{"id":11204,"date":"2023-11-23T11:46:00","date_gmt":"2023-11-23T03:46:00","guid":{"rendered":"https:\/\/flcube.com\/?p=11204"},"modified":"2024-11-04T11:49:58","modified_gmt":"2024-11-04T03:49:58","slug":"remegens-telitacicept-receives-full-approval-for-systemic-lupus-erythematosus-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=11204","title":{"rendered":"RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China"},"content":{"rendered":"\n

China-based pharmaceutical company RemeGen (HKG: 9995<\/a>) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving 335 SLE patients who received either telitacicept (160 mg) or placebo subcutaneously once a week, in addition to standard treatment, over a period of 52 weeks. The study successfully met its predetermined clinical endpoint, with the SRI-4 response rate in the telitacicept group significantly outperforming the placebo group, demonstrating the drug’s efficacy and safety.<\/p>\n\n\n\n

Telitacicept’s Mechanism of Action and Market Impact<\/strong>
Telitacicept is a novel recombinant fusion protein that targets both the B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). It was conditionally approved in China for SLE treatment in March 2021, marking the first domestic SLE drug in the country. The drug’s inclusion in the National Reimbursement Drug List (NRDL) at the end of 2021 further solidified its market position. Telitacicept is also undergoing Phase II\/III clinical studies for myasthenia gravis (MG) and rheumatoid arthritis (RA), with the latter’s marketing approval review currently underway in China.- Flcube.com<\/a><\/p>\n\n\n\n

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

China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete…<\/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":[65,1155,28,15,375],"class_list":["post-11204","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-hkg-9995","tag-multi-specific-antibodies","tag-product-approvals","tag-remegen"],"yoast_head":"\nRemeGen's Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving 335 SLE patients who received either telitacicept (160 mg) or placebo subcutaneously once a week, in addition to standard treatment, over a period of 52 weeks.\" \/>\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=11204\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RemeGen's Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China\" \/>\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=11204\" \/>\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=\"2023-11-23T03:46:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-04T03:49:58+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=11204#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11204\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China\",\"datePublished\":\"2023-11-23T03:46:00+00:00\",\"dateModified\":\"2024-11-04T03:49:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11204\"},\"wordCount\":212,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Auto-immune\",\"HKG: 9995\",\"Multi-specific antibodies\",\"Product approvals\",\"RemeGen\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=11204#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11204\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=11204\",\"name\":\"RemeGen's Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-11-23T03:46:00+00:00\",\"dateModified\":\"2024-11-04T03:49:58+00:00\",\"description\":\"China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving 335 SLE patients who received either telitacicept (160 mg) or placebo subcutaneously once a week, in addition to standard treatment, over a period of 52 weeks.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11204#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=11204\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11204#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus 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":"RemeGen's Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China - Insight, China's Pharmaceutical Industry","description":"China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving 335 SLE patients who received either telitacicept (160 mg) or placebo subcutaneously once a week, in addition to standard treatment, over a period of 52 weeks.","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=11204","og_locale":"en_US","og_type":"article","og_title":"RemeGen's Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China","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=11204","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-11-23T03:46:00+00:00","article_modified_time":"2024-11-04T03:49:58+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=11204#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=11204"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China","datePublished":"2023-11-23T03:46:00+00:00","dateModified":"2024-11-04T03:49:58+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=11204"},"wordCount":212,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Auto-immune","HKG: 9995","Multi-specific antibodies","Product approvals","RemeGen"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=11204#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=11204","url":"https:\/\/flcube.com\/?p=11204","name":"RemeGen's Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-11-23T03:46:00+00:00","dateModified":"2024-11-04T03:49:58+00:00","description":"China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving 335 SLE patients who received either telitacicept (160 mg) or placebo subcutaneously once a week, in addition to standard treatment, over a period of 52 weeks.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=11204#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=11204"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=11204#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus 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":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11204","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=11204"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11204\/revisions"}],"predecessor-version":[{"id":11205,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11204\/revisions\/11205"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11204"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=11204"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=11204"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}