{"id":26982,"date":"2022-08-10T16:05:00","date_gmt":"2022-08-10T08:05:00","guid":{"rendered":"https:\/\/flcube.com\/?p=26982"},"modified":"2025-02-16T16:07:04","modified_gmt":"2025-02-16T08:07:04","slug":"nmpa-accepts-roches-crovalimab-filing-for-pnh-treatment-with-priority-review","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=26982","title":{"rendered":"NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review"},"content":{"rendered":"\n

The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted by Swiss pharmaceutical giant Roche for its paroxysmal nocturnal hemoglobinuria (PNH) drug, crovalimab, granting it priority review status. <\/p>\n\n\n\n

About PNH<\/strong>
PNH is a rare and fatal blood system disease with an incidence of approximately 1 to 10 cases per million population, primarily affecting young adults. Around 77% of patients are aged between 20 and 40. Symptoms include fatigue, anemia, bone marrow failure, hemoglobinuria, and thrombosis. Without treatment, PNH patients face a 35% risk of death within five years. Currently, classical PNH is treated with blood transfusion and symptomatic treatment in China, with no effective therapy targeting the root cause.<\/p>\n\n\n\n

Crovalimab Overview<\/strong>
Crovalimab (RG6107) is a monoclonal antibody (mAb) targeting complement inhibitor C5, designed to block the complement system in the human immune system. Developed in-house using continuous monoclonal antibody recovery technology (Smart-Ig) engineering transformation, the drug can block the cleavage of complement C5 into C5a and C5b, inhibiting complement activation. In July of this year, crovalimab was granted priority review status for falling into categories including urgently needed drugs in short supply, innovative drugs, and modified drugs for the prevention and treatment of major infectious diseases and rare diseases; drugs included in the breakthrough therapy program; and drugs that meet conditions for approval.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted…<\/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":[38,24,163],"class_list":["post-26982","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-market-approval-filings","tag-rare-orphan-disease-drugs","tag-roche"],"yoast_head":"\nNMPA Accepts Roche's Crovalimab Filing for PNH Treatment with Priority Review - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted by Swiss pharmaceutical giant Roche for its paroxysmal nocturnal hemoglobinuria (PNH) drug, crovalimab, granting it priority review status.\" \/>\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=26982\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NMPA Accepts Roche's Crovalimab Filing for PNH Treatment with Priority Review\" \/>\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=26982\" \/>\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=\"2022-08-10T08:05:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-16T08:07:04+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=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26982#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26982\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review\",\"datePublished\":\"2022-08-10T08:05:00+00:00\",\"dateModified\":\"2025-02-16T08:07:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26982\"},\"wordCount\":230,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Market approval filings\",\"Rare \\\/ orphan disease drugs\",\"Roche\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=26982#respond\"]}],\"copyrightYear\":\"2022\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26982\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=26982\",\"name\":\"NMPA Accepts Roche's Crovalimab Filing for PNH Treatment with Priority Review - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2022-08-10T08:05:00+00:00\",\"dateModified\":\"2025-02-16T08:07:04+00:00\",\"description\":\"The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted by Swiss pharmaceutical giant Roche for its paroxysmal nocturnal hemoglobinuria (PNH) drug, crovalimab, granting it priority review status.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26982#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=26982\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26982#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review\"}]},{\"@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":"NMPA Accepts Roche's Crovalimab Filing for PNH Treatment with Priority Review - Insight, China's Pharmaceutical Industry","description":"The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted by Swiss pharmaceutical giant Roche for its paroxysmal nocturnal hemoglobinuria (PNH) drug, crovalimab, granting it priority review status.","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=26982","og_locale":"en_US","og_type":"article","og_title":"NMPA Accepts Roche's Crovalimab Filing for PNH Treatment with Priority Review","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=26982","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2022-08-10T08:05:00+00:00","article_modified_time":"2025-02-16T08:07:04+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":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=26982#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=26982"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review","datePublished":"2022-08-10T08:05:00+00:00","dateModified":"2025-02-16T08:07:04+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=26982"},"wordCount":230,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Market approval filings","Rare \/ orphan disease drugs","Roche"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=26982#respond"]}],"copyrightYear":"2022","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=26982","url":"https:\/\/flcube.com\/?p=26982","name":"NMPA Accepts Roche's Crovalimab Filing for PNH Treatment with Priority Review - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2022-08-10T08:05:00+00:00","dateModified":"2025-02-16T08:07:04+00:00","description":"The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted by Swiss pharmaceutical giant Roche for its paroxysmal nocturnal hemoglobinuria (PNH) drug, crovalimab, granting it priority review status.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=26982#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=26982"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=26982#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review"}]},{"@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\/26982","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=26982"}],"version-history":[{"count":2,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/26982\/revisions"}],"predecessor-version":[{"id":26984,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/26982\/revisions\/26984"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26982"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26982"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26982"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}