HENLIUS (02696): Clinical trial application for injection HLX43 combined with HLX07 and Hanshuang for the treatment of advanced solid tumors approved by the National Medical Products Administration.

HENLIUS (02696) announced that the clinical trial application for the combination of HLX43 (targeting PD-L1 antibody-conjugate drug), HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection), and Hansuo (sulirumab injection) for the treatment of advanced solid tumors has been approved by the National Medical Products Administration (NMPA). The company plans to conduct relevant clinical trials in China when conditions are met. The phase 1 clinical data of HLX43 were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and the 2025 World Conference on Lung Cancer (WCLC), showing good safety and promising preliminary efficacy in solid tumors such as non-small cell lung cancer (NSCLC). HLX07 is an innovative biopharmaceutical developed by the company targeting the EGFR pathway, intended for the treatment of advanced solid tumors. In February 2023, the results of a phase 1b/2 clinical study combining HLX07 with chemotherapy for the treatment of advanced solid tumors demonstrated good safety and tolerability. Hansuo is an innovative anti-PD-1 monoclonal antibody developed by the company, with indications approved for marketing in China (excluding the Greater China Region) including first-line treatment with chemotherapy for squamous non-small cell lung cancer (sqNSCLC), extensive stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC). In December 2025, the NMPA accepted the New Drug Application (NDA) for the use of Hansuo (sulirumab injection) in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer, and it has been granted priority review status.