Henlius’ HLX43 in combination with Serplulimab phase 2 NSCLC trial approved in Australia

CAR-T Digest - August 2020

Weekly Digest - June 2026

17 June 2026: Henlius’ HLX43 in combination with Serplulimab phase 2 NSCLC trial approved in Australia

Henlius has received approval from Australia’s Human Research Ethics Committee, with acknowledgment from the Therapeutic Goods Administration, to initiate the phase 2 HLX43-NSCLC203 study evaluating HLX43 in combination with Serplulimab as a neoadjuvant treatment for resectable Non-small cell lung cancer, expanding the development of its PD-L1-targeted ADC into earlier-stage disease settings
The study builds on encouraging clinical data from HLX43, including results presented at ASCO 2026 where the PD-L1 ADC demonstrated promising anti-tumor activity and a manageable safety profile in previously treated NSCLC patients across multiple subgroups regardless of histology or PD-L1 expression, supporting further exploration in earlier-stage disease
The phase 2 trial will evaluate the combination of HLX43 and Serplulimab in the neoadjuvant setting, aiming to leverage the potential synergy between ADC-mediated tumor killing and immune checkpoint inhibition to improve outcomes for patients with resectable NSCLC
HLX43 is a next-generation PD-L1-directed ADC that combines immune checkpoint blockade with a topoisomerase I inhibitor payload, offering dual mechanisms of action through both immune activation and targeted cytotoxicity, while Serplulimab is Henlius’ anti-PD-1 monoclonal antibody with approvals across multiple lung cancer indications
Strategically, the Australian approval expands HLX43’s development beyond advanced and metastatic disease into the potentially larger perioperative NSCLC market, reinforcing Henlius’ ambition to establish HLX43 as a cornerstone PD-L1 ADC franchise and strengthening its competitive position in the rapidly evolving ADC-immunotherapy combination landscape