Hyundai Bioscience Launches U.S. Phase 2 Trials for Broad-Spectrum Antiviral Xafty
Hyundai Bioscience has revealed an ambitious new plan aimed at addressing worldwide viral outbreaks, confirming the launch of its Phase 2 clinical trials in the United States.
During its presentation at Biotech Showcase 2026, the company outlined a forward-looking antiviral approach centered on Xafty, a broad-spectrum therapeutic designed to combat multiple viruses. Marking a decisive shift in focus, the company stated that preparations in Vietnam have been finalized and that efforts are now moving to the U.S. market.
A Long-Awaited Broad-Spectrum Antiviral
A major focus of the announcement was the clinical framework developed in partnership with Dr. Davey Smith, Professor of Medicine and Assistant Vice Chancellor at the University of California, San Diego (UCSD).
Dr. Smith, an internationally recognized infectious disease specialist who previously headed the U.S. government’s ACTIV-2 COVID-19 clinical trials, described the current public health landscape in the U.S. as a “tripledemic” driven by influenza, RSV, and emerging COVID-19 strains—conditions that currently lack a single, comprehensive treatment solution.
Commenting on the trial design, Dr. Smith explained that Xafty offers the potential to address several viral infections simultaneously. He noted that the innovative “basket trial” model enables efficient evaluation across multiple viruses and represents a practical response to the ongoing multi-virus challenge. Emphasizing urgency, he stressed the importance of accelerating clinical progress to bring new treatment options to patients as quickly as possible.
“One Drug, Two Tracks”: A Global Strategy
Hyundai Bioscience also introduced its “One Drug, Two Tracks” development model, which deploys Xafty across two distinct clinical pathways:
During its presentation at Biotech Showcase 2026, the company outlined a forward-looking antiviral approach centered on Xafty, a broad-spectrum therapeutic designed to combat multiple viruses. Marking a decisive shift in focus, the company stated that preparations in Vietnam have been finalized and that efforts are now moving to the U.S. market.
A Long-Awaited Broad-Spectrum Antiviral
A major focus of the announcement was the clinical framework developed in partnership with Dr. Davey Smith, Professor of Medicine and Assistant Vice Chancellor at the University of California, San Diego (UCSD).
Dr. Smith, an internationally recognized infectious disease specialist who previously headed the U.S. government’s ACTIV-2 COVID-19 clinical trials, described the current public health landscape in the U.S. as a “tripledemic” driven by influenza, RSV, and emerging COVID-19 strains—conditions that currently lack a single, comprehensive treatment solution.
Commenting on the trial design, Dr. Smith explained that Xafty offers the potential to address several viral infections simultaneously. He noted that the innovative “basket trial” model enables efficient evaluation across multiple viruses and represents a practical response to the ongoing multi-virus challenge. Emphasizing urgency, he stressed the importance of accelerating clinical progress to bring new treatment options to patients as quickly as possible.
“One Drug, Two Tracks”: A Global Strategy
Hyundai Bioscience also introduced its “One Drug, Two Tracks” development model, which deploys Xafty across two distinct clinical pathways:
- Dengue fever trials in Vietnam
- Upper respiratory viral infection trials in the United States
By advancing the same drug in different viral settings, the company aims to demonstrate Xafty’s wide-ranging antiviral capability, spanning both mosquito-transmitted and respiratory infections. The strategy mirrors the versatility of modern antibiotics that are effective against multiple bacterial strains.
Jason Kim, CEO of Hyundai Bioscience USA, noted that discussions at the showcase confirmed strong alignment between the company’s clinical strategy and unmet needs within the U.S. healthcare system. He added that all preparations are in place and that the company is ready to promptly file its Investigational New Drug (IND) application with the U.S. Food and Drug Administration.
Looking Ahead: A New Era in Antiviral Treatment
The presentation concluded with a forward-looking vision for global health. Dr. Smith observed that antiviral development has historically been reactive, focused on chasing evolving variants. He expressed confidence that a preventive, broad-spectrum approach could redefine the field, positioning this clinical trial as a potential milestone in the development of antivirals capable of targeting multiple viruses with a single therapy.
Jason Kim, CEO of Hyundai Bioscience USA, noted that discussions at the showcase confirmed strong alignment between the company’s clinical strategy and unmet needs within the U.S. healthcare system. He added that all preparations are in place and that the company is ready to promptly file its Investigational New Drug (IND) application with the U.S. Food and Drug Administration.
Looking Ahead: A New Era in Antiviral Treatment
The presentation concluded with a forward-looking vision for global health. Dr. Smith observed that antiviral development has historically been reactive, focused on chasing evolving variants. He expressed confidence that a preventive, broad-spectrum approach could redefine the field, positioning this clinical trial as a potential milestone in the development of antivirals capable of targeting multiple viruses with a single therapy.
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