{"id":41065,"date":"2025-09-10T15:00:48","date_gmt":"2025-09-10T07:00:48","guid":{"rendered":"https:\/\/flcube.com\/?p=41065"},"modified":"2025-09-10T15:00:49","modified_gmt":"2025-09-10T07:00:49","slug":"qilu-pharmaceutical-commences-phase-iii-trial-of-qls31905-for-advanced-pancreatic-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41065","title":{"rendered":"Qilu Pharmaceutical Commences Phase\u202fIII Trial of QLS31905 for Advanced Pancreatic Cancer"},"content":{"rendered":"\n<p>China\u2011based <strong>Qilu Pharmaceutical Co., Ltd.<\/strong> announced that it has opened enrollment for its first\u2011in\u2011class <strong>QLS31905<\/strong> Phase\u202fIII study, the company\u2019s registration\u2011enabling trial for the first\u2011line treatment of <strong>Claudin18.2\u2011positive advanced pancreatic cancer<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-qls31905\">What Is QLS31905?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bispecific T\u2011cell engager<\/strong> that simultaneously binds <strong>Claudin18.2<\/strong> on tumor cells and <strong>CD3<\/strong> on T\u2011cells.<\/li>\n\n\n\n<li><strong>Mechanism<\/strong> \u2013 Recruits and activates patient T\u2011cells at the tumor site, driving continuous cancer\u2011cell lysis without the need for ex\u00a0vivo cell manipulation.<\/li>\n\n\n\n<li><strong>In\u2011house Development<\/strong> \u2013 One of the few truly novel bispecific antibodies coming from a domestic Chinese biopharma.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-trial-design\">Trial Design<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td>Phase<\/td><td>III<\/td><\/tr><tr><td>Design<\/td><td>Multicenter, double\u2011blind, placebo\u2011controlled, randomized<\/td><\/tr><tr><td>Treatment Arms<\/td><td>QLS31905 + albumin\u2011bound paclitaxel + gemcitabine vs. placebo + same chemo<\/td><\/tr><tr><td>Population<\/td><td>Adults with Claudin18.2\u2011positive, unresectable or metastatic pancreatic adenocarcinoma<\/td><\/tr><tr><td>Investigators<\/td><td>Prof. Shen\u202fLin (Beijing Cancer Hospital) &amp; Prof. Hao\u202fJihui (Tianjin Medical University Cancer Institute)<\/td><\/tr><tr><td>Primary Endpoint<\/td><td>Overall survival and progression\u2011free survival<\/td><\/tr><tr><td>Safety Assessment<\/td><td>Comprehensive AE monitoring, cytokine\u2011release syndrome surveillance<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-why-this-matters\">Why This Matters<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011Ever Claudin18.2\/CD3 Bispecific in Phase\u202fIII<\/strong> \u2013 Marks a significant milestone in targeted immunotherapy for a disease historically refractory to treatment.<\/li>\n\n\n\n<li><strong>Combination Strategy<\/strong> \u2013 Leveraging standard chemotherapy (paclitaxel\u202f+\u202fgemcitabine) may enhance tumor antigen presentation and T\u2011cell activation, potentially improving clinical outcomes.<\/li>\n\n\n\n<li><strong>Domestic Innovation<\/strong> \u2013 Demonstrates China\u2019s growing capacity to develop sophisticated biologics that can compete on the global stage.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-next-steps\">Next Steps<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Recruitment Target<\/strong> \u2013 600\u2013800 patients across >\u202f30 sites in China.<\/li>\n\n\n\n<li><strong>Data Cut\u2011off<\/strong> \u2013 Scheduled for Q3\u202f2026, with results expected in early 2027.<\/li>\n\n\n\n<li><strong>Regulatory Filing<\/strong> \u2013 Pending positive outcomes, Qilu plans a global submission strategy (FDA\/EMA) to expand access.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Qilu Pharmaceutical Co., Ltd. announced that it has opened enrollment for its first\u2011in\u2011class QLS31905&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41066,"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":[62,28,208],"class_list":["post-41065","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-multi-specific-antibodies","tag-qilu-pharmaceutical"],"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>Qilu Pharmaceutical Commences Phase\u202fIII Trial of QLS31905 for Advanced Pancreatic Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Qilu Pharmaceutical Co., Ltd. announced that it has opened enrollment for its first\u2011in\u2011class QLS31905 Phase\u202fIII study, the company\u2019s registration\u2011enabling trial for the first\u2011line treatment of Claudin18.2\u2011positive advanced pancreatic cancer.\" \/>\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=41065\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qilu Pharmaceutical Commences Phase\u202fIII Trial of QLS31905 for Advanced Pancreatic Cancer\" \/>\n<meta property=\"og:description\" content=\"China\u2011based Qilu Pharmaceutical Co., Ltd. announced that it has opened enrollment for its first\u2011in\u2011class QLS31905 Phase\u202fIII study, the company\u2019s registration\u2011enabling trial for the first\u2011line treatment of Claudin18.2\u2011positive advanced pancreatic cancer.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=41065\" \/>\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=\"2025-09-10T07:00:48+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-10T07:00:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/1002.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. 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