{"id":5320,"date":"2024-04-03T00:16:52","date_gmt":"2024-04-02T16:16:52","guid":{"rendered":"https:\/\/flcube.com\/?p=5320"},"modified":"2024-10-13T18:49:37","modified_gmt":"2024-10-13T10:49:37","slug":"remegen-secures-fast-track-fda-designation-for-telitacicept-in-sjogrens-syndrome-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=5320","title":{"rendered":"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren&#8217;s Syndrome Treatment"},"content":{"rendered":"\n<p>China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sj\u00f6gren&#8217;s syndrome (SS). This follows the drug&#8217;s clearance for a global, multi-center Phase III study in the U.S. for the same indication last year.<\/p>\n\n\n\n<p>Primary Sj\u00f6gren&#8217;s syndrome (pSS) is a chronic inflammatory autoimmune disease that primarily affects secretory glands, including the lacrimal and salivary glands, and currently lacks effective treatment options. The B cell pathway is critical in the pathogenesis of pSS. Telitacicept is a novel recombinant fusion protein that targets both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), inhibiting B cell maturation and differentiation, reducing autoantibody secretion, and better controlling pSS activity. Phase II study results indicated that telitacicept significantly improved the ESSDAI score and MFI-20 in pSS patients compared to placebo, while also reducing overall immunoglobulin levels and demonstrating a favorable safety and tolerance profile.<\/p>\n\n\n\n<p>Initially conditionally approved in China for the treatment of systemic lupus erythematosus (SLE) in March 2021, telitacicept received full approval in November 2023 and was included in the National Reimbursement Drug List (NRDL) by the end of 2021. The drug is also under evaluation in multiple clinical studies for conditions such as myasthenia gravis and rheumatoid arthritis, in addition to SLE and pSS.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD)&#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":[65,1155,38,375],"class_list":["post-5320","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-hkg-9995","tag-market-approval-filings","tag-remegen"],"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>RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren&#039;s Syndrome Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sj\u00f6gren&#039;s syndrome (SS). This follows the drug&#039;s clearance for a global, multi-center Phase III study in the U.S. for the same indication last year.\" \/>\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=5320\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren&#039;s Syndrome Treatment\" \/>\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=5320\" \/>\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=\"2024-04-02T16:16:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-13T10:49:37+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=5320#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=5320\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren&#8217;s Syndrome Treatment\",\"datePublished\":\"2024-04-02T16:16:52+00:00\",\"dateModified\":\"2024-10-13T10:49:37+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=5320\"},\"wordCount\":241,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Auto-immune\",\"HKG: 9995\",\"Market approval filings\",\"RemeGen\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=5320#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=5320\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=5320\",\"name\":\"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren's Syndrome Treatment - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2024-04-02T16:16:52+00:00\",\"dateModified\":\"2024-10-13T10:49:37+00:00\",\"description\":\"China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sj\u00f6gren's syndrome (SS). This follows the drug's clearance for a global, multi-center Phase III study in the U.S. for the same indication last year.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=5320#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=5320\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=5320#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren&#8217;s Syndrome Treatment\"}]},{\"@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":"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren's Syndrome Treatment - Insight, China&#039;s Pharmaceutical Industry","description":"China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sj\u00f6gren's syndrome (SS). This follows the drug's clearance for a global, multi-center Phase III study in the U.S. for the same indication last year.","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=5320","og_locale":"en_US","og_type":"article","og_title":"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren's Syndrome Treatment","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=5320","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-04-02T16:16:52+00:00","article_modified_time":"2024-10-13T10:49:37+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=5320#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=5320"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren&#8217;s Syndrome Treatment","datePublished":"2024-04-02T16:16:52+00:00","dateModified":"2024-10-13T10:49:37+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=5320"},"wordCount":241,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Auto-immune","HKG: 9995","Market approval filings","RemeGen"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=5320#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=5320","url":"https:\/\/flcube.com\/?p=5320","name":"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren's Syndrome Treatment - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2024-04-02T16:16:52+00:00","dateModified":"2024-10-13T10:49:37+00:00","description":"China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sj\u00f6gren's syndrome (SS). This follows the drug's clearance for a global, multi-center Phase III study in the U.S. for the same indication last year.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=5320#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=5320"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=5320#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sj\u00f6gren&#8217;s Syndrome Treatment"}]},{"@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\/5320","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=5320"}],"version-history":[{"count":2,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/5320\/revisions"}],"predecessor-version":[{"id":6005,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/5320\/revisions\/6005"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5320"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5320"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5320"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}