SK Bioscience, Expansion of Andong L House, Vaccine Production Capacity↑

[Financial News] SK Bioscience is accelerating the establishment of large-scale production infrastructure to expand the global vaccine market.
SK Bioscience announced on the 29th that it has completed the expansion construction of the 'L House (HOUSE)' vaccine manufacturing facility in Andong, Gyeongbuk, and obtained building use approval from Andong City.
Through this expansion, which began in March last year, a new production space of approximately 4,200㎡ has been established.
This expansion was carried out to secure the foundation for the commercial production of the 21-valent pneumococcal vaccine candidate 'GBP410', which is being jointly developed by SK Bioscience and global pharmaceutical company Sanofi. The construction costs were jointly borne by both companies.
SK Bioscience plans to quickly proceed with the establishment of internal production facilities in the expanded space. It is also pursuing the acquisition of 'cGMP certification', which is the standard for pharmaceutical manufacturing and quality control by the U.S. Food and Drug Administration (FDA).
cGMP certification is one of the essential requirements for entering the global market, including the United States. Once acquired, L HOUSE is expected to further strengthen its status as a global vaccine production hub. L HOUSE was previously the first domestic vaccine manufacturing facility to receive EU-GMP certification from the European Medicines Agency (EMA) in 2021.
Currently, GBP410 is undergoing global phase 3 clinical trials in Australia, the United States, and Korea. It is being evaluated for immunogenicity and safety after administration to approximately 7,700 infants and adolescents aged 6 weeks to 17 years. Based on phase 2 clinical results that demonstrated equivalent immune response compared to existing approved vaccines, the clinical trials are progressing smoothly.
GBP410 is a pneumococcal conjugate vaccine that includes 21 serotypes, and it is the first candidate among vaccines entering infant clinical trials to include more than 20 serotypes.
It is expected to contribute to reducing the mortality rate of children under 5 years old by expanding the prevention range against invasive pneumococcal diseases (IPD). According to the World Health Organization (WHO), approximately 700,000 children under 5 years old die from pneumonia each year worldwide, of which 300,000 are due to pneumococcal infection.
SK Bioscience and Sanofi are leveraging their technological capabilities and global regulatory approval expertise to synergize and promote the commercialization of GBP410, and in December last year, they also signed a contract to develop a next-generation pneumococcal vaccine with broader preventive effects.
Jae-Yong Ahn, CEO of SK Bioscience, said, "This expansion is a significant milestone for SK Bioscience to establish itself as a global vaccine hub," and "We will continue to develop innovative vaccines that contribute to global public health, strengthening our role as a specialized vaccine company."

vrdw88@fnnews.com Kang Jung-mo Reporter