Announcement • Aug 15

SK Bioscience Submits Clinical Trial Application for Global Pediatric Phase 1B Study of RSM01 RSV Preventive Antibody Candidate

SK bioscience announced that it has submitted a Clinical Trial Application (CTA) to the South African Health Products Regulatory Authority (SAHPRA) for a global pediatric Phase 1b clinical trial of RSM01, a respiratory syncytial virus (RSV) preventive antibody candidate licensed from the Gates Medical Research Institute (Gates MRI), a nonprofit medical research organization affiliated with the Gates Foundation. The Phase 1b study will enroll approximately 80 infants aged 2 weeks to 8 months and evaluate the safety and pharmacokinetic profile of RSM01. Through the study, SK bioscience aims to assess the clinical development potential of RSM01 as an RSV preventive antibody for infants and establish a foundation for subsequent late-stage clinical development. RSM01 is a preventive antibody candidate that SK bioscience secured through a licensing agreement with Gates MRI in February 2026. Gates MRI conducted the candidate's early-stage research and Phase 1a clinical development in adults. The new Phase 1b study marks an important step in expanding RSM01's clinical development from adults to infants, a key population targeted for RSV prevention. RSV is a major respiratory virus that can cause severe lower respiratory tract infections in infants and young children, with a particularly significant disease burden during the first months of life. Because very young infants may have limitations in developing sufficient active immunity through direct vaccination, preventive strategies that provide immediate passive immunity through the administration of antibodies can play an important role. Against this backdrop, the development of antibody-based approaches to RSV prevention continues to advance globally. According to global market research firm Evaluate Pharma, the worldwide market for RSV preventive antibodies is projected to reach USD 4,500 million by 2032. With several preventive antibodies already commercialized, primarily in developed markets, demand for RSV prevention among infants and young children is expected to continue driving market growth. SK bioscience is expanding its respiratory disease prevention portfolio from cell-culture influenza vaccines and pneumococcal vaccines into RSV antibody-based preventive technologies. By building R&D capabilities spanning both vaccines and antibody-based approaches, the company aims to address a broader range of unmet needs in infectious disease prevention. SK bioscience continues to expand its global R&D network through collaborations including the joint development of a pneumococcal vaccine with Sanofi, its RSV prevention partnership with Gates MRI, and the introduction of injectable rotavirus vaccine technology from the U.S. Centers for Disease Control and Prevention (CDC). Building on these global partnerships, the company plans to further broaden its infectious disease prevention portfolio.

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