Henlius receives global regulatory approvals for Phase 2 MRCT of its PD-L1 ADC HLX43 on NSCLC

CAR-T Digest - August 2020

09 July 2025: Henlius receives global regulatory approvals for Phase 2 MRCT of its PD-L1 ADC HLX43 on NSCLC

Henlius received regulatory approvals from China (NMPA), U.S. (FDA), Australia (TGA), and Japan (PMDA) to begin a Phase 2 multi-regional clinical trial (MRCT) of HLX43, the first PD-L1-targeting ADC to reach Phase 2 globally, for advanced non-small cell lung cancer (NSCLC)
Phase 1 results presented at ASCO 2025 showed promising efficacy and safety in heavily pre-treated NSCLC patients, including those with EGFR mutations, brain metastases, and thymic squamous cell carcinoma, with ORRs up to 40% and DCRs up to 100% in some subgroups
Henlius is actively expanding HLX43’s clinical development across multiple solid tumors and in combination with its anti-PD-1 antibody serplulimab, for patients resistant to current PD-1/PD-L1 therapies or prior treatments