A National Multicenter, Prospective, Randomized Controlled Study of Serplulimab Injection Combined With Bevacizumab to Improve the Complete Response Rate of Neoadjuvant Therapy for Locally Advanced Stage Intermediate and Low Rectal Cancer

This is a multicenter, prospective, randomized phase II trial designed to evaluate the efficacy and safety of short-course neoadjuvant chemoradiotherapy combined with the PD-1 monoclonal antibody serplulimab and the anti-angiogenic agent bevacizumab in patients with previously untreated pMMR/MSS middle and low locally advanced rectal cancer. The study plans to enroll a total of 200 participants (100 in the experimental arm and 100 in the control arm).

开始日期2025-10-01

申办/合作机构

海军军医大学第一附属医院

NCT07134101

/ Not yet recruiting临床2期IIT

Neoadjuvant Chemoradiotherapy Combined With Serplulimab With or Without Bevacizumab for Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Phase II Randomized Trial

The goal of this clinical trial is to learn if combining serplulimab (PD-1 inhibitor) with bevacizumab and short-course total neoadjuvant therapy (TNT) works to treat locally advanced mid-to-low rectal cancer in adults. It will also learn about the safety of this combination.
The main questions it aims to answer are:
Does adding bevacizumab to serplulimab and TNT increase the complete remission rate (cCR + pCR) compared with serplulimab and TNT alone? What medical problems do participants have when receiving these treatments?
Researchers will compare:
Experimental group: serplulimab + bevacizumab + chemotherapy + short-course radiotherapy Control group: serplulimab + chemotherapy + short-course radiotherapy
Participants will:
Receive either the experimental or control regimen for about 4-5 months before surgery or a watch-and-wait approach if complete response is achieved Undergo treatment in cycles that include chemotherapy, immunotherapy (and bevacizumab if in the experimental group), and short-course radiotherapy Visit the clinic regularly for check-ups, blood tests, imaging, endoscopy, and to monitor side effects Be followed for up to 5 years after treatment to assess cancer control, organ preservation, and survival outcomes

开始日期2025-09-01

申办/合作机构

常州市第二人民医院

NCT07064876

/ Not yet recruiting临床2期IIT

A Single-Arm, Phase II Clinical Study of Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer

The goal of this clinical trial is to learn if serplulimab combined with cryoablation can effectively treat early-stage non-small cell lung cancer (NSCLC) in adults who are not eligible for or decline surgery or radiotherapy. The main questions it aims to answer are:
What is the objective response rate (ORR) after combination treatment with serplulimab and cryoablation? What are the progression-free survival (PFS), overall survival (OS), 1-year OS rate, and safety outcomes? This is a single-arm, phase II study with no comparison group.
Participants will:
Receive cryoablation under CT guidance to locally ablate the tumor Receive intravenous serplulimab (300 mg every 3 weeks) for up to 6 cycles Undergo regular imaging and laboratory tests to assess response and monitor safety Provide blood and tissue samples for optional biomarker research The study will enroll 25 patients with stage Ia NSCLC (tumor size >1 cm and ?3 cm, no ground-glass opacity, EGFR/ALK/ROS1 wild-type) and aims to explore the potential of combining local and systemic immunotherapy in non-surgical candidates.

开始日期2025-08-01

申办/合作机构-

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: Xu, Kai ; Zhang, Lingli ; 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.

2025-08-01·Cancer Communications

First‐line serplulimab plus chemotherapy in extensive‐stage small‐cell lung cancer: Updated results and biomarker analysis from the ASTRUM‐005 randomized clinical trial

Article

作者: Zhang, Shuang ; Shi, Jianhua ; Pan, Zhijie ; Pan, Yueyin ; Li, Xingya ; Shi, Jinsheng ; Shan, Yongqiang ; Min, Xuhong ; Makharadze, Tamta ; Arkania, Ekaterine ; Chen, Jun ; Bai, Yuansong ; Wang, Qingyu ; Yang, Fang ; Wang, Xicheng ; Yang, Junquan ; Ji, Yinghua ; Sun, Hongmei ; Viguro, Maksym ; Zhao, Peiyan ; Ling, Chen ; Wen, Guilan ; Melkadze, Tamar ; Wu, Lin ; Zimina, Anastasia ; Yang, Xinyi ; Li, Jing ; Han, Liang ; Yu, Haoyu ; Zhu, Jun ; Zhao, Yanqiu ; Cheng, Ying

Abstract:

Background:

The ASTRUM‐005 study previously demonstrated a significant overall survival (OS) benefit with serplulimab (a programmed death 1 inhibitor) plus chemotherapy versus chemotherapy alone in previously untreated extensive‐stage small‐cell lung cancer (ES‐SCLC). Here, we report updated efficacy and safety results after an extended median follow‐up of 19.8 months, along with the first report on findings from exploratory biomarker analyses.

