填补治疗空白！PD-L1 ADC HLX43胸腺鳞癌更新数据与H药肺癌共8项研究成果即将重磅亮相

　　2026年世界肺癌大会(WCLC)将于2026年9月12日至15日在韩国首尔举行。复宏汉霖将在本次大会上公布其创新产品的多项最新研究成果，涵盖PD-L1ADC HLX43在胸腺鳞癌(TSCC)领域的I期研究数据，以及抗PD-1单抗H药汉斯状(斯鲁利单抗，欧洲商品名：Hetronifly)在广泛期小细胞肺癌、局限期小细胞肺癌和肺大细胞神经内分泌癌领域的7项研究数据。其中，共有1项研究入选小型口头报告(Mini Oral)环节，2项入选壁报导览(Poster Tour)环节，充分展现了公司在肺癌、胸腺鳞癌等胸部肿瘤领域的创新实力，以及相关产品广泛的临床应用潜力。

　　 PD-L1ADC HLX43：

　　广谱抗肿瘤兼具IO疗效的潜在同类最优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ASCO、WCLC等多场国际学术大会，展现出“高效、低毒”的显著疗效和良好的安全性，在非小细胞肺癌、胸腺鳞癌、妇科肿瘤、食管鳞癌等多个实体瘤中展现积极疗效信号。值得关注的是，HLX43是全球首个布局胸腺癌的PD-L1ADC，其国际多中心临床研究在中、美、日、澳等国家同步推进，并于2025年10月获得FDA孤儿药资格认定，具备突破性治疗潜力，有望填补该罕见高侵袭癌种ADC治疗的空白。此前，由中国医学科学院肿瘤医院王洁教授担任牵头主要研究者的HLX43治疗晚期/实体瘤的I期研究数据已于2025年美国临床肿瘤学会(ASCO)年会上首次发布，其中包括在实体瘤患者里进行的剂量递增阶段和非小细胞肺癌剂量扩增队列的结果。本次WCLC大会期间，该I期临床研究中治疗既往经治晚期胸腺鳞癌剂量扩增队列的结果将在大会壁报导览环节进行发布。

　　 H药 汉斯状 ：

　　全球首个*获批一线治疗SCLC的抗PD-1单抗，肺癌晚期一线全覆盖

　　 H药是复宏汉霖自主研发的创新型人源化抗PD-1单抗(斯鲁利单抗，欧洲商品名：Hetronifly)，依托独特的机制优势，H药在肺癌和消化道肿瘤领域均取得突破，是全球首个*获批用于SCLC一线治疗的抗PD-1单抗，也是全球首个且唯一**获批胃癌围术期适应症的抗PD-1单抗。截至目前，H药已在全球范围内**获批鳞状非小细胞肺癌(sqNSCLC)、ES-SCLC、食管鳞癌(ESCC)和非鳞状非小细胞肺癌(nsqNSCLC)的一线治疗以及胃癌围术期治疗，覆盖全球50多个国家和地区，并在英国、奥地利、丹麦、德国、爱尔兰、意大利、西班牙和瑞典等10多个国家纳入医保或公共支付体系，进入当地主流医疗保障体系。

　　在肺癌治疗领域，H药已全面布局晚期一线治疗。除已获批适应症之外，H药联合化疗及同步放疗一线治疗局限期小细胞肺癌(LS-SCLC)的国际多中心Ⅲ期研究已完成患者入组，在美国和日本同步开展的ES-SCLC桥接试验亦已全部完成入组。

　　本次WCLC大会上，由吉林省肿瘤医院刘海峰教授牵头发起的一项H药用于ES-SCLC一线维持治疗的事后分析及荟萃分析结果将首次发布，进一步巩固H药在ES-SCLC一线治疗中的优势地位。此外，多项研究者发起的研究(IIT)结果也将于大会亮相，其中由南方医科大学附属广东省人民医院钟文昭教授牵头开展的一项H药新辅助治疗LS-SCLC的研究成功入选小型口头报告(Mini Oral)环节。这些研究不仅将H药的应用拓展至LS-SCLC更前线的治疗场景，也丰富了一线和二线治疗ES-SCLC的多种联合用药策略，并初步探索了H药联合化疗一线治疗肺大细胞神经内分泌癌(LCNEC)的前瞻性价值。

　　*2026年6月，斯鲁利单抗获得NMPA批准成为全球首个获批胃癌围术期治疗的抗PD-1单抗，截至2026年7月是唯一。

　　**2023年1月，斯鲁利单抗获得NMPA批准成为全球首个获批一线治疗ES-SCLC的抗PD-1单抗。

　　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，已在全球超50个市场获批上市；同时，多款潜力创新资产，包括PD-L1ADC 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。

　　 Henlius to Present Updated HLX43TSCC Data and Seven Serplulimab Lung Cancer Studies at WCLC2026,Addressing Unmet Needs The 2026World Conference on Lung Cancer(WCLC)will take place in Seoul,South Korea,from September12to15,2026.At this year’s meeting,Henlius will present multiple new findings from its innovative pipeline and marketed products,including Phase1study data for the PD-L1-targeting antibody-drug conjugate(ADC)HLX43in thymic squamous cell carcinoma(TSCC),as well as seven studies of the anti-PD-1monoclonal antibody(mAb)serplulimab(trade name in Europe:Hetronifly)in extensive-stage small cell lung cancer(ES-SCLC),limited-stage small cell lung cancer(LS-SCLC),and pulmonary large-cell neuroendocrine carcinoma(LCNEC).

