On the 4th, Genexine announced in a regulatory filing that its domestic product license application for 'epesataprifild syringe injection (GX-E4)', a candidate for treating anemia in non-dialysis kidney disease patients, has been rejected by the Ministry of Food and Drug Safety (MFDS).

The MFDS rejected the license application for the product on June 4, 2026. Regarding the reason for the rejection, Genexine explained, "During the MFDS review process, it was pointed out that additional supplements were needed for some of the Chemistry, Manufacturing, and Controls (CMC) data and the supplementary data related to the Risk Management Plan (RMP)."

The company plans to supplement the relevant data by incorporating the MFDS's review opinions and resubmit the product license application at an early date. Both the date of occurrence and the decision date for this disclosure are June 4, 2026, when the company received the relevant official document from the MFDS.

Meanwhile, Genexine previously disclosed the fact of the domestic product license application for GX-E4 on January 26, 2024.