FDA Clears Phase II Trial of Long-Acting Influenza Prevention Drug AK0406 in the United States
SHANGHAI, Oct. 13 — Shanghai Ark Biopharmaceutical (ArkBio) announced that the U.S. Food and Drug Administration has cleared its investigational new drug application for AK0406, a long-acting antiviral drug-Fc conjugate, enabling the company to initiate a Phase II clinical trial for influenza prevention in the general population in the United States, according to a company release via PRNewswire.
AK0406 conjugates multiple potent small-molecule antivirals to an antibody Fc domain, designed to combine direct antiviral activity with Fc-mediated immune clearance. In preclinical studies, the drug demonstrated broad-spectrum, potent activity against both influenza A and B strains, with optimized pharmacokinetics and manufacturing process.
The program previously received ethics approval in Australia in February 2026 to begin a Phase I trial; enrollment and dosing of healthy adults across all cohorts were completed in July and the study entered follow-up. Citing CDC figures, the company noted that despite seasonal vaccination, the 2025-26 U.S. influenza season resulted in at least 32 million illnesses, 380,000 hospitalizations and 24,000 deaths, and that viral variation and individual immune responses can limit vaccine protection, particularly among older adults and immunocompromised people.
(Source: ArkBio)
Source: ArkBio
Published by GSM · USA (original Chinese edition)
Photo: 禽流感病毒彩色透射电子显微图（CDC 资料图），Public domain（Wikimedia Commons，摄影/作者：Photo Credit: Cynthia Goldsmith Content Providers: CDC/ Courtes）
