A Single-arm, Open-label, Phase II Study to Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

开始日期2025-03-31

申办/合作机构

上海复宏汉霖生物技术股份有限公司

NCT06850103

/ Not yet recruiting临床2期IIT

A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases

Background and Significance:
Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.
Current Treatment Landscape:
The management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).
Treatment Evolution and Challenges:
While the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.
Innovative Approach:
Recent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable/proficient mismatch repair (MSS/pMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.
Research Objective:
This project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS/pMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.
Research Innovation:
The study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS/pMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.

开始日期2025-03-28

申办/合作机构

浙江大学医学院附属第一医院（浙江省第一医院）

NCT06860529

/ Not yet recruiting临床2期IIT

Serplulimab Combined with Chemotherapy for Early-stage HR+/HER2- Breast Cancer

The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.
The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer

开始日期2025-03-01

申办/合作机构

河南省肿瘤医院

100 项与斯鲁利单抗相关的临床结果

登录后查看更多信息

100 项与斯鲁利单抗相关的转化医学

登录后查看更多信息

100 项与斯鲁利单抗相关的专利（医药）

登录后查看更多信息

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.

2025-05-01·BMJ Open

Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol

Article

作者: Bi, Nan ; Deng, Lei ; Cao, Jianzhong ; Wang, Jianyang ; Duan, Jianchun ; Wu, Yuqi ; Zhou, Xiaohong ; Zhang, Tao

Introduction:

With the inspiring results of the PACIFIC trial in non-small-cell lung cancer (NSCLC), and the CAPIAN and IMpower133 trials in extensive-stage small-cell lung cancer (SCLC), immunotherapy has increasingly gained attention. Serplulimab, a PD-1 inhibitor, showed great antitumour activity in the ASTRUM-005 trial and has been recommended as first-line therapy in extensive-stage SCLC. Whether serplulimab following hypofractionation radiotherapy and chemotherapy could bring better outcomes in limited-stage SCLC remains to be answered.

Methods and analysis:

We designed a prospective multicentre single-arm phase II clinical trial to evaluate both the efficacy and safety of chemoradiotherapy and consolidation by serplulimab in limited-stage SCLC. Eligible patients will receive standard chemotherapy for four cycles and concurrent thoracic radiotherapy with a total dose of 45 Gy in 3 weeks and a 3 Gy dose per fraction. Prophylactic cranial irradiation is recommended for responding patients. Serplulimab will be delivered afterwards every 3 weeks for up to 1 year. Based on sample size estimation, 55 patients will be enrolled in total.

Ethics and dissemination:

Ethics approval was obtained from the Independent Ethics Committee of National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (22/236-3438).

Trial registration number:

NCT05443646 .

2025-02-01·INTERNATIONAL IMMUNOPHARMACOLOGY

Deep analysis of the trials and major challenges in the first-line treatment for patients with extensive-stage small cell lung cancer

Review

作者: Yin, Xiaoyan ; Zhuang, Lulu ; Wu, Peizhu ; Gao, Ran ; Meng, Xiangjiao

The median overall survival (OS) is approximately 10 months when chemotherapy alone is the first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). The approval of the two PD-L1 inhibitors, atezolizumab and durvalumab, marked the beginning of the immunotherapy era for ES-SCLC. Serplulimab, as the first PD-1 inhibitor to achieve success in the first-line treatment of ES-SCLC, has not only demonstrated significant improvements in patient survival outcomes but also ushered in a new era for PD-1 inhibitors in the treatment of ES-SCLC. Recently, antiangiogenic agents with chemo-immunotherapy have achieved breakthroughs in first-line ES-SCLC treatment. Improving the clinical benefits of individualized treatment for patients with ES-SCLC remains challenging. Challenges include identifying biomarkers for targeted therapy, exploring new treatments, developing new medicines, and classifying SCLC molecular subtypes. This review provides an in-depth analysis of research on first-line ES-SCLC treatment. Additionally, it discusses advances in ES-SCLC treatment.

