Shanghai Ark Biopharmaceutical Secures US FDA IND Clearance for Phase II Trial of Long-Acting Influenza Prevention Drug AK0406
13 October 2026 | Tuesday | News
Novel antiviral drug-Fc conjugate aims to provide extended protection against seasonal influenza, addressing preventive gaps among vulnerable populations.
Shanghai Ark Biopharmaceutical announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK0406, a long-acting antiviral drug-Fc conjugate (AFC), enabling the company to initiate a phase II clinical trial for influenza prevention in general population in the United States.
Addressing Gaps in Influenza Prevention
Seasonal vaccination remains central to influenza prevention. However, changes in circulating influenza viruses and variability in individual immune response can limit vaccine protection, particularly among older adults and people who are immunocompromised. Additional preventive approaches could help address these unmet needs.
According to the U.S. Centers for Disease Control and Prevention (CDC), despite the availability of influenza vaccines, the 2025–2026 influenza season resulted in at least 32 million illnesses, 380,000 hospitalizations and 24,000 deaths in the United States.
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