HanchorBio Announces Successful Completion of First 2,000L GMP Clinical Batch Production of HCB101
Head-to-head comparability results support high similarity, establishing a strong foundation for clinical advancement, future scale-up, and long-term manufacturing strategy
[Taipei, Shanghai, San Francisco | April 13, 2026] — HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and immune-related diseases, today announced that HCB101, one of its core FBDB™ (Fc-Based Designer Biologics) oncology pipeline assets, has successfully completed its first GMP clinical batch production scaled up from a 500L to a 2,000L bioreactor. This production was carried out at WuXi Biologics’ manufacturing facility, covering the full process from Drug Substance (DS) to Drug Product (DP), and achieved all predefined manufacturing objectives.
In biologics development, one of the most critical CMC (Chemistry, Manufacturing, and Control) milestones during the clinical stage is the successful scale-up of both process and production volume—while maintaining product quality—to levels required for commercialization, typically around 2,000L per batch. The successful completion of this 2,000L scale-up marks a significant step forward toward the commercial manufacturing readiness of HCB101.
According to internal head-to-head comparability studies conducted by HanchorBio, HCB101 produced at the 2,000L scale demonstrated high comparability to material produced at the 500L scale across key attributes, including purity, molecular heterogeneity, and functional quality characteristics. These results indicate that the scaled-up batch maintains consistent quality performance, reflecting strong process robustness and product consistency at a larger manufacturing scale.
HCB101 is one of HanchorBio’s key protein therapeutics under development and a core clinical asset of the Company. Currently in clinical development, its primary focus is on second-line treatment for gastric cancer. The successful scale-up to 2,000L represents another important milestone in manufacturing maturity and further underscores its strategic importance within the Company’s pipeline.
For protein therapeutics, process scale-up is not merely about increasing production capacity—it is a comprehensive validation of process understanding, analytical methods, quality control strategies, and external manufacturing integration capabilities. This is especially critical for complex fusion proteins such as FBDB™. Demonstrating consistent manufacturing performance across scales is essential for advancing clinical development and future commercialization. The successful scale-up and supporting comparability data indicate that HanchorBio has further strengthened its execution capabilities in manufacturing technology and quality control.
Dr. Scott Liu, Founder and Chairman of HanchorBio, stated that the primary objective of this scale-up was to verify whether HCB101 could maintain stable and predictable product quality when transitioning from 500L to 2,000L production. As both batches were manufactured at the same WuXi Biologics facility, the results clearly demonstrate the Company’s integrated capabilities in process scale-up execution, external manufacturing collaboration, and cross-scale quality control. This achievement is expected to significantly reduce future manufacturing risks and ensure sufficient drug supply for Phase II and Phase III clinical trials.
HCB101 is currently in Phase 1b/2a clinical development. The successful completion of the 2,000L GMP clinical batch not only supports current clinical supply readiness but also establishes a stronger foundation for future scale-up, long-term manufacturing planning, and progression toward pivotal clinical batch production. The Company will continue to advance HCB101’s CMC development in a prudent, data-driven manner while preparing for future commercial manufacturing.
Dr. Vivian Kuo, Executive Director of CMC at HanchorBio, commented that the key to biologics scale-up lies not simply in increasing production volume, but in maintaining consistent and stable product quality at higher scales. With HCB101 successfully scaled from 500L to 2,000L, the production output has increased significantly from approximately 8,000 vials to nearly 40,000 vials. Together with strong comparability results, this milestone reflects an enhanced understanding of process and quality control, laying a solid foundation for future clinical supply, pivotal batch manufacturing, and eventual commercial-scale production.
HanchorBio will continue advancing the development of HCB101 and its other core pipeline assets, while strengthening its capabilities in protein drug development, manufacturing, quality control, and supply chain management to enhance its global competitiveness and accelerate its mission to benefit cancer patients worldwide.
About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing red blood cell binding, a limitation that historically constrained development across the CD47 class. HCB101 is being evaluated across multiple clinical settings as both monotherapy and combination therapy.
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.
Forward-Looking Statements
This press release contains forward-looking statements based on the Company’s current expectations and beliefs regarding future events and developments. Actual results may differ materially due to risks and uncertainties, including clinical trial progress, regulatory review, manufacturing execution, market conditions, and other factors. The Company undertakes no obligation to update these forward-looking statements, except as required by applicable laws.