HanchorBio has achieved a major regulatory milestone with the HanchorBio FDA orphan drug designation for HCB101. The designation supports the development of the company’s next-generation immunotherapy for gastric cancer, including advanced gastric adenocarcinoma across HER2-positive and HER2-negative subtypes.
This marks the first HanchorBio FDA orphan drug designation and highlights the urgent need for better treatment options. Gastric cancer patients often face limited therapies and poor outcomes, especially in later treatment stages.
HanchorBio FDA Orphan Drug Designation Marks Key Milestone
The HanchorBio FDA orphan drug designation validates the company’s strategy to develop differentiated immunotherapies. It also provides regulatory incentives that can accelerate clinical progress.
Benefits of orphan designation include tax credits for qualified clinical trials, exemption from certain FDA fees, and the potential for seven years of market exclusivity after approval in the United States.
HCB101 Designed to Improve Immunotherapy Outcomes
HCB101 is a next-generation inhibitor targeting the CD47–SIRPα pathway. It is engineered as an affinity-optimized SIRPα-IgG4 Fc fusion protein to enhance safety and effectiveness.
The therapy aims to restore macrophage-mediated phagocytosis and improve antigen presentation. At the same time, it minimizes hematologic toxicities that have limited earlier CD47-targeting treatments. This design supports combination use with established standards of care.
Clinical Trials Show Early Promise
HCB101 is currently being evaluated in multiple clinical studies. These include a Phase 1b/2a trial assessing the therapy in combination with ramucirumab and paclitaxel for second-line advanced gastric cancer.
Early findings indicate promising antitumor activity and a safety profile aligned with the molecule’s differentiated design. Researchers have also observed consistent tumor shrinkage while maintaining compatibility with standard treatment regimens.
Addressing Unmet Needs in Gastric Cancer
Gastric cancer remains a rare disease in the United States, falling below the FDA threshold for orphan status. Despite advances in targeted therapies and immune checkpoint inhibitors, durable responses remain limited.
The HanchorBio FDA orphan drug designation underscores the seriousness of the disease and the need for innovative therapies. It strengthens HCB101’s position as a globally relevant asset and supports continued engagement with multinational partners for collaboration and licensing opportunities.
Global Development Plans for HCB101
HanchorBio plans to advance HCB101 through global clinical development. The company is also exploring its potential as a backbone immunotherapy across multiple solid tumor indications.
With strong regulatory support and encouraging early data, HanchorBio is positioning HCB101 as a promising candidate to improve outcomes for patients facing significant unmet medical needs.
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