HanchorBio Presents Next Generation Tri-specific Biologics and Manufacturing Strategies at Biologics World Taiwan 2026

Industry leaders gathered in Biologics World Taiwan 2026 to explore new biopharmaceutical developments and manufacturing strategies. HanchorBio Founder and CEO Dr. Scott Liu and Chemistry Manufacturing and Controls (CMC) Executive Director Dr. Vivian Mengwei Kuo delivered presentations during the summit to share extensive data on tri-specific Fc fusion proteins and detailed the complex manufacturing processes required to advance these therapeutic molecules into clinical trials.

Overcoming Immuno-Oncology Limitations with Fusion Proteins

In his presentation, Dr. Scott Liu discussed innovation in immuno-oncology through the development of tri-specific Fc fusion proteins from discovery to Investigational New Drug (IND) filing. He began by explaining how current immunotherapies leave a large non-responder population. By blocking the “brake” pathway cancer cells use to evade immunity, PD-1 and PD-L1 inhibitors demonstrate broad activity across many tumor types and have brought about significant improvements in overall survival rates. However, he added that these treatments only provide durable responses in certain subsets of patients. With objective response rates (ORR) often stalling between 20 and 30% in many solid tumors, patients frequently develop drug resistance through multiple mechanisms over time.

Sharing his underlying vision, Dr. Liu noted, “It’s our belief that for human beings to conquer cancer, the most promising way is through immunology”.

To address the limitation, HanchorBio utilizes an innate backbone strategy that targets the SIRPα-CD47 axis to build multi-functional fusion proteins. The company creates these molecules using its proprietary Fc-Based Designer Biologics (FBDB) platform, which leverages ligand traps to block multiple ligands much more effectively than traditional monoclonal antibodies. This structural design enables the dual activation of innate and adaptive immunity through coordinated biological mechanisms. The molecules block the CD47 and SIRPα signal pathway to activate macrophages for tumor phagocytosis while simultaneously blocking PD-1 and PD-L1 signaling to reactivate adaptive T cells to attack tumor cells.

Dr. Liu highlighted the lead candidate HCB101 as the foundation for the broader pipeline. This engineered, 3.5th-generation SIRPα–Fc fusion protein features a red blood cell sparing design to minimize hematologic toxicity and improve patient safety. Clinical data from the Phase 1 dose escalation study showed no dose-limiting toxicities even when researchers tested doses up to 36 mg/kg. 

Current data show that HCB101 has strong efficacy across both animal models and clinical settings. In animal models of multiple types of solid tumors, HCB101 has demonstrated superior efficacy compared with biologics targeting CD47 of previous generations by showing higher tumor growth inhibition (TGI). For example, the molecule achieved 89% TGI in colorectal cancer and complete clearance in small cell lung cancer. In human trials for first-line HER2-positive gastric cancer, patients experienced deep tumor size reductions ranging from 30% to 63.3%. The ORR has reached 83.3% for mid-dosing cohorts, with 5 out of 6 patients achieving a partial response, and yielded a 100% disease control rate.

The Emergence of Tri Specific Fusion Proteins and HCB301

Building on the successful foundation of HCB101, HanchorBio advanced its pipeline with the introduction of HCB301. This innovative tri-functional molecule targets PD-L1 and SIRPa while incorporating a TGF-β trap to capture immunosuppressive cytokines and improve the tumor microenvironment. Dr. Liu detailed the highly coordinated mechanism behind this structural design. The engineered SIRPa decoy directly stimulates antigen presentation by inducing macrophage phagocytosis. Simultaneously, the PD-1 decoy blocks the PD-1 and PD-L1 pathway to enhance T cell function and guide the entire molecule directly to PD-L1 expressing tumors.

Dr. Liu emphasized the critical advantage of combining these diverse functions into a single therapeutic entity. He explained that administering three separate drugs through intravenous injection cannot guarantee they will all reach the tumor site simultaneously or maintain sufficient concentration. By linking these components into one cohesive molecule, drug developers can assure that all three functions arrive at the tumor site together to create a powerful and immediate synergy. This approach also dramatically reduces the research, clinical trial, and production costs typically associated with developing multiple combination therapies.

In addition to robust efficacy, HCB301 features a carefully engineered safety profile designed to address common clinical pain points. The molecule demonstrates significantly reduced red blood cell binding to lower the risk of on-target hematologic toxicity. This comprehensive design positions HCB301 as a first-in-class biologic, and HanchorBio has already initiated global Phase 1 clinical trials across the United States, China, and Taiwan.

