GBP410 Targets Entry into Chinese Market
Global Phase 3 Trials for Children and Adolescents Progressing Smoothly
SK Bioscience announced on July 18 that it has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China for the clinical trial application (CTA) for Phase 1 and Phase 3 clinical trials of 'GBP410,' a 21-valent pneumococcal conjugate vaccine candidate jointly developed with Sanofi.
In China, securing local clinical data is a mandatory requirement for product approval, and SK Bioscience aims to quickly complete Phase 1 clinical trials locally and then proceed to Phase 3 trials.
Previously, GBP410 demonstrated immunogenicity and safety equivalent to existing approved vaccines through multinational Phase 2 clinical trials, and a global Phase 3 trial involving more than 7,700 children and adolescents is already progressing smoothly.
GBP410 is the first vaccine candidate entering pediatric Phase 3 trials to include more than 20 serotypes. Since pneumococcal disease is a leading cause of vaccine-preventable deaths among children, the demand for vaccines like GBP410, which offer broader protection, continues to rise.
According to the World Health Organization (WHO), approximately 300,000 children under the age of five die from pneumococcal diseases worldwide. In particular, in China, pneumococcus is known as a major causative agent of not only invasive diseases such as pediatric meningitis, sepsis, and bacteremia, but also of major respiratory infections including pneumonia. A study on 'community-acquired pneumonia (CAP) cases outside hospitals' conducted in mainland China from 2001 to 2015 reported that pneumococcus was the second most common bacterial pathogen among children under five.
Meanwhile, to ensure smooth commercial production of GBP410, SK Bioscience recently expanded the vaccine production facility at its 'L HOUSE' plant in Andong, Gyeongbuk, securing a new space of approximately 4,200 square meters (1,300 pyeong). The company also plans to obtain cGMP (current Good Manufacturing Practice) certification from the U.S. FDA.
SK Bioscience CEO Ahn Jae-yong stated, "This approval for clinical trials in China marks another significant milestone following the expansion of the GBP410 production base," adding, "Together with Sanofi, we will make even greater efforts to secure a solid position in the global pneumococcal vaccine market through the successful development, launch, and supply of GBP410."
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