{"id":69316,"date":"2026-07-03T14:51:17","date_gmt":"2026-07-03T06:51:17","guid":{"rendered":"https:\/\/flcube.com\/?p=69316"},"modified":"2026-07-03T14:51:18","modified_gmt":"2026-07-03T06:51:18","slug":"shandong-boan-biotechnology-secures-nmpa-approval-for-phase-ii-trial-of-ba1106-ba1104-combination-in-nsclc-chinas-first-non-il-2-blocking-anti-cd25-antibody","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=69316","title":{"rendered":"Shandong Boan Biotechnology Secures NMPA Approval for Phase II Trial of BA1106\/BA1104 Combination in NSCLC, China&#8217;s First Non-IL-2-Blocking Anti-CD25 Antibody"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Shandong Boan Biotechnology Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/6955:HKG\">HKG: 6955<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has approved its <strong>Phase II clinical trial application<\/strong> for <strong>BA1106<\/strong>, an investigational <strong>anti-CD25 monoclonal antibody<\/strong>, in combination with <strong>BA1104<\/strong> (the company&#8217;s proprietary <strong>PD-1 inhibitor<\/strong>) for the <strong>first- and second-line treatment of non-small cell lung cancer (NSCLC)<\/strong>. BA1106 represents <strong>China&#8217;s first non-IL-2-blocking innovative anti-CD25 antibody<\/strong> to advance into clinical development for solid tumors.<\/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>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>National Medical Products Administration (NMPA)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Phase II Clinical Trial Application<\/td><\/tr><tr><td><strong>Combination Therapy<\/strong><\/td><td>BA1106 (anti-CD25 mAb) + BA1104 (PD-1 inhibitor)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>First- and second-line treatment of NSCLC<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>Driver-gene-negative NSCLC subjects<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>2 July 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-innovation\" class=\"wp-block-heading\">Drug Profile &amp; Innovation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>BA1106:<\/strong> <strong>Anti-CD25 monoclonal antibody<\/strong> targeting interleukin-2 receptor alpha subunit (IL-2R\u03b1)<\/li>\n\n\n\n<li><strong>Key Differentiation:<\/strong> <strong>Non-IL-2-blocking mechanism<\/strong> \u2013 first of its kind in China for solid tumor applications<\/li>\n\n\n\n<li><strong>BA1104:<\/strong> Proprietary <strong>PD-1 inhibitor<\/strong> (nivolumab biosimilar or derivative)<\/li>\n\n\n\n<li><strong>Therapeutic Rationale:<\/strong> Dual immunotherapy approach combining T-regulatory cell modulation with PD-1 pathway inhibition<\/li>\n\n\n\n<li><strong>Innovation Status:<\/strong> First Chinese-developed anti-CD25 antibody with non-IL-2-blocking properties in clinical trials<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-trial-design\" class=\"wp-block-heading\">Clinical Trial Design<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Study Design<\/strong><\/td><td>Multicenter, single-arm, open-label<\/td><\/tr><tr><td><strong>Phase<\/strong><\/td><td>Phase II<\/td><\/tr><tr><td><strong>Primary Objectives<\/strong><\/td><td>Evaluate efficacy, safety, and pharmacokinetic (PK) profiles<\/td><\/tr><tr><td><strong>Target Population<\/strong><\/td><td>Subjects with driver-gene-negative NSCLC<\/td><\/tr><tr><td><strong>Treatment Lines<\/strong><\/td><td>First- and second-line settings<\/td><\/tr><tr><td><strong>Combination Regimen<\/strong><\/td><td>BA1106 + BA1104 dual immunotherapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-strategic-significance-amp-market-context\" class=\"wp-block-heading\">Strategic Significance &amp; Market Context<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Aspect<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>NSCLC Market Opportunity<\/strong><\/td><td>Largest lung cancer segment representing ~85% of cases; significant unmet need in driver-gene-negative population<\/td><\/tr><tr><td><strong>Immunotherapy Landscape<\/strong><\/td><td>PD-1 inhibitors established as standard of care; combination approaches represent next frontier<\/td><\/tr><tr><td><strong>CD25 Targeting Innovation<\/strong><\/td><td>Novel approach to modulate tumor microenvironment by targeting regulatory T cells without blocking IL-2 signaling<\/td><\/tr><tr><td><strong>China Biotech Leadership<\/strong><\/td><td>Demonstrates advancement of domestic innovation beyond biosimilars to novel mechanism antibodies<\/td><\/tr><tr><td><strong>Competitive Differentiation<\/strong><\/td><td>Unique non-IL-2-blocking mechanism may offer improved safety profile compared to traditional anti-CD25 approaches<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-forward-outlook\" class=\"wp-block-heading\">Forward Outlook<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The Phase II trial approval positions Shandong Boan Biotechnology to explore a potentially transformative combination immunotherapy approach for NSCLC patients who currently have limited treatment options. By combining its proprietary PD-1 inhibitor with a novel anti-CD25 antibody featuring a non-IL-2-blocking mechanism, the company aims to enhance anti-tumor immune responses while potentially avoiding the immunosuppressive effects associated with traditional IL-2 pathway blockade.