{"id":2614,"date":"2026-10-08T08:48:04","date_gmt":"2026-10-08T00:48:04","guid":{"rendered":"https:\/\/www.hanchorbio.com\/?post_type=news&#038;p=2614"},"modified":"2026-10-08T08:49:23","modified_gmt":"2026-10-08T00:49:23","slug":"hanchorbio-advances-hcb303-global-clinical-development-with-taiwan-tfda-ind-submission-following-us-fda-clearance","status":"publish","type":"news","link":"https:\/\/www.hanchorbio.com\/en\/news\/hanchorbio-advances-hcb303-global-clinical-development-with-taiwan-tfda-ind-submission-following-us-fda-clearance\/","title":{"rendered":"HanchorBio Advances HCB303 Global Clinical Development with Taiwan TFDA IND Submission Following US FDA Clearance"},"content":{"rendered":"<h2><strong>HanchorBio Advances HCB303 Global Clinical Development with Taiwan TFDA IND Submission Following US FDA Clearance<\/strong><\/h2>\n<h3><strong>\u00a0<\/strong><em>Dual regulatory milestones position HCB303 for multi-regional Phase 1 clinical development in oncology<\/em><\/h3>\n<p><em>\u00a0<\/em><\/p>\n<p><strong>[Taipei, Shanghai, San Francisco | October 8, 2026]<\/strong> \u2013 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, today announced the submission of an Investigational New Drug (IND) to the Taiwan Food and Drug Administration (TFDA) for HCB303.<\/p>\n<p>&nbsp;<\/p>\n<p>This filing follows recent IND clearance by the U.S. Food and Drug Administration (FDA), enabling HanchorBio to prepare to initiate Phase 1 clinical trials in the United States. Together, these regulatory milestones advance HCB303 into multi-regional clinical development and reflect the continued execution of HanchorBio\u2019s global growth strategy.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p>Engineered through HanchorBio\u2019s proprietary FBDB\u2122 platform, HCB303 is a first-in-class humanized trispecific fusion protein designed to simultaneously modulate the SIRP\u03b1\/CD47, PD-L1\/PD-1, and TIGIT\/PVR immune pathways. By engaging macrophages, T cells, and NK cells within a single therapeutic architecture, HCB303 coordinates both innate and adaptive antitumor responses.<\/p>\n<p>&nbsp;<\/p>\n<p>The molecule features a differentiated TIGIT-Fc ligand-trap strategy designed to intercept key TIGIT ligands (PVR\/CD155 and CD112) while preserving co-stimulatory CD226 activating signaling. Combined with PD-L1 blockade and SIRP\u03b1-mediated enhancement of macrophage phagocytosis, HCB303 represents a comprehensive multi-prolonged approach to overcoming immune evasion.<\/p>\n<p>&nbsp;<\/p>\n<p>\u201cCompleting the pre-clinical development of this extremely difficult-to-make tri-functional fusion protein and moving it from regulatory filings into active clinical trial execution is a major achievement for our team,\u201d said <strong>Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio<\/strong>. \u201cFollowing U.S. FDA IND clearance, our Taiwan filing reinforces our commitment to a seamless multi-regional development plan. Our primary focus now is disciplined execution\u2014advancing the first-in-class HCB303 efficiently across clinical sites to generate data demonstrating whether its novel biology translates into clinical efficacy for cancer patients.\u201d<\/p>\n<p>&nbsp;<\/p>\n<p>HCB303 is HanchorBio\u2019s\u00a0second trispecific immunotherapy to enter the clinic, following HCB301, further validating the efficiency and versatility of the company\u2019s FBDB\u2122 platform in generating mechanistically distinct, multi-targeted immunotherapies.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>About HCB303<\/strong><\/p>\n<p>HCB303 is an investigational, humanized trispecific fusion protein generated using HanchorBio\u2019s proprietary FBDB\u2122 platform. Designed to integrate innate and adaptive immune responses, HCB303 concurrently targets three key immune checkpoint pathways: SIRP\u03b1\/CD47, PD-L1\/PD-1, and TIGIT\/PVR.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>About HanchorBio<\/strong><\/p>\n<p>HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company dedicated to discovering and developing novel biologics for oncology and immune-mediated diseases using its proprietary FBDB\u2122 platform.<\/p>\n<p>&nbsp;<\/p>\n<p>HanchorBio\u2019s clinical and preclinical portfolio includes HCB101, a novel SIRP\u03b1-based innate immune checkpoint inhibitor; HCB301, a clinical-stage trispecific immunotherapy targeting SIRP\u03b1, PD-L1, and TGF-\u03b2; HCB303, a clinical-stage trispecific molecule integrating SIRP\u03b1\/CD47, PD-L1\/PD-1, and TIGIT\/PVR pathways; and multiple undisclosed programs.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>Forward-Looking Statements<\/strong><\/p>\n<p>This press release contains forward-looking statements, including statements regarding the\u00a0development and clinical advancement of HCB303; the timing, initiation, design, conduct, and potential outcomes of future clinical studies; the potential therapeutic characteristics, mechanisms, safety, and antitumor activity of HCB303; the development of HanchorBio\u2019s pipeline; and the capabilities and potential of the FBDB\u2122 platform. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those described.\u00a0FDA clearance of an IND permits clinical investigation to proceed but does not constitute approval of HCB303 or provide assurance regarding the safety, efficacy, timing, or success of its clinical development.\u00a0HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>Investor &amp; Media Contact:<\/strong><\/p>\n<p>Email: <a href=\"mailto:IRPR@hanchorbio.com\">IRPR@hanchorbio.com<\/a><\/p>\n<p><strong>HanchorBio Business Development Contact: <\/strong><\/p>\n<p>Email: <a href=\"mailto:BD@HanchorBio.com\">BD@HanchorBio.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>HanchorBio announced the submission of an Investigational New Drug (IND) to the Taiwan Food and Drug Administration (TFDA) for HCB303. <\/p>\n","protected":false},"featured_media":0,"template":"","news-category":[34,46],"class_list":["post-2614","news","type-news","status-publish","hentry","news-category-development-progress","news-category-development-progress-2"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news\/2614","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/media?parent=2614"}],"wp:term":[{"taxonomy":"news-category","embeddable":true,"href":"https:\/\/www.hanchorbio.com\/en\/wp-json\/wp\/v2\/news-category?post=2614"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}