HanchorBio Announces FDA Type C Meeting Minutes Supporting a Clear Development Path for HCB101 in Second-Line Gastric/GEJ Cancer
Official minutes support Phase 2 lead-in dose/schedule optimization followed by an OS-primary confirmatory strategy in HanchorBio’s lead clinical anchor indication
[Taipei, Shanghai, San Francisco | June 30, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced receipt of the official minutes from its recent U.S. Food and Drug Administration (FDA) Type C meeting regarding the post-Phase 1 development strategy for HCB101.
The official meeting minutes provide HanchorBio with a clear and workable FDA-facing development direction for HCB101 in second-line gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma, which the Company views as the lead clinical anchor for potential registrational path for the program. The purpose of the meeting was to meaningfully reduce strategic uncertainty around HCB101’s lead development path in second-line GC/GEJ cancer. Based on the FDA feedback, the Company plans to proceed with a staged combination dose/schedule exploration strategy in the ongoing Phase 1b/2a HCB101-201 multi-cohort study (NCT06771622), intended to support the selection of candidate regimens for a randomized Phase 2b lead-in, followed by the confirmatory Phase 3 study.
HCB101 is HanchorBio’s engineered SIRPα-IgG4 Fc fusion protein designed to selectively block CD47–SIRPα “don’t eat me” signaling while reducing red-blood-cell binding. The program is being developed as a myeloid-enhancing immune backbone for rational combination therapy, with second-line GC/GEJ cancer as the lead development focus.
The FDA meeting minutes document that the Agency did not object to HanchorBio’s proposal to shift the near-term development focus away from a monotherapy RP2D declaration and toward a prospective optimization of the every-2-week (Q2W) combination dose/schedule. The minutes also reflect FDA’s feedback that continued combination dose exploration with ramucirumab and paclitaxel is appropriate, and that a confirmatory Phase 3 strategy (with OS as the primary endpoint) is the appropriate registrational direction in this setting.
“The FDA meeting minutes are important because they provide a clear and workable regulatory direction for HCB101 in second-line gastric/gastroesophageal junction cancer, while also reinforcing the broader strategic direction of HanchorBio,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “We view second-line gastric/gastroesophageal junction cancer as the clinical anchor for our myeloid-enhancer platform — a setting where we can establish a disciplined development path and build the foundation for expansion into other myeloid-rich tumors. We believe this outcome supports a clear next step: optimize the dose for the Q2W schedule first, then advance to the Phase 2b lead-in followed by the Phase 3 study in a clinically defined setting with a comparator arm of the globally established standard-of-care regimen. Over time, we also believe this platform can extend beyond CD47–SIRPα biology into broader multi-axis tumor microenvironment modulation, and potentially beyond oncology into autoimmune, cardiovascular, and CNS diseases.”
In the meeting minutes, FDA indicated that the Company’s proposed staged Q2W combination regimen exploration in the ongoing Phase 1b/2a HCB101-201 multi-cohort study appears reasonable at the current stage of development, subject to full protocol submission and review. The minutes also clarify key elements of the future registrational path in second-line GC/GEJ cancer, including prior trastuzumab deruxtecan for HER2-positive patients, where locally approved and clinically appropriate, with any exceptions prospectively documented; and conduct of the future study in a multiregional framework relevant to U.S. patients. In addition, the minutes support prospective handling of biomarker-defined prior targeted therapy in the study population, aligned with current treatment practice for HER2-positive and CLDN18.2-positive disease.
“We believe second-line gastric/gastroesophageal junction cancer is the right lead development setting for HCB101 because it offers a clinically defined population, a globally established standard-of-care regimen, interpretable endpoints, and a focused registrational path,” added Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “Our objective has been to align the program around the most decision-useful next step. The FDA meeting minutes help clarify the path, supporting prospective Phase 2 lead-in dose/schedule optimization in combination with ramucirumab and paclitaxel, followed by a confirmatory Phase 3 study. Together with HCB101’s orphan drug designation in gastric cancer, this gives us a clearer framework to execute the program in a disciplined and registration-oriented manner.”
As part of this optimization strategy, HanchorBio plans to continue evaluating not only safety, pharmacokinetics, pharmacodynamics, and receptor occupancy, but also treatment deliverability in the intended ramucirumab and paclitaxel regimen, including the practical impact of paclitaxel dose modification, consistent with the FDA feedback. The Company believes this is important for disciplined regimen selection in second-line GC/GEJ cancer.
HanchorBio plans to incorporate the FDA’s feedback into the ongoing development of HCB101, including protocol refinement for dose/schedule exploration, the randomized Phase 2b lead-in dose optimization, safety characterization, and the Phase 2/3 master protocol statistical framework for future clinical study submissions.
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 myeloid-enhancing immune backbone for rational combination therapy across selected solid tumors.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company is led by an experienced team with a proven track record in biologics discovery and global development, aiming to reshape the landscape of cancer therapies. HanchorBio’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics with diverse targeting modalities, designed to activate both innate and adaptive immune pathways and overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has delivered proof-of-concept data in several in vivo tumor animal models. HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations in R&D and scalable CMC strategies. For more information, please visit: https://www.HanchorBio.com
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, regulatory decisions, protocol development, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.