HanchorBio Advances HCB303 Global Clinical Development with Taiwan TFDA IND Submission Following US FDA Clearance

HanchorBio Advances HCB303 Global Clinical Development with Taiwan TFDA IND Submission Following US FDA Clearance

 Dual regulatory milestones position HCB303 for multi-regional Phase 1 clinical development in oncology

[Taipei, Shanghai, San Francisco | October 8, 2026] – 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.

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’s global growth strategy.

Engineered through HanchorBio’s proprietary FBDB™ platform, HCB303 is a first-in-class humanized trispecific fusion protein designed to simultaneously modulate the SIRPα/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.

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 SIRPα-mediated enhancement of macrophage phagocytosis, HCB303 represents a comprehensive multi-prolonged approach to overcoming immune evasion.

“Completing 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,” said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. “Following 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—advancing the first-in-class HCB303 efficiently across clinical sites to generate data demonstrating whether its novel biology translates into clinical efficacy for cancer patients.”

HCB303 is HanchorBio’s second trispecific immunotherapy to enter the clinic, following HCB301, further validating the efficiency and versatility of the company’s FBDB™ platform in generating mechanistically distinct, multi-targeted immunotherapies.

About HCB303

HCB303 is an investigational, humanized trispecific fusion protein generated using HanchorBio’s proprietary FBDB™ platform. Designed to integrate innate and adaptive immune responses, HCB303 concurrently targets three key immune checkpoint pathways: SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR.

About HanchorBio

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™ platform.

HanchorBio’s clinical and preclinical portfolio includes HCB101, a novel SIRPα-based innate immune checkpoint inhibitor; HCB301, a clinical-stage trispecific immunotherapy targeting SIRPα, PD-L1, and TGF-β; HCB303, a clinical-stage trispecific molecule integrating SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR pathways; and multiple undisclosed programs.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the development 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’s pipeline; and the capabilities and potential of the FBDB™ 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. FDA 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. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.

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