{"id":18973,"date":"2023-05-09T00:46:00","date_gmt":"2023-05-08T16:46:00","guid":{"rendered":"https:\/\/flcube.com\/?p=18973"},"modified":"2024-12-20T00:50:26","modified_gmt":"2024-12-19T16:50:26","slug":"us-fda-nears-regulatory-decision-on-junshi-biosciences-pd-1-inhibitor-tuoyi","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=18973","title":{"rendered":"US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi"},"content":{"rendered":"\n

China-based Junshi Biosciences Co., Ltd (HKG: 1877<\/a>, SHA: 688180<\/a>) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company’s co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS<\/a>), has disclosed in its Q1 2023 financial report that the FDA plans to conduct the required inspection of the toripalimab manufacturing facility in China in May 2023.<\/p>\n\n\n\n

Historical Context and Recent Developments<\/strong>
Junshi\u2019s toripalimab was the first domestically developed PD-1 inhibitor to gain approval in China in December 2018 and initiated the approval filing process in the US with a rolling Biologics License Application (BLA) submission in March 2021. The drug was filed for the first indication of recurrent or metastatic nasopharyngeal carcinoma (NPC) but encountered a setback in July 2022 when the FDA issued a complete response letter (CRL) requesting a change in the manufacturing process. The BLA was refiled but faced further delay in December 2022 due to COVID-related disruptions that prevented the FDA from inspecting Junshi\u2019s manufacturing plant for toripalimab.<\/p>\n\n\n\n

NPC as a Rare Disease and Potential for FDA Approval<\/strong>
NPC is classified as a rare disease in the US, which could influence the FDA to consider China-derived clinical trial data in support of an approval filing, a distinction from other China-sourced PD-1 inhibitors such as Innovent Biologics\/Eli Lilly\u2019s sintilimab. The US FDA has granted orphan drug designation (ODD) to toripalimab for five indications, including NPC, mucosal melanoma, soft tissue sarcoma, esophageal cancer, and small-cell lung cancer.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone…<\/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":[16,613,899,296,18,24,900],"class_list":["post-18973","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-coherus-biosciences","tag-hkg-1877","tag-junshi-biosciences","tag-pd-1-l1","tag-rare-orphan-disease-drugs","tag-sha-688180"],"yoast_head":"\nUS FDA Nears Regulatory Decision on Junshi Biosciences' PD-1 Inhibitor Tuoyi - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company's co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has disclosed in its Q1 2023 financial report that the FDA plans to conduct the required inspection of the toripalimab manufacturing facility in China in May 2023.\" \/>\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=18973\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Nears Regulatory Decision on Junshi Biosciences' PD-1 Inhibitor Tuoyi\" \/>\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=18973\" \/>\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=\"2023-05-08T16:46:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-12-19T16:50:26+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=18973#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18973\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi\",\"datePublished\":\"2023-05-08T16:46:00+00:00\",\"dateModified\":\"2024-12-19T16:50:26+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18973\"},\"wordCount\":271,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Cancer\",\"Coherus Biosciences\",\"HKG: 1877\",\"Junshi Biosciences\",\"PD-1\\\/L1\",\"Rare \\\/ orphan disease drugs\",\"SHA: 688180\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=18973#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18973\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=18973\",\"name\":\"US FDA Nears Regulatory Decision on Junshi Biosciences' PD-1 Inhibitor Tuoyi - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-05-08T16:46:00+00:00\",\"dateModified\":\"2024-12-19T16:50:26+00:00\",\"description\":\"China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company's co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has disclosed in its Q1 2023 financial report that the FDA plans to conduct the required inspection of the toripalimab manufacturing facility in China in May 2023.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18973#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=18973\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=18973#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi\"}]},{\"@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":"US FDA Nears Regulatory Decision on Junshi Biosciences' PD-1 Inhibitor Tuoyi - Insight, China's Pharmaceutical Industry","description":"China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company's co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has disclosed in its Q1 2023 financial report that the FDA plans to conduct the required inspection of the toripalimab manufacturing facility in China in May 2023.","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=18973","og_locale":"en_US","og_type":"article","og_title":"US FDA Nears Regulatory Decision on Junshi Biosciences' PD-1 Inhibitor Tuoyi","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=18973","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-05-08T16:46:00+00:00","article_modified_time":"2024-12-19T16:50:26+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=18973#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=18973"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi","datePublished":"2023-05-08T16:46:00+00:00","dateModified":"2024-12-19T16:50:26+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=18973"},"wordCount":271,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Cancer","Coherus Biosciences","HKG: 1877","Junshi Biosciences","PD-1\/L1","Rare \/ orphan disease drugs","SHA: 688180"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=18973#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=18973","url":"https:\/\/flcube.com\/?p=18973","name":"US FDA Nears Regulatory Decision on Junshi Biosciences' PD-1 Inhibitor Tuoyi - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-05-08T16:46:00+00:00","dateModified":"2024-12-19T16:50:26+00:00","description":"China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company's co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has disclosed in its Q1 2023 financial report that the FDA plans to conduct the required inspection of the toripalimab manufacturing facility in China in May 2023.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=18973#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=18973"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=18973#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi"}]},{"@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\/18973","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=18973"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/18973\/revisions"}],"predecessor-version":[{"id":18974,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/18973\/revisions\/18974"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=18973"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18973"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18973"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}