Henlius gains NMPA approval for solid tumor combination therapy trial

Shanghai Henlius Biotech, Inc. announced that its application for a phase 1b/2 clinical trial of HLX43 (an anti-PD-L1 antibody-drug conjugate) in combination with HLX07 (a recombinant anti-EGFR humanized monoclonal antibody injection) for advanced or metastatic solid tumors has been approved by the National Medical Products Administration (NMPA). This marks a significant step in the development of new treatment options for patients.

HLX43 has shown promising results in prior trials. In updated phase 1 results released in September 2025 at the WCLC, HLX43 demonstrated an investigator-assessed objective response rate (ORR) of 37.0% and a disease control rate (DCR) of 87.0% in patients with advanced solid tumors, including those with NSCLC who failed prior checkpoint inhibitor therapy and chemotherapy. HLX07, targeting EGFR, is also undergoing several phase 2 clinical studies for various solid tumors.

Preclinical and clinical data suggest synergistic efficacy and a favorable safety profile when combining topoisomerase I inhibitors with anti-EGFR antibodies, and PD-1/PD-L1 antibodies/ADCs with EGFR inhibitors. As of this announcement, no similar combination therapy has received global marketing approval.