SK Bioscience Expands Andong Plant Significantly to Secure Production Capacity for 21-Valent Pneumococcal Vaccine

SK Bioscience's vaccine production base, Andong L-House, is embarking on a large-scale expansion. The plan is to secure production capacity in advance for the next-generation 21-valent pneumococcal vaccine, aiming for regulatory approval by 2027.

The groundbreaking ceremony for the expansion of SK Bioscience's Andong L House is taking place with the attendance of Odongho, CEO of SK Eco Engineering; Kwon Ki-chang, Mayor of Andong; Lee Cheol-woo, Governor of Gyeongbuk Province; Ahn Jae-yong, President of SK Bioscience; Pascal Robin, CEO of Sanofi Korea; Kim Hyung-dong, Member of the National Assembly; Park Jin-yong, Factory Manager of Andong L House; and Lee Jung-bae, Union Branch President (from left).
[Photo by SK Bioscience]

On the 6th, SK Bioscience announced on the 7th that it had commenced expansion construction and held a groundbreaking ceremony at L-House in Andong, Gyeongbuk. The ceremony was attended by Lee Cheol-woo, Governor of Gyeongbuk Province; Kwon Ki-chang, Mayor of Andong; Kim Hyung-dong, Member of the National Assembly (Andong City and Yecheon County); Pascal Robin, CEO of Sanofi Korea; and Ahn Jae-yong, President of SK Bioscience.

This expansion is being carried out through a joint investment between SK Bioscience and the global big pharma Sanofi. The vaccine production building will be expanded from one floor to three floors, securing a new space of 4,200㎡. The prepared space will be used for the commercial production of SkyPack (GBP410, Sanofi development code SP0202), a next-generation 21-valent pneumococcal vaccine candidate jointly developed by the two companies. The companies have completed Phase 2 clinical trials of SkyPack and submitted a Phase 3 clinical trial plan to the U.S. Food and Drug Administration (FDA) in December last year, preparing for global Phase 3 clinical trials. They aim to apply for approval by 2027.

One of the necessary requirements to strengthen SkyPack's global market competitiveness, the Good Manufacturing Practice (GMP) certification, will also be secured promptly. Having already obtained the EU-GMP certification from the European Medicines Agency (EMA) in 2021, they plan to swiftly pursue the current GMP (cGMP) certification required by the United States, which demands the highest quality standards worldwide.

SkyPack, jointly developed by SK Bioscience and Sanofi, targets a next-generation pneumococcal vaccine capable of preventing a total of 21 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F). It additionally prevents the 9N serotype compared to Pfizer's Prevnar 20, which currently holds the most serotypes among globally approved vaccines with 20 valents.

Prevnar 20, approved by the FDA in 2021 and launched thereafter, has rapidly dominated the market, boasting an overwhelming market share of over 90% in the United States. It has also been submitted for approval to the Korean Ministry of Food and Drug Safety. According to domestic standards, MSD's recently approved 15-valent vaccine 'Vaxneuvance' is the largest-valent pneumococcal vaccine approved in Korea.

Pneumonia is considered the leading cause of infectious death among children worldwide as a single disease. According to the World Health Organization (WHO), it is estimated that approximately 300,000 children under the age of five die annually from pneumococcal pneumonia.

Ahn Jae-yong, President of SK Bioscience, said, "With the proven global-level production capabilities of Andong L-House, this expansion will firmly establish it as a global vaccine hub," adding, "We will do our utmost to ensure the successful development and supply of the new vaccine, which has the potential to become a blockbuster."