{"id":22747,"date":"2023-01-17T18:15:00","date_gmt":"2023-01-17T10:15:00","guid":{"rendered":"https:\/\/flcube.com\/?p=22747"},"modified":"2025-01-23T18:20:08","modified_gmt":"2025-01-23T10:20:08","slug":"bio-theras-biosimilar-bat1806-passes-nmpa-review-targets-roches-actemra","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22747","title":{"rendered":"Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra"},"content":{"rendered":"\n

China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG\u2019s (OTCMKTS: RHHBY<\/a>) blockbuster Actemra\/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche\u2019s originator drug, which has been approved globally for multiple indications, including pediatric and systemic juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced cytokine release syndrome, and rheumatoid arthritis (RA).<\/p>\n\n\n\n

Roche’s Actemra and Its Expanding Indications<\/strong>
Roche\u2019s Actemra, an interleukin-6 receptor inhibitor, has been a cornerstone in treating various autoimmune and inflammatory conditions. Its mechanism of action involves suppressing the immune response by targeting the IL-6 receptor. The drug\u2019s versatility was further highlighted when China\u2019s health authorities included it in the 10th edition of the COVID-19 Infection Diagnosis and Treatment Plan, underscoring its potential in managing cytokine release syndrome associated with the virus.<\/p>\n\n\n\n

Global Partnerships and Market Expansion<\/strong>
In April 2021, Switzerland-based Biogen Inc. (Nasdaq: BIIB) signed a deal with Bio-Thera to acquire development and commercialization rights for BAT1806 outside Greater China. This strategic partnership aims to leverage Biogen\u2019s global reach to bring the biosimilar to markets in the US and EU, where the drug is currently under marketing review. The collaboration reflects growing interest in biosimilars as cost-effective alternatives to originator biologics.<\/p>\n\n\n\n

Competitive Landscape in China<\/strong>
Bio-Thera\u2019s success with BAT1806 comes amid a competitive environment in China, where several local players are developing their own biosimilar versions of tocilizumab. Companies such as Livzon Pharma, Qyuns Bio (QX003S), Mabpharm (CMAB806), and Hisun Pharma are actively pursuing biosimilar development, signaling a potential shift in market dynamics and increased competition for Roche\u2019s Actemra in the region.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after…<\/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":[289,43,107,940,15,163,1055],"class_list":["post-22747","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-bio-thera-solutions","tag-biosimilars","tag-immunotherapy","tag-otcmkts-rhhby","tag-product-approvals","tag-roche","tag-sha-688177"],"yoast_head":"\nBio-Thera's Biosimilar BAT1806 Passes NMPA Review, Targets Roche's Actemra - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG\u2019s (OTCMKTS: RHHBY) blockbuster Actemra\/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche\u2019s originator drug, which has been approved globally for multiple indications, including pediatric and systemic juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced cytokine release syndrome, and rheumatoid arthritis (RA).\" \/>\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=22747\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bio-Thera's Biosimilar BAT1806 Passes NMPA Review, Targets Roche's Actemra\" \/>\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=22747\" \/>\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=\"2023-01-17T10:15:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-23T10:20:08+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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22747#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22747\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra\",\"datePublished\":\"2023-01-17T10:15:00+00:00\",\"dateModified\":\"2025-01-23T10:20:08+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22747\"},\"wordCount\":302,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Bio-Thera Solutions\",\"Biosimilars\",\"Immunotherapy\",\"OTCMKTS: RHHBY\",\"Product approvals\",\"Roche\",\"SHA: 688177\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=22747#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22747\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=22747\",\"name\":\"Bio-Thera's Biosimilar BAT1806 Passes NMPA Review, Targets Roche's Actemra - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-01-17T10:15:00+00:00\",\"dateModified\":\"2025-01-23T10:20:08+00:00\",\"description\":\"China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG\u2019s (OTCMKTS: RHHBY) blockbuster Actemra\\\/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche\u2019s originator drug, which has been approved globally for multiple indications, including pediatric and systemic juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced cytokine release syndrome, and rheumatoid arthritis (RA).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22747#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=22747\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22747#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra\"}]},{\"@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":"Bio-Thera's Biosimilar BAT1806 Passes NMPA Review, Targets Roche's Actemra - Insight, China's Pharmaceutical Industry","description":"China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG\u2019s (OTCMKTS: RHHBY) blockbuster Actemra\/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche\u2019s originator drug, which has been approved globally for multiple indications, including pediatric and systemic juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced cytokine release syndrome, and rheumatoid arthritis (RA).","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=22747","og_locale":"en_US","og_type":"article","og_title":"Bio-Thera's Biosimilar BAT1806 Passes NMPA Review, Targets Roche's Actemra","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=22747","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-01-17T10:15:00+00:00","article_modified_time":"2025-01-23T10:20:08+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":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=22747#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=22747"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra","datePublished":"2023-01-17T10:15:00+00:00","dateModified":"2025-01-23T10:20:08+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=22747"},"wordCount":302,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Bio-Thera Solutions","Biosimilars","Immunotherapy","OTCMKTS: RHHBY","Product approvals","Roche","SHA: 688177"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=22747#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=22747","url":"https:\/\/flcube.com\/?p=22747","name":"Bio-Thera's Biosimilar BAT1806 Passes NMPA Review, Targets Roche's Actemra - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-01-17T10:15:00+00:00","dateModified":"2025-01-23T10:20:08+00:00","description":"China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG\u2019s (OTCMKTS: RHHBY) blockbuster Actemra\/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche\u2019s originator drug, which has been approved globally for multiple indications, including pediatric and systemic juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced cytokine release syndrome, and rheumatoid arthritis (RA).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=22747#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=22747"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=22747#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra"}]},{"@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\/22747","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=22747"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/22747\/revisions"}],"predecessor-version":[{"id":22748,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/22747\/revisions\/22748"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22747"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22747"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22747"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}