SK Bioscience Signs License-in Agreement with Gates Foundation Research Institute for RSV Preventive Antibody Technology

SK Bioscience has joined forces with a research institute under the Gates Foundation to develop a new RSV (respiratory syncytial virus) antibody drug.

SK Bioscience announced on the 3rd that it has signed a license-in agreement with the Gates Medical Research Institute (Gates MRI), a nonprofit medical research organization under the Gates Foundation, to introduce an RSV preventive monoclonal antibody candidate, RSM01.

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The RSV preventive antibody candidate introduced by SK Bioscience is intended for newborns and infants who are approaching their first RSV season after birth, or who are born during that season. It is designed so that a single dose can provide rapid and sustained protection throughout an entire RSV season, which is its key feature. This candidate was designed by Adimab, a U.S. biotech company specializing in the discovery and engineering of therapeutic monoclonal antibodies, in collaboration with Gates MRI.

The technological excellence of RSM01 has been confirmed through early-stage clinical trials. In laboratory tests and animal studies, the candidate effectively inhibited RSV infection and replication, and it also showed efficacy against certain RSV subtypes that respond poorly to existing preventive medicines. In a preceding clinical trial in the United States involving adults, the results suggested not only safety and tolerability, but also that a single dose could potentially maintain preventive efficacy for more than about five months. Based on these early clinical outcomes, SK Bioscience plans to swiftly initiate clinical trials in infants and young children to accelerate development.

Through this technology in-licensing, SK Bioscience has secured the exclusive right to supply the product worldwide, including to high-income countries. The agreement also includes a Global Access commitment that aligns with Gates MRI's public-interest goal of equitably delivering life-saving health technologies to the regions and populations that need them most. Accordingly, SK Bioscience plans to develop large-scale manufacturing processes in parallel so that it can supply the product at reasonable prices not only to high-income countries, but also to low-income countries where infant mortality from RSV is high. This reflects SK Bioscience's commitment to protecting public health by addressing unmet medical needs in low-income countries, in addition to pursuing commercial value in advanced markets.

RSV is a leading cause of severe respiratory disease in infants and young children worldwide, and it is estimated that every year around 100,000 infants under six months of age die globally from RSV-related illnesses. Notably, about 97% of these deaths occur in low- and middle-income countries, concentrating the burden of disease in specific regions and making RSV a serious global health challenge.

Due to this infection burden, global demand for RSV prevention continues to rise. According to global market research firm Evaluate Pharma, the global market for RSV preventive antibodies is projected to grow to 4.5 billion dollars (approximately 6.62 trillion won) by 2032. As there are currently few commercialized products and immunization is centered on high-income countries, the market is expected to expand further if uptake broadens beyond these countries.

The World Health Organization (WHO), in a recently published report, also analyzed that "depending on price accessibility and inclusion in National Immunization Programs (NIPs), demand for RSV preventive antibodies could increase explosively," identifying RSV prevention as one of the public health markets that warrants the closest attention going forward.

Ahn Jae-yong, CEO of SK Bioscience, said, "This RSV preventive antibody candidate we have introduced is a strategic pipeline that will secure both public health impact and business profitability, and it will become a key task for strengthening the competitiveness of our mid- to long-term portfolio," adding, "We will continue to reinforce our business competitiveness and drive sustainable growth based on technology-focused investments and expanded global partnerships."

Meanwhile, SK Bioscience and the Gates Foundation have been walking together for global public health promotion since they began collaborating in 2013 on the development of various vaccines, including those for typhoid and pediatric enteritis. In particular, with support from the Gates Foundation, SK Bioscience initiated development of a COVID-19 vaccine in 2020 and successfully commercialized it, further strengthening their partnership. During visits to Korea in 2022 and last year, Bill Gates, Chair of the Board, held one-on-one meetings with SK Bioscience to reaffirm the strong trust between the two organizations and agreed to jointly respond to a wide range of diseases and infectious threats.

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