GC Biopharma, a South Korean pharmaceutical company, has sent an Investigational New Drug application to the Thailand Food and Drug Administration to start a Phase 3 clinical trial for its varicella vaccine, BARYCELA. This trial will test the two-dose version of the vaccine and marks a significant milestone, as GC Biopharma becomes the first South Korean company to take a two-dose varicella vaccine to the Phase 3 trial stage. The study will involve 474 healthy children aged between 12 months and 12 years. It will also compare BARYCELA directly with Varivax, a well-known varicella vaccine made by a major U.S. pharmaceutical company, providing an opportunity to highlight BARYCELA’s market potential.
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The two-dose schedule for the varicella vaccine is widely used around the world. It is officially recommended in 28 countries, including the United States, Canada, Japan, and several European nations. This regimen has proven to be more effective in preventing infections than a single dose, which is why GC Biopharma is focusing on this format as it expands its vaccine offerings internationally.
GC Biopharma expects to complete the Thailand Phase 3 trial by the second half of 2027. Once finished, the company plans to apply for regulatory approval in Southeast Asia. In addition, GC Biopharma is preparing to submit an Investigational New Drug application in Vietnam, broadening its research and development efforts across new regional markets.
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Jae Woo Lee, who leads Regulatory Science and Product Development at GC Biopharma, said the trial is a critical milestone for the company. He emphasized that the study will deliver strong clinical evidence supporting the two-dose regimen of BARYCELA and demonstrate that the vaccine meets the rigorous standards required by global markets. Lee also noted that this progress strengthens the vaccine’s chances of becoming a competitive product internationally.
With a focus on developing effective, next-generation vaccines, GC Biopharma is positioning itself as a key player in the global vaccine market. This upcoming trial reflects the company’s dedication to clinical excellence and its strategic goal to bring proven, safe vaccine options to more people across Asia and beyond.
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