721

项与斯鲁利单抗相关的新闻（医药）

2025-06-20

·复宏汉霖

复宏汉霖亮相BIO 2025：创新成果引关注

美国时间6月16 - 19日，2025美国生物技术大会暨展览会（2025 BIO International Convention, “BIO 2025”）在美国麻省波士顿会展中心（Boston Convention & Exhibition Center）举行。复宏汉霖连续第七年再次亮相此次大会，在1885展台为参会嘉宾带来精彩展示，吸引了众多参会者及组织机构前来参观交流。展会期间，复宏汉霖高效开展了约130场会面，聚焦创新产品、前沿技术平台及肿瘤免疫疗法等领域的合作机遇与潜在合作伙伴展开深入交流。左右滑动查看更多复宏汉霖高级副总裁兼首席商务发展官曹平女士在BIO主题演讲中强调：公司成立以来始终践行为患者提供高质量且可负担的创新药物的使命，全球累计惠及患者超80万例，实现从研发到商业化的价值闭环。复宏汉霖首席技术官、高级副总裁许圣昌博士聚焦复宏汉霖在AI辅助药物开发领域的突破性进展进行了介绍，印证了公司"创新-可及"双引擎发展路径的国际竞争力。此外，在公司协办的“BlOCHINA Global Forum 2025@Boston”中国生物药国际化论坛上，曹平女士与公司总裁黄玮女士携手全球合作伙伴Accord、Dr.Reddy's、Palleon、Organon、Sermonix，分享与中国生物制药企业合作的核心驱动力和战略考量，全面展示了公司的国际化合作布局，引发业界的高度聚焦与广泛赞誉，进一步增强了公司在全球生物医药市场的影响。左右滑动查看更多复宏汉霖以患者需求为根基，以创新为引擎，以全球化为驱动，依托前沿的生产与质量体系和卓越的商业化运营能力，致力于为全球患者提供可负担的高品质生物药。公司就汉曲优®（美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、汉利康®、HLX11、HLX14、HLX15等多个产品，携手Accord、Abbott、Dr.Reddy’s、Eurofarma、KGbio、Sandoz和Organon等国际一流的生物制药企业拓展全球市场，授权区域全面覆盖欧美主流生物药市场和众多新兴市场。汉曲优®是在中美欧三地皆获批的“中国籍”单抗生物类似药，现已在超过50个国家和地区获批上市，其商业化供货网络已覆盖中国、东南亚、北美、欧洲、中东及拉丁美洲等地区，惠及超过25万名患者。公司另一款抗肿瘤核心产品H药汉斯状®是全球首个获批用于一线治疗小细胞肺癌（SCLC）的抗PD-1单抗，已在中国、欧洲及东南亚等30余个国家和地区获批上市。同时，H药治疗SCLC也已获得美国FDA、欧盟EC、瑞士Swissmedic的孤儿药资格认定，并获韩国MFDS授予ES-SCLC孤儿药资格，有望惠及全球更广泛的肿瘤患者群体。与此同时，公司高效推进创新管线产品的临床进展，创新型抗HER2单抗HLX22的国际多中心III期研究同步于中国、澳大利亚、欧盟、日本、美国、南美洲等国家和地区开展。潜在同类首创/最优产品HLX43（PD-L1 ADC）的国际多中心II期临床研究于中国完成首例受试者给药，是全球首个进入临床II期的靶向PD-L1的ADC产品。未来，复宏汉霖将继续携手全球合作伙伴，通过创新与合作，为全球患者带来更多优质、可负担的治疗选择。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，5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 Shines at 2025 BIO International Convention, Showcasing Its Innovative AchievementsFrom June 16-19, 2025, the 2025 BIO International Convention (“BIO 2025”) was held at the Boston Convention & Exhibition Center in Boston, Massachusetts, USA. Marking its seventh consecutive year at the conference, Henlius showcased a wide range of innovative research and development accomplishments, attracting significant attention from numerous attendees and organizations. During the conference, Henlius held around 130 in-depth meetings, driving exchanges on collaboration opportunities for in-licensing, research collaboration, or commercial right out-licensing. Ping Cao, Henlius SVP and Chief Business Development Officer, emphasized in her BIO keynote: Henlius has delivered on its mission to provide high-quality and affordable biologics since inception, benefiting over 800,000 patients globally while achieving end-to-end value integration from R&D to commercialization. Simon Hsu, CTO and SVP of Henlius, highlighted breakthroughs in AI-driven drug development, demonstrating how Henlius' double engines of innovation and accessibility fuel its global competitiveness. Additionally, at the 'BIO CHINA Global Forum 2025@Boston' co-hosted by Henlius, the company's executives engaged in in-depth discussions with global partners Accord, Dr. Reddy's, Palleon, Organon, and Sermonix on strategic drivers for global partnerships with Chinese biopharma, showcasing our international footprint. The dialogue sparked significant industry attention and further amplified the company's global influence in the biologics market. Henlius anchors its strategy in unmet patient needs, powers progress through continuous innovation and advances its global presence with manufacturing and quality systems, as well as commercialization capabilities, delievering the goals of providing innovative and affordable biologics for global patients. The company has expanded its global market presence with several products, including HANQUYOU, HANSIZHUANG, HANLIKANG, HLX11, HLX14, and HLX15, in collaboration with renowned international biopharmaceutical companies such as Accord, Abbott, Dr.Reddy’s, Eurofarma, KGbio, Sandoz and Organon. It has achieved comprehensive coverage in the mainstream biopharmaceutical markets of Europe, the United States, and numerous emerging markets, contributing to the global development of China's biopharmaceutical innovation. Henlius’ self-developed and manufactured trastuzumab biosimilar HANQUYOU (trade name: HERCESSI™ in U.S. and Zercepac® in Europe) is a China-developed mAb biosimilar approved in China, Europe, and U.S. It has been approved in over 50 countries and regions, covering China, Southeast Asia, North America, the EU, Middle East, and Latin America, benefiting over 250,000 patients. Additionally, the company prides itself on its HANSIZHUANG (serplulimab, trade name: Hetronifly ® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC), and it has been approved in more than 30 countries and regions, including China, the EU, and Southeast Asia. To date, Orphan Drug Designation (ODD) granted to HANSIZHUANG for the treatment of SCLC by U.S. FDA, EC, and Swissmedic, and for Extensive-Stage SCLC (ES-SCLC) by Korea MFDS. Meanwhile, the company is efficiently advancing the clinical progress of its innovative product portfolio. The phase 3 international multicentre clinical trails of Henlius' novel anti-HER2 mAb, HLX22, is being conducted simultaneously across China, Australia, the European Union, Japan, the United States, South America, and other countries and regions. Recently, the first subject has been dosed for a phase 2 international muticenter clinical trial of HLX43（PD-L1 ADC）, another company’s potential first/best-in-class products. At present, HLX43 is the first PD-L1 ADC progressed to phase 2 clinical trial development globally. Looking forward, Henlius will continue to collaborate closely with global partners, leveraging innovation and cooperation, to deliver more high-quality, affordable treatment options to patients worldwide.About HenliusHenlius (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 5 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

