{"id":53762,"date":"2026-01-12T20:55:38","date_gmt":"2026-01-12T12:55:38","guid":{"rendered":"https:\/\/flcube.com\/?p=53762"},"modified":"2026-01-12T20:55:39","modified_gmt":"2026-01-12T12:55:39","slug":"dongcheng-pharmas-psma-pet-agent-18f-spiritide-nda-accepted-by-nmpa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53762","title":{"rendered":"Dongcheng Pharma&#8217;s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA"},"content":{"rendered":"\n<p><strong>Yantai Dongcheng Pharmaceutical Group Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/002675:SHE\">SHE: 002675<\/a>) announced that the <strong>New Drug Application (NDA)<\/strong> for its <strong>[18F] Spiritide<\/strong> has been accepted for review by <strong>China\u2019s National Medical Products Administration (NMPA)<\/strong>. The diagnostic agent is intended for <strong>positron emission tomography (PET) imaging<\/strong> of <strong>prostate\u2011specific membrane antigen (PSMA)\u2011positive lesions<\/strong> in prostate cancer patients, addressing two critical clinical scenarios: <strong>initial staging of suspected metastatic disease<\/strong> and <strong>biochemical recurrence detection<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-amp-regulatory-milestone\">Product &amp; Regulatory 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>Product<\/strong><\/td><td>[18F] Spiritide<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Yantai Dongcheng Pharmaceutical Group (002675.SZ)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NDA accepted by CDE\/NMPA<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>PET imaging of PSMA\u2011positive lesions in prostate cancer<\/td><\/tr><tr><td><strong>Target Populations<\/strong><\/td><td>(1) Initial curative treatment patients with suspected metastasis; (2) Biochemical recurrence with elevated PSA<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>High PSMA specificity\/affinity, delivers fluorine\u201118 isotope for PET imaging<\/td><\/tr><tr><td><strong>Classification<\/strong><\/td><td>Category\u202f1 innovative diagnostic radiopharmaceutical<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-amp-differentiation\">Technology &amp; Differentiation<\/h2>\n\n\n\n<p><strong>Mechanism of Action<\/strong>: [18F] Spiritide exhibits <strong>high specificity and affinity for PSMA protein<\/strong>, enabling <strong>significant accumulation<\/strong> in PSMA\u2011overexpressing tumors. The fluorine\u201118 isotope delivery allows <strong>high\u2011resolution PET imaging<\/strong> for accurate lesion detection.<\/p>\n\n\n\n<p><strong>Clinical Advantages<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Superior Sensitivity<\/strong>: PSMA\u2011PET detects <strong>30\u201140% more lesions<\/strong> than conventional bone scans\/CT in metastatic prostate cancer<\/li>\n\n\n\n<li><strong>Earlier Detection<\/strong>: Identifies biochemical recurrence at <strong>PSA levels as low as 0.2\u202fng\/mL<\/strong><\/li>\n\n\n\n<li><strong>Treatment Guidance<\/strong>: Critical for <strong>precision therapy selection<\/strong> and <strong>radiation therapy planning<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Market Position<\/strong>: Among the <strong>first domestic PSMA\u2011PET agents<\/strong> to reach NMPA review, positioning Dongcheng with <strong>first\u2011mover advantage<\/strong> in a nascent market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-prostate-cancer-imaging-in-china\">Market Opportunity: Prostate Cancer Imaging 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>Prostate Cancer Incidence<\/strong>: <strong>110,000\u2011120,000<\/strong> new cases annually (2025), growing at <strong>10% CAGR<\/strong> due to aging population and screening adoption<\/li>\n\n\n\n<li><strong>Metastatic at Diagnosis<\/strong>: <strong>20\u201130%<\/strong> of patients present with metastatic disease \u2192 <strong>~30,000<\/strong> eligible for initial staging<\/li>\n\n\n\n<li><strong>Biochemical Recurrence<\/strong>: <strong>30\u201140%<\/strong> of post\u2011prostatectomy patients develop recurrence \u2192 <strong>~35,000<\/strong> eligible annually<\/li>\n<\/ul>\n\n\n\n<p><strong>Diagnostic Market Size<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China PET Imaging Market<\/strong>: <strong>\u00a58.5\u202fbillion<\/strong> (2025), growing at <strong>15% CAGR<\/strong><\/li>\n\n\n\n<li><strong>PSMA\u2011PET Sub\u2011segment<\/strong>: <strong>\u00a51.2\u202fbillion<\/strong> opportunity by 2030, driven by <strong>NCCN guideline adoption<\/strong> and <strong>reimbursement expansion<\/strong><\/li>\n\n\n\n<li><strong>Pricing<\/strong>: Projected <strong>\u00a515,000\u201118,000<\/strong> per scan (vs. \u00a58,000\u201110,000 for conventional bone scan\/CT)<\/li>\n<\/ul>\n\n\n\n<p><strong>[18F] Spiritide Revenue Potential<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Peak Penetration<\/strong>: <strong>25\u201130%<\/strong> market share in PSMA\u2011PET segment<\/li>\n\n\n\n<li><strong>Volume<\/strong>: <strong>20,000\u201125,000<\/strong> scans annually by 2030<\/li>\n\n\n\n<li><strong>Peak Sales<\/strong>: <strong>\u00a5300\u2011450\u202fmillion<\/strong> (US$42\u201163\u202fmillion) by 2030<\/li>\n<\/ul>\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>Product<\/th><th>Company<\/th><th>Origin<\/th><th>Stage (China)<\/th><th>Key Advantage<\/th><\/tr><\/thead><tbody><tr><td><strong>Pluvicto<\/strong><\/td><td>Novartis<\/td><td>Import<\/td><td><strong>Approved (Nov\u202f2025)<\/strong><\/td><td>Therapeutic + diagnostic (RLT)<\/td><\/tr><tr><td><strong>[68Ga]Ga\u2011PSMA\u201111<\/strong><\/td><td>Advanced Accelerator<\/td><td>Import<\/td><td>Clinical trials<\/td><td>Well\u2011established globally<\/td><\/tr><tr><td><strong>[18F] Spiritide<\/strong><\/td><td><strong>Dongcheng Pharma<\/strong><\/td><td>Domestic<\/td><td><strong>NDA accepted<\/strong><\/td><td><strong>First domestic [18F] agent<\/strong><\/td><\/tr><tr><td><strong>[18F]DCFPyL<\/strong><\/td><td>Progenics<\/td><td>Import<\/td><td>Not filed<\/td><td>Superior pharmacokinetics<\/td><\/tr><tr><td><strong>PSMA\u2011PET (others)<\/strong><\/td><td>Various<\/td><td>Import\/Local<\/td><td>Pre\u2011clinical<\/td><td>\u2013<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Strategic Moat<\/strong>: Domestic production <strong>avoids import delays<\/strong> and <strong>reduces costs by 30\u201140%<\/strong>, critical for <strong>insurance reimbursement<\/strong> and <strong>hospital adoption<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-financial-impact-amp-valuation\">Financial Impact &amp; Valuation<\/h2>\n\n\n\n<p><strong>Near\u2011Term Revenue<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>2026<\/strong>: Minimal (registration phase)<\/li>\n\n\n\n<li><strong>2027<\/strong>: <strong>\u00a550\u201180\u202fmillion<\/strong> (partial year post\u2011approval)<\/li>\n\n\n\n<li><strong>2028<\/strong>: <strong>\u00a5150\u2011200\u202fmillion<\/strong> (full commercial launch)<\/li>\n<\/ul>\n\n\n\n<p><strong>Peak Valuation<\/strong>: [18F] Spiritide could contribute <strong>\u00a55\u20117 per share<\/strong> to Dongcheng\u2019s valuation, representing <strong>8\u201112% upside<\/strong> from current trading levels.<\/p>\n\n\n\n<p><strong>Pipeline Leverage<\/strong>: Success validates Dongcheng\u2019s <strong>radiopharmaceutical platform<\/strong>, supporting <strong>3\u20114 follow\u2011on imaging agents<\/strong> in pre\u2011clinical development (PSMA\u2011targeting theranostics, FAPI\u2011PET).<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding [18F] Spiritide\u2019s regulatory review timeline, market penetration, revenue forecasts, and competitive positioning. Actual results may differ materially due to NMPA review outcomes, competitive dynamics, reimbursement negotiations, and hospital adoption rates.<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\/\u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u6c1f18F\u601d\u777f\u80bd\u6ce8\u5c04\u6db2\u4e0a\u5e02\u7533\u8bf7\u83b7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d7\u7406\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u6c1f[18F]\u601d\u777f\u80bd\u6ce8\u5c04\u6db2\u4e0a\u5e02\u7533\u8bf7\u83b7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d7\u7406\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-3d99305a-ba7d-4257-ae4a-867606b460e1\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u6c1f18F\u601d\u777f\u80bd\u6ce8\u5c04\u6db2\u4e0a\u5e02\u7533\u8bf7\u83b7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d7\u7406\u7684\u516c\u544a.pdf\">\u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u6c1f[18F]\u601d\u777f\u80bd\u6ce8\u5c04\u6db2\u4e0a\u5e02\u7533\u8bf7\u83b7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d7\u7406\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u4e1c\u8bda\u836f\u4e1a\uff1a\u5173\u4e8e\u6c1f18F\u601d\u777f\u80bd\u6ce8\u5c04\u6db2\u4e0a\u5e02\u7533\u8bf7\u83b7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d7\u7406\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3d99305a-ba7d-4257-ae4a-867606b460e1\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA)&#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":[22],"tags":[16,158,38,937],"class_list":["post-53762","post","type-post","status-publish","format-standard","hentry","category-medical-device","tag-cancer","tag-dongcheng-pharmaceutical","tag-market-approval-filings","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>Dongcheng Pharma&#039;s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA) for its [18F] Spiritide has been accepted for review by China\u2019s National Medical Products Administration (NMPA). The diagnostic agent is intended for positron emission tomography (PET) imaging of prostate\u2011specific membrane antigen (PSMA)\u2011positive lesions in prostate cancer patients, addressing two critical clinical scenarios: initial staging of suspected metastatic disease and biochemical recurrence detection.\" \/>\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=53762\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dongcheng Pharma&#039;s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA\" \/>\n<meta property=\"og:description\" content=\"Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA) for its [18F] Spiritide has been accepted for review by China\u2019s National Medical Products Administration (NMPA). The diagnostic agent is intended for positron emission tomography (PET) imaging of prostate\u2011specific membrane antigen (PSMA)\u2011positive lesions in prostate cancer patients, addressing two critical clinical scenarios: initial staging of suspected metastatic disease and biochemical recurrence detection.