SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that the company and its co-development partner, Sanofi, have received regulatory approval to initiate clinical trials in a pediatric population in China of its 21-valent pneumococcal conjugate vaccine (PCV) candidate, GBP410. This approval marks a key step toward entering one of the world’s most strategically important vaccine markets.

The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has approved the Phase 1 and Phase 3 Clinical Trial Applications (CTA) for GBP410, which is being co-developed with global pharmaceutical company Sanofi. As local clinical data is a prerequisite for a marketing authorization in China, the company plans to promptly initiate a local Phase 1 trial and will enter Phase 3 in China following completion of this study.

In an earlier multi-country Phase 2 trial in a pediatric population, GBP410 demonstrated immunogenicity and safety comparable to a licensed control vaccine. The ongoing global Phase 3 program includes more than 7,700 healthy infants to adolescents from 6 weeks old up to 17 years.

It is the first PCV candidate with more than 20 serotypes to enter phase 3 trial in the pediatric population and is expected to make a significant contribution to reducing cases of invasive pneumococcal disease (IPD), which remains a serious health concern in this age group.

According to the World Health Organization (WHO), approximately 300,000 children under the age of five worldwide die every year due to Streptococcus pneumoniae which is the leading cause of vaccine-preventable fatalities in this age group. This underscores the critical need for pneumococcal vaccines like GBP410.

Particularly, Streptococcus pneumoniae is a major pathogen of invasive diseases such as meningitis, sepsis, and bacteremia, and respiratory tract infections including pneumonia in Chinese children. A systematic review of studies on community-acquired pneumonia (CAP) in China from 2001 to 2015 indicated that Streptococcus pneumoniae was the second most common bacterial pathogen in CAP cases among children under 5 years old in mainland China.

To ensure a stable supply of GBP410, SK bioscience has recently completed the expansion of its vaccine manufacturing plant, L HOUSE in Andong, South Korea, adding approximately 4,200㎡ of new manufacturing space. The expanded site will serve as the production base for GBP410, with plans to secure U.S. FDA cGMP certification.

Jaeyong Ahn, CEO of SK bioscience, said, “Following the expansion of our production infrastructure for GBP410, the recent approval to initiate clinical trials in China represents another important milestone. With this momentum, we are committed to accelerating our joint efforts with Sanofi to establish a strong presence in the global pneumococcal vaccine market through the successful development, launch, and supply of GBP410.”