HANDOK noted that its affiliate Rezolute's hypoglycemia treatment 'RZ358' has been designated as an innovative treatment by the U.S. Food and Drug Administration (FDA), resulting in strong early gains on the 7th.
As of 9:06 a.m. on that day, HANDOK is trading at 13,450 won, up 1,840 won (15.85%) from the previous trading day.
Rezolute received the innovative treatment designation for its new hypoglycemia drug RZ358 due to insulinoma on the 5th (local time). The innovative treatment system accelerates the development of drugs that demonstrate significant effects compared to existing treatments in the early clinical stages of life-threatening diseases. This designation was based on the effectiveness observed in actual patient treatments through clinical data and an expanded access program being conducted across the United States.
Rezolute is currently conducting Phase 3 global clinical trials in 12 countries and plans to start regulatory clinical trials for insulinoma patients in the middle of this year. Topline data is expected to be announced in the second half of next year. HANDOK holds the commercialization rights for RZ358 in South Korea.