GC Biopharma, a South Korean pharmaceutical company, announced 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 effectively.

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.