{"id":18691,"date":"2024-12-18T16:28:09","date_gmt":"2024-12-18T08:28:09","guid":{"rendered":"https:\/\/flcube.com\/?p=18691"},"modified":"2024-12-18T16:28:11","modified_gmt":"2024-12-18T08:28:11","slug":"bionova-pharmaceuticals-bn104-receives-breakthrough-therapy-designation-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=18691","title":{"rendered":"BioNova Pharmaceuticals&#8217; BN104 Receives Breakthrough Therapy Designation in China"},"content":{"rendered":"\n<p>The China\u2019s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.&#8217;s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed\/refractory acute leukemia patients carrying KMT2A rearrangement and\/or NPM1 mutation in China.<\/p>\n\n\n\n<p><strong>BN104: A Selective Inhibitor of Menin for Acute Leukemia Treatment<\/strong><br>BN104 is a groundbreaking, highly selective small molecule inhibitor of menin, a scaffold protein that is pivotal in various biological pathways, including cell cycle regulation and genome stability. The drug is specifically under development to address acute leukemia with rearranged mixed lineage leukemia (MLLr) genes or acute myeloid leukemia with NPM1 mutations.<\/p>\n\n\n\n<p><strong>Pre-clinical Success and Regulatory Clearances<\/strong><br>Pre-clinical studies have demonstrated BN104&#8217;s favorable safety and toxicity profile, along with preliminary efficacy in a mouse model. This has set the stage for BN104 to receive an Orphan Drug Designation (ODD) from the US FDA in April 2023. Building on this momentum, BN104 was cleared for trials in China in August 2023 and in the US in September 2023, highlighting its potential as a treatment for leukemia patients worldwide.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The China\u2019s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.&#8217;s&#8230;<\/p>\n","protected":false},"author":1,"featured_media":18693,"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":[2004,34],"class_list":["post-18691","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-bionova-pharmaceuticals","tag-breakthrough-therapy"],"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>BioNova Pharmaceuticals&#039; BN104 Receives Breakthrough Therapy Designation in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The China\u2019s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.&#039;s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed\/refractory acute leukemia patients carrying KMT2A rearrangement and\/or NPM1 mutation in China.\" \/>\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=18691\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BioNova Pharmaceuticals&#039; BN104 Receives Breakthrough Therapy Designation in China\" \/>\n<meta property=\"og:description\" content=\"The China\u2019s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.&#039;s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed\/refractory acute leukemia patients carrying KMT2A rearrangement and\/or NPM1 mutation in China.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=18691\" \/>\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=\"2024-12-18T08:28:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-12-18T08:28:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/12\/1806.png\" \/>\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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"BioNova Pharmaceuticals&#8217; BN104 Receives Breakthrough Therapy Designation in China\",\"datePublished\":\"2024-12-18T08:28:09+00:00\",\"dateModified\":\"2024-12-18T08:28:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691\"},\"wordCount\":203,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/12\\\/1806.png\",\"keywords\":[\"BioNova Pharmaceuticals\",\"Breakthrough therapy\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=18691#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=18691\",\"name\":\"BioNova Pharmaceuticals' BN104 Receives Breakthrough Therapy Designation in China - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/12\\\/1806.png\",\"datePublished\":\"2024-12-18T08:28:09+00:00\",\"dateModified\":\"2024-12-18T08:28:11+00:00\",\"description\":\"The China\u2019s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.'s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed\\\/refractory acute leukemia patients carrying KMT2A rearrangement and\\\/or NPM1 mutation in China.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=18691\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/12\\\/1806.png\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/12\\\/1806.png\",\"width\":1080,\"height\":608,\"caption\":\"BioNova Pharmaceuticals' BN104 Receives Breakthrough Therapy Designation in China\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18691#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"BioNova Pharmaceuticals&#8217; BN104 Receives Breakthrough Therapy Designation in China\"}]},{\"@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":"BioNova Pharmaceuticals' BN104 Receives Breakthrough Therapy Designation in China - Insight, China&#039;s Pharmaceutical Industry","description":"The China\u2019s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.'s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed\/refractory acute leukemia patients carrying KMT2A rearrangement and\/or NPM1 mutation in China.","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=18691","og_locale":"en_US","og_type":"article","og_title":"BioNova Pharmaceuticals' BN104 Receives Breakthrough Therapy Designation in China","og_description":"The China\u2019s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.'s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed\/refractory acute leukemia patients carrying KMT2A rearrangement and\/or NPM1 mutation in China.","og_url":"https:\/\/flcube.com\/?p=18691","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-12-18T08:28:09+00:00","article_modified_time":"2024-12-18T08:28:11+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/12\/1806.png","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":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=18691#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=18691"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"BioNova Pharmaceuticals&#8217; BN104 Receives Breakthrough Therapy Designation in China","datePublished":"2024-12-18T08:28:09+00:00","dateModified":"2024-12-18T08:28:11+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=18691"},"wordCount":203,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=18691#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/12\/1806.png","keywords":["BioNova Pharmaceuticals","Breakthrough therapy"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=18691#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=18691","url":"https:\/\/flcube.com\/?p=18691","name":"BioNova Pharmaceuticals' BN104 Receives Breakthrough Therapy Designation in China - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=18691#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=18691#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/12\/1806.png","datePublished":"2024-12-18T08:28:09+00:00","dateModified":"2024-12-18T08:28:11+00:00","description":"The China\u2019s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.'s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed\/refractory acute leukemia patients carrying KMT2A rearrangement and\/or NPM1 mutation in China.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=18691#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=18691"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=18691#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/12\/1806.png","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/12\/1806.png","width":1080,"height":608,"caption":"BioNova Pharmaceuticals' BN104 Receives Breakthrough Therapy Designation in China"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=18691#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"BioNova Pharmaceuticals&#8217; BN104 Receives Breakthrough Therapy Designation in China"}]},{"@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\/2024\/12\/1806.png","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/18691","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=18691"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/18691\/revisions"}],"predecessor-version":[{"id":18694,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/18691\/revisions\/18694"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/18693"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=18691"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18691"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18691"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}