By Fineline Cube 
China’s Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a global, multi-center Phase II clinical study for its antibody drug conjugate (ADC) HLX43, targeting programmed death ligand 1 (PD-L1). The study focuses on advanced non-small cell lung cancer (NSCLC) in China.
HLX43 Mechanism and Innovation
HLX43 combines a highly specific humanized IgG1 PD-L1 antibody, cleavable novel ligands, and TOPO I small molecule inhibitors. This innovative ADC is designed to enhance anti-tumor efficacy while maintaining safety.
Clinical Trial Results
Previously presented at the 2025 ASCO Annual Meeting, Phase I data showed HLX43 to be safe across different doses, with significant anti-tumor activity in patients with advanced/metastatic solid tumors. The objective response rate (ORR) for Stage 1a patients was 36.8%, reaching 75% in thymic squamous cell carcinoma (TSCC) patients. For Stage 1b NSCLC patients, the ORR was 38.1%, with 40% for squamous NSCLC patients and a 100% disease control rate (DCR) in brain metastasis patients.
Global Innovation
HLX43 stands out as a groundbreaking therapy, as no similar product has been approved for marketing globally.-Fineline Info & Tech