HanchorBio Advances HCB101 Toward Global Registrational Development Following SAB Review and FDA Alignment
Six months of clinical progress establish 2L gastric cancer as the primary clinical anchor, with expanding proof-of-concept activity across 2L MSS colorectal cancer, HER2+ gastric cancer, and HNSCC, alongside growing value through partnerships and next-generation research
[Taipei, Shanghai, San Francisco | October 19, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced outcomes from its latest Scientific Advisory Board (SAB) meeting. Highlights included significant clinical progress for its lead asset, HCB101; alignment with the U.S. FDA on a registrational pathway in second-line gastric/ gastroesophageal junction (GC/GEJ) cancer; and continued expansion of the company’s research pipeline across oncology and immune-mediated diseases.
The meeting marked a clear strategic transition for HCB101 from early clinical proof of concept toward global development optimization and broad combination strategies. Discussion focused on establishing second-line GC/GEJ cancer as the clinical and registrational anchor, optimizing HCB101 dose and schedule for global development, defining expansion opportunities in MSS colorectal cancer and HNSCC, and extending HCB101’s value through external combinations and partnerships. The HCB101 clinical program was presented by Dr. Alvin Luk, President and Chief Medical Officer of HanchorBio.
“This was a very different SAB meeting from six months ago and reflected remarkable progress at HanchorBio—not only clinically, but across research, translational science and discovery,” said Professor Mingyi Chen, SAB Chairman. “HCB101 has moved from proof of biology toward a clearly defined development strategy. At the same time, the team has generated an extraordinary amount of new research across oncology, autoimmune disease, glioblastoma, and next-generation immune engineering. What impressed me most was how quickly the organization is turning scientific concepts into actionable data and development opportunities. The progress in just six months is genuinely exciting.”
2L Gastric Cancer Emerges as Clinical Anchor with FDA Alignment
The SAB reviewed encouraging clinical data evaluating HCB101 in combination with ramucirumab and paclitaxel in second-line GC/GEJ cancer. Highlights of the GC/GEJ trial include: (1) High Response Rate: HCB101 achieved a 63% objective response rate (ORR) (10/16 evaluable patients) and a 100% disease control rate (DCR) across the 5.12 and 8 mg/kg mid-dose cohorts. (2) Durable Benefit: A substantial proportion of patients remained on treatment beyond 18 weeks.
For context, in RAINBOW-Asia (NCT01939899), a Phase 3 bridging study conducted in an Asian, predominantly Chinese population, ramucirumab plus paclitaxel achieved an ORR of 26.5% and a median PFS of 4.14 months (~18 weeks). Direct cross-trial comparisons should be interpreted with caution.
Importantly, following a June 2026 meeting with the U.S. FDA, HanchorBio reached alignment on a stepwise registrational strategy. The path forward includes a randomized Phase 2 lead-in for regimen selection, followed by a confirmatory Phase 3 trial with overall survival (OS) as the primary endpoint.
Expansion Signals in MSS Colorectal and Head & Neck Cancers
HanchorBio presented expanding data for HCB101 in additional solid tumor settings:
Microsatellite-stable (MSS) Colorectal Cancer (CRC): In a second-line MSS CRC cohort evaluating HCB101 plus bevacizumab and chemotherapy, HCB101 achieved a 50% ORR (2/4 patients) and 100% DCR. Across broader sponsor-led CRC combination cohorts, responses were also observed with multiple standard-of-care regimens, supporting the potential portability of HCB101 in CRC treatment backbones. Complementary investigator-initiated trials in Taiwan showed sustained disease control with low-dose HCB101 plus bevacizumab and chemotherapy, including clinical benefit extending beyond 48 and 64 weeks in selected patients. For context, historical second-line bevacizumab-based regimens have produced ORRs of ~5–23% and median PFS of ~5.7-7.3 months (24-31 weeks). Cross-trial comparisons should be interpreted cautiously.
Head and Neck Squamous Cell Carcinoma (HNSCC): HCB101 monotherapy generated a durable partial response lasting more than 80 weeks, with recent FDA-granted single-patient expanded access (compassionate use) allowing continued treatment. Importantly, a Taiwan investigator-initiated study combining low-dose HCB101 with PD-1 blockade has produced early objective responses, including one complete response and one partial response, further supporting development of HCB101-based immunotherapy combinations.
Multiplicative Value Through Combination Partnerships
The SAB viewed HCB101 as a flexible, combination-ready macrophage backbone, rather than a drug tied to a single regimen. HanchorBio is actively evaluating rational combinations pairing HCB101 with next-generation bispecific and multispecific modalities, HER2-directed therapies, cancer vaccines, ADCs, chemotherapy, and stromal/TME-directed agents.
“Six months ago, we were still proving what HCB101 could become. Today, we have a clinical anchor, an FDA-aligned registrational development path, expanding clinical signals in CRC and HNSCC, and growing opportunities to multiply HCB101’s value through partnerships,” said Scott Liu, Ph.D., Founder and Chairman of HanchorBio. “Our ambition is larger than a single drug. We are building a global innovation engine through our FBDB™ platform that can repeatedly turn differentiated science into high-value medicines.”
Discovery Engine Advances Multi-Disciplinary Portfolio
Led by Chief Scientific Officer Dr. Wenwu Zhai, HanchorBio’s research organization presented progress across oncology, autoimmune disease, CNS disorders, and cardiovascular biology.
Glioblastoma (GBM): HanchorBio presented encouraging preclinical data exploring macrophage-directed therapy in combination with standard-of-care treatment, together with next-generation approaches designed to improve delivery across the blood-brain barrier. The SAB encouraged further validation across orthotopic models and direct demonstration of CNS exposure.
Autoimmune & Cardiovascular Biology: The SAB reviewed next-generation approaches designed to achieve deeper and more durable depletion of pathogenic B-cell and antibody-producing cell populations, as well as programs targeting inflammatory pathways implicated in treatment-resistant autoimmune disease. The SAB also reviewed exploratory research extending macrophage biology into atherosclerosis and plaque stabilization, with emphasis on identifying value beyond conventional lipid lowering.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on developing transformational immunotherapies for cancer and severe immune-related diseases. Powered by its proprietary FBDB™ platform, HanchorBio designs multi-functional biologics engineered to re-engage innate and adaptive immunity. With operations spanning Taipei, Shanghai, and San Francisco, the company is committed to advancing differentiated science into high-impact global therapies.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development of HCB101, HCB301 and HanchorBio’s pipeline; the interpretation and potential significance of preliminary clinical findings; future clinical studies, development strategies, indications, combinations and partnerships; 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. Preliminary clinical findings may change as follow-up continues and data mature. Regulatory discussions do not constitute approval or assurance of future development or product approval.
HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
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