SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the company broke ground on a major expansion of its vaccine manufacturing plant, L HOUSE, located in Andong, Gyeongsangbuk-do, South. The groundbreaking ceremony was attended by Cheol-woo Lee, Governor Gyeongsangbuk-do, GiChang Kwon, Mayor Andong City, Pascal Robin, General Manager and Representative Director of Vaccines at Sanofi Korea, and Jaeyong Ahn, CEO of SK bioscience, on March 6, 2024.
This expansion aims to strengthen its manufacturing capabilities for global supply by adding two floors to the existing vaccine manufacturing department in L HOUSE, which will create approximately 4,200㎡ of new space. The new, expanded space will serve as a production base for the next-generation pneumococcal conjugate vaccine candidate ‘GBP410’ (also known as SP0202), jointly developed by SK bioscience and Sanofi, who are co-investing in the expansion.
GBP410 includes 21 serotypes to offer enhanced coverage of pneumococcal disease. Currently, domestically licensed pneumococcal protein conjugate vaccine includes up to 15 serotypes. However, the burden of disease associated with these serotypes has diminished, while the burden of disease associated with those excluded from the vaccine has risen. Hence, there is a strong demand for a vaccine like GBP410 which encompasses a broader range of serotypes.
Diseases caused by Streptococcus pneumoniae (the pneumococcus) are a major public health problem worldwide. The World Health Organization (WHO) estimates that about a million children succumb to this disease annually, with more than 300,000 being under 5 years of age.
The Protein conjugation methods applied to GBP410 combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumococcal diseases. The protein conjugation method, which enhances immunogenicity by triggering a T-cell immune response, is said to be the most effective pneumococcal vaccine ever developed.
In June 2023, SK bioscience and Sanofi announced positive results from its Phase II clinical trials evaluating the safety and immunogenicity of ‘GBP410’ in infants, raising optimism for the development of a vaccine with blockbuster potential.
The Phase II study, which enrolled 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89 days, demonstrated comparable immunogenicity of GBP410 compared to the control vaccine, following the primary vaccination at 2, 4, and 6 months of age as well as the booster vaccination for ages of 12 to 15 months. This study was conducted in the United States, Canada, and Honduras and it commenced in May 2020.
In particular, GBP410 is expected to offer a 5 to 7 percent wider preventive range than the 20-valent vaccine currently developed globally for invasive pneumococcal disease (IPD) across all ages if GBP410 is successfully commercialized.
The data also showed a well-tolerated safety profile, with comparable reactogenicity profile to the control vaccine and no vaccine-related serious adverse events. Furthermore, GBP410 did not interfere with the immunogenicity and safety profile of the co-administered recommended pediatric vaccines, such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type b vaccines.
The companies are currently preparing for a global Phase III clinical trial with an expected regulatory submission in 2027.
In addition to facility expansion, SK bioscience plans to quickly obtain cGMP (Current Good Manufacturing Practice) certification for the new facility, which is the standard for pharmaceutical manufacturing and quality management in the United States, to enhance global competitiveness. L HOUSE has already obtained EU-GMP certification from the European Medicines Agency (EMA) in 2021, making it the first domestic vaccine manufacturing facility to do so.
SK bioscience and Sanofi plan to utilize the expanded manufacturing facility to accelerate the successful introduction of GBP410 into the global market, including United States, Europe, and South Korea. The combination of SK bioscience’s and Sanofi’s expertise is expected to create synergies and drive rapid market share expansion worldwide.
According to Evaluate Pharma, the pneumococcal vaccine market is the largest segment in the global vaccine market and is forecasted to grow from $8.47 billion in 2023 to $10.3 billion by 2028.
Jaeyong Ahn, CEO of SK bioscience, said, "L HOUSE, which demonstrates global competitiveness in manufacturing capabilities, will firmly establish itself as a global vaccine hub through this expansion. We will make every effort to achieve successful development and supply of a vaccine with blockbuster potential."
Meanwhile, SK bioscience continues to push ahead to ensure global competitiveness across all aspects, spanning from vaccine design to production by establishing the cGMP-level manufacturing facility at the R&PD Center in Songdo. This facility will play a pivotal role in collaborations with global partners, as it will be constructed as a Pilot Plant for conducting small-scale tests before the introduction of a new process or product.