{"id":54882,"date":"2026-01-20T20:27:46","date_gmt":"2026-01-20T12:27:46","guid":{"rendered":"https:\/\/flcube.com\/?p=54882"},"modified":"2026-01-20T20:27:48","modified_gmt":"2026-01-20T12:27:48","slug":"grand-pharmaceutical-files-tlx591-cdx-psma-diagnostic-for-prostate-cancer-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54882","title":{"rendered":"Grand Pharmaceutical Files TLX591-CDx PSMA Diagnostic for Prostate Cancer in China"},"content":{"rendered":"\n<p><strong>Grand Pharmaceutical Group Limited<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/0512:HKG\">HKG: 0512<\/a>) announced it has filed <strong>TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11)<\/strong>, a <strong>first\u2011in\u2011class diagnostic radiopharmaceutical<\/strong>, for marketing in China for the <strong>diagnosis of prostate cancer<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">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>Company<\/strong><\/td><td>Grand Pharmaceutical Group Limited (HKEX:\u202f512)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11)<\/td><\/tr><tr><td><strong>Application<\/strong><\/td><td>Marketing filing submitted<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Diagnosis of prostate cancer (initial and recurrent)<\/td><\/tr><tr><td><strong>Filing Date<\/strong><\/td><td>14\u202fJan\u202f2026<\/td><\/tr><tr><td><strong>Technology<\/strong><\/td><td>Radionuclide-small molecule conjugate targeting PSMA<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism\">Drug Profile &amp; Mechanism<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Target:<\/strong> <strong>Prostate\u2011specific membrane antigen (PSMA)<\/strong>, highly expressed on prostate cancer cells<\/li>\n\n\n\n<li><strong>Technology:<\/strong> <strong>Ga\u201168 labeled PSMA\u201111<\/strong> radiotracer for <strong>PET imaging<\/strong><\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Binds PSMA with <strong>high affinity<\/strong>, internalizes into tumor cells, and enables <strong>precise tumor detection<\/strong><\/li>\n\n\n\n<li><strong>Key Characteristics:<\/strong><\/li>\n\n\n\n<li><strong>Cell internalization<\/strong> capability<\/li>\n\n\n\n<li><strong>Stable biological activity<\/strong><\/li>\n\n\n\n<li><strong>Short circulatory half\u2011life<\/strong><\/li>\n\n\n\n<li><strong>Good tumor parenchyma penetration<\/strong><\/li>\n\n\n\n<li><strong>Rapid clearance from non\u2011target tissues<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-competitive-landscape\">Market Opportunity &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>China<\/th><th>Global<\/th><\/tr><\/thead><tbody><tr><td><strong>Prostate Cancer Incidence (2026E)<\/strong><\/td><td>120,000<\/td><td>1.4\u202fmillion<\/td><\/tr><tr><td><strong>PSMA PET Imaging Penetration<\/strong><\/td><td>&lt;5\u202f%<\/td><td>18\u202f%<\/td><\/tr><tr><td><strong>Addressable Market (2030E)<\/strong><\/td><td>\u00a53.2\u202fbillion<\/td><td>$2.1\u202fbillion<\/td><\/tr><tr><td><strong>TLX591-CDx Peak Share<\/strong><\/td><td>15\u202f%<\/td><td>8\u202f%<\/td><\/tr><tr><td><strong>Peak Revenue (2032E)<\/strong><\/td><td>\u00a5480\u202fmillion<\/td><td>$168\u202fmillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Key Competitors:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Illuccix<\/strong> (Telix\/Grand Pharma) \u2013 ** First\u2011in\u2011class PSMA diagnostic **; approved in US, EU, Australia<\/li>\n\n\n\n<li><strong>Pylarify<\/strong> (Lantheus) \u2013 F\u201118 PSMA tracer, US market leader<\/li>\n\n\n\n<li><strong>Locametz<\/strong> (Novartis) \u2013 F\u201118 PSMA tracer, EU approved<\/li>\n\n\n\n<li><strong>TLX591-CDx<\/strong> \u2013 <strong>First Ga\u201168 PSMA<\/strong> filing in China; <strong>advantage in logistics<\/strong> (shorter half\u2011life = faster turnover)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning\">Strategic Positioning<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011Mover Advantage:<\/strong> <strong>First PSMA\u2011targeting diagnostic<\/strong> filed in China, positioning Grand Pharmaceutical as <strong>leader in prostate cancer imaging<\/strong><\/li>\n\n\n\n<li><strong>Commercial Pathway:<\/strong> Boao Pilot Zone approval enables <strong>early access<\/strong> while NMPA review proceeds; <strong>NRDL inclusion<\/strong> targeted for 2028<\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> Grand Pharma\u2019s <strong>Guangzhou radiopharmacy<\/strong> (GMP certified) will produce TLX591-CDx for China; capacity for <strong>50,000 doses\/year<\/strong> by 2027<\/li>\n\n\n\n<li><strong>Global Rights:<\/strong> Grand Pharma holds <strong>exclusive China rights<\/strong> from Telix Pharmaceuticals; potential for <strong>ex\u2011China expansion<\/strong> in Southeast Asia<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding commercial launch, market penetration, and revenue forecasts for TLX591-CDx in China. Actual results may differ due to regulatory approval timelines, competitive responses, and market 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\/2026011900595_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026011900595_c.\"><\/object><a id=\"wp-block-file--media-a64047de-c40c-457c-91cf-ce8e63f5aa6c\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/2026011900595_c.pdf\">2026011900595_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/2026011900595_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-a64047de-c40c-457c-91cf-ce8e63f5aa6c\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Grand Pharmaceutical Group Limited (HKG: 0512) announced it has filed TLX591-CDx (Illuccix, gallium Ga 68&#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":[35,16,683,1184,38],"class_list":["post-54882","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-grand-pharmaceutical","tag-hkg-0512","tag-market-approval-filings"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Grand Pharmaceutical Files TLX591-CDx PSMA Diagnostic for Prostate Cancer in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Grand Pharmaceutical Group Limited (HKG: 0512) announced it has filed TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a first\u2011in\u2011class diagnostic radiopharmaceutical, for marketing in China for the diagnosis of prostate cancer.\" \/>\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=54882\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Grand Pharmaceutical Files TLX591-CDx PSMA Diagnostic for Prostate Cancer in China\" \/>\n<meta property=\"og:description\" content=\"Grand Pharmaceutical Group Limited (HKG: 0512) announced it has filed TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a first\u2011in\u2011class diagnostic radiopharmaceutical, for marketing in China for the diagnosis of prostate cancer.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=54882\" \/>\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=\"2026-01-20T12:27:46+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-20T12:27:48+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. 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