近日，复宏汉霖（HK2696）自主研发的抗PD-1单抗H药汉斯状(斯鲁利单抗，欧洲商品名：Hetronifly)联合化疗一线治疗广泛期小细胞肺癌(ES-SCLC)的ASTRUM-005研究最终分析结果，发表于国际权威肿瘤期刊JAMA Oncology(影响因子：23.9)，并首次公布患者报告结局(PROs)数据。最终分析证实，H药可为ES-SCLC患者带来持久且显著的生存获益，同期的专题述评高度肯定了该研究为ES-SCLC患者带来的持久获益价值。相关长期随访数据已于2025年美国临床肿瘤学会(ASCO)年会上首次发布，此次再获顶级期刊认可，为全球临床实践提供了高级别循证依据，进一步巩固了其在小细胞肺癌免疫治疗领域的领先地位。
此前，ASTRUM-005研究中期分析结果于2022年9月发表于《美国医学会杂志》(JAMA)主刊，成为全球首个登上该刊的小细胞肺癌免疫治疗临床研究，2025年，该研究更新数据分析及生物标志物探索成果发表于Cancer Communications。此外，ASTRUM-005研究还先后在2022年、2024年和2025年ASCO年会上披露了关键数据，实现了学术会议与顶级期刊的协同发布。这一贯穿四年、三度登顶国际顶刊的学术历程，不仅彰显了研究数据的高度稳健性，更标志着该研究获得国际权威学术界的一致认可。
4年OS率达21.9%，持续验证长期获益
肺癌是全球发病率最高、致死率居首的恶性肿瘤，2022年全球新发病例约250万，死亡病例约180万1。小细胞肺癌(SCLC)是肺癌中侵袭性最强的亚型，占所有肺癌病例的15%2。SCLC患者中约三分之二确诊时已处于广泛期，其5年生存率仅为7%2,3。
ASTRUM-005研究是一项随机、双盲、国际多中心、安慰剂对照的Ⅲ期临床试验，旨在评价斯鲁利单抗联合化疗(卡铂+依托泊苷)一线治疗ES-SCLC的疗效和安全性。研究在全球6个国家共114个试验中心开展，纳入585例既往未接受过治疗的ES-SCLC患者，基于该研究，H药已在中国、英国、欧盟、新加坡、印度、瑞士、秘鲁等50个国家和地区获批用于一线治疗ES-SCLC，成为全球首个获批该适应症的抗PD-1单抗，并获得美国FDA等多国监管机构的孤儿药资格认定，填补了临床治疗空白。
截至2024年5月7日数据截止时，中位随访时间为42.4个月，长期随访数据证实斯鲁利单抗方案可带来持久的临床生存获益：
总生存期(OS)：斯鲁利单抗组中位OS达15.8个月，较化疗对照组的11.1个月延长4.7个月，死亡风险降低40%(HR=0.60，95%置信区间：0.49-0.73，P<0.001)。长期生存数据尤为亮眼，斯鲁利单抗组4年总生存率高达21.9%，为化疗组(7.2%)的三倍以上。
肿瘤应答与疾病控制：斯鲁利单抗组中位无进展生存期(PFS)达5.8个月(化疗组4.3个月，HR=0.47，P<0.001)，客观缓解率(ORR)提升至68.9%，中位缓解持续时间(DOR)6.8个月，均明显优于对照组，提示更多患者可获得深度、持久的肿瘤缓解。
安全性与生活质量：长期随访未发现新增安全信号，≥3级治疗相关不良事件发生率与化疗组相近(35.0%vs29.1%)。同时，患者报告结局数据表明，斯鲁利单抗方案在延长生存期的同时，相较于化疗组，未降低患者生活质量。
不一样的PD-1，构筑免疫治疗新标杆
H药是复宏汉霖（HK2696）自主研发的创新型人源化抗PD-1单抗，具有差异化的药理机制。临床前研究证明，该药物不仅具备更强的PD-1内吞作用，可减少T细胞表面PD-1受体4，实现快速、强效的免疫激活；还能减少PD-1对共刺激分子CD28的募集，从而更大程度保留CD28信号传导5-7，增强下游AKT蛋白活性8，促进T细胞持续活化。
依托独特的机制优势，H药在肺癌和胃癌领域均取得突破，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。H药的相关关键性临床研究成果接连获得国际顶级学术期刊的权威认可，充分彰显了其循证医学证据的引领价值。肺癌领域，除ASTRUM-005研究外，针对sqNSCLC一线治疗的ASTRUM-004研究与nsqNSCLC一线治疗的ASTRUM-002研究，分别获发表于Cancer Cell和《柳叶刀.呼吸病学》(The Lancet Respiratory Medicine)；消化道肿瘤领域，针对胃癌围术期治疗的ASTRUM-006研究与一线治疗ESCC的ASTRUM-007研究，则分别荣登《柳叶刀》(The Lancet)主刊和《自然-医学》(Nature Medicine)，进一步巩固了H药在多个瘤种治疗中的学术地位。
与此同时，复宏汉霖（HK2696）围绕肺癌和消化道肿瘤等高发癌种，持续推动H药的全球临床开发。肺癌领域，H药已全面覆盖晚期肺癌一线治疗，除已获批的适应症，H药联合化疗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期临床试验已完成患者入组；在美国和日本同步开展的ES-SCLC桥接试验亦已完成全部入组。消化道肿瘤领域，H药联合贝伐珠单抗及化疗一线治疗转移性结直肠癌(mCRC)的Ⅲ期国际多中心临床研究(ASTRUM-015)已完成全球入组，有望填补免疫治疗在MSS mCRC领域的临床空白。
此外，H药的国际化征途正持续破局，商业化版图加速扩容。目前，该产品已在中国、英国、欧盟、新加坡、印度、瑞士、秘鲁等50个国家和地区获批上市，覆盖全球近半数人口。复宏汉霖（HK2696）携手Accord、Abbott等全球合作伙伴，持续推进H药的海外商业化进程。自2025年2月首次在欧盟获批以来，H药已在16个欧盟国家上市，并在奥地利、丹麦、德国、爱尔兰、意大利、西班牙、瑞典等10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，全球可及性不断提升。
*截至2026年6月22日
在创新驱动方面，复宏汉霖（HK2696）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（HK2696）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（HK2696）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’ Serplulimab Marks Third Publication in a Leading International（IGIC） Journal,with Small Cell Lung Cancer Long-Term Survival Data Published in JAMA Oncology and a4-Year OS Rate of21.9%
