复宏汉霖达雷妥尤单抗生物类似药皮下注射剂型I期临床研究申请中国获批

2026年2月12日，复宏汉霖（2696.HK）宣布，公司自主研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）的I期临床试验申请（IND）已获得国家药品监督管理局（NMPA）批准，拟用于多发性骨髓瘤的治疗。

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。达雷妥尤单抗作为多发性骨髓瘤治疗领域的重要基石药物，已在全球主要市场广泛应用，具备成熟的临床价值与商业基础。

参照中国、欧盟和美国的生物类似药技术指导原则的要求，复宏汉霖采用逐步递进、比对及相似性评价原则对HLX15进行开发。基于相似性分析研究和临床前研究，HLX15与原研达雷妥尤单抗被认为具有可比性。2024年6月，HLX15-IV（HLX15静脉注射剂型）I期临床研究（NCT05679258）已成功完成，达到了所有预设的研究终点，研究结果表明，HLX15-IV与美国、欧盟和中国市售的原研达雷妥尤单抗的药代动力学特征相似，安全性和免疫原性均可比。

本次在中国获批开展皮下注射剂型I期临床研究，进一步体现了HLX15全球开发路径的系统推进。公司将在严格遵循相关法规和技术规范的前提下，稳步推进相关临床研究工作。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。

复宏汉霖已构建了一体化全球研发、药政注册及临床开发运营平台，并建立了符合全球药监要求的生产和质量管理体系，迄今已成功推动7款产品在海外市场获批上市。公司将持续推进HLX15的全球临床开发进程，携手合作伙伴，为全球患者提供更多高质量、可负担的治疗选择。

*Darzalex^®和Darzalex Faspro^®为强生公司（Johnson & Johnson）的注册商标

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2026年初，公司共有10款产品在全球60个国家和地区获批上市，其中7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、4款产品获得欧盟EMA上市授权，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40余个市场获批上市；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。

Henlius Receives the NMPA IND Approval for Phase 1 Study of Henlius’ Subcutaneous Daratumumab Biosimilar

Shanghai, China, February 12, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the phase 1 clinical trial application for HLX15-SC, the subcutaneous formulation of its self-developed daratumumab biosimilar (recombinant anti-CD38 fully human monoclonal antibody), has been approved by the National Medical Products Administration (NMPA). The study is intended for the treatment of multiple myeloma.

HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius, and is a biosimilar candidate to daratumumab, including the intravenous formulation Darzalex® and the subcutaneous formulation Darzalex Faspro®. As a cornerstone therapy in the treatment of multiple myeloma, daratumumab has been widely adopted across major global markets and represents a high regulatory and development benchmark for biosimilar programs.

In accordance with the biosimilar guidelines of NMPA, EMA, and FDA, HLX15 is being developed following the principles of stepwise development. HLX15 and reference daratumumab are considered comparable based on analytical similarity assessment and pre-clinical studies. In June 2024, the phase 1 clinical study (NCT05679258) of HLX15 intravenous formulation (HLX15-IV) was successfully completed, meeting its primary endpoint. The findings indicate that HLX15 had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and CN-sourced daratumumab.

The approval of the phase 1 clinical trial application in Chinar further eflects the systematic advancement of HLX15’s global development pathway. Henlius will advance the clinical program in strict compliance with applicable regulations and technical requirements. In February 2025, Henlius entered into a licensing and collaboration agreement with Dr. Reddy’s, granting exclusive commercialization rights for both the intravenous and subcutaneous formulations of HLX15 in the United States and 42 European countries and regions.

Henlius has established an integrated global platform encompassing R&D, regulatory affairs, and clinical development and operations, supported by manufacturing and quality management systems that meet international regulatory requirements. To date, Henlius has successfully obtained overseas marketing approvals for seven products. Henlius will continue to advance the global clinical development of HLX15 and, together with its partners, provide more high-quality and affordable treatment options for patients worldwide.

*Darzalex^® & Darzalex Faspro^® are registered trademarks of Johnson & Johnson.

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 60 countries and regions worldwide, including seven 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 four products authorized by the European Medicines Agency (EMA), 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 more than 40 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