Hyundai Bioscience USA offers Free Drug Supply and Funding for Clinical Trials to WHO

– Dr. Davey Smith, a Leading U.S. Infectious Disease Expert: "XAFTY^® Should Be Urgently Tested to See if it Can Address the Ebola Crisis"

– Lab testing confirms potency against Ebola (IC50) stronger than against COVID-19, trials or emergency use should move quickly given previous human safety data

– Presents an emergency-administration track and regulatory rationale based on the WHO emergency-use guideline of Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI)

SAN JOSE, Calif., June 11, 2026 /PRNewswire/ -- Hyundai Bioscience USA announced on June 10 that it has pledged to provide its broad-spectrum antiviral candidate, XAFTY^® (CP-COV03), free of charge for emergency use and/or testing for patients in African countries experiencing Ebola outbreaks.

The decision came after Dr. Davey Smith, a virologist and clinical trial expert at University of California San Diego, proposed to Hyundai Bioscience USA the rapid testing of a potential therapeutic and/or prophylactic for Ebola patients in Africa. Agreeing with Dr. Smith's proposal, Hyundai Bioscience USA decided to submit an official letter conveying the proposal to the WHO and to the health authorities of the affected countries.

• No-cost clinical supply and rapid testing under emergency provisions based on expert medical judgment

Dr. Smith proposed the testing of XAFTY^® for Ebola based on his expert judgment that the spread of high-fatality Ebola constitutes a grave emergency, and that XAFTY^® meets the conditions for immediate testing under current MEURI rules.

According to the WHO MEURI framework , in a fatal-epidemic emergency for which there is no treatment alternative, a candidate may be administered to patients pre-emptively—even before formal approval, and even if an immediate clinical trial cannot be launched—provided that minimal scientific data (such as cell-based/in vitro results) and clinical safety have been secured.^{1 2} This is an international public-health mechanism allows the emergency use of unapproved drugs under defined conditions, placing the highest priority on trying to save lives in a crisis.

Dr. Smith considered XAFTY^® to fully satisfy these provisions (i.e., in vitro activity and strong human safety profile). Accepting the proposal, Hyundai Bioscience USA plans to respond to the crisis by supplying its stored XAFTY^® free of charge and immediately upon request from WHO or local authorities.

• Company-Funded Trial Support to Enable Rapid Clinical Evaluation 

At the same time, the proposal includes a contingency in case the WHO or local health authorities judge that, even amid the crisis, a rapid clinical trial to verify efficacy is more appropriate than immediate emergency administration (MEURI).

Typically, when a country or institution conducts a trial on its own during a public-health crisis, it takes a long time owing to complex procedures and budget-securing issues. Dr. Smith asked Hyundai Bioscience USA whether it would be willing to bear the trial costs directly to shorten this timeline, and the company agreed to deploy a local trial rapidly at its own expense if necessary.

In particular, XAFTY^® possesses a firm human drug history that allows it to enter trials immediately in a crisis. Under the guidelines of the International Council for Harmonisation (ICH), a drug whose safety has already been established through large-scale human administration (Phase 2 or higher) may, in a public-health emergency, skip time-consuming animal-efficacy testing and enter clinical trials immediately.³ XAFTY^® has already secured human data by successfully completing a 300-person COVID-19 trial in Korea.⁴ Further, in vitro results showed that the IC50 (the drug concentration that inhibits viral replication by 50%) of XAFTY^®'s active ingredient against the Ebola virus produced strong inhibition even at a lower concentration than against SARS-CoV-2, the virus that causes COVID-19.

Jason Kim, President of Hyundai Bioscience USA, said, "In high-fatality diseases such as Ebola, treatment opportunities must not be missed because of procedures and costs." He added, "We decided to provide the drug free of charge and to conduct a company-funded trial to save as many lives as possible. This decision was made because the spread of this highly-fatal virus cannot wait for conventional procedures."

Hyundai Bioscience USA, a member of the U.S. Department of Defense's Medical CBRN Defense Consortium (MCDC), added that the XAFTY^® clinical drug it has offered to provide to the affected countries is stored in compliance with regulations and is kept ready for rapid supply once the necessary procedures are completed.

Mr. Kim added, "The very reason a broad-spectrum antiviral exists is to have a therapy readily available when a new virus emerges and threatens lives," and "We hope the WHO and each country's health authorities will reach a rapid and transparent decision by scientifically weighing the therapeutic benefit against the potential risk."

