HanchorBio Showcases Pipeline Momentum with HCB101 and HCB301 Data Across Five Major Oncology Meetings in Q4 2025

Presentations highlight HCB101's differentiated profile and introduce first preclinical data from HCB301, underscoring HanchorBio's innovation in next-generation immunotherapies

TAIPEI, SHANGHAI and SAN FRANCISCO, Oct. 20, 2025 /PRNewswire/ -- HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, today announced that new clinical data from HCB101, its differentiated, engineered SIRPα-Fc fusion protein, and the preclinical results from HCB301, its next-generation tri-specific checkpoint immunotherapy, will be presented at five major international oncology congresses in the fourth quarter of 2025.

The upcoming presentations will showcase progress from HCB101, including both the HCB101-101 monotherapy (NCT05892718) and the HCB101-201 combination (NCT06771622) studies, as well as the preclinical data from HCB301, underscoring the company's innovation in advancing next-generation innate immune checkpoint therapies.

• Federation of Asian Clinical Oncology (FACO), October 24-25, 2025
  – Two poster presentations on HCB101 monotherapy and HCB101 in combination with standard of care in advanced cancers  
• Society for Immunotherapy of Cancer (SITC), November 5-9, 2025
  – Two late-breaking poster presentations from HCB101-101 and HCB101-201, highlighting safety, pharmacology, and emerging efficacy signals  
  – One poster presentation from HCB301, revealing the first-time the preclinical data from HanchorBio's novel tri-specific fusion protein targeting CD47-SIRPα, PD-1, and TGFb pathways
• ESMO Asia Congress, December 5-7, 2025
  – One abstract updating the results from HCB101-101, demonstrating safety and activity across solid tumors and hematologic malignancies
• American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025
  – Poster presentation of the first-in-human Phase 1 study of HCB101 in relapsed/refractory non-Hodgkin lymphoma
• ESMO Immuno-Oncology Congress (ESMO-IO), December 10-12, 2025
  – One abstract integrating the HCB101 monotherapy and combination data across multiple solid tumor indications

"Presenting across five major oncology meetings in one quarter underscores both the breadth and pace of HCB101's clinical progress," said Scott Liu, Ph.D., Chairman, CEO, and Founder of HanchorBio. "HCB101 continues to validate our differentiated approach to CD47-SIRPα blockade, while the first preclinical data from HCB301 showcase the innovation of our FBDB™ platform in advancing next-generation, multi-checkpoint therapies. Together, they highlight HanchorBio's commitment to delivering transformative treatments for patients with difficult-to-treat cancers and advancing the next generation of immunotherapies."

About HCB101: A Differentiated CD47-SIRPα Blockade
HCB101 is a 3.5^th-generation, affinity-optimized SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio's proprietary FBDB™ platform. It is engineered for selective CD47 targeting with low red blood cell (RBC) binding, thereby avoiding the anemia and thrombocytopenia commonly associated with earlier anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging.

Key Differentiators of HCB101:

• Enhanced safety: Demonstrates a cytopenia-sparing profile, with no dose-limiting toxicities observed up to 24 mg/kg and receptor occupancy >90% at ≥1.28 mg/kg, supporting a broad therapeutic window.
• Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy.
• Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma, and ovarian cancer.
• Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in second-line gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in first-line TNBC and second-line HNSCC, substantially exceeding historical benchmarks.

About HCB301: a Tri-Specific Checkpoint Immunotherapy
HCB301 is HanchorBio's next-generation immunotherapy designed to integrate three synergistic mechanisms into a single molecule: CD47-SIRPα blockade to activate macrophage-mediated phagocytosis, PD-1 inhibition to restore exhausted T cells, and TGF-b pathway suppression to improve tumor micro-environment. Developed using the proprietary FBDB™ platform, HCB301 represents a next-generation approach to multi-checkpoint immunotherapy. Preclinical studies demonstrated enhanced immune activation and potent antitumor activities, and the first results will be presented at SITC 2025.

About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx), a global biotechnology company specializing in immuno-oncology, is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and global development, aiming to rewrite cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.com

SOURCE HanchorBio Inc.