First Korean pharmaceutical company to enter clinical trials for a two-dose varicella 피망 바카라
[by Yu, Suin] GC Biopharma announced on August 27 that it has submitted an investigational new drug (IND) application to the Food and Drug Administration of Thailand (FDA Thailand) for a two-dose Phase 3 clinical trial of its varicella vaccine, Barycela. This milestone marks the first-ever two-dose Barycela vaccine clinical trial conducted by a Korean pharmaceutical company.
The 피망 바카라 3 clinical trial will enroll 474 healthy children between 12 months and 12 years of age. The study is designed to objectively evaluate the vaccine's competitiveness through a direct comparison with Varivax, Merck & Co., Inc.’s (MSD) globally leading varicella vaccine.
Globally, a two-dose regimen is recognized as the standard of care for varicella immunization. Currently, 28 countries, including developed nations such as the United States, Canada, Japan, and several European countries, recommend administration of a second dose to mitigate the risk of breakthrough infections following a single-dose regimen.
GC Biopharma has announced its intention to complete the 피망 바카라 3 clinical trial by H2 2027. According to the company, following the trial’s conclusion, the company plans to seek regulatory approval for the two-dose Barycela vaccine, prioritizing Southeast Asian markets as its first target markets.
"This 피망 바카라 3 clinical trial marks an important milestone in laying the groundwork for two-dose Barycela vaccination. It will position us to achieve global vaccine competitiveness aligned with the standards of advanced markets," remarked Lee Jae-woo, Head of the Development Department at GC Biopharma.
Conversely, GC Biopharma announced plans to file an IND in Vietnam later this year for a 피망 바카라 3 clinical trial of its two-dose Barycela vaccine.