{"id":56424,"date":"2026-02-05T20:49:13","date_gmt":"2026-02-05T12:49:13","guid":{"rendered":"https:\/\/flcube.com\/?p=56424"},"modified":"2026-02-05T20:49:14","modified_gmt":"2026-02-05T12:49:14","slug":"hanx-biopharma-hx111-adc-begins-phase-i-trial-for-lymphoma-and-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56424","title":{"rendered":"Hanx Biopharma HX111 ADC Begins Phase I Trial for Lymphoma and Solid Tumors"},"content":{"rendered":"\n<p><strong>Hanx Biopharmaceuticals (Wuhan) Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/3378:HKG\">HKG: 3378<\/a>) announced the initiation of a <strong>Phase I clinical trial<\/strong> for its self\u2011developed candidate <strong>HX111<\/strong>, an <strong>OX40\u2011targeting antibody\u2011drug conjugate (ADC)<\/strong>, in patients with <strong>relapsed or refractory lymphoma and solid tumors<\/strong>. HX111 is the first disclosed OX40\u2011targeting ADC worldwide to enter clinical stage.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone-amp-drug-profile\">Regulatory Milestone &amp; Drug Profile<\/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>Company<\/strong><\/td><td>Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (3378.HK)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>HX111<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>OX40\u2011targeting antibody\u2011drug conjugate (ADC)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Relapsed or refractory lymphoma and solid tumors<\/td><\/tr><tr><td><strong>Clinical Stage<\/strong><\/td><td>Phase I trial initiated<\/td><\/tr><tr><td><strong>Innovation<\/strong><\/td><td>First disclosed OX40\u2011targeting ADC worldwide to enter clinical stage<\/td><\/tr><tr><td><strong>Target<\/strong><\/td><td>OX40 molecules highly expressed on certain lymphomas and solid tumors<\/td><\/tr><tr><td><strong>Mechanism of Action<\/strong><\/td><td>High\u2011affinity OX40 binding \u2192 endocytosis \u2192 lysosomal protease cleavage \u2192 payload release \u2192 tumor cell apoptosis<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-mechanism-of-action-amp-clinical-rationale\">Mechanism of Action &amp; Clinical Rationale<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>OX40 Targeting:<\/strong> HX111 binds with high affinity and specificity to OX40 molecules on tumor cell surfaces<\/li>\n\n\n\n<li><strong>Efficient Delivery:<\/strong> Enters tumor cells via endocytosis; linker cleaved by lysosomal proteases to release potent payload<\/li>\n\n\n\n<li><strong>Therapeutic Potential:<\/strong> OX40 is highly expressed in certain lymphomas and solid tumors lacking effective treatment options, addressing significant unmet clinical need<\/li>\n\n\n\n<li><strong>Clinical Need:<\/strong> Relapsed\/refractory lymphoma and solid tumor patients have limited salvage therapy options; OX40 ADC offers novel immunotherapy approach<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-commercial-outlook\">Market Impact &amp; Commercial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Lymphoma &amp; Solid Tumor Market:<\/strong> China market for relapsed\/refractory lymphoma and solid tumors exceeds <strong>\u00a580\u202fbillion<\/strong> (~US$11\u202fbillion) annually<\/li>\n\n\n\n<li><strong>OX40 ADC Landscape:<\/strong> HX111 is first\u2011in\u2011class globally; positions Hanx as pioneer in OX40\u2011targeted therapy<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Analysts project <strong>\u00a52\u20134\u202fbillion<\/strong> (US$280\u2013560\u202fmillion) peak annual sales if approved, based on orphan drug pricing and high unmet need<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> Validates Hanx\u2019s ADC platform for novel targets; could attract global partnership interest<\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> Phase I dose\u2011escalation trial expected <strong>Q2\u202f2026<\/strong>; early efficacy data anticipated <strong>H2\u202f2027<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for HX111. Actual results may differ due to clinical trial outcomes, competitive dynamics, and regulatory review processes.<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\/02\/2026020402049_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026020402049_c.\"><\/object><a id=\"wp-block-file--media-1cb64293-635b-44a1-ac00-afcbd4441174\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/2026020402049_c.pdf\">2026020402049_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/2026020402049_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-1cb64293-635b-44a1-ac00-afcbd4441174\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (HKG: 3378) announced the initiation of a Phase I clinical&#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":[35,16,62,2333,4503],"class_list":["post-56424","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-clinical-trial-approval-initiation","tag-hanx-biopharmaceuticals","tag-hkg-3378"],"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>Hanx Biopharma HX111 ADC Begins Phase I Trial for Lymphoma and Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (HKG: 3378) announced the initiation of a Phase I clinical trial for its self\u2011developed candidate HX111, an OX40\u2011targeting antibody\u2011drug conjugate (ADC), in patients with relapsed or refractory lymphoma and solid tumors. HX111 is the first disclosed OX40\u2011targeting ADC worldwide to enter clinical stage.\" \/>\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=56424\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hanx Biopharma HX111 ADC Begins Phase I Trial for Lymphoma and Solid Tumors\" \/>\n<meta property=\"og:description\" content=\"Hanx Biopharmaceuticals (Wuhan) Co., Ltd. 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