{"id":42183,"date":"2025-09-24T14:12:30","date_gmt":"2025-09-24T06:12:30","guid":{"rendered":"https:\/\/flcube.com\/?p=42183"},"modified":"2025-09-24T14:12:31","modified_gmt":"2025-09-24T06:12:31","slug":"yantai-dongcheng-secures-nmpa-approval-for-225ac%e2%80%91lnc1011-alpha%e2%80%91particle-radiopharmaceutical-to-target-prostate-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=42183","title":{"rendered":"Yantai Dongcheng Secures NMPA Approval for 225Ac\u2011LNC1011 Alpha\u2011Particle Radiopharmaceutical to Target Prostate Cancer"},"content":{"rendered":"\n<p>China\u2011based <strong>Yantai Dongcheng Pharmaceutical Group Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/002675:SHE\">SHE: 002675<\/a>)<\/strong> announced that its investigational <strong>225Ac\u2011LNC1011 injection<\/strong> has received clinical\u2011trial clearance from the National Medical Products Administration (NMPA). The alpha\u2011particle\u2011emitting radiopharmaceutical is designed to target <strong>prostate\u2011specific membrane antigen (PSMA)<\/strong> in patients with advanced, PSMA\u2011positive prostate cancer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-how-225ac-lnc1011-works\">How 225Ac\u2011LNC1011 Works<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Targeted Alpha Therapy<\/strong> \u2013 225Ac delivers short\u2011range, high\u2011energy alpha particles (&lt;\u202f100\u202f\u00b5m) directly to PSMA\u2011expressing tumour cells.<\/li>\n\n\n\n<li><strong>Superior Tumor Killing<\/strong> \u2013 The multi\u2011stage alpha decay releases 80\u2011100\u202fkeV\/\u00b5m of energy, producing double\u2011strand DNA breaks and enhancing cytotoxicity.<\/li>\n\n\n\n<li><strong>Reduced Collateral Damage<\/strong> \u2013 Compared with beta emitters, alpha particles\u2019 limited penetration reduces risk to surrounding healthy tissue.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-trial-outlook\">Clinical\u2011Trial Outlook<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Phase\u202fI\/II Design<\/strong> \u2013 The first\u2011in\u2011human study will evaluate safety, tolerability, and preliminary efficacy in men with metastatic, PSMA\u2011positive disease.<\/li>\n\n\n\n<li><strong>Endpoints<\/strong> \u2013 Primary endpoints include dose\u2011limiting toxicity and maximum tolerated dose; secondary endpoints focus on PSA decline and radiographic tumour response.<\/li>\n\n\n\n<li><strong>Timeline<\/strong> \u2013 Enrollment is expected to begin in Q1\u202f2026 with results anticipated by late 2027.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-context\">Strategic Context<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Emerging Radiopharmaceutical Market<\/strong> \u2013 Alpha\u2011particle therapies are projected to account for a growing share of targeted oncology treatments, offering a new option for refractory prostate cancer.<\/li>\n\n\n\n<li><strong>Domestic Innovation<\/strong> \u2013 Yantai Dongcheng\u2019s approval underscores China\u2019s rapid development of advanced radiopharmaceuticals, potentially reducing reliance on imported therapies.<\/li>\n\n\n\n<li><strong>Regulatory Momentum<\/strong> \u2013 NMPA approval paves the way for global collaboration and eventual market entry in key regions, including the U.S. and EU.<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\/09\/\u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-6bf735f7-a7b2-44a7-9037-543d2645f417\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/\u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\">\u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/\u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-6bf735f7-a7b2-44a7-9037-543d2645f417\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that its investigational 225Ac\u2011LNC1011 injection&#8230;<\/p>\n","protected":false},"author":1,"featured_media":42185,"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":[16,62,158,937],"class_list":["post-42183","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-dongcheng-pharmaceutical","tag-she-002675"],"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>Yantai Dongcheng Secures NMPA Approval for 225Ac\u2011LNC1011 Alpha\u2011Particle Radiopharmaceutical to Target Prostate Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Yantai Dongcheng Pharmaceutical Group Co., Ltd. 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The alpha\u2011particle\u2011emitting radiopharmaceutical is designed to target prostate\u2011specific membrane antigen (PSMA) in patients with advanced, PSMA\u2011positive prostate cancer.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=42183#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=42183"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=42183#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2404.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2404.webp","width":1080,"height":608,"caption":"Yantai Dongcheng Secures NMPA Approval for 225Ac\u2011LNC1011 Alpha\u2011Particle Radiopharmaceutical to Target Prostate Cancer"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=42183#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Yantai Dongcheng Secures NMPA Approval for 225Ac\u2011LNC1011 Alpha\u2011Particle Radiopharmaceutical to Target Prostate Cancer"}]},{"@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":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2404.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42183","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=42183"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42183\/revisions"}],"predecessor-version":[{"id":42186,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42183\/revisions\/42186"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/42185"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=42183"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=42183"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=42183"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}