In a significant milestone marking the ten-year collaboration between SK bioscience and Sanofi, a global leader in healthcare, the two companies have embarked on an ambitious expansion of the L HOUSE, SK bioscience’s vaccine manufacturing plant in Andong, North Gyeongsang Province.

This expansion aims to bolster SK bioscience’s capabilities in global vaccine supply by adding approximately 4,200 square meters of new space across two additional floors in the L HOUSE vaccine manufacturing department.

Central to this expansion is the development and production of the next-generation pneumococcal conjugate vaccine (PCV) candidate, GBP410 (also known as SP0202), a joint venture between SK bioscience and Sanofi.

Diseases caused by Streptococcus pneumoniae 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 five years of age.

The vaccine aims to provide enhanced coverage against pneumococcal disease with its inclusion of 21 serotypes, addressing the rising demand for broader protection beyond the currently licensed vaccines that cover up to 15 serotypes.

SK bioscience stressed that the collaboration between the two companies has been instrumental in pushing the boundaries of pneumococcal disease prevention.

“Our efforts are poised to yield a vaccine that not only offers a wider preventive range than existing vaccines but also embodies the pinnacle of protein conjugation technology, enhancing immunogenicity through a T-cell immune response,” the company said.

The GBP410 project has already shown promise in phase 2 clinical trials, demonstrating comparable immunogenicity to the control vaccine and a well-tolerated safety profile.

The 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 two, four, and six months of age as well as the booster vaccination for ages of 12 to 15 months.

The expansion of L HOUSE is a strategic move to support the anticipated success and global distribution of GBP410, aiming for a regulatory submission by 2027.

The expanded manufacturing capabilities at L HOUSE are expected to accelerate the introduction of GBP410 into key markets, including the U.S., Europe, and Korea.

“Infrastructure is key in an industry where the process is the product. However, the expansion of our manufacturing plant L HOUSE for the 21 valent PCV product is also a key monument of the longstanding collaboration between Sanofi and SK bioscience,” SK bioscience CEO Ahn Jae-yong said in his LinkeIn post. “In fact, this year marks exactly 10 years since the inception of the PCV project.”