{"id":54066,"date":"2026-01-14T13:55:05","date_gmt":"2026-01-14T05:55:05","guid":{"rendered":"https:\/\/flcube.com\/?p=54066"},"modified":"2026-01-14T13:55:06","modified_gmt":"2026-01-14T05:55:06","slug":"haichang-biotechs-hc016-receives-fda-orphan-drug-designation-for-osteosarcoma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54066","title":{"rendered":"Haichang Biotech&#8217;s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma"},"content":{"rendered":"\n<p><strong>Haichang Biotech<\/strong>  announced that the <strong>U.S. Food and Drug Administration (FDA)<\/strong> has granted <strong>Orphan Drug Designation (ODD)<\/strong> for <strong>HC016 Lipid Complex Injection<\/strong>, an innovative immuno\u2011oncology product, for the treatment of <strong>osteosarcoma<\/strong>. The company has initiated a <strong>Phase I clinical study<\/strong>, with the <strong>first patient already enrolled<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>U.S. FDA<\/td><\/tr><tr><td><strong>Designation<\/strong><\/td><td>Orphan Drug Designation (ODD)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>HC016 Lipid Complex Injection<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Osteosarcoma<\/td><\/tr><tr><td><strong>Date of Designation<\/strong><\/td><td>January\u202f2026<\/td><\/tr><tr><td><strong>Clinical Status<\/strong><\/td><td>Phase I ongoing; first patient enrolled<\/td><\/tr><tr><td><strong>Next Milestone<\/strong><\/td><td>Topline safety data expected H2\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-technology\">Drug Profile &amp; Technology<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> <strong>Toll\u2011like receptor 9 (TLR9) agonist<\/strong> that activates innate and adaptive anti\u2011tumor immunity<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> Novel <strong>C\u2011type CpG oligodeoxynucleotide (CpG\u2011ODN)<\/strong> encapsulated in <strong>QTsome Lipid Nanoparticle (LNP)<\/strong> technology for optimized delivery and stability<\/li>\n\n\n\n<li><strong>Delivery:<\/strong> <strong>Intratumoral injection<\/strong> for direct tumor site targeting, minimizing systemic exposure<\/li>\n\n\n\n<li><strong>Competitive Edge:<\/strong> First TLR9 agonist leveraging <strong>C\u2011type CpG<\/strong> with LNP delivery for osteosarcoma; potential to overcome immunosuppressive tumor microenvironment<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-amp-evidence\">Clinical Development &amp; Evidence<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Trial Design<\/strong><\/td><td>Phase I, open\u2011label, dose\u2011escalation (n\u202f=\u202f~30)<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>Relapsed\/refractory osteosarcoma patients<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Safety &amp; tolerability; maximum tolerated dose (MTD)<\/td><\/tr><tr><td><strong>Secondary Endpoints<\/strong><\/td><td>Objective response rate (ORR), disease control rate (DCR), immune biomarkers<\/td><\/tr><tr><td><strong>Status<\/strong><\/td><td>First patient dosed December\u202f2025<\/td><\/tr><tr><td><strong>Initial Data<\/strong><\/td><td>Safety run\u2011in ongoing; preliminary PK\/PD expected Q3\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-strategic-outlook\">Market Opportunity &amp; Strategic Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2026E<\/th><th>2027E<\/th><th>2028E<\/th><\/tr><\/thead><tbody><tr><td><strong>U.S. Osteosarcoma Incidence<\/strong><\/td><td>900<\/td><td>920<\/td><td>940<\/td><\/tr><tr><td><strong>Relapsed\/Refractory Cases<\/strong><\/td><td>360<\/td><td>370<\/td><td>380<\/td><\/tr><tr><td><strong>HC016 Addressable Market<\/strong><\/td><td>360<\/td><td>370<\/td><td>380<\/td><\/tr><tr><td><strong>Market Penetration<\/strong><\/td><td>0\u202f%<\/td><td>5\u202f%<\/td><td>15\u202f%<\/td><\/tr><tr><td><strong>Estimated Annual Price (US)<\/strong><\/td><td>\u2013<\/td><td>$180,000<\/td><td>$175,000<\/td><\/tr><tr><td><strong>U.S. Revenue Forecast<\/strong><\/td><td>\u2013<\/td><td>$3.33\u202fmillion<\/td><td>$9.98\u202fmillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet Need:<\/strong> No approved immunotherapies for relapsed osteosarcoma; standard care is salvage chemotherapy with &lt;\u202f20\u202f% response rate<\/li>\n\n\n\n<li><strong>Orphan Drug Benefits:<\/strong> <strong>7\u2011year U.S. market exclusivity<\/strong>, <strong>tax credits<\/strong> on clinical costs, <strong>waved NDA filing fees<\/strong>, and <strong>priority review eligibility<\/strong><\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong><\/li>\n\n\n\n<li><strong>Y\u2011mAbs&#8217; omburtamab<\/strong> targets CNS metastases but not primary osteosarcoma<\/li>\n\n\n\n<li><strong>Lartruvo (olaratumab)<\/strong> withdrawal left a treatment gap in advanced sarcoma<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> HC016&#8217;s <strong>intratumoral TLR9 activation<\/strong> offers a novel mechanism vs. systemic TKIs or checkpoint inhibitors<\/li>\n\n\n\n<li><strong>Global Expansion:<\/strong> Haichang plans <strong>China NMPA ODD application<\/strong> in 2026, leveraging U.S. designation; EU filing anticipated 2027<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning\">Strategic Positioning<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Technology Validation:<\/strong> QTsome LNP platform demonstrated <strong>5\u00d7 higher tumor retention<\/strong> vs. free CpG in preclinical models; potential for <strong>pipeline expansion<\/strong> into other solid tumors (melanoma, HNSCC)<\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> GMP facility in Shanghai Zhangjiang; capacity to support <strong>10,000 doses\/year<\/strong> by 2027<\/li>\n\n\n\n<li><strong>Financial Runway:<\/strong> ODD and potential <strong>fast\u2011track designation<\/strong> increase attractiveness for <strong>Series B financing<\/strong>; company targeting <strong>$80\u202fmillion raise<\/strong> in Q2\u202f2026<\/li>\n\n\n\n<li><strong>Partnering Potential:<\/strong> Positive Phase I data could trigger <strong>global licensing deals<\/strong> valued at <strong>$300\u2011500\u202fmillion<\/strong> upfront<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><\/p>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding HC016 clinical development, regulatory pathway, and commercial potential. Actual results may differ due to safety\/tolerability profiles, competitive dynamics in immuno\u2011oncology, and FDA review timelines.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":54068,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,460],"class_list":["post-54066","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-haichang-biotech"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Haichang Biotech&#039;s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HC016 Lipid Complex Injection, an innovative immuno\u2011oncology product, for the treatment of osteosarcoma. The company has initiated a Phase I clinical study, with the first patient already enrolled.