Shanghai Henlius Biotech’s HLX43, a PD-L1-targeting antibody-drug conjugate (ADC), has received IND approval from the NMPA for a Phase 1b/2 trial in advanced/metastatic solid tumors

HLX43 is the first PD-L1-targeting ADC in China to enter clinical trials and addresses resistance or unresponsiveness to PD-1/PD-L1 immunotherapies

PD-L1 is expressed in various cancers, including NSCLC, CRC, and TNBC, but existing treatments are ineffective for many patients, highlighting the unmet need for ADC therapies

HLX43 combines targeted monoclonal antibodies with cytotoxic agents to treat tumors expressing PD-L1, showing promising anti-tumor effects and good safety in preclinical studies

Henlius plans to expand HLX43’s clinical development to evaluate its safety and efficacy in treating solid tumor patients who failed prior treatments, aiming to address significant unmet medical needs