中欧美日澳开发再提速，复星医药子公司复宏汉霖PD-L1 ADC HLX43 全球II期临床完成欧盟首例患者给药

• 　　全球开发提速：HLX43针对NSCLC的国际多中心II期临床在中欧美日澳等地启动，加速产品全球开发进程

• 　　 NSCLC全人群覆盖：HLX43在鳞状/非鳞状、有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者中都展现疗效，且安全性良好

• 　　“高效低毒”持续验证：HLX43针对NSCLC更新数据即将以口头报告形式亮相2026ASCO，持续验证“高效低毒”特质，提示其多线治疗潜力

　　2026年5月21日，复星医药子公司复宏汉霖宣布，公司创新型程序性死亡-配体1(PD-L1)抗体偶联药物(ADC)注射用HLX43在晚期非小细胞肺癌(NSCLC)患者中开展的国际多中心II期临床研究(HLX43-NSCLC201)已于西班牙完成欧盟首例受试者给药。HLX43-NSCLC201研究目前已在中国、欧盟、美国、日本、澳大利亚等地全面启动并，标志着这一全球首创PD-L1ADC的临床开发实现全球主要市场的全面覆盖。凭借在全人群中展现出的广泛疗效与良好的安全性特征，HLX43针对NSCLC的最新研究结果亦将于近期以口头报告的形式重磅亮相2026年美国临床肿瘤学会(ASCO)年会。

　　据GLOBOCAN最新数据显示，肺癌是全球发病率和死亡率最高的癌症，2022年全球约有超过248万新发肺癌病例，占所有癌症新发病例的12.4%1。大部分肺癌患者确诊时已处于疾病晚期阶段2，存在巨大的尚未满足的临床需求。非小细胞肺癌(NSCLC)是最常见的肺癌类型(约85%)，主要包括鳞状细胞癌(约30%)和肺腺癌(约50%)等。在全部NSCLC患者中，EGFR野生型占比高达70%-85%，涵盖几乎所有的鳞癌患者和半数以上的肺腺癌患者(50-55%)3。当前疗效优异的产品仍较少，特别在接受过标准治疗的后线人群治疗上，现行临床实践仍高度依赖以多西他赛为基础的化疗方案，且临床获益有限4,5。

　　 HLX43是一款靶向程序性死亡-配体1(PD-L1)的广谱抗肿瘤ADC，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，药物抗体比(drug-to-antibody ratio,DAR)约为8。HLX43兼具毒素精准杀伤(ADC)和肿瘤免疫治疗(IO)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。在2025美国临床肿瘤学会(ASCO)年会上，HLX43的I期临床数据首次发布，展现出令人鼓舞的初步疗效和安全性，对鳞状/非鳞状非小细胞肺癌(NSCLC)，有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者都展现了优异的治疗潜力，且安全性良好。2025年11月，HLX43肺癌领域的关键数据更新发布，并整合了HLX43-NSCLC201临床研究的初步结果。此次分析明确了2.0mg/kg或2.5mg/kg作为HLX43用于治疗NSCLC的II/III期推荐剂量(RP2/3D)，并持续印证了HLX43在对应剂量下的疗效和安全性。

　　复宏汉霖正全力推进HLX43临床开发进程，其用于晚期鳞状非小细胞肺癌的II/III期国际多中心临床研究(HLX43-NSCLC302)将于中国、美国、日本等多国开展，其III期研究阶段有望成为HLX43首个、同时也是其在非小细胞肺癌领域的关键注册临床研究，为既往标准治疗失败后的sqNSCLC患者这一难治群体带来新的治疗选择。除NSCLC外，公司积极探索其在多种实体瘤中的治疗潜力，包括食管鳞癌、宫颈癌、乳腺癌、胃癌/胃食管交界部(G/GEJ)癌、头颈鳞癌等。单药之外，HLX43联用其他产品的临床试验也正在进行中，进一步探索ADC与其他疗法的协同抗肿瘤疗效。HLX43不仅展现出克服PD/L1免疫疗法不响应或耐药问题的临床潜力，并对化疗、TKI治疗失败的患者都具有潜在疗效，有望为更多晚期/转移性实体瘤患者带来新的治疗选择。

　　关于HLX43-NSCLC201

　　本研究为一项评估HLX43在晚期非小细胞肺癌(NSCLC)患者的开放、国际多中心II期临床试验，旨在评估HLX43在晚期非小细胞肺癌(NSCLC)患者中的有效性和安全性。研究分为两个阶段：第一阶段将进行剂量探索，以选择合适的HLX43剂量进行第二阶段研究；第二阶段为单臂、多中心II期临床研究。本研究的主要研究目的为评估HLX43在晚期非小细胞肺癌(NSCLC)中的临床疗效；主要研究终点为由盲态独立中心审查委员会(BICR)根据RECIST v1.1标准评估的客观缓解率。

　　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、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40余个市场获批上市；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。

　　 Global Development Accelerates Further:Henlius’PD-L1ADC HLX43Completes First Patient Dosing in EU for Phase2MRCT

• 　　 Global Development Accelerated:Phase2MRCT for HLX43in NSCLC fully initiated across China,the U.S.,Australia and Japan

• 　　 Broad Efficacy in NSCLC:HLX43demonstrates broad efficacy in NSCLC patients,regardless of histology(squamous or non-squamous),EGFR mutation status,presence of brain/liver metastases,or PD-L1expression,with a favorable safety profile

• 　　 Continued Validation of High Efficacy and Low Toxicity:Updated clinical data for HLX43in NSCLC will be featured in an upcoming oral presentation at the2026ASCO Annual Meeting,further validating its exceptional efficacy,favorable tolerability,and immense potential across multiple lines of therapy.