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=53762\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-01-12T12:55:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-12T12:55:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=53762#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=53762\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Dongcheng Pharma&#8217;s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA\",\"datePublished\":\"2026-01-12T12:55:38+00:00\",\"dateModified\":\"2026-01-12T12:55:39+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=53762\"},\"wordCount\":529,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Cancer\",\"Dongcheng Pharmaceutical\",\"Market approval filings\",\"SHE: 002675\"],\"articleSection\":[\"Medical Device\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=53762#respond\"]}],\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=53762\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=53762\",\"name\":\"Dongcheng Pharma's PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2026-01-12T12:55:38+00:00\",\"dateModified\":\"2026-01-12T12:55:39+00:00\",\"description\":\"Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA) for its [18F] Spiritide has been accepted for review by China\u2019s National Medical Products Administration (NMPA). The diagnostic agent is intended for positron emission tomography (PET) imaging of prostate\u2011specific membrane antigen (PSMA)\u2011positive lesions in prostate cancer patients, addressing two critical clinical scenarios: initial staging of suspected metastatic disease and biochemical recurrence detection.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=53762#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=53762\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=53762#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Dongcheng Pharma&#8217;s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA\"}]},{\"@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\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Dongcheng Pharma's PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA - Insight, China&#039;s Pharmaceutical Industry","description":"Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA) for its [18F] Spiritide has been accepted for review by China\u2019s National Medical Products Administration (NMPA). The diagnostic agent is intended for positron emission tomography (PET) imaging of prostate\u2011specific membrane antigen (PSMA)\u2011positive lesions in prostate cancer patients, addressing two critical clinical scenarios: initial staging of suspected metastatic disease and biochemical recurrence detection.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=53762","og_locale":"en_US","og_type":"article","og_title":"Dongcheng Pharma's PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA","og_description":"Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA) for its [18F] Spiritide has been accepted for review by China\u2019s National Medical Products Administration (NMPA). The diagnostic agent is intended for positron emission tomography (PET) imaging of prostate\u2011specific membrane antigen (PSMA)\u2011positive lesions in prostate cancer patients, addressing two critical clinical scenarios: initial staging of suspected metastatic disease and biochemical recurrence detection.","og_url":"https:\/\/flcube.com\/?p=53762","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-01-12T12:55:38+00:00","article_modified_time":"2026-01-12T12:55:39+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=53762#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=53762"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Dongcheng Pharma&#8217;s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA","datePublished":"2026-01-12T12:55:38+00:00","dateModified":"2026-01-12T12:55:39+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=53762"},"wordCount":529,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Cancer","Dongcheng Pharmaceutical","Market approval filings","SHE: 002675"],"articleSection":["Medical Device"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=53762#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=53762","url":"https:\/\/flcube.com\/?p=53762","name":"Dongcheng Pharma's PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2026-01-12T12:55:38+00:00","dateModified":"2026-01-12T12:55:39+00:00","description":"Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA) for its [18F] Spiritide has been accepted for review by China\u2019s National Medical Products Administration (NMPA). The diagnostic agent is intended for positron emission tomography (PET) imaging of prostate\u2011specific membrane antigen (PSMA)\u2011positive lesions in prostate cancer patients, addressing two critical clinical scenarios: initial staging of suspected metastatic disease and biochemical recurrence detection.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=53762#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=53762"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=53762#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Dongcheng Pharma&#8217;s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA"}]},{"@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":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/53762","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=53762"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/53762\/revisions"}],"predecessor-version":[{"id":53764,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/53762\/revisions\/53764"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=53762"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=53762"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=53762"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}