South Korean biopharmaceutical company GC Biopharma (KRX: 006280) announced on Thursday that it has received marketing authorisation from the Drug Administration of Vietnam for its varicella vaccine, BARYCELA.
BARYCELA is a live attenuated varicella vaccine developed using GC Biopharma's proprietary MAV/06 strain, produced without antibiotics through a fully aseptic process.
The approval follows prior milestones, including domestic clearance in South Korea in 2020 and World Health Organisation Pre-Qualification in 2023.
To obtain authorisation, the company conducted local clinical trials to demonstrate BARYCELA's safety and immunogenicity, aligning with Vietnam's stringent regulatory requirements. The product is administered primarily to children, placing additional emphasis on quality certification.
GC Biopharma aims to generate stable annual revenue in Vietnam by utilising its local affiliate to navigate the country's vaccine distribution system. The Vietnamese private vaccine market reached approximately USD300m in 2021, with varicella vaccines representing nearly 10% of that segment.
Between 2018 and 2021, the country's private vaccine sector recorded a 32% compound annual growth rate, underscoring robust demand.
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