　　 Among these presentations,one study has been selected for a Mini Oral session and two studies have been selected for Poster Tour sessions,underscoring Henlius’innovation capabilities in lung cancer,TSCC,and other thoracic malignancies,as well as the broad clinical potential of its related products.

　　 HLX43:A Potential Best-in-Class PD-L1ADC with Broad-Spectrum Anti-Tumor Activity and Immuno-Oncology Efficacy HLX43 is a novel PD-L1-targeting ADC,composed of a fully humanized anti-PD-L1IgG1antibody,a novel tripeptide linker and topoisomerase inhibitor payload.The drug to antibody ratio(DAR)is around8.Its mechanism of action integrates targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1blockade.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-L1antibody of HLX43activates 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,including ASCO,WCLC etc.,showing a favourable efficacy and safety profile across several solid tumor types,including non-small cell lung cancer(NSCLC),TSCC,gynecologic malignancies,and esophageal squamous cell carcinoma.Notably,HLX43is the first PD-L1-targeting ADC globally to enter clinical development for thymic carcinoma.International multicenter clinical studies are currently underway in China,the United States,Japan,Australia,and other countries.In October2025,HLX43received Orphan Drug Designation from the U.S.FDA,highlighting its potential to address a significant unmet need in this rare and highly aggressive malignancy.

　　 Previously,Phase1data of HLX43in advanced solid tumors,led by Professor Jie Wang of the Cancer Hospital,Chinese Academy of Medical Sciences,were first reported at the2025ASCO Annual Meeting,including results from the dose-escalation phase in solid tumors and the dose-expansion cohort in NSCLC.At WCLC2026,results from the dose-expansion cohort in pretreated patients with advanced TSCC from this Phase1study will be presented during a Poster Tour session.

　　 Serplulimab:World’s First anti-PD-1mAb for1L SCLC,with Broad1L LC Coverage Serplulimab is an innovative humanized anti-PD-1mAb independently developed by Henlius.Leveraging its differentiated mechanism,serplulimab has achieved important advances in lung cancer and gastrointestinal malignancies.It is the world’s first approved anti-PD-1mAb for first-line treatment of small cell lung cancer(SCLC),and the world’s first and only approved anti-PD-1mAb for perioperative treatment of gastric cancer.To date,serplulimab has been approved in more than50countries and regions for multiple indications,including first-line treatment of squamous NSCLC(sqNSCLC),ES-SCLC,esophageal squamous cell carcinoma(ESCC),non-squamous NSCLC(nsqNSCLC),as well as perioperative treatment of gastric cancer.It has also been included in reimbursement or public healthcare payment systems in more than10countries,including the United Kingdom,Austria,Denmark,Germany,Ireland,Italy,Spain,and Sweden.

　　 In lung cancer,serplulimab has covered the full range of first-line treatment.Beyond currently approved indications,the international multicenter Phase3study of serplulimab in combination with chemotherapy and concurrent radiotherapy for first-line treatment of LS-SCLC has completed patient enrollment.Bridging studies in ES-SCLC being conducted in parallel in the United States and Japan have also completed enrollment.

　　 At WCLC2026,a post hoc analysis and meta-analysis of serplulimab as first-line maintenance therapy for ES-SCLC,led by Professor Haifeng Liu of Jilin Cancer Hospital,will be presented for the first time,further reinforcing serplulimab’s leadership in the first-line treatment of ES-SCLC.In addition,several investigator-initiated trials(IITs)will also be presented,including a study of neoadjuvant serplulimab in LS-SCLC led by Professor Wenzhao Zhong of Guangdong Provincial People’s Hospital,Southern Medical University,which has been selected for a Mini Oral session.These studies further expand the clinical exploration of serplulimab into frontline treatment of LS-SCLC,enrich combination treatment strategies in both first-and second-line ES-SCLC,and provide preliminary evidence supporting the potential of serplulimab plus chemotherapy as first-line treatment for LCNEC.

　　 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 in2010,Henlius has established an integrated,end-to-end biopharmaceutical platform encompassing global R&D,clinical operations,regulatory affairs,manufacturing,and commercialisation.The Company employs nearly4,000people 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“Globalisation2.0”phase,building a scalable and sustainable global growth model.Up to date,Henlius has achieved regulatory approvals for10products across over60countries 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 than50early-stage innovative assets,approximately70%of which are expected to be best-in-class,with over30clinical trials ongoing globally.Henlius’core product,serplulimab(trade name:Hetronifly in Europe),is the world’s first anti–PD-1mAb approved for first-line treatment of small cell lung cancer and for perioperative gastric cancer.Up to date,it has been approved in over50markets worldwide with an accelerated globalisation process.In parallel,multiple high-potential innovative assets—including the PD-L1ADC HLX43and the novel epitope anti-HER2mAb dulpatatug(HLX22)—are advancing through global pivotal clinical development.Supported by a biologics manufacturing network with a total capacity of84,000L 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.