SK bioscience has entered the final stage of clinical trials for its pneumococcal vaccine and is accelerating preparations for commercialization. The company is expanding its production facilities in partnership with Sanofi and has also entered the Chinese market, one of the largest in Asia.

Although the company posted an operating loss of 31.2 billion won ($22.5 million) in the second quarter of this year based on separate financial statements, continuing its trend of losses, it is maintaining its aggressive R&D investment policy. Notably, SK bioscience has invested 33.7 billion won to expand its vaccine portfolio, with more than half of its total R&D expenses dedicated to commercializing its vaccines.

Among the vaccines currently under development, the product closest to commercialization is GBP410, a pneumococcal vaccine for children. Since signing a joint development agreement with Sanofi in 2014, the company has been conducting global phase 3 clinical trials and is on the verge of commercialization.

GBP410 has demonstrated equivalent immunogenicity and safety to existing approved vaccines through multinational phase 2 clinical trials, and phase 3 trials are underway in about 7,700 children and adolescents worldwide. Upon launch, it is expected to compete with Pfizer's Prevenar 20 (20-valent vaccine) and MSD's Vaxneuvance (15-valent vaccine), and is being developed to cover 20 or more serotypes.

Production capacity is also being expanded in line with commercialization. SK bioscience has expanded its vaccine production facility at L House in Andong, North Gyeongsang Province, securing approximately 4,200 square meters of new space. The facility is expected to obtain certification from the U.S. FDA for current good manufacturing practices (cGMP) in mid-2026.

The company is also moving forward with its entry into the Chinese market. Clinical trials in China are mandatory for local sales, and SK bioscience recently received approval from the Center for Drug Evaluation (CDE) under the China's National Medical Products Administration (NMPA) for its phase 1 and 3 clinical trial applications (CTAs) for GBP410. The goal is to quickly complete phase 1 in China and then proceed to phase 3.

The company plans to actively utilize its cooperation network with Sanofi to penetrate the Chinese market. Sanofi has experience in launching various vaccines and immunotherapeutics in China, including the respiratory syncytial virus (RSV) preventive antibody therapy “Beyfortus” (nirsevimab), and this know-how is expected to contribute to the commercialization of GBP410.

“GBP410 is scheduled to complete global phase 3 trials by 2027 and then initiate the regulatory approval process, with commercialization expected as early as 2028,” an SK bioscience official said.