SK Boscience revealed an exclusive licensing agreement with the Gates Medical Research Institute (Gates MRI) granting SK rights to develop and commercialize RSM01, a clinical-stage respiratory syncytial virus (RSV) preventive monoclonal antibody (mAb) candidate, with specified global access commitments and differentiated supply terms across income markets. Under the arrangement, SK bioscience will hold exclusive commercial rights in high-income countries and non-exclusive supply rights in India and Gavi-supported nations, while also advancing manufacturing scale-up to support broad access.

Deal specifics, including any upfront or milestone payments and royalties, were not publicized in the company’s announcement. SK bioscience said the licence encompasses rights to advance the antibody candidate through development and enable global supply arrangements tailored by region.

Deal context

RSM01 is an RSV preventive mAb engineered with Adimab collaboration expertise and designed for administration to newborns and infants entering or during their first RSV season, with the aim of providing sustained protection through a single dose. RSV is a leading cause of severe lower respiratory tract disease in infants and young children globally, with significant mortality concentrated in low- and middle-income countries, particularly among infants under six months of age. Current preventive options, including maternal immunization during pregnancy and commercially available antibodies, offer protection against infection but have limitations in coverage windows, cost, and access, driving interest in broader, durable antibody strategies.

SK bioscience will lead clinical development, including planned progression into Phase Ib infant trials following encouraging Phase Ia safety and tolerability data in healthy adults in the United States, where the in-licensed antibody demonstrated general safety and a potential for sustained protection throughout the RSV season. The licenced candidate remains investigational and has not been approved by the US FDA or other regulators, underscoring the need for continued clinical validation.

SK and the Gates MRI have been collaborating since 2013, with previous initiatives including the development of typhoid and pediatric diarrhea vaccines and other antiviral preventive solutions, contributing to global public health. The two successfully developed SKYCovione, Korea’s first domestically developed COVID-19 vaccine, gaining approval in 2022. SK has also struck licensing and manufacturing partnerships with several firms, including long-term rights to manufacture and supply vaccines such as Novavax’s NVX-CoV2373 for the Korean market and selective regional markets, and technology transfer agreements for other viral vaccine programmes.