HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer

First SIRPα-IgG4 Fc Fusion Protein Granted Orphan Status in Gastric Cancer

Published on Feb. 13, 2026

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HanchorBio, Inc., a global clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. This milestone underscores the significant unmet medical need in gastric cancer and provides important regulatory support for the continued clinical development of HCB101 in this patient population.

Why it matters

Gastric cancer remains an area of profound unmet medical need, and this designation reinforces HanchorBio's commitment to developing differentiated immunotherapies that can meaningfully improve outcomes for patients. This designation strengthens HCB101's profile as a globally relevant asset and represents a strategically important step as the company advances the program toward U.S. and international development.

The details

HCB101 is a next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein. The molecule is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation while minimizing the hematologic toxicities that have historically limited earlier CD47-targeting approaches, enabling rational combination with established standards of care. HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial assessing the drug in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer.

  • HanchorBio received the FDA Orphan Drug Designation for HCB101 in gastric cancer on February 13, 2026.

The players

HanchorBio, Inc.

A global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.

HCB101

A next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein developed by HanchorBio.

Scott Liu, PhD

Founder, Chairman, and CEO of HanchorBio.

Alvin Luk, PhD, MBA, CCRA

President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio.

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What they’re saying

“Receiving our first FDA Orphan Drug Designation is a major milestone for HanchorBio and important validation of our scientific, regulatory, and development strategy.”

— Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio (PRNewswire)

“The FDA's decision reflects the seriousness of gastric cancer and the clinical rationale underlying HCB101's development. HCB101's IgG4-based SIRPα-Fc design was intentionally selected to support repeated dosing and combination strategies as an innate immune checkpoint backbone in solid tumors.”

— Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio (PRNewswire)

What’s next

HanchorBio plans to continue advancing HCB101 through global clinical development while exploring its potential as a backbone immunotherapy across multiple solid tumor indications.

The takeaway

This FDA Orphan Drug Designation for HCB101 in gastric cancer represents a significant regulatory milestone for HanchorBio and further validates the company's strategy of advancing differentiated immunotherapies in areas of high unmet medical need.