SK bioscience to get €50 mil. upfront from Sanofi for next-gen pneumococcal vaccine

SK bioscience and Sanofi have announced a new collaboration to develop a next-generation pneumococcal conjugate vaccine that surpasses the current 21-valent pneumococcal conjugate vaccine candidate, which is currently being developed by the two companies.

Under the new agreement, SK bioscience will receive an upfront payment of 50 million euros (75.6 billion won) from Sanofi, with additional milestone payments to follow upon the completion of development. Both companies will equally share research and development costs, and Sanofi will cover all commercialization expenses.

SK bioscience will handle sales in Korea, while Sanofi will manage global distribution.

This agreement expands upon their existing collaboration on GBP410, a 21-valent pneumococcal conjugate vaccine candidate. GBP410 is the first pneumococcal conjugate vaccine for infants to include more than 20 serotypes. The World Health Organization reports that pneumococcal disease causes approximately 300,000 deaths annually in children under five years globally.

According to SK bioscience, GBP410 entered global phase 3 clinical trials last week, with the first dose administered to a patient. The study aims to enroll approximately 7,700 participants aged six weeks to 17 years.

The phase 3 clinical trial follows the successful completion of phase 2 trials for GBP410 in June last year. The trials involved 140 children aged 12 to 15 months and 712 infants aged 42 to 89 days. The comparative study evaluated GBP410 against the reference vaccine, Prevnar 13, for both primary and booster immunizations. Results confirmed that GBP410 demonstrated immunogenicity equivalent to that of the reference vaccine.

In terms of safety, no severe adverse events related to the vaccine were reported in the GBP410 group. When co-administered with other recommended pediatric vaccines—such as those for tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type B—the immunogenicity and safety of GBP410 were comparable to the reference vaccine.

In preparation for the commercialization of GBP410, SK Bioscience began expansion work on its vaccine manufacturing facility, Andong L House, in March, as part of its joint investment with Sanofi.

"We are pleased to expand our collaboration to continue innovative conjugate vaccine research, addressing the high unmet need for vaccines preventing invasive pneumococcal disease," Sanofi Vaccines Executive Vice President Thomas Triomphe said.

SK bioscience CEO Ahn Jae-yong also said, "The decision to develop an even more advanced vaccine while entering phase 3 trials for GBP410 is based on the high probability of success for the 21-valent vaccine, positive market outlook, and strong mutual trust between SK and Sanofi.”

As Korea's leading vaccine company, the company will do its utmost to secure vaccine sovereignty, contribute to global health improvement, and successfully launch a blockbuster vaccine that will lead the market, Ahn added.