GC Biopharma (006280.KS), formerly known as GC Green Cross, has secured approval from Vietnam for an investigational new drug (IND) application to conduct a Phase 3 clinical trial of its two-dose chickenpox vaccine "Varicella-Ju," expanding its global clinical footprint.
The company said Sunday that it received IND approval for the two-dose Phase 3 trial of Varicella-Ju from Vietnam's Ministry of Health on Friday. The approval came faster than initially planned following consultations with local regulators after the IND submission in November last year.
The trial will enroll healthy children aged 12 months to 12 years to evaluate immunogenicity and safety after two doses. The study is designed as a head-to-head comparison with Merck's Varivax, which is expected to allow verification of the vaccine's competitiveness against global benchmarks.
GC Biopharma had previously obtained Phase 3 IND approval in Thailand and completed enrollment of the first patient there earlier this month. With the addition of Vietnam as a clinical site, the company has established a multi-country clinical trial framework centered on Southeast Asia.
The company plans to secure clinical results by 2027 and enter the global two-dose chickenpox vaccine market starting with Southeast Asia in 2028. Two-dose vaccination is currently the standard in major markets including the United States, Europe and Japan, and the World Health Organization (WHO) also recommends a two-dose regimen.
"Our goal is to demonstrate product competitiveness in the global standard vaccination environment," a GC Biopharma official said. "We will carry out the clinical trials without setbacks to secure a foundation for overseas market entry."