{"id":14731,"date":"2023-08-24T22:35:00","date_gmt":"2023-08-24T14:35:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14731"},"modified":"2024-11-24T22:37:38","modified_gmt":"2024-11-24T14:37:38","slug":"akeso-biopharmas-ebdarokimab-ak101-nda-accepted-for-review-by-chinas-cde","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14731","title":{"rendered":"Akeso Biopharma&#8217;s Ebdarokimab (AK101) NDA Accepted for Review by China&#8217;s CDE"},"content":{"rendered":"\n<p>China-based Akeso Biopharma (<a href=\"https:\/\/www.google.com\/finance\/quote\/9926:HKG\">HKG: 9926<\/a>) has announced that the New Drug Application (NDA) for its monoclonal antibody ebdarokimab (AK101), which targets IL-12 and IL-23, has been accepted for review by the Center for Drug Evaluation (CDE) in China. The drug is intended for the treatment of moderate to severe plaque psoriasis.<\/p>\n\n\n\n<p><strong>AK101: A Potential Game-Changer in Psoriasis Treatment<\/strong><br>AK101, designated as a &#8220;national major novel drug preparation special drug,&#8221; is under development for the treatment of a range of conditions including psoriasis, Crohn&#8217;s disease, ulcerative colitis, and lupus. It joins a class of drugs similar to Johnson &amp; Johnson\u2019s ustekinumab, which has already received approval in the US and China.<\/p>\n\n\n\n<p><strong>Clinical Studies Support AK101&#8217;s Efficacy and Safety<\/strong><br>AK101 is supported by five clinical studies, with two pivotal Phase III studies providing key efficacy and safety data for AK101 in patients with moderate to severe plaque psoriasis at 16 weeks and 52 weeks. The results demonstrated significant efficacy and good safety of AK101 in treating moderate to severe plaque psoriasis over both time periods, effectively improving patients&#8217; quality of life and skin lesions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its&#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_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":[360,850,38],"class_list":["post-14731","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-akeso-biopharma","tag-hkg-9926","tag-market-approval-filings"],"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>Akeso Biopharma&#039;s Ebdarokimab (AK101) NDA Accepted for Review by China&#039;s CDE - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its monoclonal antibody ebdarokimab (AK101), which targets IL-12 and IL-23, has been accepted for review by the Center for Drug Evaluation (CDE) in China. The drug is intended for the treatment of moderate to severe plaque psoriasis.\" \/>\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=14731\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Akeso Biopharma&#039;s Ebdarokimab (AK101) NDA Accepted for Review by China&#039;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=14731\" \/>\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=\"2023-08-24T14:35:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-24T14:37:38+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=14731#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14731\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Akeso Biopharma&#8217;s Ebdarokimab (AK101) NDA Accepted for Review by China&#8217;s CDE\",\"datePublished\":\"2023-08-24T14:35:00+00:00\",\"dateModified\":\"2024-11-24T14:37:38+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14731\"},\"wordCount\":199,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Akeso Biopharma\",\"HKG: 9926\",\"Market approval filings\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=14731#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14731\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=14731\",\"name\":\"Akeso Biopharma's Ebdarokimab (AK101) NDA Accepted for Review by China's CDE - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-08-24T14:35:00+00:00\",\"dateModified\":\"2024-11-24T14:37:38+00:00\",\"description\":\"China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its monoclonal antibody ebdarokimab (AK101), which targets IL-12 and IL-23, has been accepted for review by the Center for Drug Evaluation (CDE) in China. The drug is intended for the treatment of moderate to severe plaque psoriasis.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14731#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=14731\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14731#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Akeso Biopharma&#8217;s Ebdarokimab (AK101) NDA Accepted for Review by China&#8217;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":"Akeso Biopharma's Ebdarokimab (AK101) NDA Accepted for Review by China's CDE - Insight, China&#039;s Pharmaceutical Industry","description":"China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its monoclonal antibody ebdarokimab (AK101), which targets IL-12 and IL-23, has been accepted for review by the Center for Drug Evaluation (CDE) in China. The drug is intended for the treatment of moderate to severe plaque psoriasis.","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=14731","og_locale":"en_US","og_type":"article","og_title":"Akeso Biopharma's Ebdarokimab (AK101) NDA 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=14731","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-08-24T14:35:00+00:00","article_modified_time":"2024-11-24T14:37:38+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=14731#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=14731"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Akeso Biopharma&#8217;s Ebdarokimab (AK101) NDA Accepted for Review by China&#8217;s CDE","datePublished":"2023-08-24T14:35:00+00:00","dateModified":"2024-11-24T14:37:38+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=14731"},"wordCount":199,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Akeso Biopharma","HKG: 9926","Market approval filings"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=14731#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=14731","url":"https:\/\/flcube.com\/?p=14731","name":"Akeso Biopharma's Ebdarokimab (AK101) NDA Accepted for Review by China's CDE - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-08-24T14:35:00+00:00","dateModified":"2024-11-24T14:37:38+00:00","description":"China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its monoclonal antibody ebdarokimab (AK101), which targets IL-12 and IL-23, has been accepted for review by the Center for Drug Evaluation (CDE) in China. The drug is intended for the treatment of moderate to severe plaque psoriasis.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=14731#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=14731"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=14731#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Akeso Biopharma&#8217;s Ebdarokimab (AK101) NDA Accepted for Review by China&#8217;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\/14731","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=14731"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14731\/revisions"}],"predecessor-version":[{"id":14732,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14731\/revisions\/14732"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14731"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14731"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14731"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}