SK Bioscience Files for Global Pediatric Phase 1b Trial of RSV Antibody

What happened

SK Bioscience submitted a clinical trial application to South Africa's Health Products Regulatory Authority for a global pediatric Phase 1b trial of RSM01, a respiratory syncytial virus preventive antibody. The trial will enroll about 80 infants aged 2 weeks to 8 months to evaluate safety and pharmacokinetic profile.

Why it matters

RSV is a leading cause of severe lower respiratory tract infections in infants. Preventive antibodies provide immediate passive immunity, a key alternative to vaccines which are less effective in newborns. The trial marks a milestone in SK Bioscience's R&D transformation into next-generation biotech modalities, expanding its portfolio beyond vaccines. The global RSV preventive antibody market is projected to reach $4.5 billion by 2032.