Methods:

A total of 585 patients were randomized in a 2:1 ratio to receive 4.5 mg/kg serplulimab (n = 389) or placebo (n = 196) intravenously every 3 weeks, together with carboplatin and etoposide. The primary endpoint was OS. In addition, genomic profiling was performed to identify mutated genes, and quantitative serum proteome profiling was conducted to identify differentially expressed proteins (DEPs) between responders and non‐responders of serplulimab plus chemotherapy. Regression analysis was subsequently used to construct a protein signature based on the DEPs. The associations between efficacy outcomes (objective response rate [ORR], OS, and progression‐free survival [PFS]) and gene mutation status or DEP expression were also examined with regression analysis. Furthermore, the prognostic value of hematological parameters was evaluated.

Results:

In the intent‐to‐treat population, the median OS was 15.8 months in the serplulimab group versus 11.1 months in the placebo group (hazard ratio, 0.62; 95% confidence interval, 0.50‐0.76; P < 0.001). We identified 181 DEPs between responders and non‐responders in the serplulimab group, from which a 15‐protein signature was constructed. In the serplulimab group, patients with a higher 15‐protein signature score were associated with significantly longer OS and PFS. Also, patients harboring tumor‐suppressor retinoblastoma‐1 (RB1) mutations or mutations in Notch pathway members showed improved ORR, OS, or PFS compared with their wild‐type counterparts. Baseline neutrophil‐to‐lymphocyte ratio (NLR) and lactate dehydrogenase (LDH) level were independent prognosticators of patients with ES‐SCLC.

Conclusions:

First‐line serplulimab provided a sustained clinical benefit over placebo in patients with ES‐SCLC. A 15‐protein signature and mutations in RB1 or Notch pathway genes may serve as predictive biomarkers for benefits from serplulimab plus chemotherapy, while baseline NLR and LDH were independent prognosticators for ES‐SCLC.

2025-07-15·ANALYTICAL CHEMISTRY

On-Site Therapeutic Drug Monitoring for Program Death-1 Antibody Using a Quantum Dot Nanobeads-Based Lateral Flow Immunoassay

Article

作者: Zhang, Pengfei ; Xia, Wenwen ; Han, Huanxing ; Wang, Zhipeng ; Wu, Ying ; Cui, Lili ; Hou, Juanjuan ; Gao, Shouhong ; Liao, Xiangyi

Therapeutic drug monitoring of program death-1 (PD-1) inhibitor Serplulimab in cancer patients is of clinical importance in predicting treatment efficacy and assessing adverse reactions. However, the traditional liquid chromatography tandem mass spectrometry (LC-MS/MS) and enzyme-linked immunosorbent assay (ELISA) for antibody drug monitoring are time-consuming and laborious. Herein, a quantum dot nanobeads-based lateral flow immunoassay (LFIA) is developed for rapid and accurate monitoring of the PD-1 antibody drug in 15 min. Both competitive and indirect immunoassays were investigated for PD-1 antibody drug monitoring, and the competitive assay demonstrated better sensitivity and precision. The optimized competitive LFIA had a detection of limit of 5.1 μg/mL; a linear range of 10-100 μg/mL; recovery rates of 99.2%-113.9% at the spiked concentration of 25, 50 and 100 μg/mL; and coefficients of variations (CVs, n = 10) less than 14.5% at 50 μg/mL. The assay has a negligible nonspecific reaction with the interferents of other monoclonal antibody drugs, autoantibodies, hyper lipids, hemolysis, jaundice, and whole blood samples. Method comparison with ELISA in 30 human plasma samples has a good correlation factor of r = 0.87. All in all, the developed quantum dot nanobead-based LFIA system for PD-1 antibody drug monitoring is a versatile tool for rapidly personalized drug therapy at the point of care.

