SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced that the company’s board of directors has decided to invest in the expansion of L HOUSE, a vaccine manufacturing plant of SK bioscience located in Andong, South Korea to approximately 4,200㎡ through joint investment with Sanofi.
The newly expanded facility will be utilized to manufacture the 21-valent pneumococcal vaccine candidate ‘GBP410’ (also known as SP0202) that SK bioscience and Sanofi are jointly developing. 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.
Currently, SK bioscience and Sanofi are preparing for a global Phase III clinical trial with the goal of commercializing the vaccine candidate with expected regulatory submission in 2027. SK bioscience plans to manufacture the vaccine at L HOUSE facility, supplying it to the global market once it is authorized.
SK bioscience plans to expand new manufacturing facilities to cGMP (Current Good Manufacturing Practice) level, U.S. manufacturing and quality control standards.
The cGMP is one of the most demanding standards in the world for domestic biopharmaceutical companies to enter the U.S. market.
L HOUSE had already obtained EU-GMP from the European Medicine Agency (EMA) in 2021 for the first time among Korea’s vaccine manufacturing plants. EU-GMP is a set of regulations that evaluates and certifies the entire process of vaccine manufacturing, including purchase of raw materials, manufacturing, quality control, and shipment. It is considered the highest level of the standards in the world, along with cGMP in the United States.
Jaeyong Ahn, CEO of SK bioscience said, “This expansion will serve as a cornerstone of our strategic entry into overseas markets for the core pipeline currently under development. In addition to the R&PD Center to be established in 2025, we will grow as innovative leaders in the vaccine and bio industries with manufacturing facilities qualifying global standards.”