- SK bioscience has licensed an early-clinical stage RSV preventive monoclonal antibody from the Gates Medical Research Institute, with plans to advance development and manufacturing.
- The agreement grants exclusive commercial rights in high-income countries and includes global access commitments and non-exclusive supply to India and Gavi-eligible countries.
SK bioscience has announced that it will advance a novel respiratory syncytial virus (RSV) preventive monoclonal antibody under a licence agreement with the Gates Medical Research Institute (Gates MRI). The clinical-stage candidate is intended for the prevention of RSV infection in newborns and infants and will be developed and commercialised globally if proven safe and effective.
Under the agreement, SK bioscience has secured exclusive worldwide commercialisation rights in high-income countries, alongside non-exclusive supply rights in India and Gavi-supported countries. The licence also includes global access commitments aligned with Gates MRI’s charitable mission, with SK bioscience planning to advance large-scale manufacturing process development to support affordable supply to low- and middle-income countries.
The monoclonal antibody candidate, engineered by Adimab in collaboration with Gates MRI, is designed for single-dose administration to infants during their first RSV season. In preclinical studies, the antibody, known as RSM01, demonstrated inhibition of viral infection and replication in both in vitro and in vivo models, including activity against certain RSV strains with reduced susceptibility to currently licensed products.
In a Phase 1a first-in-human study conducted in healthy adults in the United States, the candidate was shown to be generally safe and well tolerated, with data suggesting the potential for sustained protection throughout an RSV season following a single administration. Based on these results, SK bioscience plans to progress the programme into a Phase 1b clinical trial in infants.
“This newly in-licensed RSV preventive monoclonal antibody candidate is a strategic programme that aligns public-health impact with commercial viability.”
Jaeyong Ahn, CEO of SK bioscience
The company said the programme supports its broader strategy to address unmet medical needs while strengthening its portfolio through global partnerships and expanded development capabilities.
