全球化2.0 | 中美双报，复宏汉霖纳武利尤单抗生物类似药国际多中心I期临床研究于中国完成首例患者给药

关于HLX18-MRST001

本研究为一项多中心、随机、双盲、平行对照的1期临床试验，旨在评估HLX18与OPDIVO^®在多种已切除实体瘤（食管癌或胃食管连接部癌[EC/GEJC]、黑色素瘤[MEL]或尿路上皮癌[UC]）患者中的药代动力学（PK）特征、有效性、安全性及免疫原性的相似性。筛选合格的患者将按照1:1的比例随机分配A组或B组，A组接受HLX18单药治疗，B组前4个治疗周期接受OPDIVO^®单药治疗，随后转为接受HLX18单药治疗；每4周为一个治疗周期，持续治疗至随机化后的12个月（约13个周期）或疾病进展等情况。本研究的主要研究终点为首次给药前至给药后28天的血清药物浓度－时间曲线下面积（AUC_0-28d）和第4次给药后稳态给药间隔内的血清药物浓度－时间曲线下面积（AUC_ss）。次要研究终点为其他PK参数、有效性、安全性和免疫原性指标。

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。截至目前，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（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。

About HLX18-MRST001

This study is a multicenter, randomized, double-blind, parallel-controlled phase 1 clinical study designed to evaluate the similarity of pharmacokinetic (PK) profiles, efficacy, safety, and immunogenicity between HLX18 and OPDIVO^® in participants with multiple resected solid tumors, including esophageal cancer or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC). Eligible participants will be randomized in a 1:1 ratio to either Group A or Group B. Group A will receive HLX18 monotherapy, while Group B will receive OPDIVO^® monotherapy for the first 4 treatment cycles, followed by a switch to HLX18 monotherapy. Treatment will be administered once every 4 weeks per cycle and continue for up to 12 months after randomization (approximately 13 cycles) or until disease progression or other discontinuation criteria are met. The primary endpoints of the study are the area under the serum concentration-time curve from time 0 to 28 days (AUC_0-28d) after the first dose, and the area under the serum concentration-time curve within a dosing interval at steady state (AUC_ss) after the fourth dose. Secondary endpoints include other PK parameters, efficacy, safety, and immunogenicity indicators.

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. Up to date, 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 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/.