By Fineline Cube 
Shanghai Ark Biopharmaceutical Co., Ltd. (ARK) today announced the official start of a Phase II clinical study evaluating AK0610, a fully human monoclonal antibody designed to prevent respiratory syncytial virus (RSV) infection.
Why AK0610?
- Target – AK0610 binds the RSV F‑protein at a novel epitope isolated from convalescent infants and refined through antibody engineering.
- Broad Activity – The unique binding site confers potent neutralization against circulating RSV strains, especially the mutation‑prone RSV B type.
- Long‑Lasting Protection – Phase I data in healthy adults showed a favorable safety profile and an extended half‑life, with a single dose expected to cover an entire RSV season.
Preclinical and Early Clinical Milestones
- Preclinical – Demonstrated high‑affinity, strain‑specific neutralization and a robust safety margin in animal models.
- Phase I – 100+ healthy volunteers received a single dose; no serious adverse events were reported, and the pharmacokinetic profile supported once‑season dosing.
Phase II Study Design
- Objective – Assess efficacy and safety of AK0610 in preventing RSV infection among high‑risk infants and young children during peak RSV season.
- Enrollment – 800 participants across 12 sites in China and the United States.
- Outcome Measures – Incidence of RSV‑confirmed lower respiratory tract infection, hospitalization rates, and antibody durability over 6 months.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech