SK Bioscience Completes Expansion of Andong L HOUSE

Preparing to Become a Global Vaccine Hub

SK Bioscience L HOUSE Expansion Rendering. Photo by SK Bioscience

SK Bioscience is accelerating its preparations for global expansion by newly establishing large-scale production infrastructure.

On May 29, SK Bioscience announced that it has completed the expansion of its vaccine production facility, 'Andong L HOUSE,' which began in March last year, and has obtained approval for building use from the city of Andong. Building use approval is an administrative procedure in which a local government reviews and authorizes whether a completed facility is suitable for use.

With this, SK Bioscience has expanded the vaccine production building within the existing L HOUSE from one floor to three floors, securing approximately 4,200 square meters (1,300 pyeong) of new space. This expansion aims to secure production facilities for 'GBP410,' a 21-valent pneumococcal vaccine candidate co-developed with global pharmaceutical company Sanofi. The costs required for the expansion were jointly invested by both companies.

With the completion of the expansion, SK Bioscience plans to quickly begin establishing internal process equipment and to pursue cGMP (Current Good Manufacturing Practice) certification, the U.S. standard for pharmaceutical manufacturing and quality control. cGMP is one of the strictest standards in the world and is an essential requirement for entering the U.S. market. If certification is obtained, L HOUSE is expected to become a global vaccine supply hub. L HOUSE has already demonstrated its global competitiveness by becoming the first domestic vaccine manufacturing facility to obtain EMA's EU-GMP certification in 2021.

GBP410 has been undergoing global Phase 3 clinical trials since December last year, starting in Australia and continuing in the United States, Korea, and other regions. This clinical trial is being conducted with approximately 7,700 infants, children, and adolescents aged six weeks to 17 years, comparing the immunogenicity and safety of up to four doses of GBP410 with already approved pneumococcal vaccines. In previous Phase 2 clinical trials, GBP410 demonstrated immunogenicity and safety equivalent to those of the comparator vaccine.

GBP410 is the first vaccine candidate to enter Phase 3 clinical trials for infants and young children that includes more than 20 serotypes. It is expected to make a significant contribution to reducing the incidence of invasive pneumococcal disease (IPD), which remains a serious health issue in this age group.

According to the WHO, globally, about 700,000 children under the age of five die from pneumonia each year, and approximately 300,000 of these deaths are due to pneumococcal disease. Since pneumococcal disease is a leading cause of vaccine-preventable deaths in this age group, the demand for vaccines like GBP410, which offer broader protection, continues to grow.

The two companies plan to rapidly expand their market share worldwide by leveraging SK Bioscience's outstanding technology and manufacturing capabilities, Sanofi's global product development and regulatory expertise, and both companies' scientific and technical know-how to create synergy.

Meanwhile, in December last year, SK Bioscience and Sanofi expanded the scope of their collaboration for the development and commercialization of GBP410, signing an agreement to develop a next-generation pneumococcal conjugate vaccine that is expected to offer even broader protection than currently commercialized products. Through this, they aim to further strengthen the global pneumococcal vaccine development pipeline.

Jae-Yong Ahn, CEO of SK Bioscience, said, "This expansion will make Andong L HOUSE, which has already proven its global production capabilities, a true global vaccine hub," and added, "We will become a leading vaccine company representing Korea by contributing to global public health through the successful development and supply of pneumococcal vaccines."

This content was produced with the assistance of AI translation services.