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Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio), a commercial-stage biotechnology company focused on the discovery and development of innovative therapeutics for respiratory/lung and paediatric diseases, announced 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 the National Medical Products Administration (NMPA) of China, 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. 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 show 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 optimized profile for both prophylaxis and treatment of influenza infection.
On the global clinical development front, ArkBio received approval from the Australian Human Research Ethics Committee (HREC) in February 2026 to initiate a phase I clinical trial of AK0406. Enrollment and dosing of healthy adult volunteers in all cohorts have been completed in Australia, and the trial has now entered the follow-up phase.
Influenza remains a critical global public health challenge. Current flu preventive measures centred on seasonal vaccines face significant limitations, including the inability to effectively address antigenic drift, uncertainty in annual strain prediction and matching, and substantially reduced protective efficacy among elderly and immunocompromised populations, leaving significant unmet clinical needs.
ArkBio will maintain close interactions with the CDE to advance the clinical development of AK0406 in China, while continuing the follow-up work of the ongoing phase I study in Australia. By pursuing a parallel, dual track development pathway in China and globally, the company aims to accelerate the clinical programme to deliver a safer, more effective, and convenient solution for influenza prevention worldwide.
ArkBio is a commercial-stage biotechnology company focused on the discovery and development of innovative therapeutics for respiratory/lung and paediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated R&D pipeline through internal innovation and strategic collaborations.
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