免疫疗法疫苗临床3期孤儿药

2025-06-19

·复宏汉霖

AI for Science | AS权威发表，复宏汉霖技术运营团队携手复旦大学黄强教授课题组成功设计高稳定性VHH-Fc抗体

近日，复宏汉霖技术运营团队与复旦大学黄强教授课题组在抗肿瘤治疗领域取得了重要进展。双方针对抗肿瘤治疗用VHH-Fc抗体(VFA01)，开发了一套基于计算机模拟（in silico）的综合分析流程，利用人工智能（AI）技术系统评估其蛋白稳定性，并结合实验验证，成功设计出稳定性显著提升的新变体。该成果发表于国际知名期刊Advanced Science上。纳米抗体(Nanobody，即重链单域抗体VHH)因其具有分子量小(约15kDa)、亲和力强、溶解性高和生产成本低等特性，已成为大分子创新药物研发的新兴方向。为延长VHH在血液中的半衰期，通常把VHH与全长抗体的Fc片段融合，构建VHH-Fc抗体。然而，VHH-Fc抗体常常存在蛋白质稳定性缺陷，导致药物制剂聚集或降解，从而引发安全性问题，这已成为制约VHH-Fc药物成功上市的主要障碍。目前VHH-Fc抗体开发领域缺乏系统性评估蛋白稳定性的方法，使得抗体分子难以实现精准优化，严重阻碍了其临床转化和产业化进程。因此，开发精确的VHH-Fc抗体优化方法具有重要的意义。研究团队通过同源建模和分子动力学模拟构建了VFA01的动态三维结构模型，为后续稳定性分析奠定结构基础。随后，采用计算分析方法全面评估了VFA01的构象稳定性、二硫键还原状态以及聚集和降解倾向，准确识别出影响稳定性的关键氨基酸位点。这一过程在以往研究中常被忽视或仅能通过实验手段粗略评估。通过进一步的结合肽图分析，研究人员确认了五个关键稳定性热点氨基酸：C130、F57、Y106、L120和W111。基于这些发现，研究团队对VFA01进行了系列变体设计，最终获得经实验验证的高稳定性变体M11(C130S/W111F/F57K)。与原抗体VFA01相比，变体M11的稳定性显著提升：亚微米级蛋白颗粒的聚集速率降低了6.2倍，100nm及以下蛋白颗粒的聚集速率降低了3.4倍，蛋白裂解速率降低了1.5倍；而且，M11的抗原结合亲和力和蛋白质产量均提升了1.5倍。因此，该研究为VHH-Fc类融合抗体的开发提供了一条有效的稳定性优化途径。长期以来，复宏汉霖高度重视创新技术的战略布局，自2020年起，公司技术运营团队率先布局AI for Science平台建设，通过计算机模拟和预测（in silico）等前沿技术与丰富的试验数据相结合，构建了覆盖药物结构建模、分子评估和设计、工艺开发等关键流程的AI辅助研发体系，显著提升了产品的研发效率。基于自主搭建的模拟计算平台HAI PBD，复宏汉霖成功开发出具有自主知识产权的新一代透明质酸酶Henozye™。该产品较传统方法大幅缩短开发周期，可以适配多种不同种类的蛋白分子，在单抗、双抗、多抗及ADC分子中均体现出良好的相容性，在各类缓冲体系和环境条件下均展现出卓越的稳定性，显著拓宽应用场景并极大提高了共制剂开发的成功率。除透明质酸酶外，公司还成功建立起基于AI+技术的处方开发平台，高浓度制剂处方开发平台，含有不同类型透明质酸酶的共制剂开发平台等，有望持续拓展皮下给药技术的应用边界，为更多新剂型的开发来带关键技术支撑。与此同时，聚焦抗体药物的虚拟生成、AI筛选和优化，复宏汉霖正着力构建一站式AI赋能的抗体药物早期研发平台HAI Club，形成De Novo抗体生成与验证闭环，以打通从分子设计、改造、评估到工艺开发及生产过程控制的药物开发全流程，不断提升创新研发的转化效率与成功率。关于 Advanced ScienceAdvanced Science（AS）是 Wiley旗舰期刊 Advanced 系列中的一种完全开放获取的跨学科科学期刊，发表材料科学、物理、化学、医学、生命科学、环境科学、工程和社会科学等领域的前沿基础和应用研究。期刊致力于通过开放获取出版，使前沿创新的科学研究具有更广泛的可访问性。Wiley 的 Advanced 系列是全球公认的高影响力期刊家族，传播来自资深和青年研究人员的科学成果，帮助他们实现使命并扩大科学发现的影响力。Advanced Science最新的影响因子（JIF）为14.3，五年平均影响因子为16.3，JCI引文指标为2.07，CiteScore为18.9。在2025年中国科学院院文献情报中心期刊分区表中，Advanced Science入选综合类期刊一区TOP。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，5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

