Henlius receives the NMPA IND approval for Its PD-L1 targeting ADC HLX43 in combination with novel anti-EGFR mAb HLX07

CAR-T Digest - August 2020

30 September 2025: Henlius receives the NMPA IND approval for Its PD-L1 targeting ADC HLX43 in combination with novel anti-EGFR mAb HLX07

The China NMPA approved Henlius’ IND application for a phase 1b/2 trial of HLX43 (PD-L1 ADC) in combination with HLX07 (anti-EGFR mAb) for advanced/metastatic solid tumors, marking HLX43’s second combination therapy
HLX43 is a PD-L1-targeted ADC with a novel linker and topoisomerase inhibitor payload (DAR ~8), showing strong anti-tumor activity and favorable safety across multiple PD-1/L1 resistant cancers; updated 2025 WCLC data reported cORR of 46.7% in EGFR wild-type non-squamous NSCLC and 60% at 2.5 mg/kg dose
The HLX43 + HLX07 strategy integrates immune checkpoint blockade, cytotoxic payload delivery, and EGFR pathway inhibition, potentially surpassing conventional anti-EGFR + topoisomerase inhibitor regimens in efficacy.
Henlius is advancing 10 clinical trials of HLX43 worldwide (China, U.S., Australia, Japan) across cancers including NSCLC, TC, ESCC, HCC, CC, CRC, NPC, and G/GEJ adenocarcinoma, with ongoing studies of HLX43 in multiple combination therapies to expand clinical value.