Henlius：Pimurutamab Completed First Patient Dosing in China
On May 26, 2026, Henlius (2696.HK) announced that the first patient has been dosed in China in the randomized, double-blind, multicenter, parallel-controlled Phase II/III clinical study evaluating pimurutamab (HLX07), the Company’s proprietary recombinant anti-EGFR monoclonal antibody, in combination with H药 汉斯状® (serplulimab, European brand name: Hetronifly®), an anti-PD-1 monoclonal antibody, plus chemotherapy, as a first-line treatment for patients with advanced squamous non-small cell lung cancer (sqNSCLC). This milestone marks the official progression of the study into the clinical implementation phase in China. Recently, the study has also completed clinical trial notification (CTN) in Australia, with global clinical development advancing steadily.
Pimurutamab is an anti-EGFR monoclonal antibody independently developed by Henlius, featuring lower immunogenicity and improved affinity for the EGFR target. Additionally, through Fc region engineering, its half-life has been significantly prolonged, and the 3-week dosing schedule makes it well-suited for clinical combination with immuno-oncology products. Preclinical studies have demonstrated that pimurutamab exhibits superior bioactivity compared to other anti-EGFR monoclonal antibodies, significantly inhibiting tumor cell growth in various tumor models, and shows strong synergy with H药. The combination approach not only blocks EGFR growth signals but also simultaneously activates immune responses, offering substantial synergistic therapeutic potential.
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