2026年5月10日，复宏汉霖（HK2696）(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（HK2696）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（HK2696）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。
Globalisation2.0|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 Phase1clinical 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.1-3To 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 USD1.658billion in2025,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.
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 in2010,Henlius has established an integrated,end-to-end biopharmaceutical platform encompassing global R&D,clinical operations,regulatory affairs,manufacturing,and commercialisation.The Company employs nearly4,000people 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“Globalisation2.0”phase,building a scalable and sustainable global growth model.As of early2026,Henlius has achieved regulatory approvals for10products across over60countries 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.
