YONGIN, South Korea, Aug. 28, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean pharmaceutical company, announced today that it has submitted an Investigational New Drug (IND) application to the Thailand Food and Drug Administration (FDA) to initiate a Phase 3 clinical trial for its varicella vaccine, BARYCELA (a two-dose regimen). GC Biopharma is the first South Korean company to advance a two-dose varicella vaccine into a Phase 3 clinical trial stage.
The trial will be conducted in 474 healthy children aged 12 months to 12 years. Notably, it will include a head-to-head comparison with MSD's Varivax, a U.S. pharmaceutical company and the global leader in the varicella vaccine market. The study is designed to serve as a robust platform to demonstrate the vaccine's competitive profile through objective evidence.
Globally, the two-dose varicella vaccine regimen has been established as the standard of care. This protocol is officially recommended in 28 countries, including major nations such as the United States, Canada, Japan, and several across Europe, to prevent breakthrough infections(1) effectively.(2)
GC Biopharma aims to complete the Phase 3 trial by the second half of 2027. Upon completion, the company will pursue regulatory approval for the two-dose regimen in Southeast Asian markets.
"This clinical trial will be a critical milestone, providing clear evidence for the two-dose regimen of BARYCELA," said Jae Woo Lee, Head of the Regulatory Science & Product Development at GC Biopharma. "We expect it to solidify the vaccine's global competitiveness and demonstrate that it meets the standards of major international markets.
GC Biopharma also plans to submit an Investigational New Drug (IND) application in Vietnam to begin a Phase 3 clinical trial for a two-dose regimen of BARYCELA.
(1) The phenomenon where a person becomes infected with a specific pathogen even after being vaccinated against it |
(2) Global varicella vaccination programs, Clin Exp Pediatr. 2022 Nov 2;65(12):555-562. doi: 10.3345/cep.2021.01564 |
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)
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SOURCE GC Biopharma
