GC Biopharma has submitted an Investigational New Drug (IND) application to the Thailand Food and Drug Administration to initiate a Phase 3 clinical trial for its varicella vaccine BARYCELA, marking a significant milestone as the first South Korean company to advance a two-dose varicella vaccine to this clinical stage.
Trial Design and Patient Population
The Phase 3 trial will enroll 474 healthy children aged 12 months to 12 years, featuring a head-to-head comparison with MSD's Varivax, the global leader in the varicella vaccine market. The study is designed to serve as a robust platform to demonstrate BARYCELA's competitive profile through objective evidence.
Global Standard of Care
The two-dose varicella vaccine regimen has been established as the standard of care globally, with this protocol officially recommended in 28 countries, including major nations such as the United States, Canada, Japan, and several across Europe, to effectively prevent breakthrough infections.
Development Timeline and Regulatory Strategy
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. The company also plans to submit an IND application in Vietnam to begin a Phase 3 clinical trial for the two-dose regimen of BARYCELA.
"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."
Company Background
GC Biopharma, formerly known as Green Cross Corporation, is a biopharmaceutical company headquartered in Yong-in, South Korea, with over half a century of experience in the development and manufacturing of plasma derivatives and vaccines. The company is expanding its global presence, having successfully entered the US market with Alyglo (intravenous immunoglobulin G) in 2024.
