{"id":15648,"date":"2023-07-31T12:06:00","date_gmt":"2023-07-31T04:06:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15648"},"modified":"2024-11-29T12:08:58","modified_gmt":"2024-11-29T04:08:58","slug":"transcenta-holdings-gets-cde-approval-for-phase-ii-study-of-tst002-for-bone-density","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15648","title":{"rendered":"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">China-based biotech company Transcenta Holdings Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/6628:HKG\">HKG: 6628<\/a>) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density. This development follows encouraging Phase I clinical data for the drug.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>TST002&#8217;s Dual Mechanism of Action<\/strong><br>TST002 is a drug with a dual mechanism of action that generates both anabolic and anti-resorptive effects. It stimulates bone formation while simultaneously inhibiting bone absorption, leading to a rapid increase in bone density and bone strength. This unique approach positions TST002 as a potential treatment for patients with conditions affecting bone density.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Following in the Footsteps of Romosozumab<\/strong><br>Transcenta aims to follow the success of Amgen\u2019s anti-sclerostin monoclonal antibody Evenity (romosozumab), which has been approved in the US, Europe, and Japan and is currently under clinical development in China. TST002, in-licensed from Eli Lilly in 2019, is intended for development and commercialization in Greater China. The drug has already concluded Phase II studies in postmenopausal women in the US and Japan, adding to the body of evidence supporting its potential efficacy and safety.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[62,975,181],"class_list":["post-15648","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-hkg-6628","tag-transcenta"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density. This development follows encouraging Phase I clinical data for the drug.\" \/>\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=15648\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density\" \/>\n<meta property=\"og: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 property=\"og:url\" content=\"https:\/\/flcube.com\/?p=15648\" \/>\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=\"2023-07-31T04:06:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-29T04:08:58+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: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=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15648#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15648\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density\",\"datePublished\":\"2023-07-31T04:06:00+00:00\",\"dateModified\":\"2024-11-29T04:08:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15648\"},\"wordCount\":218,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Clinical trial approval \\\/ initiation\",\"HKG: 6628\",\"Transcenta\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=15648#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15648\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=15648\",\"name\":\"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-07-31T04:06:00+00:00\",\"dateModified\":\"2024-11-29T04:08:58+00:00\",\"description\":\"China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density. This development follows encouraging Phase I clinical data for the drug.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15648#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=15648\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=15648#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density\"}]},{\"@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":"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density - Insight, China&#039;s Pharmaceutical Industry","description":"China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density. This development follows encouraging Phase I clinical data for the drug.","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=15648","og_locale":"en_US","og_type":"article","og_title":"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density","og_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","og_url":"https:\/\/flcube.com\/?p=15648","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-07-31T04:06:00+00:00","article_modified_time":"2024-11-29T04:08:58+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_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=15648#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=15648"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density","datePublished":"2023-07-31T04:06:00+00:00","dateModified":"2024-11-29T04:08:58+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=15648"},"wordCount":218,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Clinical trial approval \/ initiation","HKG: 6628","Transcenta"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=15648#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=15648","url":"https:\/\/flcube.com\/?p=15648","name":"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-07-31T04:06:00+00:00","dateModified":"2024-11-29T04:08:58+00:00","description":"China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density. This development follows encouraging Phase I clinical data for the drug.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=15648#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=15648"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=15648#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density"}]},{"@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\/15648","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=15648"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/15648\/revisions"}],"predecessor-version":[{"id":15649,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/15648\/revisions\/15649"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=15648"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=15648"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=15648"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}