Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer.
This study includes 2 parts:
Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).
Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.
Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.

开始日期2025-12-31

申办/合作机构

中国医学科学院肿瘤医院

NCT07231445

/ Not yet recruiting临床1期

A Phase Ib Study Evaluating the Safety and Efficacy of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer

This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.

开始日期2025-12-23

申办/合作机构

苏州泽璟生物制药股份有限公司

ChiCTR2500110285

/ Not yet recruiting临床2期IIT

A Multicenter, Single-Arm, Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab in Combination with Paclitaxel and Platinum-Based Chemotherapy as First-Line Treatment for Patients with Brain Metastases from Non-Small Cell Lung Cancer

开始日期2025-11-08

申办/合作机构

四川省肿瘤医院（四川省第二人民医院四川省癌症防治中心）

[+1]

100 项与斯鲁利单抗相关的临床结果

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100 项与斯鲁利单抗相关的转化医学

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100 项与斯鲁利单抗相关的专利（医药）

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项与斯鲁利单抗相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

作者: Zhang, Lingli ; Xu, Kai ; Yu, Man ; Lin, Yingtao ; Li, Xin ; Su, Dan ; Shang, Jingjing ; Gong, Jinhong ; Sun, Qingli ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

2025-10-24·MEDICINE

Two cases of immune checkpoint inhibitor-associated diabetes mellitus induced by serplulimab: Case reports

作者: Gao, Yuan ; Lin, Meiyuan ; Deng, Jun

Rationale::

Immune checkpoint inhibitors have shown promising efficacy in treating various malignancies; however, their use is associated with immune-related adverse events, including rare but severe immune checkpoint inhibitor–induced diabetes mellitus (ICI-DM). Serplulimab-induced ICI-DM has been rarely reported, and its clinical presentation can be heterogeneous.

Patient concerns::

We report 2 patients with small cell lung cancer who developed serplulimab-induced ICI-DM, both complicated by diabetic ketoacidosis (DKA). Case 1 developed delayed-onset ICI-DM after 2 years of treatment, with elevated glycated hemoglobin and moderate C-peptide deficiency. Case 2 developed ICI-DM earlier, with severe insulin deficiency and classic type 1 diabetes features. Neither patient tested positive for diabetes-related autoantibodies.

Diagnoses::

Both patients were diagnosed with serplulimab-induced ICI-DM, confirmed by hyperglycemia, C-peptide deficiency, and DKA during ongoing programmed cell death protein 1 inhibitor therapy.

Interventions::

Standard DKA management was administered for both patients. They were transitioned to subcutaneous insulin therapy and continued serplulimab treatment under close glucose monitoring.

Outcomes::

Both patients’ DKA was successfully controlled. They continued serplulimab and insulin therapy after discharge, with no recurrence of acute DKA.

Lessons::

These cases highlight the clinical heterogeneity and diagnostic challenges of ICI-DM. Routine blood glucose and glycated hemoglobin monitoring before and during immunotherapy may aid early detection. Clinicians should maintain a high index of suspicion for ICI-DM, even in patients without typical risk factors. Early recognition and insulin initiation are essential to prevent life-threatening complications of DKA. This report contributes to the limited literature on serplulimab-induced ICI-DM and provides practical insights into its diagnosis and management.

2025-09-01·CTS-Clinical and Translational Science

Population Pharmacokinetics and Exposure–Response Analysis of Serplulimab in Small Cell Lung Cancer Patients

Article

作者: Gao, Yuying ; Hu, Chen ; Xu, Fengyan ; Wang, Qingyu ; Wang, Kun ; Shen, Yuanyuan ; Zhou, Liang

ABSTRACT:

