The approvals, granted just ten days after the company submitted its request, mark a significant milestone in establishing a multicenter clinical foundation across Vietnam. This rapid regulatory clearance underscores the country’s commitment to advancing innovative treatment options for viral infections.
The granule formulation is designed to address the needs of patients who struggle with swallowing capsules due to conditions such as high fever, vomiting, or dysphagia. Hyundai Bioscience stated that the granules improve medication adherence and are expected to enhance clinical efficacy. The company noted that the dissolution rate of the granule formulation matches that of the capsules, allowing the switch without requiring additional bioequivalence testing.
Byung-joon Bae, president of Hyundai Bioscience, emphasized the significance of the dual approvals. “Securing rapid approval from both northern and southern national hospitals means we have quickly established a clinical foundation spanning all of Vietnam,” Bae said. “This sets the stage for accelerating the full-scale basket trial, which will expedite the development of a global antiviral therapy.”
The company’s progress in Vietnam positions it as a key player in the global race to develop versatile antiviral treatments, with potential implications for addressing a range of infectious diseases.
Kim Kuk Ju, HEALTH IN NEWS TEAM
press@hinews.co.kr
