{"id":12777,"date":"2023-10-18T23:43:00","date_gmt":"2023-10-18T15:43:00","guid":{"rendered":"https:\/\/flcube.com\/?p=12777"},"modified":"2024-11-14T23:47:34","modified_gmt":"2024-11-14T15:47:34","slug":"zhejiang-huahai-pharmaceutical-secures-orphan-drug-designation-for-hb0034","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12777","title":{"rendered":"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034"},"content":{"rendered":"\n

China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521<\/a>) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug’s potential as a treatment for generalized pustular psoriasis (GPP).<\/p>\n\n\n\n

Mechanism of Action and Broader Implications<\/strong><\/p>\n\n\n\n

HB0034 is designed to specifically bind to the IL-36 receptor, effectively blocking IL-36 inflammatory pathway signals. This action leads to a reduction in the release of inflammatory factors that are responsible for various inflammatory diseases and skin disorders, including generalized pustular psoriasis, inflammatory bowel disease, systemic lupus erythematosus, and fibrosis.<\/p>\n\n\n\n

Competitive Landscape<\/strong><\/p>\n\n\n\n

The approval of HB0034 comes at a time when similar products are making strides in the market. Boehringer Ingelheim’s BI655130 (spesolimab) received marketing approval in both the US and China last year. Additionally, AnaptysBio’s ANB019 (imsidolimab) is currently in the Phase III clinical trial stage, indicating a competitive landscape for treatments targeting IL-36R.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan…<\/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":[65,775,24,1381],"class_list":["post-12777","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-huahai-pharmaceutical","tag-rare-orphan-disease-drugs","tag-sha-600521"],"yoast_head":"\nZhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034 - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug's potential as a treatment for generalized pustular psoriasis (GPP).\" \/>\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=12777\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034\" \/>\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=12777\" \/>\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=\"2023-10-18T15:43:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-14T15:47:34+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=12777#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12777\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034\",\"datePublished\":\"2023-10-18T15:43:00+00:00\",\"dateModified\":\"2024-11-14T15:47:34+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12777\"},\"wordCount\":171,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Auto-immune\",\"Huahai Pharmaceutical\",\"Rare \\\/ orphan disease drugs\",\"SHA: 600521\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=12777#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12777\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=12777\",\"name\":\"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034 - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-10-18T15:43:00+00:00\",\"dateModified\":\"2024-11-14T15:47:34+00:00\",\"description\":\"China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug's potential as a treatment for generalized pustular psoriasis (GPP).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12777#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=12777\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=12777#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034\"}]},{\"@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":"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034 - Insight, China's Pharmaceutical Industry","description":"China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug's potential as a treatment for generalized pustular psoriasis (GPP).","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=12777","og_locale":"en_US","og_type":"article","og_title":"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034","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=12777","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-10-18T15:43:00+00:00","article_modified_time":"2024-11-14T15:47:34+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=12777#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=12777"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034","datePublished":"2023-10-18T15:43:00+00:00","dateModified":"2024-11-14T15:47:34+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=12777"},"wordCount":171,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Auto-immune","Huahai Pharmaceutical","Rare \/ orphan disease drugs","SHA: 600521"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=12777#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=12777","url":"https:\/\/flcube.com\/?p=12777","name":"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034 - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-10-18T15:43:00+00:00","dateModified":"2024-11-14T15:47:34+00:00","description":"China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug's potential as a treatment for generalized pustular psoriasis (GPP).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=12777#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=12777"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=12777#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034"}]},{"@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\/12777","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=12777"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/12777\/revisions"}],"predecessor-version":[{"id":12778,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/12777\/revisions\/12778"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=12777"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=12777"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=12777"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}