复宏汉霖成功完成贝伐珠单抗HLX04-O眼科适应症III期临床研究

NCT05003245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。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。

HLX04-O是复宏汉霖利用基因工程技术构建的一款重组抗VEGF人源化单克隆抗体注射液，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。根据眼科用药需求，公司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，开发了新的眼科制剂产品HLX04-O。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。

除NCT05003245外，公司亦就HLX04-O同步开展了一项国际多中心III期临床研究（NCT04740671），并在中国、澳大利亚、欧盟和美国等国家和地区入组受试者。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。

Primary Endpoint Met in Phase 3 Clinical Study of Henlius Bevacizumab for Treatment of Ophthalmic Diseases

Shanghai, China, April 2, 2025 - Henlius (2696.HK) announced that the phase 3 clinical trial for the HLX04-O, a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the company and Essex, for the treatment of Chinese patients with wet age-related macular degeneration (wAMD), met the primary endpoint. The company plans to partner with Essex to submit a New Drug Application (NDA) in China, with HLX04-O expected to become the country's first bevacizumab approved for the treatment of ophthalmic diseases.

NCT05003245 is a multi-center, 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) IVT 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 of letters in best corrected visual acuity (“BCVA”) from baseline at week 48; secondary endpoints included other efficacy, safety, tolerability, and pharmacokinetics. The results showed that the primary endpoint of this study was met, with the mean change in BCVA from baseline at 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.

HLX04-O is a recombinant anti-VEGF humanized monoclonal antibody injection constructed using genetic engineering technology independently developed by Henlius. HLX04-O can inhibit VEGF’s binding to its receptor Flt-1 (VEGFR-1) and KDR (VEGFR-2) on endothelial cells to inhibit the activation of its tyrosine kinase signalling pathway, inhibit endothelial cell proliferation and reduce angiogenesis, thereby treating eye diseases associated with angiogenesis. 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. 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.

In addition to NCT05003245, Henlius has conducted an international multicenter phase 3 clinical trial (NCT04740671) for HLX04-O, enrolling subjects in regions including China, Australia, the European Union, and the United States. 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.

媒体：PR@Henlius.com

投资者：IR@Henlius.com