复宏汉霖成功完成贝伐珠单抗HLX04-O眼科适应症III期国际多中心临床研究

2026年6月16日，复宏汉霖（2696.HK）宣布，重组抗血管内皮生长因子(Vascular endothelial growth factor, VEGF)人源化单克隆抗体注射液HLX04-O用于湿性年龄相关性黄斑变性(wet age-related macular degeneration, wAMD)的III期国际多中心临床研究（NCT04740671）已成功达到预设的主要研究终点。该研究结果将与中国III期临床研究（NCT05003245）共同构成关键数据，支持合作伙伴亿胜生物推进包括美国在内的海外市场的上市申请。此前，HLX04-O用于治疗wAMD的上市注册申请（NDA）已获中国国家药品监督管理局（NMPA）药品审评中心受理。

HLX04-O是复宏汉霖根据眼科用药需求，在贝伐珠单抗汉贝泰^®的基础上保持活性成分不变，对处方、包装材料、规格和生产工艺等进行优化，开发的新的眼科制剂产品。HLX04-O通过基因工程技术构建，能够特异性结合VEGF，阻断VEGF与内皮细胞上的受体Flt1（VEGFR-1）和KDR（VEGFR-2）结合，抑制其酪氨酸激酶信号通路的激活，进而抑制内皮细胞增生，减少新生血管生成，从而实现对wAMD等血管增生眼部疾病的治疗。可比性研究表明生产工艺和制剂处方的变更对药物制剂的质量、安全性和有效性未产生不利影响。截至目前，中国境内上市的贝伐珠单抗产品暂无wAMD适应症获批。

NCT04740671为一项多中心、随机、双盲、阳性对照的非劣效III期临床研究，旨在比较HLX04-O与雷珠单抗玻璃体内注射（IVT）在湿性年龄相关性黄斑变性（wAMD）患者中的有效性和安全性。该研究同步在中国、澳大利亚、欧盟和美国等国家和地区入组受试者。入组的所有患者按照1:1的比例随机接受HLX04-O（1.25 mg）IVT或雷珠单抗（0.5 mg）IVT给药，每四周一次，在患者未发生死亡、撤回知情同意、失访或申办方终止研究的情况下，持续治疗一年。本次研究的主要研究终点为第48周最佳矫正视力（BCVA）较基线改善的平均字母数变化，次要研究终点为其他有效性、安全性、耐受性及药代动力学指标。研究结果显示，HLX04-O组第48周BCVA较基线改善的平均字母数变化结果非劣于雷珠单抗组，达到主要研究终点。此外，HLX04-O和雷珠单抗对wAMD患者人群整体、眼部、非眼部的安全性特征均相似，且安全性良好。

未来，复宏汉霖也将积极推动创新生物药品的开发，持续高效地为全球患者提供可负担的、高效的治疗方案。

关于湿性年龄相关性黄斑变性

年龄相关性黄斑变性（AMD）是造成老年人视力损害和不可逆失明的主要原因之一¹，根据世界卫生组织报告，全球约有3000万AMD患者，每年约有50万人因为AMD而致盲²。AMD致盲患者中，以脉络膜新生血管（CNV）为特征的湿性年龄相关性黄斑变性（wAMD）比例高达90%。随着老年人口比例的不断上升，wAMD已经成为一个日益严重的社会医学问题，存在着巨大的未满足的临床需求³。随着眼底治疗方法的突破与发展，抗VEGF药物已成为wAMD的一线疗法⁴，贝伐珠单抗玻璃体注射治疗wAMD的有效性和安全性也已在多项临床研究中得到验证^5-11。

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。

Henlius Successfully Completes International Phase 3 Trial of HLX04-O for Ophthalmic Indication

June 16, 2026 — Henlius (HKEX: 2696) today announced that the international multicentre phase 3 clinical trial of HLX04-O (NCT04740671), a recombinant anti-vascular endothelial growth factor (VEGF) humanised monoclonal antibody injection, for the treatment of wet age-related macular degeneration (wAMD), has successfully met its pre-specified primary endpoint. Together with the Phase 3 clinical study conducted in China (NCT05003245), these results will constitute a pivotal data package to support the Company’s partner in advancing marketing authorisation applications in overseas markets, including the United States. Previously, the new drug application (NDA) for HLX04-O in wAMD has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

HLX04-O is a novel ophthalmic formulation developed by Henlius to address specific clinical needs in ophthalmology. According to the requirements of ophthalmic drugs, the company has developed HLX04-O which optimizes the prescription, specifications, and production processes of HANBEITAI, assuming that the active ingredients remain unchanged. Developed using genetic engineering technology, HLX04-O specifically binds to VEGF and blocks its interaction with endothelial cell receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2), thereby inhibiting downstream tyrosine kinase signalling pathways. This mechanism inhibits endothelial cell proliferation and pathological neovascularisation, enabling the treatment of eye diseases associated with angiogenesis such as wAMD. Through a series of comparability analysis, it is proved that the changes in the production process and prescription of the preparation have no adverse impact on the quality, safety and efficacy of the preparation. As of now, none of the bevacizumab products marketed in Chinese mainland has been approved for the treatment of wAMD.

NCT04740671 is a global, multi-centre, randomized, double-blind, active-controlled, non-inferiority phase 3 clinical trial aimed to compare the efficacy and safety of HLX04-O with ranibizumab administered by intravitreal injection (“IVT”) in wet age-related macular degeneration (wAMD) patients. Patients enrolled were randomized 1:1 to receive either HLX04-O (1.25 mg) or ranibizumab (0.5 mg) IVT, administered every 4 weeks. The treatment continued for 1 year until death, withdrawal of consent, loss to follow-up, or study termination by the Sponsor. The primary endpoint of this study was mean change from baseline in best corrected visual acuity (“BCVA”) at Week 36. The key secondary endpoint was mean change from baseline in BCVA at Week 48; secondary endpoints included other efficacy, safety, tolerability, and pharmacokinetics. The results showed that the primary and key secondary endpoints of this study were met, with the mean change in BCVA from baseline at Week 36 and Week 48 in the HLX04-O group being non-inferior to that in the ranibizumab group. Additionally, HLX04-O had a good safety profile, with similar overall, ocular and non-ocular safety results compared to ranibizumab in wAMD patients.

Moving forward, Henlius will actively advance the development of innovative biologics and continue to deliver affordable, effective treatment options to patients worldwide with high efficiency.

About wAMD

Age-related macular degeneration is one of the leading causes of visual impairment and blindness in the elderly worldwide.¹ According to the World Health Organization (WHO), about 30 million people have suffered from AMD globally, and about half a million people become blind due to AMD each year.² Wet age-related macular degeneration (wAMD) is characterized by the formation of subretinal choroidal neovascularization (CNV) and is responsible for approximately 90% of cases of AMD-related blindness. Due to an aging population, wAMD has become a serious social medical problem and indicated a huge burden of unmet need.³ With the development of treatment for fundus diseases, anti-VEGF drugs are becoming the first-line therapy for the management of wAMD,⁴ and the efficacy and safety of vitreous injection of bevacizumab for wAMD have been verified in multiple clinical studies.^5-11

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 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 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

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