HanchorBio Advances Myeloid-Directed Therapeutics Strategy Beyond Oncology with HCB101 Clinical Progress and FBDB™ Platform Expansion
From clinical anchor to strategic franchise: HCB101 provides human validation of macrophage-directed immunity, enabling expansion across oncology and immune-mediated diseases
[Taipei, Shanghai, San Francisco | August 21, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today shared its latest clinical and research progress in myeloid-directed therapeutics at the 2026 Autumn Industry Trends and Corporate Forum hosted by Hua Nan Securities.
The Company presented its development strategy centered on the proprietary FBDB™ multifunctional biologics platform and myeloid enhancer approach, highlighting clinical progress of HCB101 in solid tumors and the expansion of macrophage-directed biology into HCB206 for immune-mediated diseases.
Expanding Immune Therapeutics Beyond T-Cell Checkpoint Modulation
The next generation of immune therapeutics is increasingly focused on addressing broader immune regulation beyond individual checkpoint pathways, including the role of innate immune cells within the disease microenvironment.
While PD-1/PD-L1 inhibitors primarily modulate existing T-cell responses, HanchorBio’s approach focuses on macrophages as an upstream component of innate immunity, with the potential to regulate cellular clearance, antigen processing, and subsequent immune activation.
HCB101 Establishes the Clinical Anchor for Macrophage-Directed Immunobiology
Scott Liu, Ph.D., Founder and Chairman of HanchorBio, said, “HCB101 represents the first clinical anchor for our myeloid enhancer approach. Our objective is not simply to develop an individual therapeutic candidate, but to establish human clinical evidence that macrophage-directed immune modulation can become a scalable approach across oncology and immune-related diseases. The clinical data generated with HCB101 not only support its continued development but also validate the broader myeloid enhancer approach, which is designed to restore macrophage phagocytosis, enhance antigen processing and presentation, and subsequently engage adaptive antitumor immunity through T-cell responses.”
HCB101 targets the upstream CD47/SIRPα macrophage immune checkpoint and is designed to restore macrophage-mediated tumor-cell phagocytosis, promote tumor antigen processing and presentation, and potentially induce de novo tumor-reactive T-cell clones that were not previously present or activated, generating broader antitumor immune responses. By initiating immune activation through macrophage-mediated tumor-cell clearance and antigen presentation, HCB101 shares an important biological principle with emerging immune-priming approaches, including therapeutic cancer vaccines being developed by Moderna/Merck, which seek to generate new tumor-reactive immune responses through antigen-directed strategies.
Clinical data generated with HCB101 continue to support its development across selected tumor types and provide important translational insights for expansion of the broader FBDB™ platform.
Clinical Validation: HCB101 Data Support Expansion Across Tumor Types
The ongoing HCB101-201 Phase 1b/2a study is evaluating HCB101 in combination with established standards of care across selected solid tumors, including gastric cancer, colorectal cancer, triple-negative breast cancer and head and neck squamous cell carcinoma.
Rather than broadly pursuing all indications, HanchorBio prioritizes development opportunities based on tumor biology, translational findings and combination rationale.
In second-line gastric cancer/gastroesophageal junction cancer, the intermediate-dose cohort demonstrated encouraging early clinical activity, with 8 of 10 evaluable patients achieving partial responses (ORR 80%) and a disease control rate of 100% at initial imaging assessment. Follow-up remains ongoing. Most of these patients had previously experienced disease progression following PD-1/PD-L1 treatment. By comparison, the ORR associated with standard treatment is approximately 26.5-28.0%. Patient follow-up remains ongoing, and median progression-free survival (mPFS) has not yet matured.
In colorectal cancer, HCB101 combination studies have also demonstrated encouraging clinical activity. Among 11 evaluable patients receiving HCB101 in combination with different standard therapies, 6 achieved partial responses, and 5 achieved stable disease, corresponding to a pooled ORR of 54.5% and DCR of 100%. Partial responses were observed across three distinct standard-of-care treatment architectures: bevacizumab plus chemotherapy, cetuximab plus chemotherapy, and ramucirumab plus FOLFIRI. Stable disease was also observed with chemotherapy alone. The activity observed across multiple therapeutic backbones supports further evaluation of macrophage-directed immune activation across additional tumor settings. By comparison, outcomes with established second-line metastatic colorectal cancer therapies vary according to prior treatment, molecular selection, and treatment backbone. Historical objective response rates are generally approximately 10%–20% in broader, non-biomarker-selected populations.
Translating Clinical Validation into a Multi-Disease Pipeline
Building on HCB101 as the clinical anchor, HanchorBio is expanding myeloid-directed biology across additional therapeutic areas.
HCB301 and HCB303 integrate macrophage-directed biology with additional immune pathways to explore broader immune activation strategies and next-generation immunotherapeutic approaches.
HCB206 extends macrophage-mediated cellular clearance beyond oncology into B-cell depletion and immune-mediated diseases through a CD20 × SIRPα dual-targeting design, with the goal of achieving deeper and more durable immune modulation.
Preclinical studies of HCB206 demonstrated B-cell depletion activity through multiple mechanisms, including antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC), and complement-dependent cytotoxicity (CDC), supporting further evaluation in immune-mediated diseases.
Building a Strategic Franchise Through the FBDB™ Platform
HanchorBio’s FBDB™ platform integrates disease biology, AI-assisted protein engineering, translational research, and clinical feedback to continuously optimize therapeutic design and application.
Through HCB101 as the clinical anchor, HanchorBio aims to establish human validation of macrophage-directed therapeutics and leverage clinical data to guide expansion into additional disease areas.
The Company will continue advancing HCB101 across selected oncology indications while progressing its broader pipeline, including HCB301, HCB303 and HCB206, to further validate the potential of myeloid-directed therapeutic strategies across cancer, immune-mediated diseases and future applications of cellular clearance biology.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The Company’s proprietary Fc-based designer biologics (FBDB™) platform enables the engineering of multifunctional biologics with diverse targeting modalities designed to activate innate and adaptive immune pathways and address limitations of current immunotherapies.
HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations, translational development strategies, and scalable CMC capabilities.
Forward-Looking Statements
This press release contains forward-looking statements regarding HanchorBio’s clinical development programs, product candidates, regulatory strategy, and future plans. Actual results may differ materially from those expressed or implied due to various risks and uncertainties, including clinical development outcomes, regulatory decisions, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.