SHANGHAI, Oct. 30, 2025 -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced the initiation of a Phase II clinical study of AK0610, a fully human monoclonal antibody designed to prevent respiratory syncytial virus (RSV) infection. Building on ArkBio's previous experience and knowledge in development of RSV therapeutics, this milestone marks a major step forward in RSV prevention and enriches the company's innovative anti-RSV drug portfolio.
The multicenter, randomized, double-blind, placebo-controlled, dose-escalation phase II study will assess the safety, tolerability, and pharmacokinetics of AK0610 Injection in healthy infants in China. The study will be conducted at five centers nationwide, jointly led by Professor Xin Ni of Beijing Children's Hospital, Capital Medical University, and Professor Hanmin Liu of West China Second Hospital, Sichuan University.
RSV is a leading cause of acute lower respiratory tract infections (ALRTI) in children under 5 years of age worldwide. More than 80% of children become infected before their first birthday, and nearly all have been exposed at age two. Among those infected, approximately one-third may develop severe ALRTI, such as bronchiolitis or pneumonia. Infants under one year of age, particularly preterm infants, are at greatest risk of developing serious RSV-related complications, often requiring hospitalization. Given China's large infant population and persistent RSV prevalence, the country faces a significant healthcare burden, underscoring the urgent need for novel, long-acting preventive interventions.
AK0610 is a monoclonal antibody targeting the pre-fusion F protein of RSV. It was isolated from a convalescent infant and subsequently engineered to enhance durability. Distinguished by its unique binding epitope and mechanism of action, AK0610 maintains robust neutralizing activity across RSV variants, especially RSV B strains. Preclinical data demonstrated strong antiviral activity with an excellent safety profile. In the completed phase I trial in healthy adults, AK0610 was safe, well-tolerated, and exhibited favorable pharmacokinetic properties. With an extended half-life, a single dose may provide season-long protection, positioning AK0610 as a promising new-generation long-acting antibody for prophylaxis of RSV infection in infants.
Professor Xin Ni stated:
"RSV remains the leading viral cause of hospitalization among infants and young children in China, especially those under one year of age, placing a heavy burden on families and the healthcare system. There is an urgent need for domestically developed innovative preventive antibodies capable of offering durable protection throughout the RSV season. The initiation of AK0610's Phase II clinical study is an important milestone in advancing such preventive strategies. Evaluating its safety and pharmacokinetics in healthy infants is an essential step towards developing this antibody for China as well as the global vast infant population. We are optimistic that the study will pave the way for this promising drug candidate to safeguard the healthy growth of infants globally."
Professor Hanmin Liu added:
"AK0610 is a fully human monoclonal antibody with a unique mechanism of action and excellent clinical potential. Its potent, highly specific neutralizing activity and extended half-life make it a strong candidate for RSV prevention. The rigorously designed phase II study will provide important data on its safety and pharmacokinetic characteristics in infants, establishing a solid foundation for future pivotal trials. Together with participating centers across the nation, we are committed to conducting this clinical trial with scientific rigor with a goal to reduce the burden of RSV-related diseases among infants."
About ArkBio
ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory, infectious, and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal phase III results, and AK0901, an ADHD therapeutic drug, both of which have filed NDA to China CDE for market approval.
ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions.
For more information, please visit: www.arkbiosciences.com
Investor Inquiries: IR@arkbiosciences.com
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