Recently,the end-of-study analysis results from ASTRUM-005,a study of Henlius’self-developed anti-PD-1monoclonal antibody(mAb)HANSIZHUANG(serplulimab,trade name in Europe:Hetronifly)in combination with chemotherapy for the First（FFBC）-line treatment of extensive-stage small cell lung cancer(ES-SCLC),were published in the International（IGIC）ly renowned oncology journal JAMA Oncology(impact factor:23.9).The publication also reported patient-reported outcomes(PROs)data for the First（FFBC） time.The final analysis confirmed that serplulimab delivers durable and clinically meaningful survival benefits for patients with ES-SCLC,accompanied by a contemporaneous editor’s note that highly recognized the durable clinical benefit this study brings to patients with ES-SCLC.The relevant long-term follow-up data were First（FFBC） presented at the2025American Society of Clinical Oncology(ASCO)Annual Meeting,and their publication in a top-tier journal now provides high-level evidence to inform global clinical practice,further reinforcing its leading position in the field of immunotherapy for small cell lung cancer.
In September2022,the interim analysis of ASTRUM-005was published in JAMA,becoming the First（FFBC） clinical immunotherapy study in small cell lung cancer worldwide to appear in the journal.In2025,updated data analyses and biomarker exploration results were published in Cancer Communications.In addition,key data from ASTRUM-005were presented at the ASCO Annual Meetings in2022,2024,and2025,achieving coordinated dissemination through both major academic conferences and top-tier journals.This four-year academic journey,with three appearances in leading International（IGIC） journals,not only highlights the robustness of the study data but also reflects broad recognition from the global academic community.
4-Year OS Rate Reaches21.9%,Further Validating Durable Long-Term Benefit Lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer-related death worldwide,with approximately2.5million new cases and1.8million deaths reported globally in2022.1Small cell lung cancer(SCLC),the most aggressive subtype of lung cancer,accounts for around15%of all lung cancer cases.2Approximately two-thirds of patients with SCLC are diagnosed at the extensive stage,and the5-year survival rate remains only7%.2,3
ASTRUM-005is a randomized,double-blind,International（IGIC） multicenter,placebo-controlled Phase3clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy(carboplatin plus etoposide)as First（FFBC）-line treatment for ES-SCLC.Conducted across114investigational sites in6countries,the study enrolled585previously untreated patients with ES-SCLC.Based on the ASTRUM-005results,serplulimab has been approved in50countries and regions,including China,the United Kingdom,the European Union,Singapore,India,Switzerland,and Peru,for the First（FFBC）-line treatment of ES-SCLC,making it the world’s First（FFBC） anti-PD-1mAb approved for this indication.It has also received orphan drug designation from the U.S.FDA and other regulatory authorities,addressing a significant unmet clinical need.
As of the data cutoff date of May7,2024,with a median follow-up of42.4months,the long-term follow-up results demonstrated durable survival benefits with the serplulimab-based regimen:
Overall Survival(OS):Median OS reached15.8months in the serplulimab group,representing an extension of4.7months versus11.1months in the chemotherapy control group,with a40%reduction in the risk of death(HR=0.60,95%CI:0.49–0.73,P<0.001).Long-term survival outcomes were particularly notable,with a4-year OS rate of21.9%in the serplulimab group—more than triple that of the chemotherapy group(7.2%).
