{"id":12024,"date":"2023-11-03T11:05:00","date_gmt":"2023-11-03T03:05:00","guid":{"rendered":"https:\/\/flcube.com\/?p=12024"},"modified":"2024-11-11T11:09:44","modified_gmt":"2024-11-11T03:09:44","slug":"i-mab-and-hi-bios-felzartamab-earns-breakthrough-therapy-designation-from-us-fda","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12024","title":{"rendered":"I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA"},"content":{"rendered":"\n

China-based I-Mab (NASDAQ: IMAB<\/a>) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug’s potential as a treatment for primary membranous nephropathy (PMN), a rare kidney disease.<\/p>\n\n\n\n

Background on Licensing Deals<\/strong>
I-Mab secured exclusive development and commercialization rights to felzartamab in Greater China through a licensing deal with MorphoSys in November 2017. Subsequently, HI-Bio entered into an equity investment and licensing agreement with MorphoSys in June 2022, which granted HI-Bio global rights and commercialization rights to the drug outside of Greater China.<\/p>\n\n\n\n

Clinical Studies and Applications<\/strong>
I-Mab is currently conducting studies for felzartamab in both cancer and autoimmune diseases. This includes a Phase III regulatory study for the drug in combination with lenalidomide and dexamethasone for the treatment of second-line multiple myeloma (MM). The results of this study are anticipated in the coming year, offering the potential for significant advancements in the treatment of MM.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received…<\/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":[34,16,1999,182,976],"class_list":["post-12024","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-breakthrough-therapy","tag-cancer","tag-hi-bio","tag-i-mab-biopharma","tag-nasdaq-imab"],"yoast_head":"\nI-Mab and HI-Bio's Felzartamab Earns Breakthrough Therapy Designation from US FDA - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug's potential as a treatment for primary membranous nephropathy (PMN), a rare kidney disease.\" \/>\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=12024\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"I-Mab and HI-Bio's Felzartamab Earns Breakthrough Therapy Designation from US FDA\" \/>\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=12024\" \/>\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=\"2023-11-03T03:05:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-11T03:09:44+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=12024#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12024\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA\",\"datePublished\":\"2023-11-03T03:05:00+00:00\",\"dateModified\":\"2024-11-11T03:09:44+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12024\"},\"wordCount\":185,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Breakthrough therapy\",\"Cancer\",\"HI-Bio\",\"I-MAB Biopharma\",\"NASDAQ: IMAB\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=12024#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12024\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=12024\",\"name\":\"I-Mab and HI-Bio's Felzartamab Earns Breakthrough Therapy Designation from US FDA - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-11-03T03:05:00+00:00\",\"dateModified\":\"2024-11-11T03:09:44+00:00\",\"description\":\"China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug's potential as a treatment for primary membranous nephropathy (PMN), a rare kidney disease.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12024#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=12024\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12024#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA\"}]},{\"@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":"I-Mab and HI-Bio's Felzartamab Earns Breakthrough Therapy Designation from US FDA - Insight, China's Pharmaceutical Industry","description":"China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug's potential as a treatment for primary membranous nephropathy (PMN), a rare kidney disease.","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=12024","og_locale":"en_US","og_type":"article","og_title":"I-Mab and HI-Bio's Felzartamab Earns Breakthrough Therapy Designation from US FDA","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=12024","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-11-03T03:05:00+00:00","article_modified_time":"2024-11-11T03:09:44+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=12024#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=12024"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA","datePublished":"2023-11-03T03:05:00+00:00","dateModified":"2024-11-11T03:09:44+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=12024"},"wordCount":185,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Breakthrough therapy","Cancer","HI-Bio","I-MAB Biopharma","NASDAQ: IMAB"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=12024#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=12024","url":"https:\/\/flcube.com\/?p=12024","name":"I-Mab and HI-Bio's Felzartamab Earns Breakthrough Therapy Designation from US FDA - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-11-03T03:05:00+00:00","dateModified":"2024-11-11T03:09:44+00:00","description":"China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug's potential as a treatment for primary membranous nephropathy (PMN), a rare kidney disease.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=12024#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=12024"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=12024#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA"}]},{"@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\/12024","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=12024"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/12024\/revisions"}],"predecessor-version":[{"id":12025,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/12024\/revisions\/12025"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=12024"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=12024"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=12024"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}