{"id":3663,"date":"2024-05-21T23:22:04","date_gmt":"2024-05-21T15:22:04","guid":{"rendered":"https:\/\/flcube.com\/?p=3663"},"modified":"2024-10-22T17:43:21","modified_gmt":"2024-10-22T09:43:21","slug":"innovent-biologics-ibi311-new-drug-application-accepted-for-review-by-chinas-cde","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=3663","title":{"rendered":"Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE"},"content":{"rendered":"\n

Innovent Biologics Inc., (HKG: 1801<\/a>), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for the treatment of thyroid eye disease (TED).<\/p>\n\n\n\n

The acceptance of the NDA for review comes on the heels of positive results from the Phase III RESTORE-1 study, which met its primary endpoint in February 2024. The study demonstrated that IBI311 significantly outperformed the placebo in improving eyeball protrusion, disease activity, and quality of life for subjects. The drug also exhibited an overall good safety profile, with no new safety signals identified.<\/p>\n\n\n\n

IBI311’s mechanism of action involves blocking the binding of IGF-1 and IGF-2 to IGF-1R, thereby inhibiting the activation of the IGF-1R signaling pathway and the expression of downstream inflammatory factors. This inhibition reduces the adipocytosis of orbital fibroblasts (OFs) and the synthesis of hyaluronic acid and other glycosaminoglycans, which are typically increased due to OFs activation.- Flcube.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the…<\/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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[910,198,38],"class_list":["post-3663","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-hkg-1801","tag-innovent-biologics","tag-market-approval-filings"],"yoast_head":"\nInnovent Biologics' IBI311 New Drug Application Accepted for Review by China's CDE - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for the treatment of thyroid eye disease (TED).\" \/>\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=3663\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Innovent Biologics' IBI311 New Drug Application Accepted for Review by China's CDE\" \/>\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=3663\" \/>\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=\"2024-05-21T15:22:04+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-22T09:43:21+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=3663#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=3663\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE\",\"datePublished\":\"2024-05-21T15:22:04+00:00\",\"dateModified\":\"2024-10-22T09:43:21+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=3663\"},\"wordCount\":195,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"HKG: 1801\",\"Innovent Biologics\",\"Market approval filings\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=3663#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=3663\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=3663\",\"name\":\"Innovent Biologics' IBI311 New Drug Application Accepted for Review by China's CDE - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2024-05-21T15:22:04+00:00\",\"dateModified\":\"2024-10-22T09:43:21+00:00\",\"description\":\"Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for the treatment of thyroid eye disease (TED).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=3663#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=3663\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=3663#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE\"}]},{\"@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":"Innovent Biologics' IBI311 New Drug Application Accepted for Review by China's CDE - Insight, China's Pharmaceutical Industry","description":"Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for the treatment of thyroid eye disease (TED).","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=3663","og_locale":"en_US","og_type":"article","og_title":"Innovent Biologics' IBI311 New Drug Application Accepted for Review by China's CDE","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=3663","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-05-21T15:22:04+00:00","article_modified_time":"2024-10-22T09:43:21+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=3663#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=3663"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE","datePublished":"2024-05-21T15:22:04+00:00","dateModified":"2024-10-22T09:43:21+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=3663"},"wordCount":195,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["HKG: 1801","Innovent Biologics","Market approval filings"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=3663#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=3663","url":"https:\/\/flcube.com\/?p=3663","name":"Innovent Biologics' IBI311 New Drug Application Accepted for Review by China's CDE - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2024-05-21T15:22:04+00:00","dateModified":"2024-10-22T09:43:21+00:00","description":"Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for the treatment of thyroid eye disease (TED).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=3663#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=3663"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=3663#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE"}]},{"@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\/3663","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=3663"}],"version-history":[{"count":2,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/3663\/revisions"}],"predecessor-version":[{"id":8647,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/3663\/revisions\/8647"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3663"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3663"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3663"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}