Henlius: First patient dosed in China in international multicenter study of pimurutamab (HLX07) combined with H drug Hetronifly®
May 26, 2026 – Henlius (2696.HK) announces that the first patient has been dosed in China in a randomized, double‑blind, multicenter, parallel‑controlled Phase II/III clinical study of the company’s self‑developed recombinant anti‑EGFR monoclonal antibody pimurutamab (HLX07) in combination with anti‑PD‑1 monoclonal antibody H drug Hetronifly® (serplulimab, European trade name: Hetronifly®) plus chemotherapy as first‑line treatment for patients with advanced squamous non‑small cell lung cancer (sqNSCLC). This milestone marks the official initiation of the study in China. Recently, the study also received Clinical Trial Notification (CTN) clearance in Australia, demonstrating steady global clinical progress.
Pimurutamab is a self‑developed anti‑EGFR monoclonal antibody of Henlius that features lower immunogenicity and improved EGFR target affinity. Through Fc engineering, the antibody also achieves a significantly extended half‑life, and its once‑every‑three‑week dosing schedule makes it more suitable for clinical combination with immuno‑oncology products. Preclinical studies show that pimurutamab exhibits superior biological activity compared with similar anti‑EGFR antibodies, potently inhibits tumor cell growth in various tumor models, and shows strong synergy with H drug. The combination simultaneously blocks EGFR growth signals and activates immune responses, offering great synergistic therapeutic potential.
Based on this non‑clinical and clinical foundation, the Phase II/III study (HLX07‑sqNSCLC301) will further systematically evaluate the clinical value of the pimurutamab + serplulimab + chemotherapy regimen as a first‑line treatment for patients with advanced sqNSCLC. The study aims to determine whether the synergy between EGFR targeting and immune pathways can overcome the efficacy bottleneck of current first‑line therapies and provide patients with a promising new treatment option. The study adopts an international multicenter design and is advancing concurrently in China and overseas markets
