SK Bioscience to Invest 81.5 Billion KRW in Expanding Andong Plant for Next-Generation Pneumococcal Vaccine Production

Board Approves Expansion Investment for Andong L House
Facility Expansion of 1,300 Pyeong... Joint Investment with Sanofi
To Be Used as Production Facility for Pneumococcal Vaccine 'GBP410'

SK Bioscience is preparing to enter the pneumococcal vaccine market through the expansion of its vaccine production base, Andong L-House.

Exterior view of SK Bioscience Andong L-HOUSE. [Photo by SK Bioscience]

On the 28th, SK Bioscience announced that its board of directors approved the expansion of its own vaccine production facility, 'Andong L-House,' located in Andong, Gyeongbuk, and will begin procedures for the expansion. The company stated, that with the investment amount of 81.5 billion KRW decided at this board meeting, combined with Sanofi's co-investment, a new production facility of approximately 4,200㎡ (about 1,300 pyeong) will be added to Andong L-House.

The expanded production facility will be used for the production of the 21-valent pneumococcal vaccine currently being co-developed by SK Bioscience and Sanofi. SK Bioscience announced the results of the Phase 2 clinical trial of the 21-valent pneumococcal protein conjugate vaccine 'GBP410' (Sanofi project name SP0202), conducted on infants and young children, in June.

SK Bioscience is preparing for a global Phase 3 clinical trial aiming for regulatory approval in 2027, and once the approval and related procedures are completed, plans to manufacture the product at Andong L-House and supply it to the global market.

GBP410, co-developed by SK Bioscience and Sanofi, is a protein conjugate vaccine made by conjugating a specific protein to the capsular polysaccharides of pneumococci that cause pneumonia and invasive diseases. According to the company, the protein conjugate method is known to have superior preventive effects among pneumococcal vaccines.

GBP410 includes 21 serotypes, which is more than the currently commercialized pneumococcal protein conjugate vaccines. Serotypes are one of the major pathogenic factors of pneumococci and exhibit various pathogenicities depending on the serotype. SK Bioscience explains that since GBP410 contains a wide variety of serotypes, it is expected to have broad preventive effects. The newly introduced pneumococcal vaccines in Korea are known to prevent a total of 15 serotypes.

SK Bioscience plans to expand the new production facility to meet the U.S. current Good Manufacturing Practice (cGMP) standards so that GBP410 can be utilized worldwide. The cGMP certification, known as one of the most stringent standards globally, is one of the essential requirements for Korean pharmaceutical and bio companies to enter the U.S. market.

Previously, Andong L-House was the first domestic vaccine manufacturing facility to obtain the EMA (European Medicines Agency) EU-GMP certification in 2021. EU-GMP is a certification system that evaluates the entire vaccine production process from raw material procurement to manufacturing, quality control, and shipment, and is regarded as a global-level certification alongside U.S. cGMP.

Jae-yong Ahn, CEO of SK Bioscience, said, "This expansion will serve as a foundation for the strategic overseas market entry of our core pipelines currently under development," adding, "Together with the R&PD Center to be built in Songdo in 2025, we will establish production facilities that meet global standards and grow into a truly innovative leader in the vaccine and bio sectors."

Meanwhile, the new facility for pneumococcal vaccine production will be added to the existing L-House site. SK Bioscience is working on factory expansion by purchasing a site of 99,130㎡ (about 30,000 pyeong) in the nearby Gyeongbuk Bio 2nd Industrial Complex for the L-House expansion. The 'Global R&PD Center' under construction in Songdo, Incheon, will be equipped with facilities for vaccine research and development (R&D) and pilot production, and is scheduled to be completed in the first half of 2025. Once the R&PD Center is completed, the headquarters and research institute currently located in Pangyo, Gyeonggi-do, will relocate to Songdo.

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