{"id":14718,"date":"2023-08-24T22:14:00","date_gmt":"2023-08-24T14:14:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14718"},"modified":"2024-11-24T22:17:35","modified_gmt":"2024-11-24T14:17:35","slug":"nanjing-fs-pharmatech-secures-first-generic-approval-for-novartiss-entresto-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14718","title":{"rendered":"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto in China"},"content":{"rendered":"\n

Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Novartis\u2019s (NYSE: NVS<\/a>) heart failure therapy, Entresto (sacubitril, valsartan). This marks a significant milestone as Nanjing F&S’s version, an in-house developed crystal form of the molecule, has passed China’s bioequivalence (BE) clinical testing. The approval is notable as it is the first generic to be approved in China and the first to successfully challenge Entresto globally.<\/p>\n\n\n\n

Entresto’s Market Impact and Sales in China<\/strong>
Entresto, recognized as a breakthrough therapy for chronic heart failure, was first approved in China in 2017 and later for primary hypertension in June 2021. The drug has been a significant revenue generator, with close to RMB 3 billion (USD 415 million) in sales in China last year.<\/p>\n\n\n\n

Patent Landscape and Generic Market Entry<\/strong>
The Orange Book lists six patents related to the drug registered in China, all focusing on “Pharmaceutical composition containing valsartan and NEP inhibitor” (Patent No.: ZL201110029600.7). Despite one of these patents being declared invalid in April 2017, and this decision being reconfirmed by the China National Intellectual Property Administration (CNIPA) in 2018 and by the People’s Court in 2019, it was not sufficient to pave the way for generic market entry. In 2021, CNIPA confirmed that the drug’s core patent remained valid, with the 20-year patent protection period for both of Entresto’s core patents set to expire on November 8, 2026. The approval of F&S Pharma\u2019s generic version is a game-changer, allowing Chinese patients with heart failure and hypertension to access a high-quality copy drug three years ahead of the patent expiration.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, 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":[69,1409,42,108,865,15],"class_list":["post-14718","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cvd","tag-fs-pharmatech","tag-first-mover-generic","tag-high-blood-pressure","tag-nyse-nvs","tag-product-approvals"],"yoast_head":"\nNanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto in China - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Novartis\u2019s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan). This marks a significant milestone as Nanjing F&S's version, an in-house developed crystal form of the molecule, has passed China's bioequivalence (BE) clinical testing. The approval is notable as it is the first generic to be approved in China and the first to successfully challenge Entresto globally.\" \/>\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=14718\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto 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=14718\" \/>\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=\"2023-08-24T14:14:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-24T14:17:35+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=14718#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14718\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto in China\",\"datePublished\":\"2023-08-24T14:14:00+00:00\",\"dateModified\":\"2024-11-24T14:17:35+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14718\"},\"wordCount\":301,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"CVD\",\"F&S Pharmatech\",\"First-mover generic\",\"High blood pressure\",\"NYSE: NVS\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=14718#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14718\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=14718\",\"name\":\"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto in China - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-08-24T14:14:00+00:00\",\"dateModified\":\"2024-11-24T14:17:35+00:00\",\"description\":\"Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Novartis\u2019s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan). This marks a significant milestone as Nanjing F&S's version, an in-house developed crystal form of the molecule, has passed China's bioequivalence (BE) clinical testing. The approval is notable as it is the first generic to be approved in China and the first to successfully challenge Entresto globally.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14718#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=14718\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14718#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto 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":"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto in China - Insight, China's Pharmaceutical Industry","description":"Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Novartis\u2019s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan). This marks a significant milestone as Nanjing F&S's version, an in-house developed crystal form of the molecule, has passed China's bioequivalence (BE) clinical testing. The approval is notable as it is the first generic to be approved in China and the first to successfully challenge Entresto globally.","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=14718","og_locale":"en_US","og_type":"article","og_title":"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto 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=14718","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-08-24T14:14:00+00:00","article_modified_time":"2024-11-24T14:17:35+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=14718#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=14718"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto in China","datePublished":"2023-08-24T14:14:00+00:00","dateModified":"2024-11-24T14:17:35+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=14718"},"wordCount":301,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["CVD","F&S Pharmatech","First-mover generic","High blood pressure","NYSE: NVS","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=14718#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=14718","url":"https:\/\/flcube.com\/?p=14718","name":"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto in China - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-08-24T14:14:00+00:00","dateModified":"2024-11-24T14:17:35+00:00","description":"Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Novartis\u2019s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan). This marks a significant milestone as Nanjing F&S's version, an in-house developed crystal form of the molecule, has passed China's bioequivalence (BE) clinical testing. The approval is notable as it is the first generic to be approved in China and the first to successfully challenge Entresto globally.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=14718#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=14718"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=14718#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Nanjing F&S Pharmatech Secures First Generic Approval for Novartis\u2019s Entresto 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\/14718","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=14718"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14718\/revisions"}],"predecessor-version":[{"id":14719,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14718\/revisions\/14719"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14718"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14718"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14718"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}