SK Bioscience Advances RSV Antibody Candidate into Pediatric Trials — SK bioscience Co., Ltd.

Event summary

SK Bioscience submitted a Clinical Trial Application (CTA) to SAHPRA for a global Phase 1b trial of RSV preventive antibody candidate RSM01.
The study will enroll approximately 80 infants aged 2 weeks to 8 months to evaluate safety and pharmacokinetics.
RSM01 was licensed from Gates MRI in February 2026, marking SK Bioscience's expansion into antibody-based preventive technologies.
Global RSV preventive antibody market projected to reach USD 4.5 billion by 2032.

The big picture

SK Bioscience is diversifying its infectious disease prevention portfolio by expanding into antibody-based technologies, complementing its existing vaccine offerings. This strategic shift aligns with the growing demand for RSV prevention among infants and young children, driven by a projected USD 4.5 billion market by 2032. The company's global partnerships and R&D network strengthen its capabilities in next-generation infectious disease prevention.

What we're watching

Clinical Development Pace: The pace at which SK Bioscience can advance RSM01 from Phase 1b to late-stage clinical trials will determine its competitive positioning in the RSV prevention market.
Market Expansion Strategy: Whether SK Bioscience can successfully expand its respiratory disease prevention portfolio beyond vaccines into antibody-based technologies.
Global Partnerships: How SK Bioscience's growing global R&D network through collaborations will impact its ability to respond to infectious disease threats.