{"id":11478,"date":"2023-11-15T09:33:00","date_gmt":"2023-11-15T01:33:00","guid":{"rendered":"https:\/\/flcube.com\/?p=11478"},"modified":"2024-11-06T09:39:11","modified_gmt":"2024-11-06T01:39:11","slug":"eli-lillys-donanemab-on-track-for-priority-review-in-china-for-early-stage-alzheimers","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=11478","title":{"rendered":"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer&#8217;s"},"content":{"rendered":"\n<p>The China&#8217;s Center for Drug Evaluation (CDE) website has indicated that Eli Lilly\u2019s (<a href=\"https:\/\/www.google.com\/finance\/quote\/LLY:NYSE\">NYSE: LLY<\/a>) donanemab is set to receive priority review status for the treatment of early-stage Alzheimer&#8217;s disease (AD). This development is significant as it pertains to the drug&#8217;s potential use in patients with mild cognitive impairment or mild dementia, aligning with the patient population targeted in clinical trials.<\/p>\n\n\n\n<p><strong>Donanemab&#8217;s Mechanism and Recognition<\/strong><br>Donanemab is a monoclonal antibody (mAb) that specifically binds to the \u03b2 amyloid protein subtype N3pG, which is implicated in Alzheimer&#8217;s disease. By binding to this subtype, donanemab promotes the clearance of amyloid protein deposits in the brains of AD patients. This targeted approach has garnered donanemab breakthrough therapy designations (BTDs) in both the United States and China, highlighting its potential to significantly improve patient outcomes.<\/p>\n\n\n\n<p><strong>Regulatory Decision Timeline<\/strong><br>A regulatory decision in the United States for donanemab was initially anticipated by the end of 2023. However, Eli Lilly disclosed in its Q3&#8217;23 financial report that the timeline for this decision has been extended to Q1 2024. This adjustment provides additional time for regulatory bodies to thoroughly review the drug&#8217;s efficacy and safety data before making a final determination on its approval.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The China&#8217;s Center for Drug Evaluation (CDE) website has indicated that Eli Lilly\u2019s (NYSE: LLY)&#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":[199,911,80],"class_list":["post-11478","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-eli-lilly","tag-nyse-lly","tag-priority-reviews"],"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>Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer&#039;s - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The China&#039;s Center for Drug Evaluation (CDE) website has indicated that Eli Lilly\u2019s (NYSE: LLY) donanemab is set to receive priority review status for the treatment of early-stage Alzheimer&#039;s disease (AD). This development is significant as it pertains to the drug&#039;s potential use in patients with mild cognitive impairment or mild dementia, aligning with the patient population targeted in clinical trials.\" \/>\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=11478\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer&#039;s\" \/>\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=11478\" \/>\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=\"2023-11-15T01:33:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-06T01:39:11+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=11478#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11478\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer&#8217;s\",\"datePublished\":\"2023-11-15T01:33:00+00:00\",\"dateModified\":\"2024-11-06T01:39:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11478\"},\"wordCount\":220,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Eli Lilly\",\"NYSE: LLY\",\"Priority reviews\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=11478#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11478\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=11478\",\"name\":\"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer's - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-11-15T01:33:00+00:00\",\"dateModified\":\"2024-11-06T01:39:11+00:00\",\"description\":\"The China's Center for Drug Evaluation (CDE) website has indicated that Eli Lilly\u2019s (NYSE: LLY) donanemab is set to receive priority review status for the treatment of early-stage Alzheimer's disease (AD). This development is significant as it pertains to the drug's potential use in patients with mild cognitive impairment or mild dementia, aligning with the patient population targeted in clinical trials.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11478#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=11478\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11478#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer&#8217;s\"}]},{\"@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":"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer's - Insight, China&#039;s Pharmaceutical Industry","description":"The China's Center for Drug Evaluation (CDE) website has indicated that Eli Lilly\u2019s (NYSE: LLY) donanemab is set to receive priority review status for the treatment of early-stage Alzheimer's disease (AD). This development is significant as it pertains to the drug's potential use in patients with mild cognitive impairment or mild dementia, aligning with the patient population targeted in clinical trials.","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=11478","og_locale":"en_US","og_type":"article","og_title":"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer's","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=11478","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-11-15T01:33:00+00:00","article_modified_time":"2024-11-06T01:39:11+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=11478#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=11478"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer&#8217;s","datePublished":"2023-11-15T01:33:00+00:00","dateModified":"2024-11-06T01:39:11+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=11478"},"wordCount":220,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Eli Lilly","NYSE: LLY","Priority reviews"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=11478#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=11478","url":"https:\/\/flcube.com\/?p=11478","name":"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer's - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-11-15T01:33:00+00:00","dateModified":"2024-11-06T01:39:11+00:00","description":"The China's Center for Drug Evaluation (CDE) website has indicated that Eli Lilly\u2019s (NYSE: LLY) donanemab is set to receive priority review status for the treatment of early-stage Alzheimer's disease (AD). This development is significant as it pertains to the drug's potential use in patients with mild cognitive impairment or mild dementia, aligning with the patient population targeted in clinical trials.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=11478#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=11478"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=11478#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Eli Lilly\u2019s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer&#8217;s"}]},{"@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\/11478","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=11478"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11478\/revisions"}],"predecessor-version":[{"id":11479,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11478\/revisions\/11479"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11478"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=11478"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=11478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}