{"id":62721,"date":"2026-04-09T20:15:25","date_gmt":"2026-04-09T12:15:25","guid":{"rendered":"https:\/\/flcube.com\/?p=62721"},"modified":"2026-04-09T20:15:26","modified_gmt":"2026-04-09T12:15:26","slug":"sino-biopharms-chia-tai-tianqing-secures-gdmpa-approval-for-naldemedine-in-greater-bay-area-worlds-first-oral-oic-therapy-enters-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=62721","title":{"rendered":"Sino Biopharm&#8217;s Chia Tai Tianqing Secures GDMPA Approval for Naldemedine in Greater Bay Area \u2013 World&#8217;s First Oral OIC Therapy Enters China"},"content":{"rendered":"\n<p><strong>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.<\/strong> (CTTQ), a wholly\u2011owned subsidiary of <strong>Sino Biopharmaceutical Limited<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1177:HKG\">HKG:\u202f1177<\/a>), announced that the <strong>Guangdong Provincial Medical Products Administration (GDMPA)<\/strong> has granted marketing approval for <strong>naldemedine<\/strong>, an <strong>opioid\u2011induced constipation (OIC)<\/strong> therapy, for commercialization in the <strong>Greater Bay Area (GBA)<\/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>Agency<\/strong><\/td><td>GDMPA (Guangdong Province, China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Marketing authorization for GBA region<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Naldemedine (oral tablets)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Opioid\u2011induced constipation (OIC)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>April\u202f2026<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Pending NMPA national approval; Hainan Boao pilot program ongoing<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> World&#8217;s first approved <strong>oral selective peripheral \u03bc\u2011opioid receptor antagonist (PAMORA)<\/strong><\/li>\n\n\n\n<li><strong>Originator:<\/strong> <strong>Shionogi &amp; Co., Ltd.<\/strong> (Japan)<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Blocks opioid binding to <strong>\u03bc\u2011receptors in the gut<\/strong> (peripheral action only, no CNS penetration), directly restoring intestinal peristalsis and fluid secretion<\/li>\n\n\n\n<li><strong>Clinical Advantage:<\/strong> Reverses OIC at its source without compromising central analgesic effects of opioids<\/li>\n\n\n\n<li><strong>Global Status:<\/strong> Registered in <strong>US, EU, Japan, Hong Kong, Macau, and Taiwan<\/strong>; recommended by <strong>AGA<\/strong> and <strong>ESMO<\/strong> guidelines<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-licensing-amp-market-entry\">Strategic Licensing &amp; Market Entry<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Date<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Exclusive License Secured<\/strong><\/td><td>Jan\u202f2025<\/td><td>CTTQ obtains mainland China rights from Shionogi<\/td><\/tr><tr><td><strong>Hainan Boao Pilot<\/strong><\/td><td>2025\u20112026<\/td><td>Introduced as clinically urgent\u2011need drug under special policy zone<\/td><\/tr><tr><td><strong>GDMPA Approval<\/strong><\/td><td>Apr\u202f2026<\/td><td>GBA commercialization green\u2011lit<\/td><\/tr><tr><td><strong>NMPA Review<\/strong><\/td><td>Ongoing<\/td><td>National marketing application under regulatory review<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-outlook\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China OIC Landscape:<\/strong> With rising opioid prescriptions for cancer pain and post\u2011surgical care, OIC affects an estimated <strong>15\u201120\u202fmillion<\/strong> chronic opioid users; current treatment options remain limited.<\/li>\n\n\n\n<li><strong>GBA Advantage:<\/strong> The Greater Bay Area (pop.\u202f~86\u202fmillion) serves as a high\u2011value entry point with premium healthcare infrastructure and cross\u2011border patient flow from Hong Kong\/Macao.<\/li>\n\n\n\n<li><strong>Revenue Forecast:<\/strong> Sino Biopharm projects <strong>\u00a5800\u202fmillion\u2013\u00a51.2\u202fbillion<\/strong> (US$110\u202fmillion\u2013US$165\u202fmillion) in peak annual sales by 2028, assuming successful NMPA approval and tier\u20111\/2 city rollout.<\/li>\n\n\n\n<li><strong>Competitive Edge:<\/strong> As the <strong>first\u2011in\u2011class oral PAMORA<\/strong>, naldemedine holds category leadership over traditional laxatives and competing injectable therapies; guideline endorsements support rapid formulary adoption.<\/li>\n\n\n\n<li><strong>Regulatory Pathway:<\/strong> GDMPA approval leverages GBA&#8217;s accelerated review mechanism for globally validated drugs; NMPA decision expected within <strong>12\u201318\u202fmonths<\/strong>, potentially enabling national launch by late\u202f2027.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory timelines, commercial projections, and market penetration for naldemedine. Actual results may differ due to risks including NMPA approval delays, reimbursement negotiations, competitive entry, and prescribing pattern variations.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a wholly\u2011owned subsidiary of Sino Biopharmaceutical Limited&#8230;<\/p>\n","protected":false},"author":1,"featured_media":62722,"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":[661,908,15,313],"class_list":["post-62721","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-chia-tai-tianqing-pharmaceutical","tag-hkg-1177","tag-product-approvals","tag-sino-biopharmaceutical"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sino Biopharm&#039;s Chia Tai Tianqing Secures GDMPA Approval for Naldemedine in Greater Bay Area \u2013 World&#039;s First Oral OIC Therapy Enters China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a wholly\u2011owned subsidiary of Sino Biopharmaceutical Limited (HKG:\u202f1177), announced that the Guangdong Provincial Medical Products Administration (GDMPA) has granted marketing approval for naldemedine, an opioid\u2011induced constipation (OIC) therapy, for commercialization in the Greater Bay Area (GBA).\" \/>\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=62721\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sino Biopharm&#039;s Chia Tai Tianqing Secures GDMPA Approval for Naldemedine in Greater Bay Area \u2013 World&#039;s First Oral OIC Therapy Enters China\" \/>\n<meta property=\"og:description\" content=\"Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a wholly\u2011owned subsidiary of Sino Biopharmaceutical Limited (HKG:\u202f1177), announced that the Guangdong Provincial Medical Products Administration (GDMPA) has granted marketing approval for naldemedine, an opioid\u2011induced constipation (OIC) therapy, for commercialization in the Greater Bay Area (GBA).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=62721\" \/>\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=\"2026-04-09T12:15:25+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-09T12:15:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/0903.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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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(CTTQ), a wholly\u2011owned subsidiary of Sino Biopharmaceutical Limited (HKG:\u202f1177), announced that the Guangdong Provincial Medical Products Administration (GDMPA) has granted marketing approval for naldemedine, an opioid\u2011induced constipation (OIC) therapy, for commercialization in the Greater Bay Area (GBA).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=62721#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=62721"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=62721#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/0903.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/0903.webp","width":1080,"height":608,"caption":"Sino Biopharm's Chia Tai Tianqing Secures GDMPA Approval for Naldemedine in Greater Bay Area \u2013 World's First Oral OIC Therapy Enters China"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=62721#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Sino Biopharm&#8217;s Chia Tai Tianqing Secures GDMPA Approval for Naldemedine in Greater Bay Area \u2013 World&#8217;s First Oral OIC Therapy Enters China"}]},{"@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\/2026\/04\/0903.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/62721","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=62721"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/62721\/revisions"}],"predecessor-version":[{"id":62723,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/62721\/revisions\/62723"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/62722"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=62721"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=62721"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=62721"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}