全球化2.0 | 美国FDA批准复宏汉霖西妥昔单抗生物类似药HLX05-N开展临床研究

2026年5月10日，复宏汉霖（2696.HK）宣布，美国药品监督管理局（FDA）批准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）的新药临床试验（IND）申请，拟用于治疗转移性结直肠癌（mCRC）。近期，HLX05-N用于治疗转移性结直肠癌（mCRC）的I期临床试验申请已在中国获国家药品监督管理局（NMPA）批准。

表皮生长因子受体（EGFR）属于具有酪氨酸激酶活性的细胞表面红白血病病毒癌基因同源物（ErbB）家族，为一种广泛表达于正常上皮细胞及结直肠癌、头颈癌等肿瘤组织的跨膜糖蛋白。EGFR介导的信号通路通过多种途径调控肿瘤生长，在肿瘤细胞的增殖、分化、生存及转移过程中发挥关键调控作用，因此被认为是相关肿瘤的重要治疗靶点。

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。

凭借其明确的疗效和良好的安全性特征，西妥昔单抗已成为EGFR通路相关肿瘤治疗中的重要靶向药物之一^1-3。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。

尽管EGFR靶向治疗已在相关肿瘤领域广泛应用，全球范围内在治疗可及性与可负担性方面仍存在不均衡，高质量且可负担的治疗选择仍有待进一步提升。截至目前，欧美市场尚无获批上市的西妥昔单抗生物类似药，整体竞争格局仍处于早期阶段。在此背景下，持续开发兼具可靠疗效与更高可及性的治疗方案，有望为更多患者带来获益。 HLX05-N是复宏汉霖严格按照中国、欧盟、美国等生物类似药指导原则开发的西妥昔单抗生物类似药，在药学和非临床比对研究中证明了其与原研西妥昔单抗注射液高度相似。

未来，复宏汉霖将继续聚焦未满足的临床需求，持续拓宽公司在更多疾病领域的前瞻性布局，为全球患者带去高品质、可负担的创新治疗方案。

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 | U.S. FDA Clearance of IND for Cetuximab Biosimilar HLX05-N

On May 10, 2026, Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for HLX05-N, Henlius' self-developed biosimilar of cetuximab (The recombinant anti-EGFR human/murine chimeric monoclonal antibody), for the treatment of metastatic colorectal cancer (mCRC). Recently, the IND application for a Phase 1 clinical trial of HLX05-N for the treatment of mCRC has also been approved by the National Medical Products Administration (NMPA) in China.

Epidermal growth factor receptor (EGFR) is a member of the ErbB family of cell surface receptors with intrinsic tyrosine kinase activity. It is a transmembrane glycoprotein widely expressed in normal epithelial cells as well as in tumor tissues, including colorectal cancer and head and neck cancers. EGFR-mediated signaling pathways regulate tumor growth through multiple mechanisms and play a key regulatory role in tumor cell proliferation, differentiation, survival, and metastasis, and are therefore considered an important therapeutic target in related tumors.

Cetuximab specifically binds to EGFR on the surface of cells. On one hand, it competitively inhibits the binding of ligands such as EGF to EGFR, inducing receptor internalization and downregulating its surface expression, thereby blocking tyrosine kinase-dependent phosphorylation and multiple intracellular signaling pathways. This leads to inhibition of cell proliferation, induction of apoptosis, and suppression of DNA repair and angiogenesis, ultimately inhibiting tumor cell activity, invasion, and metastasis. On the other hand, cetuximab can also mediate antibody-dependent cellular cytotoxicity (ADCC), enabling immune cells to kill tumor cells.

With its well-established efficacy and favorable safety profile, cetuximab has become one of the important targeted therapies for EGFR pathway-related tumors.^1-3 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™ data, the global sales of cetuximab injection reached approximately USD 1.658 billion in 2025, reflecting the well-established clinical use of EGFR-targeted therapies and the sustained market demand in related tumor areas.

Although EGFR-targeted therapies are widely used across relevant tumor types, disparities in access and affordability persist worldwide, underscoring the need for more high-quality, cost-effective treatment options. To date, no biosimilars of cetuximab have been approved in the U.S. or Europe, and the overall competitive landscape remains at an early stage. Against this backdrop, the continued development of therapies with reliable efficacy and enhanced accessibility is expected to expand patient access and benefit a broader population. HLX05-N is a cetuximab biosimilar developed by Henlius in strict accordance with biosimilar guidelines in China, the European Union, and the United States. Analytical and non-clinical comparative studies have demonstrated a high degree of similarity between HLX05-N and the reference cetuximab injection.

Looking forward, Henlius will maintain its focus on unmet medical needs and further broaden the company’s layout in more disease areas, commit to bring high quality and affordable treatments for patients worldwide.

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/.

参考文献

References

1. NMPA Prescribing Information for Erbitux®

erbitux-epar-product-information https://www.ema.europa.eu/en/documents/productinformation/erbitux-epar-product-information_en.pdf
FDA ERBITUX product information https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf

联系方式

媒体：PR@Henlius.com

投资者：IR@Henlius.com