SK Bioscience is accelerating its efforts to expand its production infrastructure to penetrate the global market. On May 29, the company announced the completion of the expansion of its vaccine production facility, 'L HOUSE,' located in Andong, Gyeongsangbuk-do, and has received approval for building use from the city of Andong.
This expansion is part of a strategic move to secure production capacity for the 21-valent pneumococcal vaccine candidate, 'GBP410,' which SK Bioscience is co-developing with global pharmaceutical company Sanofi. The expansion transformed the previously single-story production building into a three-story facility, adding approximately 4,200 square meters of space. The funding for the expansion was provided through a joint investment by both companies.
Following the completion of the expansion, SK Bioscience plans to immediately commence the installation of internal process equipment and will pursue cGMP (current Good Manufacturing Practice) certification from the U.S. Food and Drug Administration. This certification is a mandatory requirement for entering the U.S. market and is considered one of the strictest quality standards worldwide. Obtaining it will further solidify L HOUSE's position as a global vaccine supply hub. Notably, in 2021, L HOUSE became the first domestic vaccine production facility to receive EU-GMP certification from the European Medicines Agency.
Currently, GBP410 is undergoing Phase 3 clinical trials in Australia, the United States, and South Korea. The trials involve approximately 7,700 children and adolescents aged six weeks to 17 years, evaluating the immunogenicity and safety of the vaccine in up to four doses compared to existing licensed vaccines. Phase 2 trials had previously demonstrated similar levels of immune response and safety as the control vaccine.
GBP410 is the first pneumococcal vaccine in clinical Phase 3 to include more than 20 serotypes, and it is expected to offer broad protection against invasive pneumococcal diseases (IPD). According to the World Health Organization, approximately 700,000 children under five die from pneumonia each year globally, with around 300,000 deaths attributed to pneumococcal infections. Consequently, demand for vaccines with broader preventive coverage continues to rise.
SK Bioscience and Sanofi are leveraging their respective strengths to maximize synergy. SK Bioscience focuses on vaccine production and development capabilities, while Sanofi contributes its expertise in product commercialization and regulatory approvals in the global market. Together, they are working towards the commercialization and market expansion of their co-developed product.
In December of last year, the companies expanded their development collaboration for GBP410 and initiated the development of a next-generation pneumococcal conjugate vaccine expected to provide broader preventive effects than existing products. This strategy aims to further strengthen their global vaccine pipeline.
Jae-Yong Ahn, President of SK Bioscience, stated, “The L HOUSE expansion represents a critical step towards equipping our infrastructure to meet global standards, marking a decisive moment in our emergence as a world-leading vaccine production hub.”