777

项与斯鲁利单抗相关的新闻（医药）

2025-08-28

·阿基米德Biotech

Big Pharma的新征途

在这一轮生物科技资产重估浪潮中，老牌Big pharma勇立创新潮头，整体越来越强，体现为创新药收入、早研能力、BD及全球化能力的提升。过去，复星医药由于业务结构多元，在创新领域的决心与布局，未被市场充分认知，资本市场对其只是一个综合性医药产业集团的估值。然而，近期一系列的战略动作，正像一道道强光，穿透迷雾，从将创新药收入明确写入新一期的股权激励，到多款自研小分子新药成功出海，再到核心治疗领域管线的梯队化布局，勾勒出一条清晰的创新进阶之路。一个更聚焦、更具爆发力的复星医药正在浮现，这不是脉冲式爆发，而是持续性爆发。 2025H1，复星医药创新药品稳健增长，收入超43亿元，同比增长14.26%，研发投入22.95亿元，4个创新药品5个适应症获批，高价值创新管线矩阵形成。这种战略清晰度与市场认知之间的最大预期差，构成理解复星医药当前价值的核心。复星医药正在主动走过一道聚焦的窄门。门的另一边，是一条由创新驱动的、深度全球化的更宽广的道路。资料来源：复星医药官微 01 聚焦：三驾马车驱动四大创新平台一家企业的战略意图，首先体现在资源配置上。做什么，固然重要，但不做什么，往往更能揭示其核心。复星医药正通过果断的减法，为创新加法腾出空间。2025年以来，公司已签约处置的非战略、非核心资产总额超过20亿元，其中包括退出和睦家和美国自然阳光。一系列资产剥离，向市场传递一个强有力的信号：复星医药正将宝贵的资本和管理资源，集中投向创新药品与高价值医疗器械两大核心赛道。通过优化资产结构，加速现金回流，为后续的研发投入和战略性BD合作备足弹药。如果说资产处置是外部瘦身，那么激励机制的重塑，则是内部强心。一家企业的雄心，会体现在股权激励方案中。2025年8月，复星医药推出股权激励（草案），其独特之处在于将“创新药品收入”作为一个独立的、权重高达40%的核心考核指标，与权重60%的“归母净利润”并列。一份“业绩合同”，为未来三年设定了极具挑战的目标：创新药收入2025年达到93.6亿元，2026年112.3亿元，2027年134.8亿元。这种制度设计，将驱动公司内部所有关键决策，都向着创新这一核心方向倾斜，将一份战略意图，转化为一份可度量的契约。为实现目标，复星医药的创新聚焦体现在三个层面。首先是战略聚焦。复星医药以创新和国际化为导向，围绕解决未被满足的临床需求，通过自主研发、合作开发、许可引进、基金孵化、产业投资等多元化、多层次的合作模式，持续丰富创新产品管线，提升早研转化与临床开发能力，以最大化创新技术和产品的商业价值。其次是研发体系聚焦。复星医药通过三大成熟的研发主体，复宏汉霖主要聚焦抗体和ADC，全球研发中心聚焦小分子，复星凯瑞聚焦细胞治疗技术，明确公司四大创新技术平台：抗体、ADC、细胞治疗、小分子。第三是研发策略聚焦。复星医药聚焦实体瘤、血液瘤、免疫炎症等核心治疗领域，持续丰富产品组合，并积极向慢病（心脑血管、肾脏与代谢）、中枢神经系统领域拓展布局。复星医药正围绕四大创新技术平台，构建可持续的创新引擎。这种平台化布局，远比押注单一领域产品更具韧性和爆发力，体现出Big pharma行稳致远的优势。 02 引领：量产高价值管线战略聚焦的成果，体现于开始量产优势管线，复星医药已在在多个创新领域处于国内头部地位。免疫肿瘤（IO）复星医药已在肺癌、乳腺癌等领域形成以斯鲁利单抗注射液、注射用曲妥珠单抗为代表的创新药品矩阵，2025年上半年获批的复妥宁和复迈宁两款1.1类创新药也进一步加强了在肿瘤领域的产品。目前以斯鲁利单抗为核心，复星医药正在构建一个IO产品组合。管线中不仅包括靶向PD-1靶向型IL-2融合蛋白FXB0871等下一代免疫激动剂，还包括PD-L1/VEGF双抗HLX37这类旨在克服耐药、提升疗效的创新组合分子。这体现了从单一靶点向联合疗法和协同增效演进的清晰战略。新型ADC FS-1502（HER2 ADC ）和HLX43（PD-L1 ADC）已进入国际多中心临床试验的关键阶段，其中，HLX43是全球进度最快的PD-L1 ADC，又是一款泛瘤种全覆盖、带有IO功能的广谱ADC，有望对标全球超过500亿美元的免疫治疗药物市场，体现出公司对大品种的专注。细胞治疗复星凯瑞的蓝图清晰而宏大：奕凯达的成功商业化只是第一步，收治患者超过1000位，为未来从血液瘤拓展到实体瘤，再到自免领域积累了宝贵的生产、注册和商业化经验。小分子（免疫炎症）当市场目光大多聚焦于肿瘤赛道时，复星医药已然在免疫炎症领域悄然落子。