SK bioscience, Sanofi land China trial nod for world’s broadest pediatric pneumonia vaccine
SK bioscience and Sanofi have received approval to begin clinical testing of their 21-valent pneumococcal conjugate vaccine candidate, GBP410, in China.
The green light clears a critical hurdle toward regulatory approval in a market that rivals the United States in size and demand for pediatric immunizations.
On Friday, SK bioscience said China’s Center for Drug Evaluation under the National Medical Products Administration approved its application to begin both phase 1 and phase 3 studies of GBP410.
Local data is a prerequisite for approval in China, and the company said it intends to “complete phase 1 quickly” before jumping into a registrational trial.
“This marks another major milestone following our recent expansion of the GBP410 production base,” CEO Ahn Jae-yong said in the release. “Together with Sanofi, we’re committed to securing a strong foothold in the global pneumococcal vaccine market.”
The candidate is already in a 7,700-participant global phase 3 trial involving children and adolescents aged six weeks to 17 years. It previously cleared a multi-country phase 2 study that showed it was on par with existing vaccines in terms of immunogenicity and safety.
According to the company, GBP410 stands out for its coverage. It is the first late-stage pediatric pneumococcal vaccine candidate to target more than 20 serotypes.
That broader reach, the company said, could prove essential as pneumococcal disease remains one of the leading vaccine-preventable causes of death in young children.
In China, pneumococcus is a leading cause of invasive diseases such as meningitis and sepsis, as well as respiratory infections like pneumonia. A 15-year review of pediatric pneumonia cases identified it as the second most common bacterial pathogen in children under 5.
To prepare for commercial supply, SK bioscience recently expanded its L HOUSE vaccine manufacturing site in Andong, Korea, adding more than 4,200 square meters of production space.