Jul 22, 2026

HanchorBio Expands Clinical Evidence Supporting Its Macrophage-Directed Oncology Strategy

HanchorBio Expands Clinical Evidence Supporting Its Macrophage-Directed Oncology Strategy

Expanded second-line colorectal cancer data support HCB101’s potential across gastrointestinal tumors and combination treatment settings

[Taipei, Shanghai, San Francisco | July 22, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and immune-related diseases, today announced updated early clinical observations from its HCB101 program.

The findings further support HanchorBio’s macrophage-directed oncology strategy. HCB101 is being developed as a combination-ready SIRPα-based immune backbone designed to restore macrophage-mediated tumor-cell clearance and complement established standard-of-care therapies across multiple tumor types.

Expanded Colorectal Cancer Data Support HCB101’s Potential Across Gastrointestinal Tumors

As of the July 17, 2026 data cutoff, 11 patients were efficacy-evaluable across four second-line colorectal cancer combination cohorts within the HCB101 clinical program.

Among these patients:

  • Six achieved partial responses, with tumor reductions exceeding 30%, representing an objective response rate of 54.5%
  • Five achieved stable disease
  • The disease control rate was 100%

Objective responses were observed across multiple standard-of-care combination regimens and clinical development settings, supporting continued evaluation of HCB101 as a combination-ready macrophage-directed therapy in gastrointestinal cancers.

The sponsor-led HCB101-201 study contributed emerging evidence of tumor reduction across several second-line colorectal cancer combination cohorts. Separately, an investigator-initiated study in Taiwan continued to demonstrate encouraging durability, including one patient remaining on HCB101-based treatment for more than one year and another maintaining stable disease for more than 48 weeks before progression.

Historical objective response rates (ORR) for currently available second-line colorectal cancer treatment regimens are generally approximately 15% to 25%, depending on patient characteristics, prior treatment exposure, molecular profile, and the specific regimen administered. These historical outcomes highlight the continued need for treatment approaches capable of improving response depth and durability in this setting.

These findings remain preliminary and are based on small, nonrandomized cohorts. Although historical outcomes with currently available therapies underscore the need for continued innovation in this setting, cross-study comparisons should not be made. Additional enrollment and longer follow-up will be required to further characterize response durability, progression-free survival, safety, and the contribution of HCB101 to each combination regimen.

Second-line gastric and gastroesophageal junction cancer remains HanchorBio’s lead clinical development indication for HCB101. The colorectal cancer findings provide complementary evidence supporting further evaluation of the HCB101 macrophage backbone across gastrointestinal tumor types and standard-of-care treatment regimens. By 2036, the potential second-line gastric cancer market opportunity is estimated at approximately US$280 million in China and US$430 million in overseas markets, while the potential second-line colorectal cancer market opportunity is estimated at approximately US$640 million in China and US$2.9 billion in overseas markets.

Clinical experience also continues to accumulate from other HCB101 combination studies, including gastric cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer, helping establish its potential applicability across distinct tumor types and therapeutic settings.

“Our strategy is not simply to expand the number of indications under development,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “We are using clinical evidence to deepen our understanding of macrophage biology and to identify where macrophage-directed therapy may add value to established treatment regimens. The latest colorectal cancer findings further support our evaluation of HCB101 beyond gastric cancer and across a broader range of gastrointestinal tumors.”

“The key clinical finding is the consistency of objective responses across three distinct second-line colorectal cancer treatment backbones,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio.  “A preliminary 54.5% response rate across these heterogeneous cohorts, together with durable disease control observed in the separate Taiwan study, strengthens the rationale for HCB101 as a portable macrophage-directed immune backbone across gastrointestinal cancers. Second-line gastric cancer remains our lead clinical value program, while the colorectal cancer findings expand the clinical evidence supporting the platform.”

 

About HCB101

HCB101 is HanchorBio’s differentiated engineered SIRPα-IgG4 Fc fusion protein designed to selectively block CD47–SIRPα signaling while reducing red-blood-cell binding. By restoring macrophage-mediated tumor-cell phagocytosis and supporting antigen presentation, HCB101 is being developed as a combination-ready macrophage immune backbone across selected solid tumors.

 

About HanchorBio

HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company developing next-generation immunotherapies based on a fundamental belief: immunity is not one-dimensional, and the medicines designed to harness it should not be either.

Rooted in Taiwan with operations in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio is advancing a pipeline of immunotherapies for oncology and immune-mediated diseases. The Company’s proprietary Fc-Based Designer Biologics (FBDB™) platform enables the design of multi-functional biologics that bring complementary immune mechanisms together within a single molecular architecture.

HanchorBio’s clinical pipeline is anchored by HCB101, an engineered SIRPα-IgG4 Fc fusion protein designed to restore macrophage-mediated antitumor activity and enable rational combination strategies. Clinical and translational learnings from HCB101 inform the Company’s broader platform expansion, including multi-axis immunotherapies and programs beyond oncology.

Listed on the Taiwan Stock Exchange Innovation Board (TWSE: 7827), HanchorBio is advancing its clinical development, regulatory strategy, and global partnerships from a foundation built in Taiwan and designed for global development.

 

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 interactions and decisions, protocol development, execution of collaboration, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.

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