14 December, 2023, Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is pleased to announce that our drug candidate MRG004A, a novel tissue factor-targeted site-specifically conjugated antibody drug conjugate, for the treatment of pancreatic cancer has been granted the Orphan-drug Designation by the Food and Drug Administration of the United States (the “FDA”) recently. Previously, in February 2021, we received an investigational new drug (the “IND”) clearance for MRG004A from the FDA for Phase I/II clinical trials in the United States. In August 2021, we also received an IND approval for MRG004A from the National Medical Products Administration of the People’s Republic of China (the “PRC” or “China”).

The Orphan-drug Designation obtained from the FDA will help MRG004A enjoy certain incentives for the follow-up research and development, registration and commercialization of designated drugs for the treatment of pancreatic cancer in the United States, including but not limited to (1) tax credits for qualified clinical trials; (2) exemption from user fees; and (3) potential seven years of market exclusivity after approval.

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 on pancreatic cancer, triple-negative breast cancer and cervical cancer.