[References]

1. World Health Organization. Emergency use of unproven clinical interventions outside clinical trials: ethical considerations. Technical document. Geneva: WHO; 25 March 2025. ISBN 9789240041745.
2. World Health Organization. Notes for the record: Consultation on Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) for Ebola Virus Disease (EVD). 17 May 2018.
3. International Council for Harmonisation. M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Current Step 4 version, 11 June 2009. Section 1.3.
4. Kim JH, Kym S, Kim S-W, et al. A randomized, double-blind, placebo-controlled trial of niclosamide nanohybrid for the treatment of patients with mild to moderate COVID-19. Nat Commun. 2025;16:7084. doi:10.1038/s41467-025-62423-4

[Appendix] Supporting Materials

[Appendix 1] The Origins of XAFTY^® and the Development of a Broad-Spectrum Antiviral

• Witnessing civil-society solidarity and launching development: XAFTY^®'s development began in the early days of the 2020 COVID-19 pandemic, as the company witnessed the "Clap for Carers" civic movement that spread from London to major cities around the world. Seeing the solidarity between the healthcare workers who cared for patients despite the risk of infection and the citizens who supported them, Hyundai Bioscience took up therapeutic development out of a sense of responsibility that, as a drug-development company, it too should make a tangible technological contribution.
  
  
• Shortening pandemic cycles and defenseless exposure without alternatives: At the time, Hyundai Bioscience analyzed data from the earlier SARS (2003) and MERS (2012) outbreaks and noted the scientific reality that the cycle of new viral epidemics was steadily shortening. Although a pandemic of variant viruses was a foreseeable future, the global pharmaceutical industry had not established in advance a universal treatment platform capable of responding immediately. As a result, in the early days of COVID-19, elderly and frail people isolated in nursing homes and underserved medical areas faced the tragic reality of mass death—left defenseless, with no therapeutic available.
  
  
• A disgrace the pharmaceutical industry must never repeat: Analyzing the large-scale loss of life that occurred in nursing homes, the company engaged in deep self-reflection. It concluded that allowing humanity to be left so defenseless—and to suffer such collective loss—even in the face of an entirely foreseeable shortening of viral cycles was a disgrace and a gap on the part of the pharmaceutical industry as a whole. The conviction that such defenseless sacrifice must never recur became the foundation of XAFTY^®'s development.
  
  
• A latecomer's reversal—turning crisis into opportunity: At a time when global pharmaceutical giants such as Pfizer and Merck had moved first to develop therapeutics targeting the specific COVID-19 virus, Hyundai Bioscience was clearly a latecomer. Yet the company turned the disadvantage of late entry into an opportunity. Rather than settling for a drug that treats only the COVID-19 in front of it, it resolved to create a "universal antiviral" capable of addressing even the unknown variant pandemics of the future with a single drug. It treated the pandemic situation—where trial patients were concentrated—as an opportunity to rapidly verify the efficacy of a broad-spectrum drug.
  
  
• The historic precedent of penicillin and a host-cell-targeting mechanism: Just as human average life expectancy was extended by more than 20 years—even without vaccines—after the appearance of penicillin, the first broad-spectrum antibiotic of the 20th century, the company judged that, in the viral-disease domain as well, a universal therapeutic capable of subduing multiple viruses with a single drug is essential. To solve "drug resistance," the chronic limitation of existing targeted therapeutics, it adopted an innovative paradigm that targets the "host-directed pathway" the virus uses to replicate, rather than the virus itself. The philosophy of administering treatment rapidly at the early symptomatic stage—without diagnostic delay for confirmation—to save lives when a new variant emerges: this is the very essence and development story of XAFTY^®.

[Appendix 2] Dr. Davey Smith's Global Authority in Infectious Diseases and Key Clinical Credentials

• Infectious-disease command at a top-tier global research institution: Dr. Davey Smith currently serves as Chief of the Division of Infectious Diseases and Global Public Health at UC San Diego (UCSD). He is a medical authority who has gone beyond basic infectious-disease research to connect real-world clinical practice with public-health policy and to help establish global standards for treating infectious diseases.
  
  
• Lead of the world's largest U.S. government (NIH)-led pandemic trial: During the COVID-19 pandemic, he served as Lead Principal Investigator of the global ACTIV-2 program, into which the U.S. government (NIH) poured an enormous national budget to accelerate therapeutic development worldwide. He rigorously evaluated the candidate therapeutics of numerous global pharmaceutical companies and personally designed and directed multinational trial protocols, gaining experience overseeing global health infrastructure at the front line of pandemic-crisis response.
  
