Hyundai Bioscience Offers Free XAFTY® Supply and Trial Funding to WHO for Ebola Emergency Response
核心洞察
Hyundai Bioscience USA (搜索) pledged to provide its broad-spectrum antiviral XAFTY® (搜索) (CP-COV03) free of charge for emergency use in African Ebola (搜索) outbreaks, following a proposal from UCSD virologist Dr. Davey Smith.
Lab testing shows XAFTY® (搜索)'s IC50 against Ebola (搜索) is stronger than against SARS-CoV-2, and the drug has completed a 300-patient COVID-19 (搜索) Phase 2/3 trial establishing human safety.
The proposal invokes the WHO MEURI framework, which permits emergency administration of unapproved interventions during fatal epidemics when no treatment alternatives exist.
Hyundai Bioscience USA (搜索) announced on June 10, 2026, that it has pledged to provide its broad-spectrum antiviral candidate, XAFTY® (搜索) (CP-COV03), free of charge for emergency use and/or testing for patients in African countries experiencing Ebola (搜索) outbreaks. The decision follows a proposal from Dr. Davey Smith, a virologist and clinical trial expert at the University of California San Diego, who urged the rapid testing of XAFTY® as a potential therapeutic and/or prophylactic for Ebola patients. Hyundai Bioscience USA has submitted an official letter conveying the proposal to the World Health Organization (WHO) and to the health authorities of affected countries.
The MEURI Framework and Emergency-Use Rationale
Dr. Smith's proposal rests on the WHO's Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) framework. Under MEURI, in a fatal-epidemic emergency for which no treatment alternative exists, 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 or in vitro results) and clinical safety have been secured. The framework places the highest priority on trying to save lives in a crisis.
Dr. Smith assessed that XAFTY® (搜索) fully satisfies these provisions, citing its in vitro activity against Ebola (搜索) and its strong human safety profile. Hyundai Bioscience USA (搜索) plans to supply its stored XAFTY® free of charge and immediately upon request from WHO or local authorities.
Pre-Existing Human Safety Data and Potency Against Ebola (搜索)
XAFTY® (搜索) has already secured human safety data by successfully completing a 300-person COVID-19 (搜索) Phase 2/3 trial in Korea. Under International Council for Harmonisation (ICH) guidelines, a drug whose safety has 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.
In vitro results showed that the IC50 of XAFTY® (搜索)'s active ingredient against the Ebola (搜索) virus produced strong inhibition even at a lower concentration than against SARS-CoV-2, the virus that causes COVID-19 (搜索). The active ingredient, niclosamide, has demonstrated antiviral activity against 33 human-infecting viruses across 16 viral families through a mechanism that modulates the host cell's autophagy pathway rather than directly targeting the virus, conferring resilience to viral variants.
Company-Funded Trial Contingency
The proposal also includes a contingency for cases where WHO or local health authorities judge that a rapid clinical trial to verify efficacy is more appropriate than immediate emergency administration under MEURI. Dr. Smith asked Hyundai Bioscience USA (搜索) whether it would be willing to bear the trial costs directly to shorten the typically lengthy timeline associated with crisis trials, and the company agreed to deploy a local trial rapidly at its own expense if necessary.
Jason Kim, President of Hyundai Bioscience USA (搜索), stated: "In high-fatality diseases such as Ebola (搜索), treatment opportunities must not be missed because of procedures and costs. 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."
Dr. Davey Smith's Expertise
Dr. Smith serves as Chief of the Division of Infectious Diseases and Global Public Health at UC San Diego. During the COVID-19 (搜索) pandemic, he served as Lead Principal Investigator of the U.S. government's ACTIV-2 program, rigorously evaluating candidate therapeutics from numerous global pharmaceutical companies. He has also participated as a key investigator in large-scale NIAID clinical trials addressing African endemic diseases and the global Mpox crisis, providing him with deep insight into Africa's public-health infrastructure and the clinical management of high-risk viruses.
Hyundai Bioscience USA (搜索), a member of the U.S. Department of Defense's Medical CBRN Defense Consortium (MCDC), confirmed that the XAFTY® (搜索) clinical drug supply is stored in compliance with regulations and is kept ready for rapid supply once necessary procedures are completed.