First regulatory clearance in Latin America marks a strategic milestone for regional market expansion
- World's first antibiotic-free manufacturing process ensures superior safety profile

GC Biopharma(006280.KS), a leading provider of biopharmaceutical products in South Korea, announced that its varicella vaccine, BARYCELA Inj., has been granted marketing authorization from the Ministry of Public Health and Social Assistance (Ministerio de Salud Pública y Asistencia Social) of Guatemala. This approval marks a significant milestone as the first regulatory clearance for BARYCELA Inj. in the Latin American region, paving the way for expanded access to high-quality immunization across neighboring markets.

BARYCELA Inj. is a live attenuated vaccine developed using GC Biopharma's proprietary MAV/06 strain. Distinguishing itself from conventional vaccines, BARYCELA Inj. is the world's first varicella vaccine manufactured through an entirely antibiotic-free process. By eliminating the use of antibiotics—such as kanamycin, neomycin, and erythromycin—during production, the vaccine fundamentally prevents potential adverse reactions associated with antibiotic residues, ensuring an enhanced safety profile for pediatric populations.

Furthermore, with its recent inclusion in the World Health Organization (WHO) position paper, BARYCELA inj. has been officially recognized for its interchangeability with existing vaccines based on the Oka strain. This official endorsement significantly broadens the clinical utility of BARYCELA Inj. in global markets, allowing for seamless integration into diverse national immunization programs. Leveraging its validated product profile, GC Biopharma intends to accelerate its penetration into both international procurement agencies and individual private markets.

"Securing this first marketing authorization in Latin America is a testament to the global competitiveness of our vaccine technology," Jae Woo Lee, Head of the Regulatory Science & Product Development at GC Biopharma. "We are committed to strengthening our position in the global market by providing a differentiated and safer preventive solution to healthcare systems worldwide."