其小分子平台产出的XH-S004（DPP-1抑制剂）和FXS6837（免疫调节剂），凭借其创新性和潜力，成功吸引了海外专业生物技术公司的青睐，达成了两笔高价值的对外授权合作。这体现了一种差异化的竞争策略。免疫和炎症领域是巨大的慢性病市场，口服小分子药物具有天然优势。通过在这一领域的布局，复星医药不仅避开了部分红海竞争，也为其长期增长开辟新蓝海。慢病及神经领域复星医药的管线布局，也体现出对未来疾病谱变化的深刻洞察。在慢病（心血管、肾脏与代谢）领域，一系列重磅产品已陆续上市：用于心衰和高血压治疗的一心坦、新一代拟钙剂旁必福、全球首款磷吸收抑制剂万缇乐，以及钾离子竞争性酸阻滞剂倍稳。这些产品针对的都是患者基数庞大、存在巨大未满足需求的慢性病市场。而在风险与回报都极高的神经科学领域，复星医药通过引进阿尔茨海默病在研药物AR1001，迈出关键一步，不仅是产品线的延伸，更是对人口老龄化这一重大社会趋势的战略回应。创新药械协同相比其他Big pharma “药械协同”是复星医药的独特优势，可为疾病提供一体化解决方案。在神经退行性疾病领域，公司许可引进用于延缓阿尔茨海默病（AD）进程的小分子口服药物AR1001，以协同医疗器械与医学诊断业务资源，探索神经退行性疾病诊疗一体化解决方案。在肿瘤领域，这一战略已初见成效。直观复星旗下的达芬奇手术机器人已在中国累计装机超450台，服务患者超76万人次。而新近实现商业化落地的Ion支气管导航操作系统，则能更精准地实现肺部病灶的早期诊断和定位。从Ion系统的精准导航，到达芬奇机器人的微创手术，再到后续的创新药物治疗，复星医药正在打造一个覆盖诊疗全流程的闭环，构筑起远超单一产品竞争的强大护城河。 03 BD：全球化能力再升级如果说研发创新是发动机，那么全球化能力就是放大器，把一款创新药的价值，从中国市场放大至全球市场。复星医药的全球化能力在国内Bigpharma中是领先者，其深度和广度早已超越单纯的产品出海或交易型BD，而是构建起一个海外本地化生产能力+临床及商业化自营于一体的立体化全球网络。如今，BD又为全球化能力插上新的翅膀。 2025年8月，复星医药接连完成两笔自研小分子新药的海外授权。DPP-1抑制剂XH-S004授权给美国Expedition Therapeutics，潜在总金额近6.5亿美元；免疫调节剂FXS6837授权给英国Sitala，潜在总金额高达6.7亿美元。交易对手均由顶尖跨国药企团队和一线生命科学风投加持。这两笔交易以真金白银验证了复星医药小分子平台的全球竞争力，迫使市场重估其早研能力的价值，因为更多的XH-S004和FXS6837正在孵化之中。长期以来，市场对复星医药的创新认知，多集中于肿瘤领域或生物药，这两笔BD交易向资本市场揭示复星医药预期差，其小分子平台已具备国际竞争力，在差异化的免疫炎症领域藏着一批BIC或FIC品种。 BD的成功，并非偶然，其背后是复星医药数十年构建的全球化运营体系。这个体系如同一条宽阔的护城河，既能“引进来”，也能“走出去”，形成了难以复制的战略优势。斯鲁利单抗获欧盟批准并授权至70余个国家和地区，是中国PD-1出海的标杆。目前，复星医药已在美国自建临床运营团队和商业化团队，加速推进斯鲁利单抗在美国的临床和上市前的商业化筹备工作。而青蒿琥酯系列产品，更是拯救了非洲8000多万重症疟疾患者的生命，让复星医药在新兴市场扎下了深厚的根基。这一切都建立在坚实的基础设施之上。近千人的海外商业化团队，确保了产品在当地的推广和销售。多条通过美国FDA和欧盟GMP认证的生产线，保障了全球供应链的稳定和合规。正在建设的非洲科特迪瓦产业园，则是其深耕新兴市场的又一力证。这种本土化的运营模式，不仅可以助力复星医药的创新产品的全球化，未来更多的中国Biotech出海，或许又多了一个海外的合作伙伴选择。强大的全球化能力，最终反映在财务数据上。2025年上半年，复星医药海外收入54.78亿元，收入比重超接近30%。这意味着，对复星医药任何一款创新药的价值评估，都必须从“中国故事”切换到“全球故事”，其潜在市场空间和估值模型已发生根本性改变。市场对复星医药的认知，似乎还部分停留在过去的旧故事里。但复星医药的战略转型路径已经非常清晰。一个更聚焦、更高效、更全球化的新故事已经展开。通过激励计划校准了内部航向，通过重磅交易验证了研发成色，通过梯队化管线布局确保了创新可持续性，并通过全球化网络放大了创新成果的价值。市场对复星医药的预期差，正是其未来价值释放的核心空间。当更多像DPP-1抑制剂出海这样的“价值锚点”出现时，市场的认知也将随之修正。穿过战略聚焦的窄门，复星医药正稳步走在一条更宽广的创新和全球化之路上。

