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GC Biopharma Receives Marketing Authorization for BARYCELA in Vietnam

Cision | Thu, Jul 17 2025 03:56 PM AEST

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Image Source: Sivastatz

YONGIN, South Korea, July 17, 2025 /PRNewswire/ -- 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.

About GC Biopharma

GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo® (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/

This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.

GC Biopharma Contacts (Media)

Sohee Kim
shkim20@gccorp.com

Yelin Jun
yelin@gccorp.com

Yoonjae Na
yjy6520@gccorp.com

[1] Life-course immunization in Vietnam (2024), KPMG

 

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