While PD‐L1 antibodies have demonstrated efficacy in small cell lung cancer, the therapeutic benefits remain limited. To address this unmet medical need, serplulimab was developed as an innovative monoclonal antibody targeting PD‐1. This study evaluated the pharmacokinetic (PK) properties of serplulimab and their relationship with efficacy and safety in patients with extensive‐stage small cell lung cancer (ES‐SCLC), using population pharmacokinetics (PopPK) and exposure–response (E–R) analysis to inform dose selection. Data from 1144 patients across eight Phase I–III clinical trials supported a two‐compartment PopPK model with time‐dependent clearance. Cox proportional hazards models were employed to analyze the correlation between exposure (Cavg1 and Cmin1) and overall survival (OS)/progression‐free survival (PFS), and adverse events (AEs) with exposure (Cavg1 and Cmax1). Body weight, albumin (ALB), and gender significantly influenced the clearance and volume distribution of serplulimab; however, the observed differences in exposure ratio did not reach clinically relevant thresholds (0.8–1.25), thereby obviating the need for dose adjustments. Safety analysis revealed no monotonic increase in AE probability with increasing exposure (p > 0.05). Efficacy analysis indicated no significant correlation between exposure and OS (p > 0.05), whereas lactate dehydrogenase (LDH) and tumor burden emerged as significant predictors of OS (p < 0.05). Results confirm favorable PK and safety of serplulimab at the recommended dose, requiring no adjustment for above covariates. These findings suggest that the current dose is on the plateau of the E–R curve, and dose escalation is unlikely to improve clinical outcomes.Trial Registration:ClinicalTrials.gov identifier: NCT03952403, NCT04818359, NCT05246164, NCT04747236, NCT03973112, NCT04297995, NCT04778904, NCT04063163

