2026年5月26日，复宏汉霖(2696.HK)宣布，公司自主研发的重组抗EGFR单克隆抗体pimurutamab (HLX07) 联合抗PD-1单抗H药 汉斯状®(斯鲁利单抗，欧洲商品名：Hetronifly®)及化疗，用于一线治疗晚期鳞状非小细胞肺癌(sqNSCLC)患者的随机、双盲、多中心、平行对照的II/III期临床研究已在中国完成首例患者给药，标志着该研究在中国正式进入临床实施阶段。近期，该研究也已在澳大利亚完成临床试验备案(CTN)，全球临床开发稳步推进。

Pimurutamab是复宏汉霖自主研发的一款抗EGFR单克隆抗体，具备更低的免疫原性和更优的EGFR靶点亲和力。同时通过Fc端改造，显著延长其半衰期，3周的给药频率使其更适合与肿瘤免疫产品的临床联用。临床前研究表明，pimurutamab相较同类抗EGFR单抗具有更出色的生物活性，在不同肿瘤模型中均能显著抑制肿瘤细胞的生长，并与H药显示出很强的协同作用1。两者联用，不仅阻断EGFR生长信号，更同步激活免疫应答，极具联合协同治疗潜力。

此前，pimurutamab联合斯鲁利单抗及化疗用于一线治疗EGFR高表达晚期或转移性sqNSCLC的II期剂量探索研究(HLX10HLX07-sqNSCLC-201)已取得积极结果，中位随访18.6个月与23.5个月的具体数据已先后在2025年世界肺癌大会(WCLC)及2025年11月举办的国际肺癌前沿及创新论坛上公布。

基于上述非临床与临床研究基础，该II/III期研究(HLX07-sqNSCLC301)将进一步系统评估 pimurutamab+斯鲁利单抗+化疗这一联合方案作为一线治疗在晚期sqNSCLC患者中的临床价值，验证其通过EGFR靶点与免疫通路协同作用，是否能够突破现有一线治疗的疗效瓶颈，为患者提供更具潜力的新治疗选择。该研究采用国际多中心设计，正在中国及海外市场同步推进。

复宏汉霖深度布局肺癌治疗领域，已形成覆盖多种组织学类型、多个治疗阶段、兼具免疫、靶向、抗血管与抗体偶联药物(ADC)等多机制的综合产品矩阵。公司核心产品H药 汉斯状®作为全球首个获批用于小细胞肺癌一线治疗的抗PD-1单抗，已在全球40多个国家和地区获批上市，在肺癌领域全面覆盖广泛期小细胞肺癌(ES-SCLC)、鳞状非小细胞肺癌(sqNSCLC)及非鳞状非小细胞肺癌(nsqNSCLC)等关键适应症的一线标准治疗，其一线治疗局限期小细胞肺癌(LS-SCLC)的国际多中心III期临床研究亦已完成全球入组。与此同时，贝伐珠单抗汉贝泰®进一步完善公司在肺癌领域的抗血管靶向治疗布局，为晚期、转移性或复发性NSCLC患者提供了更可负担的高质量治疗选择。在创新研发方面，公司全面推进多元机制、差异化优势突出的创新管线。具备广谱抗肿瘤潜力的PD-L1 ADC HLX43作为潜在同类最优药物，已在肺癌等多个瘤种中展现“高效、低毒”的显著治疗优势，并在中、美、日、澳等多国启动临床试验;抗EGFR单抗pimurutamab与H药的联合治疗方案在EGFR高表达鳞状NSCLC人群中释放出具有突破性的临床信号，推动精准治疗不断向前发展。此外，公司早期研发布局还包括拟用于小细胞肺癌治疗的DLL3 x DLL3 x CD3 x CD28四特异性T细胞衔接器HLX3901，以及拟用于NSCLC治疗的cMET x EGFR双抗ADC HLX48等。

未来，复宏汉霖将持续深化肺癌领域创新布局，通过多元化的产品组合和全球化的临床开发，为患者带来更多突破性治疗方案，创造更大的临床价值和社会效益。

关于HLX07-sqNSCLC301

本研究是一项评估pimurutamab (HLX07) 联合汉斯状®和化疗对比安慰剂联合汉斯状®或帕博利珠单抗和化疗，作为一线治疗晚期鳞状非小细胞肺癌(sqNSCLC)患者的随机、双盲、多中心、平行对照的II/III期临床研究。研究包括两个阶段，第一阶段为II期研究，受试者将按1:1:1的比例随机分配至三组之一：A组为pimurutamab 1000mg联合斯鲁利单抗和化疗;B组为pimurutamab 600mg联合斯鲁利单抗和化疗;C组为安慰剂联合斯鲁利单抗和化疗。每三周一次(Q3W)，共4个周期，随后分别进入相应剂量的pimurutamab或安慰剂联合汉斯状®的维持治疗阶段。第一阶段的主要终点为独立影像评估委员会(BICR)评估的无进展生存期(PFS)及客观缓解率(ORR)。第二阶段为III期研究，pimurutamab的给药剂量将根据第一阶段的研究结果确定。合格受试者将按1:1的比例随机分配至两组之一。试验组为pimurutamab联合汉斯状®和化疗，每三周一次(Q3W)，共4个周期;后续接受pimurutamab联合斯鲁利单抗维持治疗。对照组为安慰剂联合帕博利珠单抗和化疗，每三周一次(Q3W)，共4个周期;后续接受安慰剂联合帕博利珠单抗维持治疗。第二阶段的主要终点为BICR评估的PFS和总生存期(OS)。本次研究的主要目的是评估pimurutamab联合汉斯状®和化疗对比安慰剂联合汉斯状®或帕博利珠单抗和化疗一线治疗晚期sqNSCLC患者的疗效。次要目的包括评估pimurutamab联合汉斯状®和化疗的安全性、药代动力学特征及免疫原性，并评估肿瘤组织EGFR表达、PD-L1表达与疗效的关系。

关于复宏汉霖

复宏汉霖(2696.HK)是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60余个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、5款产品获得欧盟EC批准，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。

在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器(包括多特异性TCE)、抗体偶联药物(ADC)以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳(Best-in-Class)潜力，并在全球同步推进30余项临床研究。核心产品H药 汉斯状®(斯鲁利单抗，欧洲商品名：Hetronifly®)作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市;同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。

Globalisation 2.0 | Henlius Completes First Patient Dosed in China for MRCT of pimurutamab (HLX07) Plus serplulimab, Accelerating Global Development

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.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.