Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") announced that all cohorts of healthy volunteers have been dosed in an Australian Phase I trial with AK0406, a novel long-acting antiviral-Fc conjugate (AFC) drug for influenza prophylaxis. The clinical trial has now entered the follow‑up phase.

AK0406 is a novel long-acting antiviral agent developed by ArkBio. By precisely conjugating highly potent antiviral drugs to an antibody Fc fragment, AK0406 is designed to provide sustained pre- and post-exposure prophylaxis and potential therapeutic benefits to public population, addressing the unmet needs for influenza prevention. Preclinical data show that AK0406 exhibits broad-spectrum high-potent activity against both influenza A and B viruses, retains Fc-mediated effector functions, and provides prolonged protective effect. AK0406 has been optimized to offer an ideal pharmacological profile for both prophylaxis and treatment of influenza infection.

Influenza remains a critical global public health challenge. Current preventive measures, such as seasonal vaccines, face limitations of antigenic drift, uncertainty in strain prediction, and reduced protective efficacy among elderly and immunocompromised populations. As a new generation of AFC drug, AK0406 has the promise to deliver a safer, more effective, and convenient innovative solution for influenza prevention globally.