HanchorBio Doses First Patient in Taiwan in Phase 1 Trial of HCB301
Marks the first clinical milestone in Taiwan for what the Company believes is the world’s first tri-specific SIRPα-Fc fusion protein in clinical evaluation
[Taipei, Shanghai, San Francisco | April 8, 2026] — HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and immune-related diseases, today announced that the first patient in Taiwan has been dosed in HCB301-101, the Company’s ongoing first-in-human Phase 1 clinical study of HCB301.
HCB301-101 is an open-label, multiregional, multicenter, dose-escalation study evaluating HCB301 in adults with advanced solid tumors or relapsed/refractory classical Hodgkin lymphoma. The study is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity, while supporting dose finding for future development.
To HanchorBio’s knowledge, HCB301 is the first tri-specific SIRPα-Fc fusion protein to enter global clinical evaluation, and this milestone marks the first such program to reach the clinic in Taiwan.
HCB301 was designed to coordinate blockade of three interdependent immune suppressive pathways—CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R—within a single engineered Fc fusion molecule. As previously disclosed by the Company, HCB301 integrates an AI-guided (AlphaFold), structurally engineered SIRPα-Fc backbone, an anti-PD-L1 VHH, and an engineered TGF-β receptor. The program reflects HanchorBio’s broader view that, in many tumors, durable anti-tumor activity may require multi-pronged, synergistic modulation of innate immune suppression, adaptive checkpoint signaling, and suppression in the tumor micro-environment (by a dominant cytokine), rather than the blockade of a single immunosuppressive pathway.
“This first-patient-dosed milestone in Taiwan is important not only for HCB301, but also for what it represents scientifically and technologically,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “To our knowledge, HCB301 is the first tri-specific SIRPα-Fc fusion protein to enter clinical evaluation globally, and this milestone marks the first such program to reach the clinic in Taiwan. HCB301 was designed from the outset around a clear translational hypothesis: in tumors shaped by prolonged immune resistance, targeting a single checkpoint may not be enough. We believe coordinated modulations of three signaling pathways, namely CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R may offer a more clinically powerful and potentially more efficacious approach to addressing innate, adaptive, and stromal immune suppression simultaneously by a single biological molecule. Equally important, a molecular of this complexity must be developed in a way that supports manufacturability, quality control, and reliable clinical supply.”
The Taiwan milestone is also significant because it moves HCB301 beyond regulatory readiness and into active clinical execution in Taiwan. For the physicians and patients this program is intended to serve, this milestone marks an important transition from molecular design and study activation to real-world clinical development.
“We have seen strong interest in HCB301 from oncologists and immuno-oncology specialists in Taiwan, particularly because it was designed to simultaneously modulate three important immunosuppressive pathways in a single molecule,” added Alvin Luk, Ph.D., M.B.A., C.C.R.A., President & Chief Medical Officer (Group) and CEO (USA) of HanchorBio. “Reaching this first clinical milestone in Taiwan is important not only scientifically and clinically, but also because it demonstrates real execution behind the program. The challenge in multi-functional immunotherapy is not simply adding more targeting arms, but doing so in a way that remains clinically usable. This milestone marks the beginning of real clinical development for HCB301.”
HCB301 is part of HanchorBio’s proprietary FBDB™ (Fc-Based Designer Biologics) platform, which focuses on engineering multifunctional biologics designed to modulate complex immune pathways and support rational therapeutic development across oncology and immune-related diseases.
The Company will continue to advance HCB301-101 in accordance with the clinical protocol and applicable regulatory requirements.
About HCB301-101
HCB301-101 (NCT06487624) is an ongoing first-in-human, open-label, multiregional, multicenter Phase 1 study evaluating HCB301 in adults with advanced solid tumors or relapsed/refractory classical Hodgkin lymphoma. The study is assessing safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity (RECIST/iRECIST) and is intended to support dose-finding for future development.
About HCB301
HCB301 is an investigational tri-specific fusion protein designed to simultaneously modulate the CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R pathways. The molecule is intended to simultaneously trigger innate immune activation, adaptive checkpoint inhibition, and stromal modulation in a single construct.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx) 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.