并购

2025-08-27

·复宏汉霖

2025中期业绩亮点 | 海外产品利润激增200%，创新爆款分子蓄势待发

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，已有6款产品在中国获批上市，4款产品在国际获批上市，6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国内首个生物类似药汉利康®（利妥昔单抗）、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®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、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®）以及汉奈佳®（奈拉替尼）。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。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

上市批准生物类似药免疫疗法

2025-08-26

·复宏汉霖

复宏汉霖应邀亮相首届Evercore中国生物科技峰会

近日日，复宏汉霖（2696.HK）应邀出席首届Evercore中国生物科技峰会（Evercore China Biotech Summit）。本届峰会由全球领先的独立投资银行Evercore主办，汇聚来自欧美及亚太地区生物医药产业的领导者、投资机构及创新企业，共同探讨全球创新药物研发趋势与投资商机。复宏汉霖执行董事、首席执行官朱俊博士在大会上回顾了公司十五年的发展历程，并分享了未来的战略蓝图。复宏汉霖正从以生物类似药为主的“1.0时代”，迈向“以创新驱动全球化”的“2.0时代”，持续打造有国际竞争力的创新型Biopharma。朱俊博士表示，自2010年成立以来，复宏汉霖始终以患者为中心，已在中美欧等主要市场实现突破。截至目前，公司已有 6款产品在中国获批上市、4款产品在海外获批上市，覆盖美国、欧洲、印度等50多个国家和地区，累计惠及超过85万名患者。朱俊博士指出，复宏汉霖已逐步形成了包括早期研发、临床转化、国际标准CMC、全球注册、商业化网络等在内的五大核心能力，支撑公司加速迈入“2.0时代”。当前，公司多元生物药管线覆盖单抗、多抗、抗体偶联药物（ADC）、融合蛋白和小分子药物等丰富的药物形式。进入“2.0时代”，复宏汉霖聚焦“生物类似药+创新+全球化”，围绕肺癌、乳腺癌、消化道肿瘤等全球高发瘤种，着力打造差异化的创新药管线，开发更多潜在“first-in-class”产品。 HLX43是复宏汉霖的一款创新型广谱抗肿瘤ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。临床前研究显示，HLX43在PD-1/PD-L1单抗耐药的非小细胞肺癌（NSCLC）、宫颈癌、食管鳞癌等多个瘤种中显示出显著疗效，且耐受性良好。WCLC公布的HLX43的临床I期研究摘要提示，HLX43在晚期实体瘤、尤其是绝大多数接受过检查点抑制剂（CPI）治疗并失败的后线耐药NSCLC患者中，持续表现出高应答率，在特定亚组如EGFR野生型非鳞状非小细胞肺癌（nsNSCLC）人群中展现了更为优异的疗效，ORR达47.4%，同时延续了良好的安全性。值得关注的是，HLX43在PD-L1阳性/阴性/未知患者人群中皆显示良好的疗效，不依赖肿瘤标志物筛选。公司自主研发的创新药H药汉斯状®（斯鲁利单抗）是全球首个获批用于广泛期小细胞肺癌（ES-SCLC）一线治疗的PD-1单抗，已在中国、英国、德国、印度、印度尼西亚、新加坡等近40个国家获批上市。截至目前，H药已获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、ES-SCLC、食管鳞状细胞癌（ESCC）和nsNSCLC。此外，复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究，其在研阶段适应症覆盖胃癌围术期、局限期小细胞肺癌、转移性结直肠癌等高发瘤种。聚焦乳腺癌和消化道肿瘤等领域，公司正在积极推进新表位HER2单抗HLX22的研发，该产品有望与现有疗法形成互补，为HER2阳性患者带来更多治疗选择。HLX22已于2025年获得美国食品药品监督管理局（FDA）和欧盟委员会（EC）授予的孤儿药资格认定（Orphan Drug Designation, ODD），用于胃癌的治疗。其头对头对比一线标准疗法（曲妥珠单抗+化疗±帕博利珠单抗）的国际多中心III期研究（HLX22-GC-301）正同步于中国、澳大利亚、欧盟、日本、美国、南美洲等国家和地区推进开展。截至目前，该研究已于中国、日本、澳大利亚、韩国完成首例受试者给药，并已在智利、巴西、阿根廷等国家和地区获得临床试验开展许可。此外，复宏汉霖近期亦启动一项HLX22联合德曲妥珠单抗治疗HER2低表达HR阳性乳腺癌的II期临床研究（HLX22-BC201）并于中国境内完成首例患者给药。从“1.0时代”到“2.0时代”，复宏汉霖正以持续创新与国际化战略加速成长。凭借扎实的商业化基础和前瞻性的管线布局，公司正稳步迈向一家“全球布局、以创新驱动的国际化生物制药企业”。 “我们的目标，不仅是把药物带到更多国家，更是把中国创新的价值、标准和责任带到全球市场。”朱俊博士强调，“复宏汉霖将持续立足国际标准，推动中国高质量原创生物药在全球范围内创造更大价值。” 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，已有6款产品在中国获批上市，4款产品在国际获批上市，6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国内首个生物类似药汉利康®（利妥昔单抗）、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®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、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®）以及汉奈佳®（奈拉替尼）。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。 Henlius Featured at the 2025 Evercore China Biotech Summit On August 21, Henlius (2696.HK) was invited to participate in the 2025 Evercore China Biotech Summit. Organized by the leading independent investment bank Evercore, the summit gathered leaders from the biopharmaceutical industry, investment institutions, and innovative companies across Europe, the U.S., and the Asia-Pacific region to explore trends in global drug development and investment opportunities. Dr. Jason Zhu, Executive Director and CEO of Henlius, reviewed the company’s 15-year journey and shared its strategic blueprint for the future. Henlius is evolving from its "1.0 era" focused on biosimilars to the "2.0 era" of innovation-driven globalization, building itself into a competitive international biopharma. Dr. Zhu highlighted that since its founding in 2010, Henlius has remained committed to its patient-centric mission and achieved breakthroughs in key markets such as China, the U.S., and Europe. To date, six products have been approved in China and four have gained approvals overseas, covering more than 50 countries and regions including the U.S., Europe, and India, benefitting