YUBIOLOGICS Applies for Export Approval of COVID-19 Vaccine
[Asia Economy Reporter Chunhee Lee] UbioLogics announced on the 22nd that it has applied to the Ministry of Food and Drug Safety for export approval of its COVID-19 vaccine, "Yukobac-19 Multi." The company expects that the review and approval process for export approval, which usually takes about 4 to 6 months due to the clinical development stage, could be completed within this year at the earliest.
This export approval application was made based on the import request specifications from a Philippine pharmaceutical company. UbioLogics confirmed the safety and immunogenic efficacy of Yukobac-19 through domestic Phase 1 and 2 clinical trials and is currently conducting Phase 3 trials in the Democratic Republic of the Congo. They also plan to start Phase 3 comparative clinical vaccinations in the Philippines.
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A UbioLogics official said, "This export approval application will serve as a catalyst to expedite product registration in underdeveloped countries where even basic vaccinations have not yet been carried out," adding, "Based on the successful commercialization of the prototype vaccine, we will continue to develop vaccines against new and variant viruses and universal vaccines using the same platform."
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