SK bioscience has submitted a Clinical Trial Application (CTA) to South Africa’s health regulator for a global Phase 1b clinical trial of RSM01, an RSV preventive antibody candidate licensed from the Gates Medical Research Institute.

The trial will evaluate the safety and pharmacokinetics of RSM01 in around 80 infants aged 2 weeks to 8 months. The study marks an expansion of the candidate’s clinical development from adults to infants, who are particularly vulnerable to severe RSV infections.

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The development strengthens SK bioscience’s infectious disease prevention portfolio beyond vaccines into antibody-based preventive technologies. The company is also expanding its global R&D network through partnerships focused on RSV, pneumococcal and rotavirus vaccines, with the aim of developing broader solutions against infectious disease threats.

Jaeyong Ahn, CEO of SK bioscience, said, “Advancing this next-generation infectious disease prevention technology, secured through a global partnership, into global clinical development by combining it with our own R&D capabilities represents a meaningful milestone. We will continue to strengthen our ability to respond to global infectious disease threats by securing and advancing diverse prevention platforms.”

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