over 850,000 patients. He emphasized that Henlius has gradually developed five core capabilities—early-stage R&D, clinical development, international-standard CMC, global regulatory expertise, and commercialization networks—that are driving the company into its "2.0 era". With a diverse pipeline spanning monoclonal antibodies, bispecifics, ADCs, fusion proteins, and small molecules, Henlius is focused on "biosimilars + innovation + globalization". The company is strategically advancing differentiated innovations in high-incidence cancers such as lung, breast, and gastrointestinal cancers, aiming to develop more potential first-in-class therapies. HLX43 is Henlius' innovative broad-spectrum anti-tumour ADC with dual mechanisms of checkpoint blockade and cytotoxic payload delivery. Preclinical studies demonstrated marked efficacy and good tolerability across multiple tumour types resistant to PD-1/PD-L1 antibodies, including non small cell lung cancer (NSCLC), cervical cancer, and esophageal squamous cell carcinoma (ESCC). According to the abstract released for WCLC, the phase 1 study of HLX43 showed sustained high response rates in advanced solid tumours, particularly in heavily pretreated NSCLC patients who failed checkpoint inhibitor (CPI) therapy. Notably, in the EGFR wild-type non-squamous NSCLC (nsNSCLC) subgroup, HLX43 achieved an ORR of 47.4%, while maintaining a favourable safety profile. Importantly, HLX43 demonstrated consistent efficacy across PD-L1 positive, negative, and unknown subgroups, highlighting its biomarker-independent potential. Henlius' self-developed anti-PD-1 monoclonal antibody serplulimab is the world's first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), with approvals in nearly 40 countries including China, the UK, Germany, India, Indonesia, and Singapore. To date, serplulimab has been approved for squamous NSCLC, ES-SCLC, ESCC, and nsNSCLC. Globally, Henlius is conducting more than 10 clinical studies of serplulimab-based immunotherapy combinations, covering high-incidence indications such as perioperative gastric cancer, limited-stage SCLC, and metastatic colorectal cancer. In breast and gastrointestinal cancers, Henlius is advancing HLX22, a novel epitope HER2 expected to complement existing therapies and bring more options to HER2-positive patients. HLX22 received orphan drug designation from both the U.S. FDA and the European Commission in 2025 for gastric cancer. Its global phase 3 head-to-head study (HLX22-GC-301), comparing HLX22 plus chemotherapy with or without pembrolizumab against standard of care (trastuzumab + chemotherapy ± pembrolizumab), is ongoing in China, Australia, the EU, Japan, the U.S., and South America. The first patient has been dosed in China, Japan, Australia, and South Korea, and trial approvals have also been obtained in Chile, Brazil, and Argentina. Recently, Henlius also launched a phase 2 trial of HLX22 plus T-DXd in HER2-low, HR-positive breast cancer, with the first patient dosed in China. From "1.0" to "2.0", Henlius is accelerating growth with continuous innovation and a globalization strategy. With solid commercialization foundations and forward-looking pipeline development, the company is steadily advancing toward becoming an innovation-driven global biopharmaceutical enterprise. "Our goal is not only to bring medicines to more countries, but also to deliver the values, standards, and responsibilities of China's innovations to the global market," Dr. Zhu emphasized. "Henlius will continue to uphold international standards and create greater value worldwide with high-quality original biologics from China." 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. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 6 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 HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). 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

