全球化2.0｜复宏汉霖伊匹木单抗生物类似药HLX13完成美国首例患者给药，国际多中心临床稳步推进

复宏汉霖

2026/06/25

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2026年6月25日，上海 —— 复宏汉霖（2696.HK）宣布，公司自主开发的伊匹木单抗生物类似药HLX13（重组抗CTLA-4全人单克隆抗体注射液）的国际多中心I期临床研究（HLX13-HCC102）完成美国首例患者给药。此前，该研究已在中国完成首例患者给药。这一进展标志着HLX13全球临床开发进一步提速，也体现了公司在全球自主临床运营体系下推进高质量国际多中心研究的能力。复宏汉霖正加速推动包括HLX13在内的多款产品在全球范围内的临床开发与注册进程。

HLX13是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规自主研发的伊匹木单抗生物类似药，已有的药学相似性比对研究、临床前研究数据表明，HLX13与原研药伊匹木单抗相似或无明显差异。目前，原研药伊匹木单抗（YERVOY^®）作为全球首个CTLA-4抑制剂，已在多个国家和地区获批上市，适应症包括联合纳武利尤单抗用于黑色素瘤、肝细胞癌等一系列适应症。2025年4月，复宏汉霖与Sandoz达成授权合作，授予其对HLX13在美国、欧洲42个国家和地区、日本、加拿大及澳大利亚的独家商业化权益。

HLX13-HCC102为一项国际多中心、随机、双盲、平行对照1期临床研究，旨在评估HLX13或其原研药YERVOY^®分别联合OPDIVO^®（国际通用名：纳武利尤单抗），在既往未经治疗的不可切除的晚期肝细胞癌（HCC）患者中的药代动力学（PK）特征、安全性、疗效和免疫原性。合格的受试者将按1:1的比例随机分配至两组，在前4个周期，受试者每3周接受一次HLX13或YERVOY^®联合OPDIVO^®治疗，随后每4周接受一次OPDIVO^®单药维持治疗。本研究的主要目的为在目标患者群体中比较HLX13与YERVOY^®的PK相似性。主要终点为从给药前至首次给药后21天的血药浓度－时间曲线下面积（AUC0-21d）和第4次给药后稳态给药间隔内血药浓度-时间曲线下面积（AUCss）或第4次给药后稳态下从0时到无穷的血药浓度-时间曲线下面积（AUCinf）。次要终点包括其他PK参数、有效性评估、安全性及免疫原性。

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高品质、可负担的治疗选择。

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。

Henlius’ Proposed Ipilimumab Biosimilar HLX13 Completes First Patient Dosing in the U.S., Advancing Global Multicenter Clinical Development

Shanghai, China, June 25, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its independently developed investigational ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) has completed first patient dosing in the United States in its international multicenter phase 1 clinical study (HLX13-HCC102). The study had previously achieved first patient dosing in China. This milestone marks continued progress in HLX13’s global clinical development and demonstrates the company’s ability to conduct quality international multicenter studies through its in-house global clinical operations. Henlius is advancing the global clinical development and regulatory advancement of multiple pipeline products, including HLX13.

HLX13 is a biosimilar of ipilimumab independently developed by Henlius in accordance with international biosimilar guidelines, including those of National Medical Products Administration (NMPA), EMA and FDA. Henlius has conducted preliminary comparative analytical assessments and a series of head-to-head preclinical studies to evaluate the similarity of HLX13 and the reference product ipilimumab. The results demonstrated a high similarity and no significant difference between HLX13 and the reference product ipilimumab. The reference product of HLX13, YERVOY^®, the world’s first CTLA-4 inhibitor, has been approved in various countries and regions in combination with nivolumab for the treatment of metastatic melanoma and hepatocellular carcinoma, among other indications. In April 2025, Henlius entered into a license agreement with Sandoz, granting Sandoz exclusive commercialization rights for HLX13 in the United States, 42 European countries and regions, Japan, Canada, and Australia.

This study is an international multicenter, randomized, double-blind, parallel-controlled phase 1 clinical study to evaluate the pharmacokinetic (PK) characteristics, safety, efficacy, and immunogenicity of HLX13 compared with its reference product YERVOY^®, each in combination with OPDIVO^® (INN: nivolumab), in patients with previously untreated, unresectable advanced hepatocellular carcinoma (HCC). Eligible subjects will be randomly assigned to two groups at a 1:1 ratio. Subjects will receive HLX13 or YERVOY^® in combination with OPDIVO^® once every 3 weeks for the first 4 cycles, followed by maintenance monotherapy with OPDIVO^® administered every 4 weeks. The primary objective of this study is to evaluate the PK similarity of HLX13 and YERVOY^® in the target patient population. The primary endpoints are area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose and the area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 4th dose, or area under the serum concentration-time curve from time 0 to infinity at steady-state (AUCinf) after the 4th dose. Secondary endpoints include other PK parameters, efficacy assessments, safety and immunogenicity.

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 high-quality, affordable treatment options to 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 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 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