{"id":42071,"date":"2025-09-23T13:39:38","date_gmt":"2025-09-23T05:39:38","guid":{"rendered":"https:\/\/flcube.com\/?p=42071"},"modified":"2025-09-23T13:39:39","modified_gmt":"2025-09-23T05:39:39","slug":"visen-pharmaceuticals-secures-hainan-approval-for-palopegteriparatide","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=42071","title":{"rendered":"Visen Pharmaceuticals Secures Hainan Approval for Palopegteriparatide"},"content":{"rendered":"\n<p><strong>Visen Pharmaceuticals<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2561:HKG\">HKG: 2561<\/a>) announced today that its innovative drug <strong>palopegteriparatide<\/strong> (TransCon\u202fPTH) has received official approval for clinical use in the Hainan\u202fBoao\u202fLecheng International Medical Tourism Pilot Zone. The once\u2011daily, sustained\u2011release prodrug will be administered at <strong>Ruijin Hospital Hainan Hospital<\/strong>, affiliated with Shanghai Jiao Tong University School of Medicine, to treat adults with chronic hypoparathyroidism (HP).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-overview\">Product Overview<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism<\/strong> \u2013 Palopegteriparatide is a sustained\u2011release prodrug of PTH1\u201134 that delivers stable physiological levels of parathyroid hormone throughout a 24\u2011hour period via a single subcutaneous injection.<\/li>\n\n\n\n<li><strong>Clinical Need<\/strong> \u2013 Chronic hypoparathyroidism is a rare, life\u2011threatening condition that urgently requires safe, long\u2011acting therapy; palopegteriparatide addresses this unmet need with a novel dosing strategy.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pilot\u2011Zone Approval<\/strong> \u2013 The Hainan Boao Lecheng International Medical Tourism Pilot Zone is a high\u2011profile regulatory sandbox; approval here signals strong confidence in the drug\u2019s safety and efficacy profile.<\/li>\n\n\n\n<li><strong>Strategic Placement<\/strong> \u2013 By securing a launch in one of China\u2019s most internationally focused medical tourism hubs, Visen positions palopegteriparatide for rapid uptake by both domestic and foreign patients.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-context\">Clinical Context<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Target Population<\/strong> \u2013 Adults with chronic hypoparathyroidism who require daily PTH replacement.<\/li>\n\n\n\n<li><strong>Treatment Advantage<\/strong> \u2013 The once\u2011daily, stable\u2011release profile reduces dosing burden and improves adherence compared with current intermittent PTH therapies.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-joint-venture-background\">Joint Venture Background<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Visen Pharmaceuticals<\/strong> \u2013 A 2018 joint venture between <strong>Ascendis<\/strong> and Chinese investors, combining Ascendis\u2019s expertise in peptide drug development with local manufacturing and distribution capabilities.<\/li>\n\n\n\n<li><strong>Manufacturing Capabilities<\/strong> \u2013 The partnership leverages state\u2011of\u2011the\u2011art Chinese production facilities to ensure scalable, cost\u2011effective supply of palopegteriparatide.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-implications-for-china\">Implications for China<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Market Expansion<\/strong> \u2013 The approval opens a new therapeutic class for endocrine disorders in China, potentially creating a sizable market for the company.<\/li>\n\n\n\n<li><strong>Innovation Signal<\/strong> \u2013 Demonstrates China\u2019s willingness to fast\u2011track advanced biologics in pilot zones, encouraging further collaboration between domestic and foreign biopharma.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Visen Pharmaceuticals (HKG: 2561) announced today that its innovative drug palopegteriparatide (TransCon\u202fPTH) has received official&#8230;<\/p>\n","protected":false},"author":1,"featured_media":42072,"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":[91,4363,393],"class_list":["post-42071","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-boao-lecheng-pilot-zone","tag-hkg-2561","tag-visen-pharmaceuticals"],"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>Visen Pharmaceuticals Secures Hainan Approval for Palopegteriparatide - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Visen Pharmaceuticals (HKG: 2561) announced today that its innovative drug palopegteriparatide (TransCon\u202fPTH) has received official approval for clinical use in the Hainan\u202fBoao\u202fLecheng International Medical Tourism Pilot Zone. 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