942

项与斯鲁利单抗相关的新闻（医药）

2025-11-17

·资鲸

复宏汉霖与Organon共同宣布美国首个帕妥珠单抗生物类似药POHERDY®获FDA批准

上海和新泽西州泽西市2025年11月17日/美通社/ -- 复宏汉霖（2696.HK）与Organon（纽交所代码：OGN）今日共同宣布，帕妥珠单抗注射液（420 mg/14 mL）POHERDY®（pertuzumab-dpzb）生物制品许可申请（BLA）获美国食品药品监督管理局（FDA）批准，并可与原研产品PERJETA（pertuzumab）互换使用，成为美国首款且唯一的PERJETA生物类似药，覆盖其在美国已获批的所有适应症[1],[2]。这一获批标志着在提升特定HER2阳性乳腺癌患者获得兼具品质与潜在更可负担治疗的可及性方面迈出了具有里程碑意义的一步。Organon生物类似药和成熟药业务美国商业主管Jon Martin表示："提升女性高发疾病的治疗可及性，包括乳腺癌这一美国女性最常见的癌症（不含皮肤癌）[3]，是我们始终坚守的核心使命。POHERDY®不仅是首个在美获批的PERJETA生物类似药，它的获批也延续了Organon近来在女性健康与肿瘤领域不断丰富生物类似药管线的良好势头。我们与复宏汉霖的紧密合作，对于实现我们为美国患者打造更可持续医疗体系的目标至关重要。"复宏汉霖执行董事兼首席执行官朱俊博士表示："POHERDY®的获批代表复宏汉霖在生物药领域全球布局和质量开发方面实现了又一次具有里程碑意义的突破。作为美国首个获批的帕妥珠单抗生物类似药[2]，这一重要成果展现了我们以严谨的科学和监管标准构建可持续全球研发体系的核心能力，也印证了复宏汉霖秉持'以患者为中心'的核心理念，坚定推进全球化战略的长期承诺。我们将加速推动具有品质的生物药惠及全球更多患者，为人类健康事业创造更大价值。"复宏汉霖首席商务发展官兼高级副总裁曹平表示："POHERDY®的获批进一步体现了公司在国际注册方面的良好成绩，以及我们在质量管理和商业化协作方面的综合实力。我们期待与合作伙伴Organon紧密协作，充分发挥双方在供应链、市场与渠道方面的协同优势，共同提升具有品质的生物药的可及性，为更多患者提供兼具品质与经济性的治疗选择。"帕妥珠单抗是一种针对HER2受体的单克隆抗体，是HER2阳性乳腺癌治疗的重要组成部分，适用于：转移性乳腺癌，即与曲妥珠单抗和多西他赛联合，治疗既往未接受过转移性乳腺癌抗HER2治疗或化疗的HER2阳性、转移性乳腺癌患者；以及早期乳腺癌，即与曲妥珠单抗和化疗联合，作为早期乳腺癌整体治疗方案的一部分，用于HER2阳性、局部晚期、炎性或早期乳腺癌患者（直径＞2cm或淋巴结阳性）的新辅助治疗，以及用于具有高复发风险HER2阳性早期乳腺癌患者的辅助治疗。完整适应症见文末。此次FDA的批准主要是基于一整套全面数据的审查，包括分析相似性研究、临床药代动力学研究及临床比对研究。研究表明，POHERDY®在安全性、纯度和效力方面（即安全性和有效性）与原研产品PERJETA高度相似，并可实现互换使用[4],[5]。2022年，复宏汉霖与 Organon 签订许可与供应协议，授予 Organon 对包括POHERDY®在内的多个生物类似药在除中国以外的全球区域的独家商业化权益[6]。POHERDY®在美国的获批，将进一步丰富双方在肿瘤领域的产品组合并助力将具有品质的生物药带给更多患者。PERJETA为基因泰克公司（Genentech, Inc.）在美国注册的商标；Organon与该商标持有人不存在任何关联。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，3个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、国内首个生物类似药汉利康®（利妥昔单抗）、地舒单抗BILDYOS®和BILPREVDA®，以及帕妥珠单抗POHERDY®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。关于OrganonOrganon（纽约证券交易所代码：OGN）是一家全球化医疗健康公司，以提供创新性的药品和解决方案，实现更健康的每一天为使命。Organon在全球提供超过70种药物和医疗解决方案，并持续推动这些亟需疗法在超140个市场的广泛可及，重点业务包括女性健康、经典产品和生物类似药，专注于为女性特有疾病、对女性影响重大或不同的疾病寻求解决方案。Organon总部设在美国新泽西州泽西市，致力于提升医药健康领域的可及性、可负担性和创新发展。访问www.organon.com，并关注我们的 LinkedIn、Instagram、X、YouTube、TikTok 和 Facebook以了解更多有关Organon的信息。