Hyundai Bioscience Confirms Entry into U.S. FDA Phase 2 Trials for Broad-Spectrum Antiviral 'XAFTY' Following 2026 Biotech Showcase Consensus

- UCSD's Dr. Davey Smith, former ACTIV-2 Protocol Chair, endorses 'Xafty' as "The weapon to end the virus war." 
- Announces "One Drug, Two Tracks" strategy: Targeting Dengue in Vietnam and Respiratory Viruses (Flu, COVID, RSV) in the U.S. with the same drug. 
- Dr. Davey Smith: "With this multi-virus treatment, 2026 may mark the inaugural year of modern treatments that can treat multiple viruses with one drug, perhaps even viruses that haven't hit us yet."

SAN FRANCISCO, Jan. 14, 2026 /PRNewswire/ -- Hyundai Bioscience (KOSDAQ: 048410) today announced a groundbreaking roadmap to combat global viral epidemics, officially declaring its entry into Phase 2 clinical trials in the United States.

Presenting at the Biotech Showcase 2026, the company unveiled its pre-emptive therapeutic strategy using Xafty™, a broad-spectrum antiviral drug. The presentation highlighted a bold transition: "Preparation in Vietnam is complete. Now, it is America."

- Dr. Davey Smith: "The Broad-Spectrum Weapon We Have Been Waiting For."

The core of the announcement centered on the clinical strategy designed in collaboration with Dr. Davey Smith, Professor of Medicine and Assistant Vice Chancellor at the University of California, San Diego (UCSD).

Dr. Smith, a world-renowned expert who previously led the U.S. government's ACTIV-2 COVID-19 trials, diagnosed the current U.S. healthcare crisis as a "tripledemic" of Influenza, RSV, and COVID-19 variants, for which there is no unified countermeasure.

In a statement regarding the new clinical design, Dr. Smith emphasized, "We now have a promising weapon to fight multiple viruses at the same time. Xafty's 'Basket Trial' design is the only efficient way to solve this multi-viral crisis." He further urged, "There is no time to lose. We must proceed with the trials necessary with maximum speed to deliver this solution to patients who are currently defenseless."

- "One Drug, Two Tracks": A Universal Solution

Hyundai Bioscience presented its unique "One Drug, Two Tracks" global strategy. The company is using the same drug (Xafty) to target:

* Dengue Fever in Vietnam (Track 1)

* Upper-Respiratory Infection Viruses in the US (Track 2)

This approach validates the drug's breadth and potency, demonstrating its potential to treat both mosquito-borne and respiratory viral infections. This mechanism is analogous to modern antibiotics that can treat multiple bacterial types with a single drug.

Mr. Jason Kim, CEO of Hyundai Bioscience USA, stated, "At the showcase, we confirmed that our strategy, designed with Dr. Smith, perfectly aligns with the unmet needs of the U.S. medical field. Our preparation is complete. We are ready to submit our IND application to the FDA immediately."

- Vision: "2026, The Inaugural Year of a Virus-Free Era"

The announcement concluded with a historic vision for global public health, articulated by Dr. Smith. "For too long, we have been chasing after variants," Dr. Smith noted. "But with this pre-emptive, broad-spectrum approach, we are finally getting ahead of the curve. I am confident that this trial will be a turning point for modern antivirals that can tackle multiple viruses with one drug."

About Hyundai Bioscience:

Hyundai Bioscience is a biotechnology company focused on developing novel drug delivery systems (DDS) to repurpose existing drugs for new therapeutic applications. The company is a member of the US Medical CBRN Defense Consortium (MCDC). Its lead candidate, Xafty (CP-COV03), is an oral antiviral drug based on niclosamide, modified for enhanced bioavailability.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially. The Company undertakes no obligation to update these statements except as required by law.

Media Contact:
Jason Kim
[email protected]
(562)964-3910

SOURCE Hyundai Bioscience