2026 ASCO | 复宏汉霖10余项研究即将登陆，多款创新药联袂亮相

2026年美国临床肿瘤学会（ASCO）年会将于5月29日-6月2日在美国芝加哥隆重召开。本届学术会议上，复宏汉霖将重磅发布公司创新管线中十余项研究的进展，覆盖抗PD-1单抗H药汉斯状^®（斯鲁利单抗，欧洲商品名：Hetronifly^®）、HLX43（PD-L1 ADC）、抗EGFR单抗pimurutamab（HLX07）和创新CDK4/6抑制剂复妥宁^®（枸橼酸伏维西利胶囊）等创新分子的最新/更新研究数据，聚焦肺癌、乳腺癌和消化道肿瘤等领域，多个潜在“同类首创（FIC）”领域布局加速进入临床验证阶段。

其中，两项研究成功入选口头报告，包括由北京大学肿瘤医院季加孚、沈琳教授牵头的H药胃癌围术期III期研究（ASTRUM-006），以及由中国医学科学院肿瘤医院王洁教授牵头的HLX43在非小细胞肺癌中的研究，凸显公司核心创新资产在全球顶尖学术舞台的持续突破。此外，复妥宁^®注册性研究结果也将首次发布。

H药汉斯状^®

（斯鲁利单抗，欧洲商品名：Hetronifly^®）

H药是全球首个获批一线治疗小细胞肺癌（SCLC）的抗PD-1单抗，目前已在中国、英国、欧盟、新加坡、印度、瑞士、秘鲁等40多个国家和地区获批上市。2022年3月，H药正式在中国获批上市，目前可用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）及非鳞状非小细胞肺癌（nsqNSCLC）。

H药持续在肺癌和消化道肿瘤上取得突破，剑指多项“全球首个”。继成为全球首个获批一线治疗SCLC的抗PD-1单抗，H药也是全球首个胃癌围术期以免疫单药取代术后辅助化疗的治疗方案。在中国，H药获得国家药品监督管理局突破性疗法认定用于胃癌围手术期治疗，相关上市申请已获受理并纳入优先审评，并有望于2026年获批。在欧盟，H药治疗nsqNSCLC和ESCC的适应症也已于2026年获得上市申请积极意见。在美国，H药一线治疗ES-SCLC的美国桥接试验已完成患者入组，计划2026年向FDA递交相应生物制品许可申请（BLA）。随着全球商业化势能与差异化临床价值的加速释放，H药目标成为下一款全球年销售额突破百亿人民币的国产创新药。

HLX43 (PD-L1 ADC)

HLX43是一款靶向程序性死亡-配体1（PD-L1）的新型ADC候选药物，由全人源IgG1抗PD-L1抗体与创新连接子-拓扑异构酶抑制剂荷载偶联而成，其药物抗体比（drug-to-antibody ratio, DAR）约为8。HLX43兼具毒素精准杀伤和肿瘤免疫作用的复合功能，其毒素不仅能够藉靶点内吞进入肿瘤细胞后进行释放，并在肿瘤微环境中释放后借助旁观者效应进入肿瘤细胞，阻断DNA复制，从而导致肿瘤细胞凋亡。此外，HLX43的PD-L1靶向抗体可激活免疫调节机制，发挥协同抗肿瘤效应。

HLX43首次人体研究结果、多项实体瘤概念验证数据先后亮相多场国际学术大会，展现出“高效、低毒”的显著疗效，尤其在NSCLC人群中不依赖生物标志物筛选，有望覆盖所有亚型患者。除NSCLC外，HLX43已在妇科肿瘤、食管鳞癌等多个实体瘤中展现积极疗效信号。单药之外，公司也积极探索其与抗EGFR单抗pimurutamab、H药等药物的联合治疗潜力。

此外，复宏汉霖还将在本届ASCO大会上展示多项创新管线的最新进展，包括已获批上市的创新CDK4/6抑制剂复妥宁^®（枸橼酸伏维西利胶囊）和抗EGFR单抗pimurutamab等在研产品，以及围绕H药开展的一系列研究者发起研究（IIT）。相关研究的摘要信息如下：

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。

ASCO 2026 | Henlius to Present Latest Data from Over 10 Innovative Therapies

The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting will take place from May 29 to June 2 in Chicago, USA. At this year’s congress, Henlius will present significant updates from more than 10 studies across its innovative pipeline, including its anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name: Hetronifly^® in Europe), the novel CDK4/6 inhibitor FUTUONING (fovinaciclib), HLX43 (PD-L1 ADC), and the anti-EGFR mAb pimurutamab (HLX07). These presentations will span multiple tumour types, including lung cancer, breast cancer, and gastrointestinal cancers. Several programmes with the potential to be first-in-class (FIC) are also advancing into clinical validation.