关于前瞻性声明的注意事项除历史信息外，本新闻稿包含的某些陈述和披露属于1995年《美国私人证券诉讼改革法案》安全港条款所指的"前瞻性陈述"，包括但不限于有关扩大HER2阳性乳腺癌患者治疗可及性、POHERDY的潜在市场机会、Organon生物类似药产品组合的扩展、Organon与复宏汉霖的合作，以及复宏汉霖的全球布局和生物药研发的相关表述。前瞻性陈述通常可通过以下词语识别： "目标"、继续"、"向前"、"愿景"、"使命"、"预期"、"探索"、"未来"、"相信"、"将"、"潜在"等类似表达。这些前瞻性陈述基于公司管理层当前的信念和预期，但同时受到重大风险和不确定性的影响。如果基础假设不准确或风险/不确定性事项发生，实际结果可能与这些前瞻性声明中所述存在重大差异。风险和不确定性因素包括但不限于：无法在欧洲上市HLX11（Perjeta®（帕妥珠单抗）在研生物类似药）；Organon所在市场的品牌与品类竞争加剧；贸易保护措施、进出口许可要求，以及美国或其他政府实施的关税（包括可能的医药行业关税）、贸易制裁或类似限制措施的直接或间接影响；美国及其他国家/地区政府各级财政预算分配的变化，包括分配给Organon客户或业务合作伙伴的时间及金额；Organon无法控制的宏观经济因素，如通胀、利率变化、经济衰退压力及外汇波动；Organon依赖的第三方未能按预期履行职责导致业务增长受阻；供应商未能按照约定提供原料、材料或服务，或未能履行相关义务；供应、生产、包装及运营成本上升；与商业合作伙伴建立或维持合作关系的困难；全球范围内的价格压力，包括由医疗保险管理组织、司法判决及政府法律法规（涉及或影响医保、医疗改革、药品定价、报销、准入制度、国际参考定价（包括"最低优惠国家"规则）及其他定价政策）所带来的影响；Organon未能全面落实产品开发与商业化计划；生产困难或延迟；美国FDA、美国证券交易委员会（SEC）及其他美国或海外监管机构的运作中断；美国及其他司法辖区内法律法规的变动，包括与产品研发、审批、注册、生产、供应、分销和/或营销相关的法规及知识产权和环境保护法规的变化及其执法力度；产品出现或被认为出现疗效、安全性或其他质量问题（无论是否有科学依据），导致产品召回、退市、标签变更或销售下降；第三方未来行为的影响，包括客户关系的重大变化，或医疗产品与服务购买者消费行为、医疗消费模式变化，例如推迟医疗程序、限用处方药、减少就诊频率或放弃医疗保险；Organon或其第三方合作伙伴及其供应商未能履行监管或质量义务；大宗商品价格、燃料、运输费用的波动影响产品供应成本或供货能力。公司不承担因新信息、未来事件或其他原因而更新前瞻性声明的义务。更多可能导致实际结果与前瞻性声明存在重大差异的因素，可见公司向美国SEC提交的文件，包括最新的Form 10-K年度报告（及其修订版）、Form 10-Q 季度报告（及其修订版）、Form 8-K当前报告及其他SEC文件，相关资料可在SEC官网（www.sec.gov）查询。PERJETA为基因泰克公司（Genentech, Inc.）在美国注册的商标；Organon与该商标持有人不存在任何关联。参考文献：References[1]. PERJETA. Prescribing Information. Genentech Inc.; 2025. [2]. Overview for health care professionals. US Food and Drug Administration. Updated August 1, 2024. Accessed November 10, 2025.https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals[3]. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834[4]. Review and approval. U.S. Food and Drug Administration. December 13, 2022. Accessed July 28, 2025.https://www.fda.gov/drugs/biosimilars/review-and-approval[5]. Biosimilar product regulatory review and approval. U.S. Food and Drug Administration. Accessed May 1, 2025.https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf[6]. Organon Enters into Global License Agreement to Commercialize Henlius' Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed July 28, 2025.https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/

