{"id":35419,"date":"2025-06-17T22:03:10","date_gmt":"2025-06-17T14:03:10","guid":{"rendered":"https:\/\/flcube.com\/?p=35419"},"modified":"2025-06-17T22:03:11","modified_gmt":"2025-06-17T14:03:11","slug":"sino-biopharmaceuticals-tdi01-receives-breakthrough-therapy-designation-for-cgvhd-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35419","title":{"rendered":"Sino Biopharmaceutical’s TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment"},"content":{"rendered":"\n

China-based Sino Biopharmaceutical Ltd (HKG: 1177<\/a>) announced that its Class 1 drug TDI01 has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation covers its use in treating moderate-to-severe chronic graft-versus-host disease (cGVHD) in patients who have undergone 1 to 5 prior lines of systemic therapy.<\/p>\n\n\n\n

Mechanism of Action<\/strong><\/p>\n\n\n\n

TDI01 is a novel, oral, and highly selective ROCK2 inhibitor. It effectively suppresses pro-inflammatory Th17 cells and promotes regulatory T cells (Tregs), restoring immune homeostasis. Additionally, it targets fibroblast ROCK2, blocking their differentiation into myofibroblasts and inducing apoptosis of existing myofibroblasts. This dual mechanism allows for immune regulation and fibrosis reversal.<\/p>\n\n\n\n

Clinical Progress<\/strong><\/p>\n\n\n\n

Previously, TDI01 was cleared in China for clinical trials targeting idiopathic pulmonary fibrosis (IPF), pneumoconiosis, and liver fibrosis.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been…<\/p>\n","protected":false},"author":1,"featured_media":35420,"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":[34,908,313],"class_list":["post-35419","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-breakthrough-therapy","tag-hkg-1177","tag-sino-biopharmaceutical"],"yoast_head":"\nSino Biopharmaceutical's TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation covers its use in treating moderate-to-severe chronic graft-versus-host disease (cGVHD) in patients who have undergone 1 to 5 prior lines of systemic therapy.\" \/>\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=35419\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sino Biopharmaceutical's TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment\" \/>\n<meta property=\"og:description\" content=\"China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation covers its use in treating moderate-to-severe chronic graft-versus-host disease (cGVHD) in patients who have undergone 1 to 5 prior lines of systemic therapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=35419\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-17T14:03:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-17T14:03:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/1702-1.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. 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=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Sino Biopharmaceutical’s TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment\",\"datePublished\":\"2025-06-17T14:03:10+00:00\",\"dateModified\":\"2025-06-17T14:03:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419\"},\"wordCount\":148,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/1702-1.webp\",\"keywords\":[\"Breakthrough therapy\",\"HKG: 1177\",\"Sino Biopharmaceutical\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=35419#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=35419\",\"name\":\"Sino Biopharmaceutical's TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/1702-1.webp\",\"datePublished\":\"2025-06-17T14:03:10+00:00\",\"dateModified\":\"2025-06-17T14:03:11+00:00\",\"description\":\"China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation covers its use in treating moderate-to-severe chronic graft-versus-host disease (cGVHD) in patients who have undergone 1 to 5 prior lines of systemic therapy.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=35419\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/1702-1.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/1702-1.webp\",\"width\":1080,\"height\":608,\"caption\":\"Sino Biopharmaceutical's TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=35419#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Sino Biopharmaceutical’s TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment\"}]},{\"@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":"Sino Biopharmaceutical's TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment - Insight, China's Pharmaceutical Industry","description":"China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation covers its use in treating moderate-to-severe chronic graft-versus-host disease (cGVHD) in patients who have undergone 1 to 5 prior lines of systemic therapy.","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=35419","og_locale":"en_US","og_type":"article","og_title":"Sino Biopharmaceutical's TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment","og_description":"China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation covers its use in treating moderate-to-severe chronic graft-versus-host disease (cGVHD) in patients who have undergone 1 to 5 prior lines of systemic therapy.","og_url":"https:\/\/flcube.com\/?p=35419","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-06-17T14:03:10+00:00","article_modified_time":"2025-06-17T14:03:11+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/1702-1.webp","type":"image\/png"}],"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":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=35419#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=35419"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Sino Biopharmaceutical’s TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment","datePublished":"2025-06-17T14:03:10+00:00","dateModified":"2025-06-17T14:03:11+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=35419"},"wordCount":148,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=35419#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/1702-1.webp","keywords":["Breakthrough therapy","HKG: 1177","Sino Biopharmaceutical"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=35419#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=35419","url":"https:\/\/flcube.com\/?p=35419","name":"Sino Biopharmaceutical's TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=35419#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=35419#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/1702-1.webp","datePublished":"2025-06-17T14:03:10+00:00","dateModified":"2025-06-17T14:03:11+00:00","description":"China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation covers its use in treating moderate-to-severe chronic graft-versus-host disease (cGVHD) in patients who have undergone 1 to 5 prior lines of systemic therapy.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=35419#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=35419"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=35419#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/1702-1.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/1702-1.webp","width":1080,"height":608,"caption":"Sino Biopharmaceutical's TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=35419#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Sino Biopharmaceutical’s TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment"}]},{"@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\/2025\/06\/1702-1.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/35419","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=35419"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/35419\/revisions"}],"predecessor-version":[{"id":35421,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/35419\/revisions\/35421"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/35420"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=35419"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=35419"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=35419"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}