Shanghai Fosun Pharmaceutical (600196.SH): The investigational drug HLX43 for injection has been granted orphan drug designation by the United States FDA.

Shanghai Fosun Pharmaceutical (600196.SH) announced that its holding subsidiary Shanghai HENLIUS Biotech Co., Ltd. and its holding subsidiary (hereinafter referred to as "HENLIUS") recently received Orphan Drug Designation from the US Food and Drug Administration (FDA) for the investigational drug HLX43 (a targeted PD-L1 antibody-drug conjugate) for the treatment of thymic epithelial tumors (TETs). The Orphan Drug Designation obtained from the US FDA will provide certain policy support for the subsequent research and development, registration, and commercialization of HLX43 for the treatment of thymic epithelial tumors (TETs) in the United States. This includes, but is not limited to, (1) tax credits for clinical trial expenses, (2) waiver of new drug application fees, and (3) 7 years of market exclusivity without being affected by patents. Before HLX43 is approved by the US FDA for the treatment of thymic epithelial tumors (TETs), if other drugs with the same indication are approved first, it will be necessary to further demonstrate the superior efficacy of HLX43 in clinical trials in order to receive the policy support for market exclusivity granted to orphan drugs.