抗体药物偶联物上市批准生物类似药临床1期

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,

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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,

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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

分期

评价

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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


WCLC2025	-	非小细胞肺癌新辅助	55	Serplulimab+Platinum containing dual drug chemotherapy	醖範蓋鏇憲齋鬱願選鏇(範遞餘窪艱憲膚鹹範觸) = 構選襯衊觸壓蓋壓網夢壓憲鑰繭蓋鹹餘簾鑰製 (壓繭鹽蓋網窪範築餘積 ) 更多	积极	2025-09-08
NCT03952403 (ASTRUM002, WCLC2025 \| NEWS 1 \| NEWS 2)	临床3期	鳞状细胞肺癌一线 Driver gene negative	636	Serplulimab+Bevacizumab-HLX04+Platinum containing dual drug chemotherapySerplulimab+Bevacizumab-HLX04+Platinum containing dual drug chemotherapy	鹽願鏇網鬱願夢願艱鬱(築糧獵膚網觸遞遞鹹製) = 遞鑰夢夢繭製鏇鹽壓襯網餘觸繭廠壓窪醖鬱觸 (鑰構遞顧製艱膚膚獵顧, 8.7 ~ 14.0) 更多	积极	2025-09-07
NCT03952403 (ASTRUM002, WCLC2025 \| NEWS 1 \| NEWS 2)	临床3期	鳞状细胞肺癌一线 Driver gene negative	636	Serplulimab+Platinum containing dual drug chemotherapy	鹽願鏇網鬱願夢願艱鬱(築糧獵膚網觸遞遞鹹製) = 夢鬱夢積範築構顧繭遞網餘觸繭廠壓窪醖鬱觸 (鑰構遞顧製艱膚膚獵顧, 8.44 ~ 12.71) 更多	积极	2025-09-07
NCT04063163 (ASTRUM-005, Pubmed \| Cancer Commun (Lond))	临床3期	广泛期小细胞肺癌 mutations in Notch pathway members \| lactate dehydrogenase (LDH) level	585	Serplulimab 4.5 mg/kg + Carboplatin and Etoposide	壓鏇觸鑰簾齋膚觸積醖(選鑰鑰膚構製繭鬱顧觸) = 艱觸膚膚鬱製淵夢選艱夢艱鹹積簾鏇窪餘憲獵 (窪積夢鹽窪願構餘構繭 )	积极	2025-08-01
NCT04063163 (ASTRUM-005, Pubmed \| Cancer Commun (Lond))	临床3期		585	Placebo + Carboplatin and Etoposide	壓鏇觸鑰簾齋膚觸積醖(選鑰鑰膚構製繭鬱顧觸) = 憲網壓繭糧願醖鹽襯顧夢艱鹹積簾鏇窪餘憲獵 (窪積夢鹽窪願構餘構繭 )	积极	2025-08-01
NCT04063163 (ASTRUM-005, ASCO2025 \| Pubmed) 人工标引	临床3期	广泛期小细胞肺癌一线	585	Serplulimab plus chemotherapy	糧窪窪願繭鹽鬱製蓋積(壓膚鹹範築遞構廠構糧) = 衊鹽艱壓齋窪餘範齋遞鬱鏇築願糧鏇願築觸壓 (衊餘獵獵夢鬱範積憲窪 ) 更多	积极	2025-05-30