  
• Field experience and clinical control of high-fatality viruses in Africa: He participated as a key investigator in large-scale global clinical trials (such as STOMP) that the U.S. NIH's National Institute of Allergy and Infectious Diseases (NIAID) pursued to address African endemic disease and the global Mpox crisis. Through this, he has gained the most accurate and deep insight into Africa's under-resourced public-health infrastructure, the clinical control of high-risk viruses, and practical cooperation with local health authorities.

[Appendix 3] Dr. Davey Smith's Assessment of the Ebola Crisis and the Background to the XAFTY^® Proposal

• The urgency of Ebola's spread and the necessity of deploying a universal therapeutic: Dr. Smith assessed that the current spread of Ebola in Africa is a grave public-health crisis. In particular, comparing it with Vietnam's dengue outbreak—where flexible regulatory innovation was demonstrated by approving a rapid XAFTY^® trial to help overcome the crisis—he judged that, because Ebola's fatality is equal to or greater, the rapid deployment of a "universal antiviral" that can work immediately regardless of variant is essential.
  
  
• Scientific validity based on data for 33 viruses across 16 families: The core basis for Dr. Smith's designation of XAFTY^® as an Ebola treatment alternative lies in the broad-spectrum profile of its main active ingredient, niclosamide. According to numerous publications, niclosamide has demonstrated strong in vitro inhibitory activity against 33 major human-infecting viruses representing 16 viral families. This is thanks to a mechanism that modulates the host cell's autophagy pathway, and Ebola, too, can be effectively addressed through this approach.
  
  
• Pre-established human safety and risk–benefit analysis: XAFTY^® has already secured human safety data (Human Data)—including the attainment of blood drug concentrations in the body—by completing a 300-subject COVID-19 Phase 2/3 trial in Korea. Vietnam's Ministry of Health likewise approved a dengue trial without animal-efficacy testing on the basis of this scientific data. Dr. Smith analyzed that, rather than the risk of waiting months for animal testing amid a shortage of BSL-4 facilities, the therapeutic benefit obtained by administering a drug already confirmed safe is overwhelmingly greater.

[Appendix 4] International Guidelines for Emergency Clinical Trials and Administration, and the Validity of XAFTY^®'s Drug History

• 1. The WHO emergency-use rule (MEURI framework) and emergency validity: The WHO's MEURI guideline is an official provision that permits even an unapproved drug—provided that safety data exist and the scientific basis is clear—to be administered pre-emptively to patients during the spread of an infectious disease for which there is no treatment alternative. Because XAFTY^® has secured a firm safety profile, Dr. Smith judged that the current Ebola emergency fully meets these conditions.
  
  
• 2. Grounds for company-funded trial entry and omission of animal testing in a crisis (ICH rules): Under the guidelines of the International Council for Harmonisation (ICH), a drug whose safety has already been established through large-scale human administration (Phase 2 or higher) may, in a public-health emergency, skip animal-efficacy testing and immediately enter clinical trials.
  
  
• 3. Immediate-trial feasibility based on XAFTY®'s drug history: XAFTY^® has already secured COVID-19 human data (Human Data). The U.S. affiliate's offer to bear the full cost and support a rapid trial is a realistic and scientific alternative that uses the fast track permitted under international rules to lawfully save patients.

[Appendix 5] Broad-Spectrum Profile and in vitro (Cell-Based) Results of the Active Ingredient Niclosamide

• Antiviral activity against 33 viruses across 16 families: Niclosamide, XAFTY^®'s main ingredient, showed meaningful antiviral activity at the cellular level against 33 human-infecting viruses belonging to 16 viral families. Because it assists the cell's autophagy mechanism rather than directly attacking a specific virus, it is resilient to variants.
  
  
• Ebola virus IC50 analysis: When the IC50—the concentration required to inhibit by 50% the activity of a virus, cell, enzyme, or the like—was measured, XAFTY^®'s IC50 against the Ebola virus was superior (i.e., at a lower concentration) to that against COVID-19, whose efficacy has been proven in human trials, or against dengue virus, currently in trials.
  
  
• Pharmacokinetic (PK) validity: On the basis of the blood drug concentrations in the body confirmed through the trial in 300 COVID-19 patients, the Ebola virus, too, can be expected to show sufficiently effective inhibitory activity within the existing dosing range.

SOURCE Hyundai Bioscience