{"id":70519,"date":"2026-07-23T22:08:40","date_gmt":"2026-07-23T14:08:40","guid":{"rendered":"https:\/\/flcube.com\/?p=70519"},"modified":"2026-07-23T22:08:41","modified_gmt":"2026-07-23T14:08:41","slug":"sino-biopharmaceutical-subsidiary-secures-nmpa-approval-for-im-101-therapeutic-vaccine-in-chronic-hepatitis-b","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=70519","title":{"rendered":"Sino Biopharmaceutical Subsidiary Secures NMPA Approval for IM-101 Therapeutic Vaccine in Chronic Hepatitis B"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ)<\/strong>, a subsidiary of <strong>Sino Biopharmaceutical Limited<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/1177:HKG\">HKG: 1177<\/a>), announced that <strong>IM-101<\/strong>, a <strong>Class 1 innovative drug<\/strong>, has received <strong>clinical trial approval<\/strong> from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for the treatment of <strong>chronic hepatitis B (CHB)<\/strong>. The PreS1-targeted recombinant fusion protein represents a novel therapeutic vaccine approach designed to break immune tolerance and restore HBV-specific immune responses.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">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>Parent Company<\/strong><\/td><td>Sino Biopharmaceutical Limited (HKG: 1177)<\/td><\/tr><tr><td><strong>Operating Subsidiary<\/strong><\/td><td>Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ)<\/td><\/tr><tr><td><strong>Drug Designation<\/strong><\/td><td>IM-101 (Class 1 innovative drug)<\/td><\/tr><tr><td><strong>Regulatory Authority<\/strong><\/td><td>National Medical Products Administration (NMPA)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Clinical trial authorization<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Chronic hepatitis B (CHB)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<h3 id=\"h-molecular-characteristics\" class=\"wp-block-heading\">Molecular Characteristics<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class<\/strong>: Therapeutic vaccine for chronic hepatitis B<\/li>\n\n\n\n<li><strong>Structure<\/strong>: Innovative PreS1-targeted recombinant fusion protein<\/li>\n\n\n\n<li><strong>Target<\/strong>: PreS1 domain of hepatitis B surface antigen (HBsAg)<\/li>\n\n\n\n<li><strong>Development Status<\/strong>: First-in-class therapeutic approach in CTTQ pipeline<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-immunological-mechanism\" class=\"wp-block-heading\">Immunological Mechanism<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Immune Tolerance Breakthrough<\/strong>: Designed to overcome T-cell exhaustion and immune tolerance characteristic of chronic HBV infection<\/li>\n\n\n\n<li><strong>HBV-Specific Immunity<\/strong>: Rebuilds virus-specific immune responses through targeted antigen presentation<\/li>\n\n\n\n<li><strong>Functional Cure Potential<\/strong>: Aims to achieve sustained HBsAg loss and anti-HBs seroconversion without lifelong antiviral therapy<\/li>\n\n\n\n<li><strong>Therapeutic Paradigm<\/strong>: Shifts from viral suppression to immune-mediated viral clearance<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-amp-strategic-implications\" class=\"wp-block-heading\">Market Impact &amp; Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet Medical Need<\/strong>: Addresses 70 million chronic HBV patients in China representing the world&#8217;s largest CHB population<\/li>\n\n\n\n<li><strong>Current Treatment Limitations<\/strong>: Existing nucleos(t)ide analogues suppress viral replication but rarely achieve functional cure (&lt;10% after long-term therapy)<\/li>\n\n\n\n<li><strong>Competitive Differentiation<\/strong>: First PreS1-targeted therapeutic vaccine in Chinese clinical development<\/li>\n\n\n\n<li><strong>Commercial Opportunity<\/strong>: Potential to capture significant share of $2.5 billion Chinese CHB therapeutics market<\/li>\n\n\n\n<li><strong>Global Expansion<\/strong>: Success in China may support international regulatory filings given high global HBV burden<\/li>\n\n\n\n<li><strong>Pipeline Validation<\/strong>: Demonstrates CTTQ&#8217;s capability in complex biologic development and immunotherapy innovation<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-context\" class=\"wp-block-heading\">Strategic Context<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The IM-101 approval represents Sino Biopharmaceutical&#8217;s strategic expansion into therapeutic vaccines, complementing its established small molecule and biologic portfolio. Chronic hepatitis B remains a critical public health challenge in China, where current treatments fail to address the underlying immune dysfunction that perpetuates viral persistence.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IM-101&#8217;s PreS1-targeting approach leverages the immunodominant region of HBV surface antigen, potentially enabling more effective immune recognition compared to conventional HBsAg-based vaccines. The therapeutic vaccine strategy aligns with global efforts to develop functional cure regimens that can eliminate the need for lifelong antiviral therapy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory pathways, and commercial potential. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, competitive developments, and market acceptance.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKG:&#8230;<\/p>\n","protected":false},"author":1,"featured_media":70520,"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":true,"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":[661,62,908,313,89],"class_list":["post-70519","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-chia-tai-tianqing-pharmaceutical","tag-clinical-trial-approval-initiation","tag-hkg-1177","tag-sino-biopharmaceutical","tag-viral-hepatitis"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sino Biopharmaceutical Subsidiary Secures NMPA Approval for IM-101 Therapeutic Vaccine in Chronic Hepatitis B - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKG: 1177), announced that IM-101, a Class 1 innovative drug, has received clinical trial approval from China&#039;s National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B (CHB). The PreS1-targeted recombinant fusion protein represents a novel therapeutic vaccine approach designed to break immune tolerance and restore HBV-specific immune responses.\" \/>\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=70519\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sino Biopharmaceutical Subsidiary Secures NMPA Approval for IM-101 Therapeutic Vaccine in Chronic Hepatitis B\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKG: 1177), announced that IM-101, a Class 1 innovative drug, has received clinical trial approval from China&#039;s National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B (CHB). 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(CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKG: 1177), announced that IM-101, a Class 1 innovative drug, has received clinical trial approval from China's National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B (CHB). The PreS1-targeted recombinant fusion protein represents a novel therapeutic vaccine approach designed to break immune tolerance and restore HBV-specific immune responses.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=70519#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=70519"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=70519#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2303.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2303.webp","width":1080,"height":608,"caption":"Sino Biopharmaceutical Subsidiary Secures NMPA Approval for IM-101 Therapeutic Vaccine in Chronic Hepatitis B"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=70519#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Sino Biopharmaceutical Subsidiary Secures NMPA Approval for IM-101 Therapeutic Vaccine in Chronic Hepatitis B"}]},{"@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\/07\/2303.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/70519","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=70519"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/70519\/revisions"}],"predecessor-version":[{"id":70521,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/70519\/revisions\/70521"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/70520"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=70519"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=70519"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=70519"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}