HanchorBio, Inc., a global clinical-stage biotechnology company focused on advancing next-generation immunotherapies for oncology and autoimmune diseases, has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation (ODD) to its lead candidate HCB101 for the treatment of gastric cancer. This designation, announced on February 13, 2026, covers gastric cancer broadly, encompassing advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes. The decision underscores the pressing unmet medical needs in this rare disease area, where current therapies often fall short in providing durable responses and manageable toxicity profiles.

HCB101 represents an innovative approach in immuno-oncology as the first SIRPα-IgG4 Fc fusion protein to receive Orphan Drug status specifically for gastric cancer. Engineered with affinity optimization and toxicity mitigation, HCB101 targets the CD47–SIRPα pathway to restore macrophage-mediated phagocytosis and enhance antigen presentation. Unlike earlier CD47-targeting agents that were hampered by hematologic toxicities, HCB101's design enables safer combination with standard-of-care treatments, positioning it as a potential backbone for innate immune checkpoint inhibition in solid tumors.

This Orphan Drug Designation provides HanchorBio with critical incentives, including tax credits for qualified clinical trial expenses, exemption from FDA user fees, and seven years of market exclusivity upon approval in the United States. These benefits are particularly valuable for advancing rare disease programs like gastric cancer, which affects fewer than 200,000 individuals annually in the U.S., qualifying it under FDA's orphan criteria. The milestone validates HanchorBio's strategic focus on differentiated immunotherapies and supports ongoing efforts to engage multinational partners for collaboration and licensing opportunities.

Currently, HCB101 is under evaluation in a Phase 1b/2a clinical trial (NCT06771622), combining it with ramucirumab and paclitaxel in second-line advanced gastric cancer patients. Preliminary data have shown promising antitumor activity, including depth of tumor shrinkage and response consistency, alongside a safety profile that aligns with standard combination regimens. This data reinforces the molecule's potential in a setting where second-line options offer limited efficacy, highlighting HCB101's role in addressing gaps in gastric cancer treatment.

Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio, emphasized the importance of this achievement, stating it confirms the company's scientific, regulatory, and development strategies. Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.), noted that the IgG4-based design supports repeated dosing and combination therapies, crucial for solid tumor applications. HanchorBio, with operations in Taipei, Shanghai, and the San Francisco Bay Area, leverages its team's expertise in biologics discovery and international development to push forward transformative cancer therapies.

The broader implications for the pharmaceutical industry are noteworthy. Orphan Drug Designations like this one facilitate investment in underserved areas, potentially accelerating innovation in oncology. For contract research organizations (CROs), contract manufacturing organizations (CMOs), and pharmaceutical outsourcing partners, HCB101's progression signals opportunities in clinical trial support, CMC manufacturing, and supply chain solutions tailored to biologics. As HanchorBio advances toward U.S. and global development, it could spur partnerships in pharmaceutical process machinery, validation services, and quality assurance, aligning with key B2B categories.

Gastric cancer's poor prognosis, especially in advanced stages, drives demand for novel agents like HCB101. Despite progress in HER2-targeted therapies and checkpoint inhibitors, second-line outcomes remain suboptimal. HanchorBio's focus on minimizing on-target toxicities positions HCB101 for rational combinations, potentially expanding its utility beyond gastric cancer into other solid tumors. This development also highlights the FDA's role in fostering biotech innovation through regulatory incentives, benefiting R&D heads, regulatory teams, and technology vendors in the ecosystem.

Looking ahead, HanchorBio plans to leverage this designation to expedite clinical advancement and explore strategic alliances. The company's pipeline, emphasizing multi-functional molecular configurations and improved CMC processes, addresses critical unmet needs. Stakeholders in biotechnology, contract services, and pharmaceutical instrumentation will monitor HCB101's trajectory closely, as it exemplifies how targeted regulatory strategies can propel next-generation therapies toward commercialization. This milestone not only bolsters HanchorBio's position but also contributes to the evolving landscape of immuno-oncology, promising enhanced patient outcomes through collaborative B2B efforts.