HanchorBio Expands HCB101 Colorectal Cancer Program in Taiwan as Early 2L CRC Data Show 50% ORR and 100% DCR
First patient dosed in Taiwan expands HCB101’s global CRC development following positive responses across multiple treatment regimens and durable clinical benefit with HCB101 plus bevacizumab and chemotherapy
[Taipei, Shanghai, San Francisco | October 14, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced that the first patient in Taiwan has been dosed in the colorectal cancer (CRC)-specific cohort of its global Phase 1b/2a HCB101-201 study (NCT06771622), expanding the Company’s global development program in second-line metastatic CRC.
The Taiwan expansion of the HCB101-201 study is evaluating HCB101, an AI-assisted, structure-guided SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ platform, in combination with standard-of-care regimens in patients with second-line metastatic CRC.
The expansion builds on encouraging early activity across HanchorBio’s sponsor-led second-line microsatellite-stable CRC cohorts. Among 12 efficacy-evaluable patients who received HCB101 at 5 or 8 mg/kg in combination with different standard-of-care regimens, six achieved partial responses and six achieved stable disease, corresponding to a 50% objective response rate (ORR) and 100% disease control rate (DCR) at first assessment.
“The emerging CRC data are important because the activity is not confined to a single regimen,” said Scott Liu, Ph.D., Founder, Chairman, and CEO (Group) of HanchorBio. “We are seeing responses across multiple standard-of-care backbones, while the earlier investigator-initiated data from Taiwan provides complementary evidence of durable disease control. That combination of breadth and durability strengthens our rationale to expand HCB101 development in second-line CRC.”
Broad Activity Across Multiple Second-Line CRC Backbones
Across the current sponsor-led CRC cohorts, partial responses have been observed with:
- HCB101 + bevacizumab + chemotherapy
- HCB101 + cetuximab + chemotherapy
- HCB101 + ramucirumab + FOLFIRI
The bevacizumab-plus-chemotherapy combination therapy provides a particularly relevant bridge between the sponsor-led program and earlier investigator-initiated clinical data from Taiwan. In sponsor-led HCB101-201 Cohort 3a, four evaluable patients treated with HCB101 8 mg/kg plus bevacizumab and chemotherapy achieved 2 partial responses and 2 stable diseases, corresponding to a 50% ORR and 100% DCR.
Separately, in a Taiwan investigator-initiated study (NCT07204574), three evaluable CRC patients received lower-dose HCB101 2.56 mg/kg plus bevacizumab and chemotherapy. All three achieved disease control at first assessment, including one patient with ongoing clinical benefit beyond 63 weeks and another who maintained disease control for more than 48 weeks before progression.
For clinical context, bevacizumab plus chemotherapy has historically produced ORRs of approximately 5%–23% and median progression-free survival of approximately 5.7–7.3 months in randomized second-line metastatic CRC studies. Cross-trial comparisons should be interpreted cautiously because of differences in study design, patient characteristics, prior therapy, and other factors.
“What stands out is the consistency of the emerging signal,” said Alvin Luk, Ph.D., M.B.A., C.C.R.A., President and Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “Across our current sponsor-led CRC cohorts, HCB101 combinations have produced a 50% ORR and 100% disease control, with responses across anti-VEGF-, anti-EGFR-, and chemotherapy-based treatment architectures. With bevacizumab plus chemotherapy specifically, we have now seen objective responses in the sponsor-led study together with prolonged disease control in the earlier investigator-initiated study in Taiwan. These remain small, early datasets and should not be directly compared or pooled, but the consistency of the observations supports continued prospective development.”
From Early Taiwan Clinical Observations to Global Development
Early investigator-initiated clinical observations in Taiwan contributed important observations to the development of HCB101 in colorectal cancer, particularly regarding the potential durability of disease control with HCB101 in combination with bevacizumab and chemotherapy.
Initiation of HCB101-201 enrollment in Taiwan now extends those early observations into HanchorBio’s global sponsor-led development program, enabling prospective evaluation within a multicenter clinical study.
HCB101-201 is a global, multicenter, open-label Phase 1b/2a study evaluating HCB101 in rational combinations across prioritized solid tumors, including gastric/GEJ cancer, colorectal cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer.
About HCB101
HCB101 is an investigational engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ platform. HCB101 blocks CD47-SIRPα signaling and is designed to enhance macrophage-mediated antitumor immunity. It is being evaluated as monotherapy (NCT05892718) and in combinations (NCT06771622) across solid and hematologic malignancies. HCB101 has received U.S. FDA Orphan Drug Designation for gastric cancer.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on inventing and developing next-generation biologics for cancer and immune-mediated diseases using its proprietary FBDB™ platform. HanchorBio’s pipeline includes HCB101, its lead SIRPα-based innate immune checkpoint program; HCB301, a clinical-stage trispecific immunotherapy targeting SIRPα, PD-L1, and TGF-β biology; HCB303, an IND-cleared trispecific immunotherapy integrating SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR biology; and additional programs across oncology and immune-mediated diseases.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development of HCB101, the HCB101-201 study and its CRC cohorts, HCB101 combination strategies, and HanchorBio’s pipeline and FBDB™ platform. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Early clinical and investigator-initiated data may not predict results from larger or later-stage studies, and historical results are provided for context only; cross-trial comparisons should be interpreted cautiously. There can be no assurance that HCB101 will demonstrate safety or efficacy or obtain regulatory approval. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
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