March 11, 2024，Lepu Biopharma Co., Ltd. (the “Company”) announce that, our drug candidate MRG004A, a novel tissue factor-targeted site-specifically conjugated antibody drug conjugate, has been granted the Fast Track Designation (the “FTD”) by the Food and Drug Administration of the United States (the “FDA”) for the treatment of pancreatic cancer.

This obtainment of the FTD marks another important milestone for the Company, which comes shortly after MRG004A was granted the ODD from the FDA. Previously, in December 2023, we received the Orphan-drug Designation (the “ODD”) 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.

ABOUT MRG004A

MRG004A is a novel tissue factor-targeted site-specifically conjugated antibody drug conjugate. We are currently conducting a Phase I/II clinical study in the United States and China. We have observed anti-tumor activity signal in pancreatic cancer, triple-negative breast cancer and cervical cancer.