生物类似药上市批准

2025-11-17

·复星医药

复星医药子公司复宏汉霖H药汉斯状®进入拉美市场，获秘鲁药监局批准上市

H药汉斯状®是全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗 H药汉斯状®目前已在40个国家和地区获批上市，覆盖全球近半数人口 H药汉斯状®成为公司第四款在拉美市场获批上市的产品复星医药子公司复宏汉霖（2696.HK）宣布，公司自主研发的抗PD-1单抗 H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）正式获得秘鲁药监局（Dirección General de Medicamentos, Insumos y Drogas, “DIGEMID”）批准上市，用于广泛期小细胞肺癌（ES-SCLC）的一线治疗。此次获批标志着H药成为拉美地区首个且唯一获批该适应症的抗PD-1单抗。H药在秘鲁的本地商业化由合作伙伴Abbott负责，商品名为Olizu®。此次H药在秘鲁的获批主要基于欧盟委员会（EC）已批准斯鲁利单抗联合卡铂和依托泊苷用于成人广泛期小细胞肺癌（ES-SCLC）一线治疗的决定，以及ASTRUM-005研究的临床结果。ASTRUM-005研究是一项随机、双盲、安慰剂对照的国际多中心III期研究，旨在评估斯鲁利单抗联合化疗对比安慰剂联合化疗用于ES-SCLC一线治疗的疗效和安全性。在2025年美国临床肿瘤学会（ASCO）年会上，ASTRUM-005研究公布了研究结束分析结果，数据显示中位随访达42.4个月时，斯鲁利单抗联合化疗对比安慰剂联合化疗的中位OS分别为15.8个月 vs. 11.1个月（分层风险比[HR] 0.60，95% CI 0.49–0.73）；两组4年OS率（95% CI）分别为21.9%（17.6–26.6）和7.2%（3.8–12.1），证实了该免疫治疗方案对ES-SCLC患者的长期生存获益。肺癌是全球发病率和死亡率最高的恶性肿瘤，据GLOBOCAN最新数据显示，在拉美地区，肺癌在癌症发病率和死亡率中均位列第4位，2022年新发病例10.5万，死亡病例9.1万 [1]。小细胞肺癌（SCLC）约占肺癌总数的15%，是肺癌中侵袭性最强的亚型，治疗选择有限。H药汉斯状®为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，此次在秘鲁成功获批上市，有望为当地肺癌患者带来更多治疗选择，解决该领域长期以来存在的治疗空白。继汉曲优®、汉利康®、汉贝泰®之后，汉斯状®成为公司第四款在拉美市场获批上市的产品，也是公司在该地区获批的首款创新型药物，开启了公司扩展新兴市场的战略新篇章。作为公司全球化战略的重要支点，H药正持续加速其全球布局。截至目前，H药已在中国、英国、德国、印度、印度尼西亚、新加坡等40个国家和地区获批上市，覆盖全球近半数人口。未来，公司将持续践行“以患者为中心”的使命，携手国际合作伙伴，加速创新疗法的全球布局，让更多患者受益于前沿医疗成果。【参考文献】 [1] Bray, F., Laversanne, M., Sung, H., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. DOI: 10.3322/caac.21834 关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市9款产品，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、国内首个生物类似药汉利康®（利妥昔单抗）、以及地舒单抗生物类似药Bildyos®和Bilprevda®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Serplulimab Approved in Peru, Expanding into LATAM Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC The product has been approved in 40 countries and regions, covering close to half of the world’s population Serplulimab’s approval in Peru becomes Henlius’ fourth product to be approved in the Latin America market Recently, Henlius (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name in Europe: Hetronifly®) has been approved in Peru by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This approval establishes serplulimab as the first and only anti-PD-1 mAb approved for the first-line treatment of ES-SCLC in the LATAM. Serplulimab will be commercialized by Henlius’ partner, Abbott, in Peru under the brand name Olizu®. The approval was primarily supported by the European Commission (EC) approval of serplulimab in combination with carboplatin and etoposide as a first-line treatment of adult patients with ES-SCLC, along with the clinical results from the ASTRUM-005 study. The ASTRUM-005 study is a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study, evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 and 42.4 months of median follow-up data were presented. As of data cutoff on May 7, 2024, median OS was 15.8 in the serplulimab arm vs.11.1 months (stratified HR 0.60, 95% CI 0.49–0.73) in the placebo arm; estimated 4-year OS rate (95% CI) was 21.9% (17.6–26.6) and 7.2% (3.8–12.1). These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC. Lung cancer continues to be malignancy with the highest global incidence and mortality rates. According to the latest GLOBOCAN data, lung cancer mortality ranked 4th among all cancer types in Latin America. Latin America witnessed approximately 105,000 new lung cancer cases and 91,000 deaths in 2022[1]. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options. The approval of serplulimab in Peru will bring a new first-line immunotherapy option to local lung cancer patients, and is expected to fill the long-standing treatment gap in this field. Following the commercialization of HLX02 (trastuzumab), HLX01 (rituximab) and HLX04 (bevacizumab) in the Latin American market, serplulimab has become the Henlius’ fourth product to be approved there through diverse partnership agreements. It is also the company's first innovative product approved in this area, signifying a pivotal milestone in the company's strategic expansion into emerging markets. As a core product of Henlius’ globalisation strategy, serplulimab has now been approved in 40 countries and regions including China, the UK, Germany, India, Indonesia and Singapore, covering close to half of the world’s population. Looking ahead, Henlius will continue to collaborate with global partners to enhance accessibility and bring more innovative therapies to patients worldwide. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 9 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab BILDYOS and BILPREVDA. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

