SHANGHAI, April 10, 2026 -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the first cohort of healthy volunteers has been dosed in a phase I clinical trial of AK0406, a novel long-acting antiviral drug-Fc conjugate (ADFC) drug for influenza infection, following approval by the Human Research Ethics Committee (HREC) in Australia. This milestone marks the first-in-human (FIH) evaluation of AK0406 and an important step in the global clinical development of ArkBio's influenza pipeline.
AK0406 is a next-generation, long-acting ADFC candidate discovered and developed by ArkBio. By conjugating a potent small-molecule antiviral to the antibody Fc domain, AK0406 is designed to combine the direct antiviral effect of the payload with Fc-mediated immune clearance and an extended half-life. 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 first-generation ADFC molecules, AK0406 is engineered to offer an optimized profile for both prophylaxis and treatment of influenza infection.
The phase I trial is a single-center, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of AK0406 in healthy adult participants in Australia. Data from this FIH study will inform subsequent dose selection and future proof-of-concept trials in populations at risk for influenza infection.
Influenza remains a significant global public health burden, causing substantial morbidity and mortality each year and posing an ongoing pandemic threat. Current preventive measures, including seasonal vaccination, are challenged by antigenic drift, strain-selection uncertainty, and reduced effectiveness in the general population, especially in vulnerable groups such as older adults and immunocompromised individuals. With its long-acting, broad-spectrum ADFC design, AK0406 has the potential to address key limitations of existing therapies and offer improved options for both prevention and treatment of seasonal influenza and potential pandemic outbreaks. ArkBio will continue to accelerate the clinical development of AK0406 and work with global partners to advance better prevention and treatment options for patients worldwide.
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 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 agent with positive phase 2 results in idiopathic pulmonary fibrosis and is advancing into Phase 3 registrational trials; AK0901, approved and commercialized in China for the treatment of ADHD. The company also has multiple first-in-class or best-in-class innovative candidates in clinical or preclinical development.
ArkBio has established strategic partnerships with multinational pharmaceutical companies including Roche and Genentech, leading academic institutions such as The Scripps Research Institute and the Institute of Microbiology of the Chinese Academy of Sciences, Qilu Pharmaceutical as well as other domestic and international biotech companies and CROs.
For more information, please visit: www.arkbiosciences.com
Investor Inquiries: IR@arkbiosciences.com
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