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 offer improved 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.
According to Hyundai Bioscience, these approvals pave the way for a preliminary phase of what is described as the world’s first antiviral basket trial. In a basket trial, a single drug is tested for efficacy against multiple viral diseases simultaneously. Xafty is slated for evaluation in patients with various viral infections, including dengue fever, as part of this innovative clinical approach.
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