上市批准临床3期免疫疗法临床结果ASCO会议

2025-11-14

·复宏汉霖

复宏汉霖H药汉斯状®进入拉美市场，获秘鲁药监局批准上市

H药汉斯状®是全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗 H药汉斯状®目前已在40个国家和地区获批上市，覆盖全球近半数人口 H药汉斯状®成为公司第四款在拉美市场获批上市的产品复宏汉霖（2696.HK）宣布，公司自主研发的抗PD-1单抗 H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）正式获得秘鲁药监局（Dirección General de Medicamentos, Insumos y Drogas, “DIGEMID”）批准上市，用于广泛期小细胞肺癌（ES-SCLC）的一线治疗。此次获批标志着H药成为拉美地区首个且唯一获批该适应症的抗PD-1单抗。H药在秘鲁的本地商业化由合作伙伴Abbott负责，商品名为Olizu®。此次H药在秘鲁的获批主要基于欧盟委员会（EC）已批准斯鲁利单抗联合卡铂和依托泊苷用于成人广泛期小细胞肺癌（ES-SCLC）一线治疗的决定，以及ASTRUM-005研究的临床结果。ASTRUM-005研究是一项随机、双盲、安慰剂对照的国际多中心III期研究，旨在评估斯鲁利单抗联合化疗对比安慰剂联合化疗用于ES-SCLC一线治疗的疗效和安全性。在2025年美国临床肿瘤学会（ASCO）年会上，ASTRUM-005研究公布了研究结束分析结果，数据显示中位随访达42.4个月时，斯鲁利单抗联合化疗对比安慰剂联合化疗的中位OS分别为15.8个月 vs. 11.1个月（分层风险比[HR] 0.60，95% CI 0.49–0.73）；两组4年OS率（95% CI）分别为21.9%（17.6–26.6）和7.2%（3.8–12.1），证实了该免疫治疗方案对ES-SCLC患者的长期生存获益。肺癌是全球发病率和死亡率最高的恶性肿瘤，据GLOBOCAN最新数据显示，在拉美地区，肺癌在癌症发病率和死亡率中均位列第4位，2022年新发病例10.5万，死亡病例9.1万 [1]。小细胞肺癌（SCLC）约占肺癌总数的15%，是肺癌中侵袭性最强的亚型，治疗选择有限。H药汉斯状®为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，此次在秘鲁成功获批上市，有望为当地肺癌患者带来更多治疗选择，解决该领域长期以来存在的治疗空白。继汉曲优®、汉利康®、汉贝泰®之后，汉斯状®成为公司第四款在拉美市场获批上市的产品，也是公司在该地区获批的首款创新型药物，开启了公司扩展新兴市场的战略新篇章。作为公司全球化战略的重要支点，H药正持续加速其全球布局。截至目前，H药已在中国、英国、德国、印度、印度尼西亚、新加坡等40个国家和地区获批上市，覆盖全球近半数人口。未来，公司将持续践行“以患者为中心”的使命，携手国际合作伙伴，加速创新疗法的全球布局，让更多患者受益于前沿医疗成果。【参考文献】 [1] Bray, F., Laversanne, M., Sung, H., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. DOI: 10.3322/caac.21834 关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市9款产品，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、国内首个生物类似药汉利康®（利妥昔单抗）、以及地舒单抗生物类似药Bildyos®和Bilprevda®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Serplulimab Approved in Peru, Expanding into LATAM Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC The product has been approved in 40 countries and regions, covering close to half of the world’s population Serplulimab’s approval in Peru becomes Henlius’ fourth product to be approved in the Latin America market Recently, Henlius (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name in Europe: Hetronifly®) has been approved in Peru by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This approval establishes serplulimab as the first and only anti-PD-1 mAb approved for the first-line treatment of ES-SCLC in the LATAM. Serplulimab will be commercialized by Henlius’ partner, Abbott, in Peru under the brand name Olizu®. The approval was primarily supported by the European Commission (EC) approval of serplulimab in combination with carboplatin and etoposide as a first-line treatment of adult patients with ES-SCLC, along with the clinical results from the ASTRUM-005 study. The ASTRUM-005 study is a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study, evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 and 42.4 months of median follow-up data were presented. As of data cutoff on May 7, 2024, median OS was 15.8 in the serplulimab arm vs.11.1 months (stratified HR 0.60, 95% CI 0.49–0.73) in the placebo arm; estimated 4-year OS rate (95% CI) was 21.9% (17.6–26.6) and 7.2% (3.8–12.1). These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC. Lung cancer continues to be malignancy with the highest global incidence and mortality rates. According to the latest GLOBOCAN data, lung cancer mortality ranked 4th among all cancer types in Latin America. Latin America witnessed approximately 105,000 new lung cancer cases and 91,000 deaths in 2022[1]. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options. The approval of serplulimab in Peru will bring a new first-line immunotherapy option to local lung cancer patients, and is expected to fill the long-standing treatment gap in this field. Following the commercialization of HLX02 (trastuzumab), HLX01 (rituximab) and HLX04 (bevacizumab) in the Latin American market, serplulimab has become the Henlius’ fourth product to be approved there through diverse partnership agreements. It is also the company's first innovative product approved in this area, signifying a pivotal milestone in the company's strategic expansion into emerging markets. As a core product of Henlius’ globalisation strategy, serplulimab has now been approved in 40 countries and regions including China, the UK, Germany, India, Indonesia and Singapore, covering close to half of the world’s population. Looking ahead, Henlius will continue to collaborate with global partners to enhance accessibility and bring more innovative therapies to patients worldwide. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 9 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab BILDYOS and BILPREVDA. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