NCT04063163 (ASTRUM-005, ASCO2025 \| Pubmed) 人工标引	临床3期	广泛期小细胞肺癌一线	585	Placebo plus chemotherapy	糧窪窪願繭鹽鬱製蓋積(壓膚鹹範築遞構廠構糧) = 餘艱範廠艱蓋網廠繭憲鬱鏇築願糧鏇願築觸壓 (衊餘獵獵夢鬱範積憲窪 ) 更多	积极	2025-05-30
NCT05585580 (STILL, ASCO2025)	临床2期	胃食管交界处腺癌二线 PD-L1 combined positive score (CPS)	47	Serplulimab + Lenvatinib + Paclitaxel	廠衊艱觸製製鬱獵餘顧(構築淵鬱鹹衊糧鹽築積) = 網鑰觸獵積繭廠鏇築廠鹹遞鑰鹹鏇願窪齋顧積 (選鬱襯願壓鹽蓋遞範鹹, 35.1% ~ 67.1) 更多	积极	2025-05-30
ASCO2025	N/A	局部晚期胃食管交界处腺癌新辅助 PD-1 inhibitor	25	Serplulimab + SOX chemotherapy	網鏇衊鏇鹹簾積窪鬱築(繭積糧築網獵鏇觸衊繭) = Median DFS not reached 窪鑰蓋壓鬱範襯膚餘艱 (壓繭構遞夢鏇鏇鹹窪構 ) 更多	积极	2025-05-30
NCT06099951 (PANFORTE, ASCO2025)	临床2期	错配修复缺陷直肠癌辅助 proficient mismatch repair	53	FOLFOXIRI plus serplulimab (200 mg)	廠積壓淵衊糧廠鏇衊醖(選憲淵醖網鹹襯廠簾鏇) = 鏇窪鏇鹽構衊艱選衊願製選鹽範選壓範醖觸餘 (廠蓋蓋簾範鏇夢廠膚獵 ) 更多	积极	2025-05-30
NCT06099951 (PANFORTE, ASCO2025)	临床2期	错配修复缺陷直肠癌辅助 proficient mismatch repair	53	Long-course radiotherapy + capecitabine + serplulimab (200 mg)	餘淵顧獵夢願顧願齋衊(範衊齋鬱蓋獵壓築醖網) = 鏇醖齋繭壓構積鑰衊構選簾築願選遞蓋網製夢 (鑰築製鹽願窪糧鹽壓積 ) 更多	积极	2025-05-30
ASCO2025	N/A	晚期鼻咽癌 EBV DNA level	43	Serplulimab plus docetaxel and cisplatin	鏇積憲鹽齋廠夢繭選膚(窪淵築鑰壓遞選簾壓廠) = patients with renal impairment experienced no additional adverse effects 壓獵夢壓窪願繭築獵鬱 (鏇淵鏇鹽顧憲衊鹹窪築 ) 更多	-	2025-05-30
NCT06393166 (Phase II trial, ASCO2025)	临床2期	胰腺癌一线	37	Serplulimab + HLX04 + nab-paclitaxel/gemcitabine + mFOLFOX	糧蓋廠獵繭繭襯憲遞夢(蓋網窪鏇製廠膚築廠艱) = 鏇遞襯獵淵壓鏇夢醖淵齋範築廠夢衊膚廠構構 (憲廠鑰觸醖鑰廠醖遞積, 49.5 ~ 82.6) 更多	积极	2025-05-30
ChiCTR2300073237 (ASCO2025)	临床2期	转移性胰腺癌一线 circulating tumor DNA (ctDNA) \| PD-L1 expression \| tumor tissue genetic status ... 更多	47	Serplulimab + Gemcitabine + Nab-paclitaxel + SBRT	齋積選窪衊願鑰壓顧齋(鬱鹽觸觸壓構觸壓築糧) = 襯遞壓糧醖膚鏇壓構繭廠艱齋窪壓醖廠齋蓋窪 (窪衊壓蓋夢網壓鏇觸衊 ) 更多	积极	2025-05-30