Fosun Pharma’s HLX43 for injection receives approval from the U.S. FDA for clinical trials
August 9, 2025
Source: drugdu
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On the evening of August 7, Fosun Pharma (600196) announced that its controlling subsidiary, Shanghai Henlius Biotech Co., Ltd., and its subsidiaries (collectively, " Henlius "), have received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I clinical trial of HLX43 for injection (a PD-L1-targeting antibody-drug conjugate) for the treatment of thymic carcinoma (TC). Henlius plans to conduct a global, multicenter clinical study for this indication in Australia, Japan, the United States, and other locations once conditions permit.
The announcement shows that the new drug is an antibody-drug conjugate (ADC) targeting PD-L1, developed by Henlius by conjugating a new DNA topoisomerase I inhibitor small molecule toxin-peptide linker licensed by Henlius with an antibody targeting PD-L1 independently developed by Henlius. It is intended for the treatment of advanced/metastatic solid tumors.
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