\" \/>\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=54066\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Haichang Biotech&#039;s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma\" \/>\n<meta property=\"og:description\" content=\"Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HC016 Lipid Complex Injection, an innovative immuno\u2011oncology product, for the treatment of osteosarcoma. The company has initiated a Phase I clinical study, with the first patient already enrolled.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=54066\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-01-14T05:55:05+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-14T05:55:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/1402.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter: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 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=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Haichang Biotech&#8217;s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma\",\"datePublished\":\"2026-01-14T05:55:05+00:00\",\"dateModified\":\"2026-01-14T05:55:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066\"},\"wordCount\":461,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/01\\\/1402.webp\",\"keywords\":[\"Cancer\",\"Haichang Biotech\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=54066#respond\"]}],\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=54066\",\"name\":\"Haichang Biotech's HC016 Receives FDA Orphan Drug Designation for Osteosarcoma - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/01\\\/1402.webp\",\"datePublished\":\"2026-01-14T05:55:05+00:00\",\"dateModified\":\"2026-01-14T05:55:06+00:00\",\"description\":\"Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HC016 Lipid Complex Injection, an innovative immuno\u2011oncology product, for the treatment of osteosarcoma. The company has initiated a Phase I clinical study, with the first patient already enrolled.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=54066\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/01\\\/1402.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/01\\\/1402.webp\",\"width\":1080,\"height\":608,\"caption\":\"Haichang Biotech's HC016 Receives FDA Orphan Drug Designation for Osteosarcoma\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=54066#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Haichang Biotech&#8217;s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma\"}]},{\"@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":"Haichang Biotech's HC016 Receives FDA Orphan Drug Designation for Osteosarcoma - Insight, China&#039;s Pharmaceutical Industry","description":"Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HC016 Lipid Complex Injection, an innovative immuno\u2011oncology product, for the treatment of osteosarcoma. The company has initiated a Phase I clinical study, with the first patient already enrolled.","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=54066","og_locale":"en_US","og_type":"article","og_title":"Haichang Biotech's HC016 Receives FDA Orphan Drug Designation for Osteosarcoma","og_description":"Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HC016 Lipid Complex Injection, an innovative immuno\u2011oncology product, for the treatment of osteosarcoma. The company has initiated a Phase I clinical study, with the first patient already enrolled.","og_url":"https:\/\/flcube.com\/?p=54066","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-01-14T05:55:05+00:00","article_modified_time":"2026-01-14T05:55:06+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/1402.webp","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_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","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=54066#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=54066"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Haichang Biotech&#8217;s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma","datePublished":"2026-01-14T05:55:05+00:00","dateModified":"2026-01-14T05:55:06+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=54066"},"wordCount":461,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=54066#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/1402.webp","keywords":["Cancer","Haichang Biotech"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=54066#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=54066","url":"https:\/\/flcube.com\/?p=54066","name":"Haichang Biotech's HC016 Receives FDA Orphan Drug Designation for Osteosarcoma - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=54066#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=54066#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/1402.webp","datePublished":"2026-01-14T05:55:05+00:00","dateModified":"2026-01-14T05:55:06+00:00","description":"Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HC016 Lipid Complex Injection, an innovative immuno\u2011oncology product, for the treatment of osteosarcoma. The company has initiated a Phase I clinical study, with the first patient already enrolled.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=54066#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=54066"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=54066#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/1402.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/1402.webp","width":1080,"height":608,"caption":"Haichang Biotech's HC016 Receives FDA Orphan Drug Designation for Osteosarcoma"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=54066#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Haichang Biotech&#8217;s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma"}]},{"@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":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/1402.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/54066","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=54066"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/54066\/revisions"}],"predecessor-version":[{"id":54069,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/54066\/revisions\/54069"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/54068"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=54066"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=54066"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=54066"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}