SK Bioscience Seeks Global RSV Antibody Trial

Дата публикации: 14-08-2026 15:27:38

SK Bioscience is expanding its research and development scope in earnest beyond vaccines to antibody-based preventive medicines.SK Bioscience announced on August 14 that it submitted a clinical trial application (CTA) for a global Phase 1b clinical trial in pediatric patients for ‘RSM01’, a respirat

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SK Bioscience is expanding its research and development scope in earnest beyond vaccines to antibody-based preventive medicines.

SK Bioscience announced on August 14 that it submitted a clinical trial application (CTA) for a global Phase 1b clinical trial in pediatric patients for ‘RSM01’, a respiratory syncytial virus (RSV) preventive antibody candidate licensed from Gates MRI, a non-profit medical research institute under the Gates Foundation, to the South African Health Products Regulatory Authority (SAHPRA). This clinical trial will be conducted on about 80 infants between two weeks and eight months of age, and plans to focus on evaluating the safety and pharmacokinetic characteristics, which are the body’s responses to RSM01.

RSV is considered a major virus that causes severe lower respiratory tract infections in infants and toddlers. In particular, infants in the early stages of life with immature immune systems face a significant disease burden as it is difficult for them to form active immunity through vaccines. Accordingly, passive immunity technology, which provides immediate protective effects by directly administering antibodies, is emerging as a global alternative.

This clinical trial is significant in that it expands the development scope of RSM01, which has completed initial validation in adults, to infants, who are the actual main targets for prevention. SK Bioscience has continued its research since signing the technology transfer agreement with Gates MRI in February. Through this Phase 1b trial, the company plans to verify the possibility of clinical development and lay the foundation for entering later-stage clinical trials.

According to the global market research firm Evaluate Pharma, the global RSV preventive antibody market is expected to grow to $4.5 billion, or approximately 6.3 trillion won ($4.84 billion), by 2032. SK Bioscience is strengthening its ability to respond to respiratory diseases by broadening its lineup to include the RSV preventive antibody, following its cell-cultured influenza vaccine and protein conjugate pneumococcal vaccine.

Ahn Jae-yong, CEO of SK Bioscience, emphasized, “This is an achievement made by advancing the next-generation technology secured through global partnerships by combining it with our own R&D capabilities,” and added, “We will leap forward as a company with global competitiveness by securing various infectious disease prevention platforms.”

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