Chinese biopharmaceutical company Shanghai Ark Biopharmaceutical Co Ltd (ArkBio) announced on Wednesday that the Investigational New Drug (IND) application for AK0406 injection, the company's first long-acting antiviral drug-Fc conjugate (AFC) candidate for influenza prophylaxis, has been approved by China's National Medical Products Administration (NMPA), making AK0406 the first influenza AFC drug to enter clinical development in China.

AK0406 is a new generation, long-acting antiviral agent discovered and developed by ArkBio. The company says that by precisely conjugating a highly potent antiviral small molecule with an antibody Fc fragment, AK0406 is designed to provide sustained pre- and post-exposure prophylaxis and potential therapeutic benefits, addressing the high unmet needs for influenza prevention during peak seasons.

Preclinical data showed that AK0406 exerts broad-spectrum, high-potency activity against both influenza A and B viruses, maintains immune effector function, and provides prolonged exposure. Compared with other AFC molecules, AK0406 is engineered to offer an optimised profile for both prophylaxis and treatment of influenza infection.

ArkBio also received approval from the Australian Human Research Ethics Committee (HREC) in February 2026 to initiate a phase I clinical trial of AK0406. Enrolment and dosing of healthy adult volunteers in all cohorts have been completed in Australia, and the trial has now entered the follow-up phase.