{"id":2794,"date":"2024-06-27T09:51:18","date_gmt":"2024-06-27T01:51:18","guid":{"rendered":"https:\/\/flcube.com\/?p=2794"},"modified":"2024-10-16T23:43:13","modified_gmt":"2024-10-16T15:43:13","slug":"shanghai-junshi-biosciences-toripalimab-gains-nmpa-nod-for-first-line-tnbc-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=2794","title":{"rendered":"Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment"},"content":{"rendered":"\n

Shanghai Junshi Biosciences Co., Ltd (HKG: 1877<\/a>; SHA: 688180<\/a>) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment of recurrent or metastatic triple negative breast cancer (TNBC) with positive PD-L1 (CPS \u2265 1) as determined by fully validated tests.<\/p>\n\n\n\n

The approval follows the successful results of the TORCHLIGHT study, which met its pre-set superiority threshold for the primary endpoint in an interim analysis conducted in February 2023. This study stands as the first regulatory Phase III study for immunotherapy in advanced TNBC to report positive results. In the study, the median progression-free survival (PFS) in the toripalimab group was 8.4 months, with a 35% reduction in the risk of disease progression or death (P=0.0102). Additionally, the median overall survival (OS) in the toripalimab group was extended to 13.3 months, with a 38% reduction in the risk of death (P=0.0148). The safety profile of toripalimab remains consistent with known risks, and no new safety signals were identified.<\/p>\n\n\n\n

Toripalimab, China’s first domestically approved PD-1 inhibitor, was initially approved in December 2018 as a second-line treatment for melanoma. It has since received a total of nine indication approvals in China. The drug also has six indications that are reimbursed under the National Reimbursement Drug List (NRDL).- Flcube.com<\/a><\/p>\n\n\n\n

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

Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has 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":[16,899,296,18,15,900],"class_list":["post-2794","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-hkg-1877","tag-junshi-biosciences","tag-pd-1-l1","tag-product-approvals","tag-sha-688180"],"yoast_head":"\nShanghai Junshi Biosciences' Toripalimab Gains NMPA Nod for First-Line TNBC Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China's National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment of recurrent or metastatic triple negative breast cancer (TNBC) with positive PD-L1 (CPS \u2265 1) as determined by fully validated tests.\" \/>\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=2794\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Shanghai Junshi Biosciences' Toripalimab Gains NMPA Nod for First-Line TNBC 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=2794\" \/>\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=\"2024-06-27T01:51:18+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-16T15:43:13+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=2794#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=2794\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment\",\"datePublished\":\"2024-06-27T01:51:18+00:00\",\"dateModified\":\"2024-10-16T15:43:13+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=2794\"},\"wordCount\":241,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Cancer\",\"HKG: 1877\",\"Junshi Biosciences\",\"PD-1\\\/L1\",\"Product approvals\",\"SHA: 688180\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=2794#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=2794\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=2794\",\"name\":\"Shanghai Junshi Biosciences' Toripalimab Gains NMPA Nod for First-Line TNBC Treatment - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2024-06-27T01:51:18+00:00\",\"dateModified\":\"2024-10-16T15:43:13+00:00\",\"description\":\"Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China's National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment of recurrent or metastatic triple negative breast cancer (TNBC) with positive PD-L1 (CPS \u2265 1) as determined by fully validated tests.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=2794#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=2794\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=2794#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC 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":"Shanghai Junshi Biosciences' Toripalimab Gains NMPA Nod for First-Line TNBC Treatment - Insight, China's Pharmaceutical Industry","description":"Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China's National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment of recurrent or metastatic triple negative breast cancer (TNBC) with positive PD-L1 (CPS \u2265 1) as determined by fully validated tests.","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=2794","og_locale":"en_US","og_type":"article","og_title":"Shanghai Junshi Biosciences' Toripalimab Gains NMPA Nod for First-Line TNBC 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=2794","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-06-27T01:51:18+00:00","article_modified_time":"2024-10-16T15:43:13+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=2794#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=2794"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment","datePublished":"2024-06-27T01:51:18+00:00","dateModified":"2024-10-16T15:43:13+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=2794"},"wordCount":241,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Cancer","HKG: 1877","Junshi Biosciences","PD-1\/L1","Product approvals","SHA: 688180"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=2794#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=2794","url":"https:\/\/flcube.com\/?p=2794","name":"Shanghai Junshi Biosciences' Toripalimab Gains NMPA Nod for First-Line TNBC Treatment - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2024-06-27T01:51:18+00:00","dateModified":"2024-10-16T15:43:13+00:00","description":"Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China's National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment of recurrent or metastatic triple negative breast cancer (TNBC) with positive PD-L1 (CPS \u2265 1) as determined by fully validated tests.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=2794#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=2794"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=2794#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC 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\/2794","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=2794"}],"version-history":[{"count":2,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/2794\/revisions"}],"predecessor-version":[{"id":7225,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/2794\/revisions\/7225"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}