South Korean biopharmaceutical company GC Biopharma Corp (KRX:006280) announced on Thursday that it has submitted an Investigational New Drug application to the Thailand Food and Drug Administration to initiate a Phase 3 clinical trial of its two-dose varicella vaccine, BARYCELA.

The trial will enrol 474 healthy children aged 12 months to 12 years, and will feature a direct comparison with Varivax, a varicella vaccine developed by US-based pharmaceutical company Merck & Co., Inc. (LON:0QAH), operating as Merck Sharp & Dohme or MSD.

Two-dose regimens for varicella vaccines are already considered the global standard of care. This approach is officially recommended in 28 countries, including the United States, Canada, Japan, and several European nations, to reduce the risk of breakthrough infections.

GC Biopharma expects to complete the study by the second half of 2027. Following the trial, the company intends to seek regulatory approval across Southeast Asian markets.

The company also plans to submit an additional Investigational New Drug application in Vietnam to initiate another Phase 3 study of BARYCELA.