全球化2.0｜中美双报，复宏汉霖西妥昔单抗生物类似药HLX05-N I期临床研究于中国完成首例患者给药

2026年7月8日，复宏汉霖（2696.HK）宣布，公司自主开发的西妥昔单抗生物类似药HLX05-N（重组抗EGFR人鼠嵌合单克隆抗体注射液）在治疗转移性结直肠癌（mCRC）的I期临床研究（HLX05-N-mCRC102）于中国完成首例患者给药。此前，HLX05-N用于转移性结直肠癌治疗的I期临床试验申请（IND）已获美国食品药品监督管理局（FDA）批准。截至目前，在中国及欧美日等全球生物药主流市场尚无获批上市的西妥昔单抗生物类似药。

HLX05-N是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规开发的西妥昔单抗生物类似药，经药学和非临床比对研究证明，HLX05-N与原研西妥昔单抗相似。表皮生长因子受体（EGFR）是一种表达于正常上皮及结直肠癌、头颈癌等肿瘤组织的跨膜糖蛋白。西妥昔单抗可特异性结合细胞表面的EGFR。一方面，其通过竞争性抑制EGF等配体与EGFR的结合，诱导EGFR内化并下调其在细胞表面的表达，阻断酪氨酸激酶依赖的磷酸化过程及胞内多种信号转导通路，从而抑制细胞增殖，诱导细胞凋亡，抑制DNA修复及血管生成，抑制肿瘤细胞活性、侵袭和转移。另一方面，西妥昔单抗还可通过抗体依赖的细胞介导的细胞毒作用（ADCC），介导免疫细胞对肿瘤细胞的杀伤。

截至目前，西妥昔单抗已在全球多个国家和地区获批上市，主要用于治疗mCRC和头颈部鳞状细胞癌（HNSCC）。根据IQVIA MIDAS^™数据显示，2025年度西妥昔单抗注射液的全球销售额约为16.58亿美元，反映出EGFR靶向治疗在相关肿瘤领域已具备成熟的临床应用基础和稳定的市场需求。

未来，复宏汉霖将继续聚焦未满足的临床需求，依托一体化的全球研发与临床体系，持续拓展更多疾病领域的前瞻性布局，致力于为全球患者带来更多治疗选择。

关于HLX05-N-mCRC102研究

本研究是一项在KRAS/NRAS野生型且BRAF V600E无突变的转移性结直肠癌参与者中，比较HLX05-N与美国及欧盟来源ERBITUX^®联合化疗（mFOLFOX6）治疗的多中心、随机、双盲、平行对照1期临床研究。参与者将按1:1:1随机分配至HLX05-N组、美国来源ERBITUX^®组或欧盟来源ERBITUX^®组，并根据ECOG体能状态和性别进行分层。前三个周期，各组参与者将接受相应研究药物联合化疗；此后，美国或欧盟来源ERBITUX^®组参与者将在盲态下转换为HLX05-N并继续联合化疗，直至达到方案规定的停药标准。本研究的主要目的是评估HLX05-N与ERBITUX^®在单次和多次静脉输注后的药代动力学（PK）相似性，次要目的是比较两者的药代动力学（PK）特征、有效性、安全性和免疫原性。

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。截至目前，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8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和首个获批胃癌围术期适应症的抗PD-1单抗，正加速全球布局，已在全球50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（通用名：dulpatatug）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。

First Patient Dosed in China for Phase 1 Clinical Trial of Henlius’ Cetuximab Biosimilar HLX05-N

Shanghai, China, 8 July, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient has been dosed in China in the phase 1 clinical trial (HLX05-N-mCRC102) of its independently developed cetuximab biosimilar, HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), for the treatment of metastatic colorectal cancer (mCRC). Previously, the Investigational New Drug (IND) application for the phase 1 clinical trial of HLX05-N in mCRC had also been cleared by the U.S. Food and Drug Administration (FDA). To date, no cetuximab biosimilar has been approved in China or other major global biologics markets, including the United States, Europe, and Japan.

HLX05-N is being developed as a biosimilar to cetuximab in accordance with biosimilar regulatory guidelines in China, the European Union, and the United States. Comprehensive analytical and non-clinical comparability studies have demonstrated a high degree of similarity between HLX05-N and the reference cetuximab injection.

The epidermal growth factor receptor (EGFR) is a transmembrane glycoprotein expressed on normal epithelial cells as well as a variety of tumor types, including colorectal cancer and head and neck cancer. Cetuximab specifically binds to EGFR on the cell surface, competitively blocking the binding of endogenous ligands such as epidermal growth factor (EGF). This leads to receptor internalization and downregulation of EGFR expression, inhibits tyrosine kinase-dependent phosphorylation and downstream signaling pathways, thereby suppressing tumor cell proliferation, inducing apoptosis, and inhibiting DNA repair, angiogenesis, tumor cell invasion, and metastasis. In addition, cetuximab exerts antitumor activity through antibody-dependent cell-mediated cytotoxicity (ADCC), enabling immune cells to eliminate tumor cells.

To date, cetuximab has been approved in multiple countries and regions worldwide, primarily for the treatment of metastatic colorectal cancer (mCRC) and head and neck squamous cell carcinoma (HNSCC). According to IQVIA MIDAS^™, global sales of cetuximab reached approximately US$1.658 billion in 2025, reflecting the well-established clinical value of EGFR-targeted therapies and sustained market demand in these disease areas.

Looking ahead, Henlius will continue to focus on unmet medical needs, leveraging its integrated global R&D and clinical development capabilities to expand its presence across therapeutic areas and deliver more treatment options to patients worldwide.

About HLX05-N-mCRC102

This study is a multicenter, randomized, double-blind, parallel-controlled phase 1 clinical study comparing HLX05-N with US- and EU-sourced ERBITUX^®, each in combination with chemotherapy (mFOLFOX6), in participants with metastatic colorectal cancer characterized by wild-type KRAS/NRAS and no BRAF V600E mutation. Participants will be randomized in a 1:1:1 ratio to the HLX05-N, US-sourced ERBITUX^®, or EU-sourced ERBITUX^® group, with stratification by ECOG performance status and gender. During the first 3 cycles, participants will receive the assigned study drug in combination with chemotherapy. Thereafter, participants in the US- or EU-sourced ERBITUX^® groups will switch to HLX05-N under blinded conditions and continue combination chemotherapy until a protocol-defined discontinuation criterion is met. The primary objective of this study is to evaluate the PK similarity between HLX05-N and ERBITUX^® following single and multiple intravenous infusions. The secondary objective is to compare their PK characteristics, efficacy, safety, and immunogenicity.

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. Up to date, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight 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 for perioperative gastric cancer. Up to date, it has been approved in 50 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 dulpatatug (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/.

联系方式

媒体：PR@Henlius.com

投资者：IR@Henlius.com