Among these, two studies have been selected for oral presentation: the phase 3 perioperative gastric cancer study of serplulimab (ASTRUM-006), led by Dr. Jiafu Ji and Dr. Lin Shen from Beijing Cancer Hospital, and the study of HLX43 in non-small cell lung cancer, led by Dr. Jie Wang from the Cancer Hospital Chinese Academy of Medical Sciences. These selections highlight the continued progress of Henlius’ core innovative assets on leading global academic platforms. In addition, results from the pivotal study of FUTUONING will be presented for the first time.

Serplulimab (trade name: Hetronifly^® in Europe)

Serplulimab is the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC) and has been approved for marketing in over 40 countries and regions including China, the U.K., EU, Singapore, India, Switzerland, and Peru. In March 2022, serplulimab was officially approved for marketing in China and is currently indicated for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC).

With continued progress in lung and gastrointestinal cancers, serplulimab is expected to set multiple new cancer treatment standards. As the first anti–PD-1 mAb approved globally for first-line treatment of SCLC, serplulimab is also the first perioperative gastric cancer treatment globally to replace adjuvant chemotherapy with immunotherapy monotherapy. In China, the product has been granted Breakthrough Therapy Designation by the National Medical Products Administration for perioperative treatment of gastric cancer. The corresponding marketing application has been accepted and granted priority review, with approval anticipated in 2026. In the European Union, serplulimab has also received positive opinions for its marketing authorization applications in nsqNSCLC and ESCC in 2026. In the United States, the bridging study for first-line ES-SCLC has completed enrolment, with a Biologics License Application (BLA) submission planned for 2026. With its global commercial potential and differentiated clinical value continuing to expand, Henlius aims to position serplulimab as the next China-developed innovative biologic to surpass RMB 10 billion in annual global sales.

HLX43（PD-L1 ADC）

HLX43 is a novel PD-L1-targeting ADC, composed of a fully humanized anti-PD-L1 IgG1 antibody, a novel tripeptide linker and topoisomerase inhibitor payload. The drug to antibody ratio (DAR) is around 8. Its mechanism of action integrates targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1 blockade. Upon binding to PD-L1-expressing tumour cells, HLX43's cytotoxic payload can be delivered into tumour cells via dual mechanisms—First, the ADC undergoes receptor-mediated endocytosis, releasing the cytotoxic payload intracellularly via linker cleavage, and the payload further diffuses into neighbouring tumour cells via bystander effect, thereby blocking DNA replication and triggering tumour cell apoptosis. Meanwhile, the anti-PD-L1 antibody of HLX43 activates immune modulation and blocks immune checkpoints, driving synergistic antitumor efficacy.

Early clinical data from its first-in-human study, along with multiple proof-of-concept results across solid tumours, have been presented at several international scientific conferences, showing a favourable efficacy and safety profile. Notably, in non-small cell lung cancer (NSCLC), HLX43 has demonstrated activity without the need for biomarker-based patient selection, suggesting potential applicability across a broad patient population. In addition to NSCLC, encouraging signals have also been observed in gynaecological tumours, esophageal squamous cell carcinoma (ESCC), and other solid tumours. Beyond monotherapy, the Company is actively exploring combination strategies of HLX43 with anti-EGFR mAb pimurutamab and serplulimab, aiming to further expand its clinical potential.

In addition, Henlius will present updates across multiple programmes from its innovative pipeline at this year’s ASCO Annual Meeting, including the approved CDK4/6 inhibitor FUTUONING (fovinaciclib), and investigational assets such as the anti-EGFR mAb pimurutamab, as well as a series of investigator-initiated trials (IITs) centred on serplulimab. Details of the abstracts are summarized below:

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 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 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 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