SHANGHAI, July 24, 2026 -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today 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.
About ArkBio
ArkBio is a commercial-stage biotechnology company focused on the discovery and development of innovative therapeutics for respiratory/lung and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated R&D pipeline through internal innovation and strategic collaborations.
Key clinical pipeline assets include: ziresovir (AK0529), the first direct-acting antiviral for RSV with positive pivotal phase 3 results; AK3280, a potentially best-in-class anti-fibrotic drug with positive phase 2 results in idiopathic pulmonary fibrosis, which advances into a pivotal phase 3 trial; AK0901, a new generation ADHD drug that has been approved and commercialized in China for the treatment of pediatric and adult ADHD. ArkBio has other first-in-class or best-in-class innovative drug candidates in clinical or preclinical development.
ArkBio has established strategic partnerships with multinational and domestic pharmaceutical companies including Roche, Genentech, Qilu Pharmaceutical, and leading academic institutions such as Scripps Research and the Institute of Microbiology of the Chinese Academy of Sciences, as well as other domestic and international biotech companies and CROs, for drug discovery and development.
For more information, please visit: www.arkbiosciences.com
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