Henlius receives an IND approval for Its PD-L1-targeting ADC HLX43 in combination with anti-PD-1 mAb Serplulimab and novel anti-EGFR mAb HLX07

CAR-T Digest - August 2020

Weekly Digest - January 2026

27 January 2026: Henlius receives an IND approval for Its PD-L1-targeting ADC HLX43 in combination with anti-PD-1 mAb Serplulimab and novel anti-EGFR mAb HLX07

Shanghai Henlius Biotech has secured regulatory clearance in China to move forward with a new clinical trial evaluating HLX43, its PD-L1–targeting antibody–drug conjugate, in advanced solid tumors, marking another step in the company’s push to deepen combination immunotherapy strategies
This approval reflects a broader industry shift, as limitations of single-agent PD-1/PD-L1 therapies continue to drive interest in combination approaches that can deliver stronger and more durable responses, particularly through the integration of ADCs with immuno-oncology backbones
Building on this momentum, Henlius is pairing HLX43 with its own anti-PD-1 antibody serplulimab and its innovative anti-EGFR antibody HLX07, aiming to address immune resistance mechanisms that have constrained the long-term impact of earlier targeted and immunotherapy regimens
Early clinical signals have reinforced this strategy, with HLX43 showing manageable safety and encouraging anti-tumor activity across multiple solid tumor types, while serplulimab and HLX07 have each demonstrated differentiated efficacy and favorable profiles in lung, gastric, and other EGFR-driven cancers
By advancing from dual combinations into a planned triple-combination regimen, Henlius is positioning its core pipeline around synergistic immune checkpoint blockade and precision targeting, underscoring its long-term commitment to expanding treatment options for patients with hard-to-treat solid tumors worldwide