{"id":65211,"date":"2026-05-13T22:49:38","date_gmt":"2026-05-13T14:49:38","guid":{"rendered":"https:\/\/flcube.com\/?p=65211"},"modified":"2026-05-13T22:49:39","modified_gmt":"2026-05-13T14:49:39","slug":"immuneonco-receives-nmpa-approval-for-imm0306-clinical-study-in-primary-sjogrens-syndrome-expanding-dual-target-bispecific-platform","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=65211","title":{"rendered":"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren&#8217;s Syndrome, Expanding Dual-Target Bispecific Platform"},"content":{"rendered":"\n<p><strong>ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1541:HKG\">HKG: 1541<\/a>) announced it has received <strong>clinical approval from China&#8217;s National Medical Products Administration (NMPA)<\/strong> for its <strong>dual-target macromolecular drug amulirafusp alfa (IMM0306)<\/strong> to proceed with clinical evaluation in <strong>primary Sj\u00f6gren&#8217;s syndrome (pSS)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-amp-regulatory-milestone\">Development &amp; Regulatory Milestone<\/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>Company<\/strong><\/td><td>ImmuneOnco Biopharmaceuticals (HKG: 1541)<\/td><\/tr><tr><td><strong>Drug Candidate<\/strong><\/td><td>Amulirafusp alfa (IMM0306)<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>CD47\u00d7CD20 bispecific molecule<\/td><\/tr><tr><td><strong>Innovation Status<\/strong><\/td><td>World&#8217;s first CD47\u00d7CD20 bispecific in clinical development<\/td><\/tr><tr><td><strong>Technology Platform<\/strong><\/td><td>Proprietary &#8220;mAb-Trap&#8221; technology<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>Primary Sj\u00f6gren&#8217;s syndrome (pSS)<\/td><\/tr><tr><td><strong>Regulatory Authority<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Clinical study authorization<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-disease-profile-amp-unmet-need\">Disease Profile &amp; Unmet Need<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-primary-sjogren-s-syndrome-pss\">Primary Sj\u00f6gren&#8217;s Syndrome (pSS)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Disease characterization<\/strong>: Chronic, systemic autoimmune disorder predominantly featuring <strong>lymphocytic infiltration of exocrine glands<\/strong><\/li>\n\n\n\n<li><strong>Patient impact<\/strong>: Severely compromises quality of life through dry eyes, dry mouth, fatigue, and systemic complications<\/li>\n\n\n\n<li><strong>Treatment gap<\/strong>: Limited therapeutic options with no disease-modifying treatments currently approved<\/li>\n\n\n\n<li><strong>Market opportunity<\/strong>: Estimated <strong>4 million patients globally<\/strong>, with significant prevalence in Asia-Pacific region<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-innovation\">Drug Profile &amp; Mechanism Innovation<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-proprietary-mab-trap-technology\">Proprietary &#8220;mAb-Trap&#8221; Technology<\/h3>\n\n\n\n<p>IMM0306 represents a <strong>first-in-class bispecific approach<\/strong> leveraging ImmuneOnco&#8217;s proprietary platform:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Target<\/th><th>Function<\/th><th>Therapeutic Rationale<\/th><\/tr><\/thead><tbody><tr><td><strong>CD47<\/strong><\/td><td>&#8220;Don&#8217;t eat me&#8221; signal on immune cells<\/td><td>Blockade enhances phagocytosis of pathogenic B-cells<\/td><\/tr><tr><td><strong>CD20<\/strong><\/td><td>B-cell surface marker<\/td><td>Direct targeting of autoreactive B-cell populations<\/td><\/tr><tr><td><strong>Bispecific design<\/strong><\/td><td>Simultaneous dual targeting<\/td><td>Enhanced specificity and reduced off-target effects compared to monospecific approaches<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-clinical-validation-foundation\">Clinical Validation Foundation<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>SLE Phase Ib\/II data<\/strong>: Demonstrated <strong>favorable safety profile<\/strong> and <strong>strong therapeutic potential<\/strong> in systemic lupus erythematosus<\/li>\n\n\n\n<li><strong>IgG4-RD evaluation<\/strong>: Currently being assessed in IgG4-related disease, validating platform across multiple autoimmune conditions<\/li>\n\n\n\n<li><strong>Mechanistic rationale<\/strong>: Dual targeting addresses both B-cell depletion and immune checkpoint modulation simultaneously<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-expanded-clinical-development-strategy\">Expanded Clinical Development Strategy<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-multi-indication-platform-approach\">Multi-Indication Platform Approach<\/h3>\n\n\n\n<p>The pSS approval extends IMM0306&#8217;s clinical program across <strong>three distinct autoimmune diseases<\/strong>:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Indication<\/th><th>Development Stage<\/th><th>Strategic Rationale<\/th><\/tr><\/thead><tbody><tr><td><strong>Systemic Lupus Erythematosus (SLE)<\/strong><\/td><td>Phase Ib\/II completed<\/td><td>Proof-of-concept for bispecific mechanism in systemic autoimmunity<\/td><\/tr><tr><td><strong>IgG4-Related Disease (IgG4-RD)<\/strong><\/td><td>Ongoing studies<\/td><td>Validation in fibroinflammatory condition<\/td><\/tr><tr><td><strong>Primary Sj\u00f6gren&#8217;s Syndrome (pSS)<\/strong><\/td><td>Newly approved<\/td><td>Addressing high-unmet-need exocrine gland autoimmune disorder<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-competitive-differentiation\">Competitive Differentiation<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First-mover advantage<\/strong>: World&#8217;s first CD47\u00d7CD20 bispecific provides significant intellectual property protection<\/li>\n\n\n\n<li><strong>Safety optimization<\/strong>: Bispecific design potentially reduces CD47-related hematological toxicity seen with monospecific CD47 inhibitors<\/li>\n\n\n\n<li><strong>Platform validation<\/strong>: Success across multiple indications would validate &#8220;mAb-Trap&#8221; technology for broader application<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications-amp-market-context\">Strategic Implications &amp; Market Context<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-for-immuneonco\">For ImmuneOnco<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pipeline diversification<\/strong>: Expands beyond oncology into high-value autoimmune therapeutic area<\/li>\n\n\n\n<li><strong>Platform validation<\/strong>: Multiple indication success would demonstrate broad applicability of proprietary technology<\/li>\n\n\n\n<li><strong>Global potential<\/strong>: First-in-class status positions for international partnerships and regulatory submissions<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-autoimmune-disease-landscape\">Autoimmune Disease Landscape<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>B-cell targeting evolution<\/strong>: Next-generation approaches moving beyond simple B-cell depletion to precision immune modulation<\/li>\n\n\n\n<li><strong>Combination potential<\/strong>: Bispecific mechanism may enable monotherapy efficacy where combination regimens currently required<\/li>\n\n\n\n<li><strong>Chinese innovation leadership<\/strong>: Represents China&#8217;s growing capability in complex biologic development for global markets<\/li>\n<\/ul>\n\n\n\n<p>The pSS clinical approval positions IMM0306 as a <strong>transformative therapeutic candidate<\/strong> for a disease with significant unmet medical need, while validating ImmuneOnco&#8217;s innovative bispecific platform across multiple autoimmune conditions.