SK Bioscience Seeks South Africa Approval for Phase 1b RSV Antibody Trial

What happened

SK bioscience submitted a Clinical Trial Application (CTA) to the South African Health Products Regulatory Authority (SAHPRA) on August 17, 2026, to begin a global pediatric Phase 1b trial of RSV preventive antibody RSM01. The trial will enroll approximately 80 infants aged 2 weeks to 8 months.

Why it matters

This marks SK bioscience's expansion from vaccines into antibody-based infectious disease prevention. RSV causes severe lower respiratory tract infections in infants, and the global market for preventive antibodies is projected to reach USD 4.5 billion by 2032.