[Edaily Reporter Shin Ha-yeon] #Genexine announced on the 4th that its application for marketing authorization for "Epesapre-filled Syringe (GX-E4)," indicated for the treatment of anemia in patients with non-dialysis kidney disease, had been rejected by the Ministry of Food and Drug Safety (MFDS).
According to the company, during the review process, the MFDS indicated that additional review of supplementary data related to manufacturing and quality control (CMC) and the risk management plan (RMP) was necessary, leading to the rejection of the marketing authorization application on that day.
The company explained, "We plan to address the review comments from the Ministry of Food and Drug Safety and resubmit the marketing authorization application as soon as possible."
According to the company, during the review process, the MFDS indicated that additional review of supplementary data related to manufacturing and quality control (CMC) and the risk management plan (RMP) was necessary, leading to the rejection of the marketing authorization application on that day.
The company explained, "We plan to address the review comments from the Ministry of Food and Drug Safety and resubmit the marketing authorization application as soon as possible."
