Hyundai Bioscience (CEO Sang-gi Oh) announced on the 24th that it received approval from the Department of Science, Technology and Training (ASTT) under the Ministry of Health (MOH) of Vietnam on the 20th to conduct clinical trials of CP-COV03 for dengue fever and dengue-like illnesses.
On the 9th, Hyundai Bioscience completed the submission of the 'Clinical Trial Research Application' and 'Documents Related to Clinical Trial Drugs' to the Department of Science, Technology and Training (ASTT) under the Ministry of Health (MOH) of Vietnam as the official first step to conduct clinical trials locally in Vietnam and as a preliminary stage for the clinical trial plan approval application.
While Korea prioritizes IND approval from the Ministry of Food and Drug Safety, the clinical approval process in Vietnam involves obtaining Pre-IND authorization from the Vietnamese health authorities, followed by clinical plan (IND) approvals from the Local Ethics Committee and the National Ethics Committee, and finally receiving approval from the health authorities to begin the clinical trial.
Hyundai Bioscience explained that this basket clinical trial is the world's first randomized, single-blind, placebo-controlled study conducted locally in Vietnam to evaluate the safety and efficacy of CP-COV03 in patients with dengue fever or dengue-like illnesses, and that it received an exceptionally rapid approval.
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