{"id":13669,"date":"2023-09-20T01:19:00","date_gmt":"2023-09-19T17:19:00","guid":{"rendered":"https:\/\/flcube.com\/?p=13669"},"modified":"2025-01-06T18:16:04","modified_gmt":"2025-01-06T10:16:04","slug":"beigene-regains-full-rights-to-tislelizumab-after-terminating-novartis-deal","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13669","title":{"rendered":"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal"},"content":{"rendered":"\n

China-based biotech company BeiGene (NASDAQ: BGNE<\/a>) has reached a mutual agreement with Novartis (NYSE: NVS<\/a>) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene now resumes full control of global development, manufacturing, and commercialization of tislelizumab, with no further financial obligations to Novartis. Novartis will provide transitional services and support, while BeiGene will supply the drug for ongoing clinical studies.<\/p>\n\n\n\n

Details of the Agreement and Financial Terms<\/strong>
The original 2021 deal between Novartis and BeiGene included an upfront fee of USD 650 million and potential milestone payments of up to USD 1.55 billion. The termination does not specify reasons for the decision, marking the end of Novartis’s recent collaboration with BeiGene. This follows another deal termination in July, where Novartis backed out of a development agreement for the TIGIT-targeted drug candidate ociperlimab, which involved a USD 300 million upfront payment. Consequently, BeiGene has received nearly USD 1 billion from Novartis with no return.<\/p>\n\n\n\n

Positive Regulatory Progress for Tislelizumab<\/strong>
Despite the agreement termination, there is positive regulatory news for tislelizumab. BeiGene announced that the European Commission has approved tislelizumab as a monotherapy for treating unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) in patients previously treated with platinum-based chemotherapy. Additionally, the US FDA has accepted a market approval filing for tislelizumab as a first-line treatment for irresectable locally advanced, recurrent, or metastatic ESCC, with a decision expected in H2 2024.<\/p>\n\n\n\n

Tislelizumab’s Global Clinical and Regulatory Landscape<\/strong>
Tislelizumab is the subject of 21 regulatory clinical studies across over 30 countries and has received 11 indication approvals in China. Ten Phase III pivotal studies have shown positive results, covering a range of cancers including non-small cell lung cancer, gastric cancer, ESCC, hepatocellular carcinoma, nasopharyngeal carcinoma, and others.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS)…<\/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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[185,2092,846,3046,140,865,18],"class_list":["post-13669","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-beigene","tag-beone-medicines","tag-nasdaq-bgne","tag-nasdaq-onc","tag-novartis","tag-nyse-nvs","tag-pd-1-l1"],"yoast_head":"\nBeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene now resumes full control of global development, manufacturing, and commercialization of tislelizumab, with no further financial obligations to Novartis. Novartis will provide transitional services and support, while BeiGene will supply the drug for ongoing clinical studies.\" \/>\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=13669\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal\" \/>\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=13669\" \/>\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=\"2023-09-19T17:19:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-06T10:16:04+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=13669#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13669\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal\",\"datePublished\":\"2023-09-19T17:19:00+00:00\",\"dateModified\":\"2025-01-06T10:16:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13669\"},\"wordCount\":318,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"BeiGene\",\"BeOne Medicines\",\"NASDAQ: BGNE\",\"NASDAQ: ONC\",\"Novartis\",\"NYSE: NVS\",\"PD-1\\\/L1\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=13669#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13669\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=13669\",\"name\":\"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-09-19T17:19:00+00:00\",\"dateModified\":\"2025-01-06T10:16:04+00:00\",\"description\":\"China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene now resumes full control of global development, manufacturing, and commercialization of tislelizumab, with no further financial obligations to Novartis. Novartis will provide transitional services and support, while BeiGene will supply the drug for ongoing clinical studies.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13669#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=13669\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=13669#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal\"}]},{\"@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":"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal - Insight, China's Pharmaceutical Industry","description":"China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene now resumes full control of global development, manufacturing, and commercialization of tislelizumab, with no further financial obligations to Novartis. Novartis will provide transitional services and support, while BeiGene will supply the drug for ongoing clinical studies.","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=13669","og_locale":"en_US","og_type":"article","og_title":"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal","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=13669","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-09-19T17:19:00+00:00","article_modified_time":"2025-01-06T10:16:04+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=13669#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=13669"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal","datePublished":"2023-09-19T17:19:00+00:00","dateModified":"2025-01-06T10:16:04+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=13669"},"wordCount":318,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["BeiGene","BeOne Medicines","NASDAQ: BGNE","NASDAQ: ONC","Novartis","NYSE: NVS","PD-1\/L1"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=13669#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=13669","url":"https:\/\/flcube.com\/?p=13669","name":"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-09-19T17:19:00+00:00","dateModified":"2025-01-06T10:16:04+00:00","description":"China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene now resumes full control of global development, manufacturing, and commercialization of tislelizumab, with no further financial obligations to Novartis. Novartis will provide transitional services and support, while BeiGene will supply the drug for ongoing clinical studies.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=13669#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=13669"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=13669#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal"}]},{"@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\/13669","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=13669"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/13669\/revisions"}],"predecessor-version":[{"id":13670,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/13669\/revisions\/13670"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=13669"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=13669"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=13669"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}