GC Biopharma Initiates Phase 3 Clinical Trial for BARYCELA Vaccine in Thailand

GC Biopharma, a leading biopharmaceutical company based in South Korea, has recently made significant strides in the field of immunization by submitting an Investigational New Drug (IND) application to the Thailand Food and Drug Administration (FDA). This submission marks the beginning of a Phase 3 clinical trial for its varicella vaccine, BARYCELA, which utilizes a two-dose regimen. Notably, this event positions GC Biopharma as the first South Korean firm to progress a two-dose varicella vaccine into this advanced stage of clinical research.

The upcoming trial will include a comprehensive evaluation of 474 healthy children between the ages of 12 months and 12 years. Importantly, the study is designed to compare BARYCELA head-to-head with Varivax, a product developed by the American pharmaceutical giant MSD, which is recognized as a global leader in the varicella vaccine arena. This strategic design aims not only to assess BARYCELA's effectiveness but also to provide substantial evidence to support its competitive standing in the market.

Globally, a two-dose varicella vaccination protocol is already established as the standard of care for preventing the spread of chickenpox. Notably, this regimen is officially recommended in 28 countries, including prominent nations such as the United States, Canada, and Japan, among others across Europe. This widespread endorsement underscores the importance of developing vaccines that effectively prevent breakthrough infections among vaccinated populations.

GC Biopharma has ambitious plans to conclude the Phase 3 trial by the latter half of 2027. Following the successful completion of this research, the company intends to seek regulatory approval to market the two-dose regimen throughout Southeast Asia, which holds considerable potential for growth in the healthcare sector.

Jae Woo Lee, who heads the Regulatory Science Product Development at GC Biopharma, remarked, "This clinical trial will represent a crucial milestone for us, providing clear and robust evidence in support of the two-dose BARYCELA regimen. We anticipate that the successful outcomes of this trial will strengthen the vaccine's global competitiveness, demonstrating its compliance with the standards set by major international markets."

In addition to its efforts in Thailand, GC Biopharma plans to extend its research by submitting an IND application in Vietnam, thereby initiating another Phase 3 clinical trial for BARYCELA in the region. This dual approach reflects the company's commitment to ensuring that effective vaccines reach as many children as possible, thereby enhancing public health in Southeast Asia.

About GC Biopharma - Founded over 50 years ago, GC Biopharma has established itself as a frontrunner in the biopharmaceutical industry, specializing in the development and production of plasma derivatives and vaccines. The company has consistently expanded its global footprint, recently marking successful entry into the U.S. market with its product Alyglo® (intravenous immunoglobulin G) in 2024. GC Biopharma is dedicated to fostering innovation through its cutting-edge research and development capabilities, focusing on advancing therapies for rare diseases and immunology-related disorders. For further information about the company and its initiatives, visit GC Biopharma's official website.