The board of directors of Lepu Biopharma Co., Ltd. announced that, drug candidate MRG004A, a novel tissue factor-targeted site-specifically conjugated antibody drug conjugate, has been granted the Fast Track Designation by the Food and Drug Administration of the United States for the treatment of pancreatic cancer. Previously, in December 2023, received the Orphan-drug Designation for MRG004A from the FDA. The FTD is established to facilitate and expedite the clinical development and review process of drugs with a view to meeting the unmet medical demands of serious or life-threatening diseases.

According to the relevant regulations, the obtainment of FTD status for drug candidates would provide the opportunity to accelerate the review process in various forms.