　　 Shanghai,China,May21,2026—Shanghai Henlius Biotech,Inc.(2696.HK)today announced that the first patient in the European Union(EU)has been successfully dosed in Spain in the international multi-center Phase2clinical trial(HLX43-NSCLC201)evaluating HLX43,an innovative programmed death-ligand1(PD-L1)targeting antibody-drug conjugate(ADC),for the treatment of advanced non-small cell lung cancer(NSCLC).The HLX43-NSCLC201study has now been fully initiated across China,the EU,the United States,Japan,and Australia,marking comprehensive coverage of major global markets for the clinical development of this first-in-class PD-L1ADC.Building on its broad efficacy and favorable safety profile across diverse patient populations,the latest research results of HLX43in NSCLC are also scheduled for a highly anticipated oral presentation at the2026ASCO Annual Meeting.

　　 Lung cancer is the most common cancer worldwide in terms of incidence and mortality.According to GLOBOCAN2022,there were over2.48million new cases of lung cancer globally in2022,accounting for12.4%of all new cancer cases.1The majority of lung cancer patients are diagnosed at advanced stages,2indicating a significant unmet clinical need.Non-small cell lung cancer(NSCLC)is the most common type of lung cancer(approximately85%).By histology,NSCLC can be classified into squamous cell carcinoma(approximately30%),adenocarcinoma(approximately50%)and other subtypes including large cell carcinoma.EGFR wild-type cases account for70%-85%of all NSCLC patients,including nearly all squamous cell carcinoma cases and50-55%of adenocarcinoma cases.3Currently,the treatment landscape of EGFR wild-type NSCLC remains limited by a scarcity of highly effective options,particularly in second-line and later(2L+)therapy,where docetaxel-based chemotherapy continues to serve as the standard of care despite its suboptimal efficacy.4,5

　　 HLX43is a broad-spectrum anti-tumor ADC candidate targeting PD-L1,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 mechanisms of action integrate targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1blockade.Upon bonding to tumor cells with PD-L1expression,the cytotoxic payload of HLX43will be delivered into tumor cells via dual mechanisms.HLX43will undergo receptor-mediated endocytosis,releasing the cytotoxic payload intracellularly via linker cleavage,and the payload further diffuses into neighboring tumor cells via bystander effect,thereby blocking DNA replication and triggering tumor cell apoptosis.Meanwhile,the anti-PD-L1antibody of HLX43activates immune modulation and blocks immune checkpoints,driving synergistic anti-tumor efficacy.The results from the phase1clinical trial of HLX43has been first released at the2025ASCO Annual Meeting,demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC,including squamous and non-squamous NSCLC patients(sqNSCLC and nsqNSCLC),patients with or without EGFR mutation,patients with or without brain/liver metastasis,and PD-L1positive or negative patients.In November2025,updated data in lung cancer—integrating preliminary results from the HLX43-NSCLC201study—were released.This analysis established2.0mg/kg or2.5mg/kg as the recommended Phase2/3dose(RP2/3D)for HLX43in NSCLC,consistently validating the drug's efficacy and safety at these dose levels.

　　 Henlius is vigorously advancing the clinical development of HLX43.An international multi-center Phase2/3study(HLX43-NSCLC302)for advanced squamous NSCLC(sqNSCLC)is slated to launch across multiple countries,including China,the US,and Japan.The Phase3portion of this study is poised to become the first pivotal registrational trial for HLX43in NSCLC,potentially offering a novel therapeutic option for the hard-to-treat population of sqNSCLC patients who have failed prior standard therapies.Beyond NSCLC,the company is actively exploring the potential of HLX43across various solid tumors,including esophageal squamous cell carcinoma(ESCC),cervical cancer,breast cancer,gastric/gastroesophageal junction(G/GEJ)cancer,and head and neck squamous cell carcinoma(HNSCC).In addition to monotherapy,clinical trials investigating HLX43in combination with other agents are ongoing to further explore the synergistic anti-tumor efficacy of ADCs with complementary therapies.HLX43demonstrates the clinical potential to overcome primary or acquired resistance to PD-1/L1immunotherapies and offers potential efficacy for patients who have failed chemotherapy or TKI treatments,bringing hope for a new generation of treatments to patients with advanced or metastatic solid tumors.

　　 About HLX43-NSCLC201

　　 This is an open-label,multi-centre,international phase2clinical study to evaluate HLX43in patients with advanced non-small cell lung cancer(NSCLC).This study aims to evaluate the efficacy and safety of HLX43in advanced non-small cell lung cancer(NSCLC)patients.It consists of two parts:Part1,which focuses on dose exploration to identify the optimal HLX43dosage for Part2;and Part2,which is a single-arm,multi-centre phase2clinical trial.The primary objective of this study is to evaluate the clinical efficacy of HLX43in advanced non-small cell lung cancer(NSCLC)patients.The primary endpoint of the study is objective response rate evaluated by the Blinded Independent Central Review(BICR)according to RECIST v1.1.

　　 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 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.As of early2026,Henlius has achieved regulatory approvals for10products across over60countries 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 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 has been approved in more than40markets worldwide with an accelerated globalisation process.In parallel,multiple high-potential innovative assets—including the PD-L1ADC HLX43and the novel epitope anti-HER2mAb 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.

　　 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/.