The Phase 1b trial will focus on infants aged two weeks to eight months, evaluating both the safety and pharmacokinetic profile of the candidate. RSM01 was licensed from the Gates Medical Research Institute in February 2026, following successful early-stage research and adult clinical testing. By targeting the passive immunity market, the company aims to address a critical gap in care, as infants often struggle to generate sufficient active immunity through standard vaccination alone.

This development aligns with a broader industry push toward antibody-based respiratory defenses. Market projections suggest the global RSV prevention sector could reach 4.5 billion dollars by 2032. For SK bioscience, the project represents a diversification of its R&D pipeline, which already includes collaborations with Sanofi on pneumococcal vaccines and technology transfers from the U.S. Centers for Disease Control and Prevention. CEO Jaeyong Ahn noted that integrating these global partnerships into the firm’s internal research infrastructure marks a milestone in their strategy to combat infectious disease threats.