HENLIUS (02696): NMPA Approves Phase 1b/2 Clinical Trial Application for HLX43 Injection Combined with HLX07 in Advanced/Metastatic Solid Tumors

Stock News

Sep 30

HENLIUS (02696) announced that the National Medical Products Administration (NMPA) has recently approved its Phase 1b/2 clinical trial application for HLX43 injection (PD-L1-targeted antibody-drug conjugate) in combination with HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) for the treatment of advanced/metastatic solid tumors.

HLX43 represents a PD-L1-targeted antibody-drug conjugate (ADC) developed by the company through conjugating a licensed novel DNA topoisomerase I inhibitor small molecule toxin-peptide linker with its proprietary PD-L1-targeting antibody, intended for treating advanced/metastatic solid tumors. HLX07 is an innovative biological drug independently developed by the company targeting the EGFR pathway, planned for advanced solid tumor treatment.

In February 2023, Phase 1b/2 clinical study results of HLX07 combined with chemotherapy for advanced solid tumor treatment demonstrated favorable safety and tolerability profiles. Currently, multiple Phase 2 clinical studies involving HLX07 are being conducted within China, primarily including a Phase 2 clinical trial of HLX07 monotherapy for treating advanced cutaneous squamous cell carcinoma (CSCC) and other solid tumors, as well as a Phase 2 clinical trial of Hansizhuang® combined with HLX07 for treating advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) and other solid tumors.

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