Tumor Response and Disease Control:Median progression-free survival(PFS)was5.8months in the serplulimab group versus4.3M（MMM）onths in the chemotherapy group(HR=0.47,P<0.001).The objective response rate(ORR)improved to68.9%,and median duration of response(DOR)was6.8months,both markedly superior to the control arm,suggesting that more patients achieved deeper and more durable tumor responses.
Safety and Quality of Life:No new safety signals were identified during long-term follow-up.The incidence of grade≥3treatment-related adverse events was comparable between the serplulimab and chemotherapy groups(35.0%vs29.1%).Meanwhile,PRO data showed that the serplulimab regimen prolonged survival without compromising patients’quality of life.
As an Innovative（IIPR） anti-PD-1mAb independently developed by Henlius,serplulimab is distinguished by a differentiated mechanism.Preclinical studies have proven that serplulimab not only induces stronger PD-1internalization—reducing PD-1receptor presence on T cells for rapid and potent immune activation4—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28,thereby preserving CD28signaling,5-7enhancing downstream AKT activity,8and promoting sustained T-cell activation.
Leveraging its unique mechanistic advantages,serplulimab has achieved breakthroughs in both lung cancer and gastric cancer.It is the world’s First（FFBC） anti-PD-1mAb approved for First（FFBC）-line treatment of SCLC,and also the First（FFBC） and only*anti-PD-1mAb approved for the perioperative treatment of gastric cancer.To date,serplulimab has been approved globally**for First（FFBC）-line treatment of squamous non-small cell lung cancer(sqNSCLC),ES-SCLC,esophageal squamous cell carcinoma(ESCC),and non-squamous non-small cell lung cancer(nsqNSCLC),as well as perioperative treatment of gastric cancer.Key clinical studies of serplulimab have been successively published in leading International（IGIC） medical journals,highlighting the strong value and leadership of its evidence base.In lung cancer,beyond the ASTRUM-005study,results from the ASTRUM-004study in First（FFBC）-line sqNSCLC and the ASTRUM-002study in First（FFBC）-line nsqNSCLC were published in Cancer Cell and The Lancet Respiratory Medicine,respectively.In gastrointestinal cancers,the ASTRUM-006study in perioperative gastric cancer and the ASTRUM-007study in First（FFBC）-line ESCC were published in The Lancet and Nature Medicine,respectively,further reinforcing the academic influence of serplulimab across multiple tumor types.
At the same time,Henlius continues to advance the global clinical development of serplulimab across high-incidence cancers,including lung cancer and gastrointestinal malignancies.In lung cancer,serplulimab now covers the full spectrum of First（FFBC）-line treatment for advanced lung cancer.Beyond already approved indications,patient enrollment has been completed in an International（IGIC） multicenter Phase3trial evaluating serplulimab in combination with chemotherapy and concurrent radiotherapy as First（FFBC）-line treatment for limited-stage SCLC(LS-SCLC).In addition,bridging studies for ES-SCLC being conducted in parallel in the United States and Japan have also completed enrollment.In gastrointestinal cancer,global enrollment has been completed in the International（IGIC） multicenter Phase3study ASTRUM-015,which is evaluating serplulimab in combination with bevacizumab and chemotherapy as First（FFBC）-line treatment for metastatic colorectal cancer(mCRC),with the potential to address an unmet need for immunotherapy in patients with MSS mCRC.
In addition,serplulimab continues to make breakthroughs International（IGIC）ly,with its commercial footprint expanding rapidly.Up to date,it has been approved in50countries and regions including China,the United Kingdom,the European Union,Singapore,India,Switzerland,and Peru,covering nearly half of the global population.Henlius,together with its regional partners including Accord and Abbott,has continued to advance market access and commercialisation efforts for serplulimab in overseas markets.Since receiving its First（FFBC） approval in the European Union in February2025,to date,serplulimab has been commercially launched in16European countries and has been included in reimbursement or public healthcare coverage systems in10countries,including Austria,Denmark,Germany,Ireland,Italy,Spain,and Sweden,thereby gaining access to mainstream healthcare systems in these markets.
*As of June22,2026
**Approved indications may vary by country or region.Please refer to the prescribing information and approvals issued by the relevant local regulatory authorities.
Driven by innovation,Henlius has built a Diversified（DHC）,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（IIPR） 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（FFBC） anti–PD-1mAb approved for First（FFBC）-line treatment of small cell lung cancer and has been approved in50markets worldwide with an accelerated globalisation process.In parallel,multiple high-potential Innovative（IIPR） 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.
