全球化2.0 | 复宏汉霖K药生物类似药完成美国首例患者给药，全球临床开发再进一步

2026年6月5日，复宏汉霖（2696.HK）宣布，公司自主开发的帕博利珠单抗生物类似药HLX17（重组抗PD-1人源化单克隆抗体注射液）的国际多中心I期临床研究（HLX17-MRST001）完成美国首例受试者给药，拟用于辅助治疗多种已切除实体肿瘤。此前，该研究已于中国完成首例患者给药。HLX17有望依托国际多中心开发路径，加速积累更广泛人群中的临床数据，为后续全球注册开发奠定基础。

HLX17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帕博利珠单抗注射液生物类似药，经药学比对，临床前药理学、药效学、药代动力学和免疫原性研究证明，HLX17与原研帕博利珠单抗相似。目前帕博利珠单抗已在多个国家和地区获批用于完全切除术后的非小细胞肺癌（NSCLC）、黑色素瘤（MEL）以及肾细胞癌（RCC）患者的辅助治疗等一系列适应症。

HLX17-MRST001是一项多中心、随机、双盲、平行对照的 I 期临床研究，旨在评估 HLX17与美国市售KEYTRUDA^®在多种已切除实体肿瘤（包括非小细胞肺癌、黑色素瘤或肾细胞癌）受试者中的药代动力学（PK）特征、有效性、安全性和免疫原性。合格的受试者将按1:1的比例随机分配至A组或B组。A组受试者自第 1 周期起接受 HLX17 200 mg 静脉注射每三周一次（Q3W），持续至随机化后 12 个月（约 17 个周期）或发生疾病复发、死亡、开始新的抗肿瘤治疗、不可耐受毒性、撤回知情同意或研究终止。B 组前 8 个周期（24周）接受美国市售 KEYTRUDA^® 200 mg Q3W，随后转为接受 HLX17 200 mg Q3W，持续至随机化后 12 个月或满足停药标准。本研究的主要目的是评估 HLX17 与美国市售 KEYTRUDA^® 在单次及多次静脉输注后PK相似性，主要终点包括首次给药后从0到21天血清浓度-时间曲线下面积（AUC0-21d），以及第 6 次给药后稳态下单个给药间隔内的血清浓度-时间曲线下面积（AUCss）。次要研究终点包括其他 PK 参数、有效性、安全性和免疫原性。

未来，复宏汉霖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。

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。

Globalisation 2.0 | Henlius Advances Global Clinical Development of Pembrolizumab Biosimilar with First U.S. Patient Dosed

Shanghai, China, June 5, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient in the United States has been dosed in the international multicentre Phase 1 clinical trial (HLX17-MRST001) of HLX17, the company’s independently developed pembrolizumab biosimilar (recombinant anti-PD-1 humanised monoclonal antibody injection), intended for the adjuvant treatment of multiple resected solid tumours. Prior to this, the study had already completed first patient dosing in China. Leveraging a global multicentre development strategy, HLX17 is expected to accelerate the accumulation of clinical data across broader patient populations and lay the foundation for future global registration and development.

HLX17 is a pembrolizumab biosimilar independently developed by Henlius in accordance with the NMPA, EMA, FDA and other international biosimilar guidelines. The pharmacologic comparative study, and preclinical pharmacology study, pharmacodynamics, pharmacokinetics and immunogenicity studies have demonstrated that HLX17 is similar to the reference pembrolizumab. Pembrolizumab has been approved in various countries and regions for a range of different indications, such as for the adjuvant treatment of non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC).

This study is a multicentre, randomised, double‑blind, parallel‑controlled Phase I clinical study designed to evaluate the pharmacokinetic (PK) profile, efficacy, safety and immunogenicity of HLX17 vs. US-sourced KEYTRUDA^® in patients with multiple resected solid tumours, including non‑small cell lung cancer, melanoma, or renal cell carcinoma. Eligible participants will be randomised in a 1:1 ratio to Arm A or Arm B. Participants in Arm A will receive HLX17 (200 mg) by intravenous infusion once every three weeks (Q3W) starting from Cycle 1, and treatment will continue until 12 months after randomization (approximately 17 cycles) or until the occurrence of disease recurrence, death, initiation of new anti‑tumour therapy, unacceptable drug toxicity, withdrawal of informed consent, or study termination. Participants in Arm B will receive US‑sourced KEYTRUDA^® (200 mg) Q3W for the first 8 cycles (24 weeks), after which they will switch to HLX17 200 mg Q3W, and continue treatment until 12 months after randomization or until the discontinuation criteria are met. The primary objective of this study is to evaluate the PK similarity between HLX17 and US‑sourced KEYTRUDA^® following single and multiple intravenous infusions, with primary endpoints including the 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 6th dose. Secondary endpoints include additional PK parameters, efficacy, safety, and immunogenicity.

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.

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 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