2026年7月13日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自主开发的达雷妥尤单抗生物类似药HLX15（重组抗CD38全人单克隆抗体）皮下注射剂型（HLX15-SC）一线治疗新诊断多发性骨髓瘤(NDMM)的国际多中心I期临床研究（HLX15-SC-NDMM-001）完成美国首例患者给药。此前，该研究已于中国完成首例患者给药，后续还计划在澳大利亚、塞尔维亚、格鲁吉亚等多个国家进一步推进国际多中心临床研究。截至目前，欧美日等全球生物药主流市场尚无获批上市的达雷妥尤单抗生物类似药。
HLX15是复宏汉霖自主开发的一款全人源抗CD38 IgG1κ单克隆抗体，是达雷妥尤单抗静脉注射剂型Darzalex和皮下注射剂型Darzalex Faspro的生物类似药候选药物。2025年2月，复宏汉霖与Dr. Reddy’s达成授权合作，授予其HLX15皮下注射和静脉注射两种剂型在美国及42个欧洲国家和地区的独家商业化权益。
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。
*Darzalex和Darzalex Faspro为强生公司（Johnson & Johnson）的注册商标。
关于HLX15-SC-NDMM-001
本研究是一项在不适合移植的新诊断多发性骨髓瘤患者中，比较HLX15-SC 和对照药美国市售的DARZALEX FASPRO（US-DARZALEX FASPRO）联合来那度胺-地塞米松（Rd）的PK相似性、安全性、耐受性和免疫原性的多中心、随机、双盲、平行对照I期研究。本研究的主要目的是在目标患者中比较单次和多次SC注射后HLX15-SC 与对照药的PK相似性。次要目的是比较单次和多次SC注射后HLX15-SC与对照药的PK特征、安全性、耐受性、免疫原性和有效性。
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。
First Patient Dosed in the U.S. for International Multi-center Phase 1 Clinical Trial of Henlius’ Subcutaneous Daratumumab Biosimilar HLX15-SC
Shanghai, China, July 13, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient in the U.S. has been dosed in the international multi-center Phase 1 clinical trial (HLX15-SC-NDMM-001) of its self-developed subcutaneous formulation of daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody), HLX15-SC, for the first-line treatment of newly diagnosed multiple myeloma (NDMM). Previously, the trial also completed first patient dosed in China, and further international multicenter clinical studies are planned to advance across multiple countries, including Australia, Serbia, and Georgia. To date, no daratumumab biosimilar has been approved in major global biologics markets including the United States, Europe and Japan.
HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius and is being developed as a biosimilar candidate to both the intravenous formulation Darzalex and the subcutaneous formulation Darzalex Faspro of daratumumab. In February 2025, Henlius entered into a license agreement with Dr. Reddy’s Laboratories, granting Dr. Reddy’s the exclusive commercialization rights to both the SC and IV formulations of HLX15 in the United States and 42 European countries and regions.
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 quality and affordable treatments for patients worldwide.
*Darzalex & Darzalex Faspro are registered trademarks of Johnson & Johnson.
About HLX15-SC-NDMM-001
This study is a multicenter, randomized, double-blind, parallel-controlled phase 1 trial in transplant-ineligible patients with newly diagnosed multiple myeloma, aiming to compare the pharmacokinetic (PK) characteristics, safety, tolerability, and immunogenicity of HLX15-SC versus the US-licensed DARZALEX FASPRO (US-DARZALEX FASPRO), each in combination with lenalidomide and dexamethasone (Rd). The primary objective of this study is to evaluate the PK similarity of HLX15-SC and US-DARZALEX FASPRO after single and multiple SC injections in the target patient population. The secondary objective is to compare the PK characteristics, safety, tolerability, immunogenicity, and efficacy of HLX15-SC and the reference product following single and multiple SC injections.
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.
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