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Success in this trial could establish BA1106 as a valuable addition to the immuno-oncology arsenal and validate CD25 as a viable target for solid tumor immunotherapy in the Chinese market. The company plans to leverage its established clinical development infrastructure and partnerships with leading oncology centers across China to accelerate patient enrollment and data generation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This milestone reinforces Shandong Boan&#8217;s commitment to innovative antibody development and positions the company as a leader in next-generation immuno-oncology combinations within China&#8217;s rapidly evolving biopharmaceutical landscape.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory approvals, and therapeutic potential. Actual results may differ due to risks including clinical trial outcomes, safety findings, competitive dynamics, and regulatory decisions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2026070203494_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026070203494_c.\"><\/object><a id=\"wp-block-file--media-6c8c2602-c63e-42be-b9f3-d3de6df357a7\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2026070203494_c.pdf\">2026070203494_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/2026070203494_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-6c8c2602-c63e-42be-b9f3-d3de6df357a7\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that China&#8217;s National Medical Products Administration (NMPA)&#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_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":[220,16,62,29,1024],"class_list":["post-69316","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-boan-biotechnology","tag-cancer","tag-clinical-trial-approval-initiation","tag-combination-therapy","tag-hkg-6955"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Shandong Boan Biotechnology Secures NMPA Approval for Phase II Trial of BA1106\/BA1104 Combination in NSCLC, China&#039;s First Non-IL-2-Blocking Anti-CD25 Antibody - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shandong Boan Biotechnology Co., Ltd. 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(HKG: 6955) announced that China&#039;s National Medical Products Administration (NMPA) has approved its Phase II clinical trial application for BA1106, an investigational anti-CD25 monoclonal antibody, in combination with BA1104 (the company&#039;s proprietary PD-1 inhibitor) for the first- and second-line treatment of non-small cell lung cancer (NSCLC). 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(HKG: 6955) announced that China's National Medical Products Administration (NMPA) has approved its Phase II clinical trial application for BA1106, an investigational anti-CD25 monoclonal antibody, in combination with BA1104 (the company's proprietary PD-1 inhibitor) for the first- and second-line treatment of non-small cell lung cancer (NSCLC). BA1106 represents China's first non-IL-2-blocking innovative anti-CD25 antibody to advance into clinical development for solid tumors.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=69316#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=69316"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=69316#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Shandong Boan Biotechnology Secures NMPA Approval for Phase II Trial of BA1106\/BA1104 Combination in NSCLC, China&#8217;s First Non-IL-2-Blocking Anti-CD25 Antibody"}]},{"@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\/69316","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=69316"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/69316\/revisions"}],"predecessor-version":[{"id":69319,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/69316\/revisions\/69319"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=69316"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=69316"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=69316"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}