By Fineline Cube 
China’s Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA) has approved its HLX43 for injection to initiate a Phase 1 clinical trial for the treatment of thymic carcinoma (TC). This marks a significant step forward in the development of innovative therapies for this rare and aggressive form of cancer.
Drug Profile
HLX43 is a novel antibody drug conjugate (ADC) co-developed by Henlius and Suzhou-based Medilink Therapeutics. The ADC combines a novel DNA topoisomerase I inhibitor payload and peptide linker licensed from Medilink with a PD-L1-targeting antibody independently developed by Henlius. This innovative combination is designed to deliver targeted therapy for patients with advanced/metastatic solid tumors, including thymic carcinoma.
Clinical Trial Objectives
The Phase 1 clinical trial will evaluate the safety, tolerability, and preliminary efficacy of HLX43 in patients with thymic carcinoma. The trial aims to establish the recommended dose for future studies and assess the potential of HLX43 to address the significant unmet medical need in this patient population.-Fineline Info & Tech