HENLIUS (02696) has announced that its self-developed pimurutamab HLX07, a recombinant anti-EGFR humanized monoclonal antibody injection, has received approval from the relevant human research ethics committee and has been filed with Australia's Therapeutic Goods Administration for a Phase 2/3 clinical trial. The trial will evaluate HLX07 in combination with HANSIZHUANG® (serplulimab injection) and chemotherapy, compared to a placebo combined with either HANSIZHUANG® or pembrolizumab and chemotherapy, as a first-line treatment for advanced squamous non-small cell lung cancer (sqNSCLC). HLX07 is an innovative biologic drug targeting EGFR, developed by the company for the treatment of advanced solid tumors. In February 2023, results from a Phase 1b/2 clinical study of HLX07 combined with chemotherapy for advanced solid tumors showed a favorable safety and tolerability profile. Currently, multiple Phase 2 clinical studies for HLX07 are underway in mainland China, including a trial of HLX07 as a monotherapy for advanced cutaneous squamous cell carcinoma (CSCC) and other solid tumors, and a Phase 2 trial of HANSIZHUANG® combined with HLX07 for advanced or metastatic sqNSCLC and other solid tumors. HANSIZHUANG®, an innovative anti-PD-1 monoclonal antibody developed by the company, has approved indications in mainland China for first-line combination therapy in 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 new drug application for HANSIZHUANG® combined with chemotherapy as a neoadjuvant/adjuvant treatment for gastric cancer was accepted by China's NMPA and granted priority review status. Additionally, HANSIZHUANG® has been approved for marketing in the European Union, the United Kingdom, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has received orphan drug designations from regulatory authorities in the United States, Switzerland, and South Korea. The company is also progressing multiple global clinical trials for HANSIZHUANG® and related combination therapies, covering indications such as lung cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer. In March 2026, the clinical trial application for HLX07 combined with HANSIZHUANG® and chemotherapy for advanced sqNSCLC was approved by China's NMPA. As of the date of this announcement, no similar combination therapy has been approved for marketing globally.
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