上市批准临床3期临床结果ASCO会议免疫疗法

100 项与斯鲁利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	斯鲁利单抗	-	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
非鳞状非小细胞肺癌	中国	上海复宏汉霖生物制药有限公司	2024-12-01
食管鳞状细胞癌	中国	上海复宏汉霖生物制药有限公司	2023-09-19
广泛期小细胞肺癌	中国	上海复宏汉霖生物制药有限公司	2023-01-16
鳞状非小细胞肺癌	中国	上海复宏汉霖生物制药有限公司	2022-10-25
晚期胃癌	中国	上海复宏汉霖生物制药有限公司	2022-03-22
结直肠癌	中国	上海复宏汉霖生物制药有限公司	2022-03-22
MSI-H 实体瘤	中国	上海复宏汉霖生物制药有限公司	2022-03-22

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
食管癌	申请上市	中国	上海复宏汉霖生物制药有限公司	2022-08-26
MSI 癌症	申请上市	中国	上海复宏汉霖生物技术股份有限公司	2021-04-23
胃癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
晚期宫颈癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2022-09-30
局限期小细胞肺癌	临床3期	美国	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	奥地利	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	捷克	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	德国	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	希腊	上海复宏汉霖生物技术股份有限公司	2022-05-17

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ChiCTR2300069000 (ESMO2025)	临床2期	局部晚期胃食管交界处腺癌新辅助	30	serplulimab + S-1 + oxaliplatin	觸衊糧齋鏇顧鏇獵壓淵(糧鹽廠憲簾淵繭夢遞觸) = 醖壓製醖簾鬱願膚餘網廠鑰糧窪糧艱齋範鬱鏇 (膚窪簾築糧鏇遞觸壓艱, 19.9 ~ 56.1) 更多	积极	2025-10-17
NCT03952403 (ASTRUM-002, ESMO2025)	临床3期	晚期非小细胞肺癌一线	636	Serplulimab + HLX04 + chemo	選醖壓鏇襯構鬱製範獵(鏇衊淵觸襯鑰襯糧網廠) = 憲淵膚醖鹹製糧繭顧艱淵淵鏇鏇蓋廠壓蓋夢憲 (鹹壓淵積艱選夢壓齋繭, 20.5 ~ 27.5) 更多	积极	2025-10-17
				Serplulimab + chemo	選醖壓鏇襯構鬱製範獵(鏇衊淵觸襯鑰襯糧網廠) = 齋願蓋鹹築築壓醖壓鹽淵淵鏇鏇蓋廠壓蓋夢憲 (鹹壓淵積艱選夢壓齋繭, 21.2 ~ 30.9) 更多
NCT05731726 (SCAR, ESMO2025)	临床2期	局部晚期直肠癌新辅助 pMMR	22	Serplulimab combined with capeOX and celecoxib	構齋積蓋廠淵顧廠願蓋(膚範鑰選齋築觸蓋壓簾) = 艱餘餘衊窪齋糧鑰積簾襯鏇願築鑰夢艱醖構遞 (廠獵夢範壓醖積顧膚淵, 49.8 ~ 89.3) 更多	积极	2025-10-17
