{"id":64070,"date":"2026-04-27T21:28:15","date_gmt":"2026-04-27T13:28:15","guid":{"rendered":"https:\/\/flcube.com\/?p=64070"},"modified":"2026-04-27T21:28:16","modified_gmt":"2026-04-27T13:28:16","slug":"shandong-boan-biotech-advances-first-in-china-anti-cd25-antibody-ba1106-into-phase-ii-nsclc-trial-in-combination-with-nivolumab-biosimilar-ba1104","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64070","title":{"rendered":"Shandong Boan Biotech Advances First-in-China Anti-CD25 Antibody BA1106 into Phase II NSCLC Trial in Combination with Nivolumab Biosimilar BA1104"},"content":{"rendered":"\n<p><strong>Shandong Boan Biotechnology Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/6955:HKG\">HKG: 6955<\/a>) announced that the <strong>Center for Drug Evaluation (CDE)<\/strong> of China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has accepted its <strong>Phase II clinical trial application<\/strong> for the combination of <strong>BA1106<\/strong> (anti-CD25 monoclonal antibody) and <strong>BA1104<\/strong> (nivolumab biosimilar) in <strong>driver gene-negative non-small cell lung cancer (NSCLC)<\/strong>.<\/p>\n\n\n\n<p>The multicenter, single-arm, open-label study will evaluate the <strong>efficacy, safety, and pharmacokinetic (PK) profile<\/strong> of the regimen in patients with advanced NSCLC lacking actionable EGFR, ALK, ROS1, or other driver mutations\u2014a population heavily reliant on immunotherapy but with limited durable response rates to PD-1 monotherapy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-asset-profiles-amp-innovation-status\">Asset Profiles &amp; Innovation Status<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Molecule<\/th><th>Type<\/th><th>Key Differentiation<\/th><th>Development Stage<\/th><\/tr><\/thead><tbody><tr><td><strong>BA1106<\/strong><\/td><td>First-in-China <strong>anti-CD25 innovative mAb<\/strong> for solid tumors<\/td><td>Targets regulatory T cells (Tregs) in tumor microenvironment to overcome immunosuppression<\/td><td>Phase II (NMPA filing accepted)<\/td><\/tr><tr><td><strong>BA1104<\/strong><\/td><td><strong>Biosimilar of Opdivo\u00ae (nivolumab)<\/strong><\/td><td>Demonstrates high analytical and functional similarity to originator<\/td><td>Phase I completed; biosimilarity established<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-scientific-rationale-amp-early-clinical-signals\">Scientific Rationale &amp; Early Clinical Signals<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism<\/strong>: BA1106 depletes or modulates <strong>CD25+ regulatory T cells (Tregs)<\/strong>, which suppress antitumor immunity\u2014potentially enhancing PD-1 blockade by BA1104<\/li>\n\n\n\n<li><strong>Phase I Results<\/strong>: Combination showed <strong>promising efficacy signals<\/strong> across multiple tumor types, including <strong>lung adenocarcinoma, lung squamous cell carcinoma, and gastric cancer<\/strong><\/li>\n\n\n\n<li><strong>Safety<\/strong>: Favorable tolerability with no unexpected immune-related adverse events (irAEs), suggesting manageable risk profile<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications-for-boan-biotech\">Strategic Implications for Boan Biotech<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Innovation Milestone<\/strong>: BA1106 is the <strong>first domestically developed anti-CD25 antibody<\/strong> to enter clinical trials for solid tumors in China, marking a shift from biosimilars to novel immuno-oncology<\/li>\n\n\n\n<li><strong>Commercial Synergy<\/strong>: Pairing an innovative Treg-targeting agent with an in-house nivolumab biosimilar creates a <strong>differentiated, vertically integrated combo<\/strong><\/li>\n\n\n\n<li><strong>Market Opportunity<\/strong>: Driver-negative NSCLC represents ~40% of Chinese NSCLC cases; current PD-1 monotherapy yields &lt;20% objective response rate<\/li>\n\n\n\n<li><strong>Global Potential<\/strong>: If successful, the data could support international partnerships or IND filings in regions with high unmet need<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<p>While global pharma explores Treg-targeting strategies (e.g., anti-CTLA-4, CCR4 inhibitors), CD25 remains an underexploited target due to historical concerns about systemic T-cell depletion. Boan\u2019s tumor-focused approach may offer a safer therapeutic window.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief reflects regulatory acceptance of a clinical trial application. Enrollment, efficacy outcomes, and approval timelines remain subject to trial execution and regulatory review.<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\/04\/2026042600114_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026042600114_c.\"><\/object><a id=\"wp-block-file--media-9e351655-2406-44ce-8c9a-85fe815419fa\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2026042600114_c.pdf\">2026042600114_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2026042600114_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-9e351655-2406-44ce-8c9a-85fe815419fa\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that the Center for Drug Evaluation (CDE)&#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":[43,220,90,1024,18],"class_list":["post-64070","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biosimilars","tag-boan-biotechnology","tag-clinical-trial-filings","tag-hkg-6955","tag-pd-1-l1"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Shandong Boan Biotech Advances First-in-China Anti-CD25 Antibody BA1106 into Phase II NSCLC Trial in Combination with Nivolumab Biosimilar BA1104 - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA) has accepted its Phase II clinical trial application for the combination of BA1106 (anti-CD25 monoclonal antibody) and BA1104 (nivolumab biosimilar) in driver gene-negative non-small cell lung cancer (NSCLC).\" \/>\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=64070\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Shandong Boan Biotech Advances First-in-China Anti-CD25 Antibody BA1106 into Phase II NSCLC Trial in Combination with Nivolumab Biosimilar BA1104\" \/>\n<meta property=\"og:description\" content=\"Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA) has accepted its Phase II clinical trial application for the combination of BA1106 (anti-CD25 monoclonal antibody) and BA1104 (nivolumab biosimilar) in driver gene-negative non-small cell lung cancer (NSCLC).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=64070\" \/>\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=\"2026-04-27T13:28:15+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-27T13:28:16+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. 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