In particular, Dr. Liu quoted that the global pharmaceutical industry currently develops more than 2400 biologic candidates in the clinical stage. With mono-functional drugs dominating this landscape at 73.7% while bi-functional drugs accounting for 24.4%, tri-functional molecules remain incredibly rare and represent only 1.6% of the entire pipeline. Since no tri-functional antibody or fusion protein holds global approval today, HanchorBio is eager to utilize its highly advanced FBDB platform to capture this specialized market and deliver breakthrough therapies to patients worldwide.

Mastering Manufacturing Complexity for Next-generation Fusion Protein Drugs

Moving from drug design to production, Dr. Vivian Kuo presented strategies for shifting from complexity to control. She detailed process and manufacturing excellence for next generation innovative drugs. Global regulatory agencies have approved over 160 antibody drugs. This total includes 17 bi-specific drugs, yet no tri-functional antibody or fusion protein holds global approval today. Highlighting this unique market position, Dr. Kuo described the tri-functional biologics space as an untapped ‘blue ocean’ full of opportunities”.

Next, Dr. Kuo explained the specific CMC challenges associated with the FBDB platform. When compared with antibodies, the FBDB-derived tri-specific fusion proteins usually have lower isoelectric points and melting temperature, as well as higher numbers of N-glycosylation sites and disulfide bonds. Collectively, these distinct structural and biophysical properties lead to increased physical instability of the candidate proteins and create immense manufacturing hurdles across every phase of development. For example, upstream cell cultures often suffer from low productivity, while downstream purification teams must battle high aggregation, mispairing, and difficult impurity removal. The complexity also strains analytical testing by complicating species identification and potency attribution. Ultimately, these structural hurdles result in narrow formulation windows and shorter shelf lives for the final drug products. 

HanchorBio’s manufacturing team implemented several advanced strategies to overcome these roadblocks. For upstream cell culture development, they transitioned from the traditional fed-batch (TFB) method to intensified fed-batch (IFB) process. This shift in biomanufacturing increases productivity by 1.5 to 2 fold and decreases high molecular weight impurities during the cell culture phase by 25 to 35%.

Downstream purification and formulation required equal innovation to ensure commercial viability. The engineering team navigated complex polishing chromatography steps to remove host cell proteins and aggregates. The engineers shifted the final drug product from a standard liquid format to a lyophilized powder to solve critical instability issues and provide a much longer shelf life. The freeze-dried drug maintained 94% purity after four weeks at elevated temperatures, and the overall recovery rates reached an impressive 35 to 40 %.

According to Dr. Kuo, HanchorBio established a comprehensive suite of in-house analytical tools to safeguard product quality by conducting nearly all drug substance release and stability tests internally. Their scientists utilize advanced techniques including intact mass analysis and peptide mapping, driving an analytical capacity growth of 160% to keep pace with the complex back-end requirements.

Accelerating Candidate Discovery and Development Through AI Integration

Dr. Kuo also highlighted how the integration of artificial intelligence (AI) into the development workflow accelerates candidate discovery. Historically, determining a single protein structure required time-consuming experimental methods like X-ray crystallography or NMR. Nowadays, the AlphaFold database generated by Google DeepMind provides computational access to over 214 million predicted structures. These AI predictions offer remarkable reliability, with approximately 80% of the structures achieving high or confident accuracy scores. 

Leveraging this vast resource, Hanchor’s team used AlphaFold to predict structures and rank the developability of numerous sequence variants through a rigorous de-risking funnel. They evaluated 37 initial candidates by predicting their CMC profiles and managed to screen out unstable formats, allowing them to identify the top three lead candidates for advancement. Overall, this process significantly decreases time-consuming and costly wet lab work and enables the in-house team to achieve Investigational New Drug readiness from DNA in just 13 months, saving between 5 and 17 months of development time compared to traditional outsourcing models.

Strategic Growth and TWSE Innovation Board Listing

These scientific and manufacturing milestones strongly support the broader corporate strategy of HanchorBio. The company recently announced progress toward a listing on the Taiwan Stock Exchange Innovation Board to expand its market presence. This upcoming listing will accelerate global clinical development, support continuous platform expansion, and drive international partnering efforts.

HanchorBio continues to build a robust pipeline powered by a validated innate immune backbone. The company maintains strict timeline predictability and technological independence by keeping discovery and manufacturing processes completely in-house. The compelling data shared at Biologics World Taiwan 2026 confirms that HanchorBio possesses the scientific framework and the manufacturing capabilities required to bring next-generation immuno-oncology treatments to the global market.

Author

Richard Chau