ACCESS Newswire·Aug 13, 2026, 10:00 AM ET

Ukraine's Ministry Of Health Advances Entolimod Review Into Technical Assessment Phase

Ukraine's Ministry of Health accepted Valion Bio's Entolimod regulatory dossier for formal review on July 22, 2026.
The Ministry has initiated a technical assessment \& issued its first round of questions regarding the physicochemical characterization of the drug product.
Valion Bio has identified specific regulatory requirements including analytical testing, quality-control validation, GMP verification, import documentation, \& Ukrainian-language labeling.
The company anticipates a potential regulatory decision as early as the fourth quarter of 2026, though timing \& outcome remain uncertain.
A favorable decision would mark Entolimod's first national registration \& could establish a pathway for inclusion in Ukraine's strategic reserves \& government procurement.
No procurement, purchase, or stockpiling agreements have been executed \& registration alone would not generate revenue.
Entolimod is an investigational TLR5 agonist designed as a medical countermeasure for acute radiation syndrome (ARS) to protect hematopoietic \& gastrointestinal tissues.
The regulatory review follows a Ministry Request for Information regarding potential inclusion in national strategic reserves amidst heightened radiological risks.
Management states a favorable outcome would open a path toward potential strategic stockpiling subject to separate procurement processes.
Valion Bio notes that Entolimod has received FDA Fast Track \& Orphan Drug designations but these do not constitute marketing approval.