GC Biopharma (006280.KS), a South Korean pharmaceutical company, announced that its varicella vaccine BARYCELA has received marketing authorization from the Drug Administration of Vietnam (DAV).

Following domestic approval in 2020 and WHO Pre-Qualification (PQ) in 2023, GC Biopharma has been accelerating individual country registrations as part of its dual-track strategy—pursuing both global procurement channels and direct market entry initiatives.

To obtain approval in Vietnam, GC Biopharma conducted local clinical trials to establish the product's safety and immunogenicity. This achievement highlights the company's ability to meet the increasingly stringent regulatory standards set by DAV. As a vaccine administered primarily to children, quality certification holds particular importance in the varicella segment.

GC Biopharma plans to establish stable annual revenue in Vietnam by leveraging its local affiliate to engage directly in sales activities, in consideration of the country's private market-oriented vaccine distribution system.

From 2018 to 2021, Vietnam's private vaccine market recorded a compound annual growth rate (CAGR) of 32%, reaching approximately USD 300 million in 2021. Varicella vaccines accounted for nearly 10% of the private market^[1], with demand for private vaccinations continuing to grow steadily.

"This marketing authorization represents more than a product export—it is the result of a localization strategy and a significant step toward expansion in Southeast Asia," said Jae Woo Lee, Head of Development Department at GC Biopharma. "We will continue to strengthen our position as a trusted vaccine brand by delivering clinical and quality standards that meet global expectations."

BARYCELA is a live attenuated varicella vaccine developed by GC Biopharma using its proprietary MAV/06 virus strain. The vaccine is characterized by high viral titer and manufacturing yield. Notably, BARYCELA is the world's first varicella vaccine produced without antibiotics, utilizing a fully aseptic manufacturing process.