NCT05766800 (ESMO2025)	临床2期	不可切除的非小细胞肺癌	100	serplulimab + platinum-based doublet chemotherapy (Surgery)	範醖選顧鹹願獵醖夢蓋(製願鑰積範製觸艱襯簾): HR = 0.38 (95.0% CI, 0.14 ~ 1.01) 更多	积极	2025-10-17
				serplulimab + platinum-based doublet chemotherapy (Radiotherapy)
ASTRUM-006 (Company_Website) 人工标引	临床3期	早期胃癌	-	HANSIZHUANG + Chemotherapy as neoadjuvant, then HANSIZHUANG as adjuvant	製製鏇醖壓鹹衊醖範範(餘夢鹽選鏇製憲選網範) = Compared with placebo plus chemotherapy, HANSIZHUANG plus chemotherapy significantly prolonged EFS, with a significant reduction in the risk of recurrence. 蓋網廠膚選糧鬱積膚壓 (鬱築廠壓築膚繭夢襯顧 ) 达到更多	积极	2025-10-09
				Placebo + Chemotherapy as neoadjuvant, then Placebo as adjuvant
NEWS 人工标引	N/A	广泛期小细胞肺癌一线	-	斯鲁利单抗+标准化疗 (MRD阳性组)	夢網鹹積膚製築襯糧鹹(鏇鹽繭獵範遞壓壓淵艱) = 糧積簾廠築壓衊願餘鹽淵遞糧構網製顧構夢糧 (鏇膚網糧醖壓網願夢窪 )	积极	2025-09-10
				斯鲁利单抗+标准化疗 (MRD清除组)	-
WCLC2025 人工标引	临床2期	非小细胞肺癌一线	27	HLX07 800 mg+ serplulimab（300mg）+ chemo	顧淵遞顧餘糧獵鬱糧餘(衊糧築網衊夢糧廠糧憲) = 鑰襯積積醖膚繭網鑰鹽壓獵蓋壓醖窪鬱蓋糧簾 (獵衊築餘築鹽窪憲糧壓, 38.6 ~ 90.9) 更多	积极	2025-09-10
				HLX07 1000 mg+ serplulimab（300mg）+ chemo	顧淵遞顧餘糧獵鬱糧餘(衊糧築網衊夢糧廠糧憲) = 獵繭鹹築鹹艱鑰壓製觸壓獵蓋壓醖窪鬱蓋糧簾 (獵衊築餘築鹽窪憲糧壓, 41.9 ~ 91.6) 更多
NEWS 人工标引	临床2期	非鳞状非小细胞肺癌	-	斯鲁利单抗+贝伐珠单抗+培美曲塞+卡铂	鹹鹽糧遞餘膚襯憲衊願(齋繭鏇選願壓齋獵遞膚) = 蓋鹽鑰獵餘簾鑰築廠範窪積齋膚蓋餘鏇積憲糧 (繭壓遞構鬱蓋網顧蓋積 ) 更多	积极	2025-09-10
WCLC2025	-	非小细胞肺癌新辅助	55	Serplulimab+Platinum containing dual drug chemotherapy	壓蓋齋艱鏇觸顧淵蓋淵(憲艱選顧糧餘鹽構遞繭) = 簾顧醖窪鬱簾憲淵遞夢鑰鬱糧繭簾願簾網窪簾 (網襯衊構糧蓋鏇網築簾 ) 更多	积极	2025-09-08
NCT06334757 (WCLC2025) 人工标引	临床2期	EGFR阳性非鳞状非小细胞肺癌 EGFR Mutation	46	HLX04 + Serplulimab + Chemotherapy (EGFR-TKI-resistant nsq-NSCLC)	壓鹹願獵衊夢鹹衊網窪(齋範蓋鬱餘觸憲艱膚範) = 簾鏇衊繭繭遞蓋顧夢繭構築繭廠繭觸觸膚繭憲 (願構製餘餘壓獵願艱廠, 32.9 ~ 63.0) 更多	积极	2025-09-07
				HLX04 + Serplulimab + Chemotherapy (EGFR-TKI-resistant nsq-NSCLC + brain metastases)	壓鹹願獵衊夢鹹衊網窪(齋範蓋鬱餘觸憲艱膚範) = 網蓋膚廠繭鏇繭願網夢構築繭廠繭觸觸膚繭憲 (願構製餘餘壓獵願艱廠 ) 更多