets-nmpa-green-light-for-rezvilutamide%e2%80%91hs%e2%80%9120093-combination-trial-in-prostate-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=45763","title":{"rendered":"Hengrui Gets NMPA Green Light for Rezvilutamide\u2011HS\u201120093 Combination Trial in Prostate Cancer"},"content":{"rendered":"\n<p>China\u2011based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (<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 today that the China National Medical Products Administration (NMPA) has approved a clinical study evaluating <strong>rezvilutamide<\/strong> in combination with <strong>HS\u201120093<\/strong> for patients with advanced prostate cancer. The move positions Hengrui at the forefront of next\u2011generation androgen\u2011receptor (AR) blockade paired with antibody\u2011drug conjugate (ADC) technology.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-why-this-combination-is-clinically-promising\">Why This Combination Is Clinically Promising<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Element<\/th><th>Feature<\/th><th>Clinical Significance<\/th><\/tr><\/thead><tbody><tr><td><strong>Rezvilutamide<\/strong><\/td><td>Second\u2011generation AR inhibitor, potent AR blockade, no agonistic activity<\/td><td>Superior efficacy over first\u2011gen AR agents for metastatic hormone\u2011sensitive prostate cancer (mHSPC)<\/td><\/tr><tr><td><strong>HS\u201120093<\/strong><\/td><td>B7\u2011H3\u2011targeted ADC, previously studied in lung, sarcoma, and head\u2011and\u2011neck cancers<\/td><td>Expands therapeutic reach to solid tumors, potentially synergizing with AR inhibition<\/td><\/tr><tr><td><strong>Combination Synergy<\/strong><\/td><td>Dual engagement of tumor growth pathways<\/td><td>May overcome resistance mechanisms seen with monotherapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-milestones-amp-next-steps\">Key Milestones &amp; Next Steps<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NMPA approval (Nov\u202f2025)<\/strong> \u2013 Enables Phase\u202fI\/II trial start in mainland China.<\/li>\n\n\n\n<li><strong>Trial design<\/strong> \u2013 Multi\u2011center, dose\u2011escalation followed by safety\u2011and\u2011efficacy evaluations.<\/li>\n\n\n\n<li><strong>Patient enrollment<\/strong> \u2013 Target population: high\u2011volume metastatic prostate cancer patients, with optional extension to CRPC (castration\u2011resistant).<\/li>\n\n\n\n<li><strong>Global expansion<\/strong> \u2013 Upon favorable safety signals, the study will seek regulatory approval pathways in the U.S. and other markets.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-amp-market-implications\">Regulatory &amp; Market Implications<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Strategic advantage for Hengrui<\/strong> \u2013 First\u2011in\u2011class AR\/ADC combination trial in Asia, unlocking a rapid entry to a high\u2011revenue oncology segment.<\/li>\n\n\n\n<li><strong>Share performance<\/strong> \u2013 Hengrui\u2019s Shanghai and Hong Kong shares responded positively, reflecting investor confidence in the combination platform.<\/li>\n\n\n\n<li><strong>Pipeline diversification<\/strong> \u2013 Reinforces Hengrui\u2019s portfolio of approved agents (rezvilutamide for 2022\u2011approved mHSPC) and ADC candidates (HS\u201120093) across multiple solid\u2011tumor indications.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\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\/11\/2025110303127_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025110303127_c.\"><\/object><a id=\"wp-block-file--media-b1bc6b6a-d536-4521-86b6-c9de75cfd875\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025110303127_c.pdf\">2025110303127_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025110303127_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-b1bc6b6a-d536-4521-86b6-c9de75cfd875\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced today that the China&#8230;<\/p>\n","protected":false},"author":1,"featured_media":45765,"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":[35,16,62,29,2586,4228,852],"class_list":["post-45763","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-clinical-trial-approval-initiation","tag-combination-therapy","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-sha-600276"],"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 Gets NMPA Green Light for Rezvilutamide\u2011HS\u201120093 Combination Trial in Prostate Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced today that the China National Medical Products Administration (NMPA) has approved a clinical study evaluating rezvilutamide in combination with HS\u201120093 for patients with advanced prostate cancer. The move positions Hengrui at the forefront of next\u2011generation androgen\u2011receptor (AR) blockade paired with antibody\u2011drug conjugate (ADC) technology.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=45763\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui Gets NMPA Green Light for Rezvilutamide\u2011HS\u201120093 Combination Trial in Prostate Cancer\" \/>\n<meta property=\"og:description\" content=\"China\u2011based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced today that the China National Medical Products Administration (NMPA) has approved a clinical study evaluating rezvilutamide in combination with HS\u201120093 for patients with advanced prostate cancer. 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