<\/p>\n\n\n\n<p><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory pathways, and therapeutic potential for IMM0306. Actual results may differ due to risks including clinical trial outcomes, safety profile, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China&#8217;s&#8230;<\/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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[65,62,1028,229],"class_list":["post-65211","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-clinical-trial-approval-initiation","tag-hkg-1541","tag-immuneonco-biopharmaceuticals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren&#039;s Syndrome, Expanding Dual-Target Bispecific Platform - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China&#039;s National Medical Products Administration (NMPA) for its dual-target macromolecular drug amulirafusp alfa (IMM0306) to proceed with clinical evaluation in primary Sj\u00f6gren&#039;s syndrome (pSS).\" \/>\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=65211\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren&#039;s Syndrome, Expanding Dual-Target Bispecific Platform\" \/>\n<meta property=\"og:description\" content=\"ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China&#039;s National Medical Products Administration (NMPA) for its dual-target macromolecular drug amulirafusp alfa (IMM0306) to proceed with clinical evaluation in primary Sj\u00f6gren&#039;s syndrome (pSS).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=65211\" \/>\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=\"2026-05-13T14:49:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-13T14:49:39+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: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=65211#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=65211\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren&#8217;s Syndrome, Expanding Dual-Target Bispecific Platform\",\"datePublished\":\"2026-05-13T14:49:38+00:00\",\"dateModified\":\"2026-05-13T14:49:39+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=65211\"},\"wordCount\":547,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Auto-immune\",\"Clinical trial approval \\\/ initiation\",\"HKG: 1541\",\"ImmuneOnco Biopharmaceuticals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=65211#respond\"]}],\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=65211\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=65211\",\"name\":\"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren's Syndrome, Expanding Dual-Target Bispecific Platform - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2026-05-13T14:49:38+00:00\",\"dateModified\":\"2026-05-13T14:49:39+00:00\",\"description\":\"ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China's National Medical Products Administration (NMPA) for its dual-target macromolecular drug amulirafusp alfa (IMM0306) to proceed with clinical evaluation in primary Sj\u00f6gren's syndrome (pSS).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=65211#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=65211\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=65211#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren&#8217;s Syndrome, Expanding Dual-Target Bispecific Platform\"}]},{\"@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":"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren's Syndrome, Expanding Dual-Target Bispecific Platform - Insight, China&#039;s Pharmaceutical Industry","description":"ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China's National Medical Products Administration (NMPA) for its dual-target macromolecular drug amulirafusp alfa (IMM0306) to proceed with clinical evaluation in primary Sj\u00f6gren's syndrome (pSS).","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=65211","og_locale":"en_US","og_type":"article","og_title":"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren's Syndrome, Expanding Dual-Target Bispecific Platform","og_description":"ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China's National Medical Products Administration (NMPA) for its dual-target macromolecular drug amulirafusp alfa (IMM0306) to proceed with clinical evaluation in primary Sj\u00f6gren's syndrome (pSS).","og_url":"https:\/\/flcube.com\/?p=65211","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-05-13T14:49:38+00:00","article_modified_time":"2026-05-13T14:49:39+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_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=65211#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=65211"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren&#8217;s Syndrome, Expanding Dual-Target Bispecific Platform","datePublished":"2026-05-13T14:49:38+00:00","dateModified":"2026-05-13T14:49:39+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=65211"},"wordCount":547,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Auto-immune","Clinical trial approval \/ initiation","HKG: 1541","ImmuneOnco Biopharmaceuticals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=65211#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=65211","url":"https:\/\/flcube.com\/?p=65211","name":"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren's Syndrome, Expanding Dual-Target Bispecific Platform - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2026-05-13T14:49:38+00:00","dateModified":"2026-05-13T14:49:39+00:00","description":"ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China's National Medical Products Administration (NMPA) for its dual-target macromolecular drug amulirafusp alfa (IMM0306) to proceed with clinical evaluation in primary Sj\u00f6gren's syndrome (pSS).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=65211#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=65211"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=65211#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sj\u00f6gren&#8217;s Syndrome, Expanding Dual-Target Bispecific Platform"}]},{"@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\/65211","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=65211"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/65211\/revisions"}],"predecessor-version":[{"id":65212,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/65211\/revisions\/65212"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=65211"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=65211"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=65211"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}