HanchorBio Outlines Global Growth Strategy and Multi-Asset Pipeline at Second Annual R&D Day

Lead asset HCB101 advances toward global registrational Phase 2/3 trial in second-line gastric cancer, supported by robust clinical activity data.

[TAIPEI, SHANGHAI, SAN FRANCISCO | September 23, 2026] — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today hosted its second R&D Day. The Company presented its evolution from a single-asset clinical validation model into a multi-asset, macrophage-directed immunotherapy platform with global commercial potential.

At the center of HanchorBio’s strategy is its proprietary FBDB™ platform, designed to engage both innate and adaptive immunity. Lead candidate, HCB101 (SIRPα-IgG4-Fc fusion protein) serves as the clinical foundation, complemented by an expanding pipeline targeting distinct mechanism of immune resistance in oncology and immune-mediated diseases.

HCB101: Defined Registrational Path in Gastric Cancer and Portfolio Expansion

HanchorBio highlighted second-line gastric and gastroesophageal junction (GC/GEJ) cancer as the lead registrational path for HCB101, supported by a benchmarkable standard-of-care regimen, encouraging clinical activity and a defined global development strategy.

Key clinical milestones and updates include:

High Responses Rates in GC/GEJ – in response-evaluable patients receiving mid-dose HCB101 (5.12–8 mg/kg QW) alongside with ramucirumab and paclitaxel, the combination demonstrated an 80% confirmed objective response rate (ORR) and a 100% disease control rate (n=10 participants).
Global Registrational Trials Strategy – Following a recent face-to-face meeting with the U.S. FDA, HanchorBio is advancing a Q2W dose and schedule exploration protocol through the ongoing Phase 1b/2a HCB101-201 trial, followed by an international randomized Phase 2 lead-in to select the final regimen for a planned global confirmatory Phase 3 study evaluating overall survival (OS) rates.
Expanding Franchise into CRC and HNSCC: As of July 2026, 6 of 12 efficacy-evaluable patients with microsatellite stable colorectal cancer (MSS CRC) achieved partial responses (50% overall ORR and 100% DCR) in 2L CRC cohorts. Development also continues in head and neck squamous cell carcinoma (HNSCC) in combination with an anti-PD-1 monoclonal antibody.

“HCB101 has moved beyond proof of biology,” said Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) & CEO (USA) of HanchorBio. “We now have a clear registrational path in second-line GC/GEJ cancer, while strong preliminary antitumor activity signals in CRC and HNSCC demonstrate how broadly this biology can apply. Our focus is turning those clinical signals into disciplined global trials and strategic partnerships.”

Multi-Asset Pipeline: Moving Beyond HCB101.

HanchorBio’s research engine is advancing three additional differentiated assets through preclinical and clinical development:

HCB301: Target TGFβ-associated immune exclusion to reactive cold tumors.
HCB303:Combines SIRPα, PD-L1, and TIGIT/PVR biology to overcome adaptive immune resistance.
HCB206: Extends the FBDB™ immune-engineering platform into autoimmune diseases through deep B-cell depletion initially targeting systemic lupus erythematosus (SLE).

“Our strategy centers on building differentiated biology, validating it in patients, and scaling through internal research projects and external partnerships,” said Scott Liu, PhD, Founder and Chairman of HanchorBio. “HCB101 is our clinical anchor, but our FBDB™ platform gives us an enabling engine to generate novel therapeutics across oncology and immunity.”

Strategic Collaborations to Accelerate Platform Research

HanchorBio continues to build external partnerships to maximize platform potential:

InxMed Collaboration – Combining HCB101 with small-molecule FAK inhibitor IN10018/ifebemtinib to tackle stroma-rich solid tumors.

AI-Driven Clinical Development – Partnering with InSilicoTrials to integrate AI modeling and simulation into clinical trial design, aiming to optimize dose selection and reduce patient burden during global execution.

External Innovation – Actively evaluating combination trials involving cancer mRNA/DNA vaccines, ADCs, and bispecific antibodies with global biopharmaceutical partners.

Build the platform. Generate the pipeline. Validate it in patients. Expand it globally.

Immunity was never one-dimensional. Neither are we.

One Clinical Anchor. A Broader Platform. Multiple Paths to Value.

About HanchorBio

HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company dedicated to developing transformative immunotherapies for cancer and immune-mediated diseases. Driven by its proprietary FBDB™ platform, HanchorBio designs multi-functional biologics engineered to overcome immune-resistance mechanisms. With operations in Taipei, Shanghai, and San Francisco, HanchorBio is advancing multi-asset pipeline through global clinical trials and strategic partnerships. For more information, please visit http://hanchorBio.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the clinical development of HCB101 and HCB301, interpretation and potential significance of preliminary clinical findings, future clinical studies and development strategies, potential therapeutic characteristics of HanchorBio’s product candidates, 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. Clinical findings, including preliminary results, may change as additional patients are enrolled, data mature, and analyses are completed. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.

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