SK bioscience said it completed a large-scale expansion of its flagship vaccine manufacturing facility in Andong, North Gyeongsang Province, as it accelerates efforts to become a global vaccine supplier in partnership with multinational pharmaceutical company Sanofi.

The Korean company has received final approval from the Andong municipal government to begin operating the newly expanded section of its L HOUSE plant. The authorization follows the completion of a building inspection confirming that the upgraded infrastructure meets local safety and usage standards.

With this milestone, SK bioscience has added approximately 4,200 square meters of new space to its existing vaccine production wing, expanding the building from a single-story to a three-story structure. The construction was jointly funded by SK bioscience and Sanofi.

The company plans to rapidly install production equipment and initiate validation processes to obtain current good manufacturing practice (cGMP) certification from the U.S FDA.

The company had previously become the first Korean vaccine production site to receive EU-GMP certification from the European Medicines Agency (EMA) in 2021.

The expansion will support the manufacturing of GBP410, a 21-valent pneumococcal conjugate vaccine candidate. The vaccine entered global phase 3 trials in December 2024, beginning in Australia and expanding to the U.S. and Korea. The trial targets more than 7,700 participants aged six weeks to 17 years and compares the safety and immunogenicity of GBP410 against licensed pneumococcal vaccines across up to four dosing cycles.

In earlier phase 2 trials, GBP410 demonstrated immunogenicity and safety levels comparable to existing vaccines. Notably, it is the first pneumococcal conjugate vaccine candidate in pediatric phase 3 trials to include more than 20 serotypes, which may significantly reduce the incidence of invasive pneumococcal disease (IPD) in infants and children.

According to the World Health Organization, pneumonia is responsible for the deaths of approximately 700,000 children under the age of five each year, with nearly 300,000 of those linked to pneumococcal infections.

SK bioscience and Sanofi also expanded their collaboration in December 2024 to include a new-generation pneumococcal conjugate vaccine that is expected to offer even greater protective efficacy than currently marketed products.

“The expansion of L HOUSE marks a major step forward in our goal of becoming a global vaccine hub,” SK bioscience CEO Ahn Jae-yong said. “Through the successful development and global supply of our pneumococcal vaccine, we aim to contribute meaningfully to global public health and establish ourselves as Korea’s leading vaccine developer.”