Henlius：Hetronifly® Serplulimab Injection has achieved the first patient administration in China
On May 26, 2026, Henlius (2696.HK) announced that the first patient has been dosed in China in a randomized, double-blind, multicentre, parallel-controlled Phase 2/3 clinical trial evaluating its self-developed recombinant anti-EGFR mAb pimurutamab (HLX07) in combination with the anti-PD-1 mAb serplulimab (trade name: Hetronifly® in Europe) and chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sqNSCLC). This milestone marks the official initiation of the study’s clinical execution phase in China. Recently, the study also completed Clinical Trial Notification (CTN) in Australia, with global clinical development progressing steadily.
Pimurutamab is a humanized anti-EGFR mAb developed by Henlius, featuring reduced immunogenicity and enhanced binding affinity to the EGFR target. Through Fc engineering, pimurutamab demonstrates a significantly prolonged half-life, and the 3-week dosing frequency makes it more suitable for clinical use in combination with immunotherapies. Preclinical trials have shown that, compared with existing anti-EGFR mAbs, pimurutamab exhibits improved biological activity, significantly inhibiting tumour cell growth across multiple tumour models and demonstrating strong synergistic effects when combined with serplulimab.1 The combination not only blocks EGFR-mediated proliferative signalling but also simultaneously enhances antitumor immune responses, highlighting its promising potential as a synergistic combination therapy.
Positive results have been reported from a Phase 2 dose-exploration trial (HLX10HLX07-sqNSCLC-201) evaluating pimurutamab in combination with serplulimab and chemotherapy as a first-line treatment for patients with EGFR-overexpressing advanced or metastatic sqNSCLC. Updated data with median follow-up durations of 18.6 months and 23.5 months were successively presented at the 2025 World Conference on Lung Cancer (WCLC) and the International Summit on Frontiers and Innovations in Lung Cancer held in November 2025.
Building on the aforementioned preclinical and clinical findings, the Phase 2/3 trial (HLX07-sqNSCLC301) is designed to further systematically evaluate the clinical value of pimurutamab in combination with serplulimab and chemotherapy as a first-line treatment for patients with advanced sqNSCLC. The study aims to assess whether the synergistic effects of EGFR-targeted therapy and immunotherapy can overcome the efficacy limitations of current first-line treatment options and provide patients with a potentially more effective therapeutic option. The study adopts a multi-regional clinical trial (MRCT) design and is being advanced simultaneously in both China and ex-China markets.
Henlius has established a comprehensive portfolio in the field of lung cancer, spanning multiple histological subtypes and treatment stages, and incorporating diverse therapeutic mechanisms including immunotherapy, targeted therapy, anti-angiogenic therapy, and antibody–drug conjugates (ADCs). The Company’s flagship product, serplulimab (trade name: Hetronifly® in Europe), is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer (SCLC). It has been approved in more than 40 countries and regions worldwide, covering key first-line indications across lung cancer, including extensive-stage small cell lung cancer (ES-SCLC), squamous non-small cell lung cancer (sqNSCLC), and non-squamous non-small cell lung cancer (nsqNSCLC). In addition, the global Phase 3 multicentre clinical trial evaluating serplulimab for first-line treatment of limited-stage small cell lung cancer (LS-SCLC) has completed global patient enrolment. Meanwhile, HLX04 (bevacizumab biosimilar) further strengthens the company’s anti-angiogenic therapy portfolio in lung cancer, providing a high-quality and more affordable treatment option for patients with advanced, metastatic, or recurrent NSCLC. On the innovation front, Henlius is advancing a diversified pipeline with differentiated mechanisms of action. HLX43, a PD-L1-targeting ADC with broad anti-tumour potential and considered a potential best-in-class candidate, has demonstrated a compelling “high efficacy, low toxicity” profile across multiple tumour types including lung cancer, and clinical trials have been initiated in China, the United States, Japan, and Australia. In addition, the combination regimen of the anti-EGFR mAb pimurutamab with serplulimab has shown breakthrough clinical signals in EGFR-high-expressing sqNSCLC, further advancing precision treatment strategies. The Company’s early-stage pipeline also includes HLX3901, a DLL3 × DLL3 × CD3 × CD28 tetravalent T-cell engager being developed for SCLC, and HLX48, a bispecific ADC targeting cMET × EGFR for the treatment of NSCLC.
Looking ahead, Henlius will continue to deepen its innovation strategy in lung cancer, leveraging a diversified product portfolio and global clinical development capabilities to deliver more breakthrough treatment options for patients and generate greater clinical and societal value.
About HLX07-sqNSCLC301
This study is a randomized, double-blind, multicentre, parallel-controlled Phase 2/3 clinical study designed to evaluate pimurutamab in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab or pembrolizumab and chemotherapy as first-line treatment in patients with advanced sqNSCLC. The study consists of two parts. Part I is a Phase 2 study, in which participants will be randomized in a 1:1:1 ratio to one of the three groups: Group A: pimurutamab 1000 mg in combination with serplulimab and chemotherapy; Group B: pimurutamab 600 mg in combination with serplulimab and chemotherapy; and Group C: placebo in combination with serplulimab and chemotherapy. Treatment will be administered once every 3 weeks (Q3W) for a total of 4 cycles, followed by maintenance therapy with the corresponding dose of pimurutamab or placebo in combination with serplulimab. The primary endpoints of Part I are progression-free survival (PFS) and objective response rate (ORR), as assessed by Blinded Independent Central Review (BICR). Part II is a Phase 3 study, and the dose of pimurutamab in Part II will be determined based on the results of Part I. Participants will be randomized in a 1:1 ratio to one of two groups. Experimental group: pimurutamab in combination with serplulimab and chemotherapy, administered Q3W for 4 cycles, followed by maintenance therapy with HLX07 in combination with serplulimab. Control group: placebo in combination with pembrolizumab and chemotherapy, administered Q3W for 4 cycles, followed by maintenance therapy with placebo in combination with pembrolizumab. The primary endpoints of Part II are PFS assessed by BICR, and overall survival (OS). The primary objective of this study is to evaluate the efficacy of pimurutamab in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab or pembrolizumab and chemotherapy as first-line treatment in patients with advanced sqNSCLC. Secondary objectives include evaluating the safety, pharmacokinetic (PK) characteristics, and immunogenicity of pimurutamab in combination with serplulimab and chemotherapy, as well as evaluating the relationship between EGFR and PD-L1 expression in tumour tissues and efficacy.
About Henlius
Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.
Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly® in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.
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