Large-scale production facility completed for GBP410, a 21-valent pneumococcal conjugate vaccine candidate, co-developed with Sanofi.

Company accelerates efforts for global launch through ongoing global Phase 3 trials of GBP410 and plans to obtain cGMP certification.

“We will contribute to global public health and vaccine access through successful vaccine development and supply.”

SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that the company has completed a major expansion of its vaccine production facility, L HOUSE, in Andong to strengthen its global infrastructure and accelerate entry into the global vaccine market.

The facility recently received building use approval from the City of Andong. The approval is an official certification issued by local authorities confirming the safety and suitability of newly constructed or expanded buildings for use.

The expansion aims to establish commercial-scale production capacity for GBP410, a 21-valent pneumococcal conjugate vaccine (PCV) candidate jointly developed with global pharmaceutical company Sanofi. Through joint investment, SK bioscience added two floors to the existing vaccine manufacturing department in L HOUSE, which created approximately 4,200㎡ of new space.

SK bioscience plans to swiftly obtain the U.S. FDA’s cGMP (current Good Manufacturing Practices) certificate, the standard for pharmaceutical manufacturing and quality management in the United States. With the cGMP certificate, L HOUSE is expected to take a major step forward in becoming a global vaccine supply hub. Notably, L HOUSE previously demonstrated its global competitiveness by becoming the first Korean vaccine manufacturing site to obtain EU-GMP certification from the European Medicines Agency (EMA) in 2021.

GBP410 entered global Phase 3 studies in December last year, starting in Australia and expanding to the U.S., South Korea, and other countries. The trial evaluates the immunogenicity and safety of GBP410 in more than 7,700 healthy infants, toddlers, young children, and adolescents aged 6 weeks to 17 years after up to four doses, depending on the age at enrollment. In earlier Phase 2 trials, GBP410 demonstrated immunogenicity and safety comparable to the control vaccine, Prevnar 13.

GPB410 is the first PCV candidate with more than 20 serotypes to enter phase 3 trials in infants and toddlers and is expected to make a significant contribution to reducing cases of invasive pneumococcal disease (IPD), which remains a serious health concern in this age group.

According to the World Health Organization (WHO), approximately 300,000 children under the age of five worldwide die every year due to Streptococcus pneumoniae which is the leading cause of vaccine-preventable fatalities in this age group. This underscores the critical need for pneumococcal vaccines like GBP410.

SK bioscience and Sanofi expect to leverage the scientific and technical know-how of both companies, including SK bioscience’s advanced technology and production capacity and Sanofi’s expertise in global product development, regulatory affairs and in launching innovative vaccines to achieve rapid market share expansion worldwide.

Furthermore, in December 2024, the two companies expanded their collaboration beyond the development and commercialization of GBP410. The expanded agreement aims to co-develop next-generation PCVs for both pediatric and adult populations with the potential to provide broader protection than those currently licensed, further strengthening the companies’ pneumococcal development pipeline.

Jaeyong Ahn, CEO of SK bioscience, said, “The expansion of L HOUSE marks a key milestone in establishing the facility as a global vaccine hub. Through our successful partnership with Sanofi, we will continue to lead as Korea’s premier vaccine company and contribute to advancing global public health.”