2025-06-17

·复宏汉霖

医企协作，创新共赢 | 复宏汉霖与上海市胸科医院达成战略合作

今日，复宏汉霖（2696.HK）与上海市胸科医院签署战略合作协议，双方将在临床研究、人才培养和公益事业等领域展开深度合作，整合各自优势资源，共同推动生物医药行业的高质量发展。上海胸科医院院长侯旭敏教授、副院长孙加源教授，复宏汉霖执行董事、首席执行官朱俊先生，复宏汉霖首席科学官袁纪军先生、免疫肿瘤事业部副总裁杨明先生等出席了战略合作签约仪式。复宏汉霖执行董事、首席执行官朱俊先生表示复宏汉霖始终坚持‘以患者为中心’的理念。此次与上海市胸科医院达成战略合作，双方将聚焦转化医学研究、临床医学人才建设、医疗公益事业等方面，通过医企协同创新，提升我国胸部肿瘤等疾病领域的诊疗水平，让更多患者受益，为医药产业高质量发展注入新动能。上海市胸科医院院长侯旭敏教授表示上海市胸科医院始终重视临床研究与科研转化。此次与复宏汉霖的战略合作，将充分发挥双方技术、行业和专业的资源优势互补，共同推进创新药物的临床研究与转化应用，同时提升医学人才培养质量，并开展系列公益项目，切实履行公立医院的社会责任，助力健康中国建设。复宏汉霖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。自2010年成立以来，公司成功构建覆盖研发、生产及商业化的一体化生物制药平台，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。截至目前，公司已有6款产品在中国获批上市，4款产品在国际获批上市。通过自主研发与外部合作，复宏汉霖持续布局多抗、ADC等前沿技术领域，打造具有差异化优势的创新药物和多元化产品管线，更好地满足全球患者需求。上海市胸科医院创建于1957年，为我国最早建立的集医疗、教学、科研为一体的，以诊治心胸疾病为主的三级甲等专科医院。医院聚焦胸部肿瘤与心血管疾病两大学科群，掌握国内疾病谱最广、门类最全的心胸疾病诊治技术。上海市胸科医院始终致力于提高临床研究型医院建设水平，科教研人才厚度持续提升，为实现医院跨越式发展注入源源不断的科研动能。未来，复宏汉霖将继续积极携手多元合作伙伴，充分发挥产学研医结合的创新力量，提高创新研发效率，加速科研成果转化，促进医药卫生领域高质量发展，让更多高质量、可负担的创新治疗方案惠及全球更多患者。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，5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

抗体药物偶联物上市批准IPO

100 项与斯鲁利单抗相关的药物交易

登录后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


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	願遞鬱鬱壓鬱簾網觸顧(衊鬱齋夢顧積艱鏇簾餘) = 膚遞鬱醖築鏇築築膚鏇觸獵鏇遞淵廠艱鏇艱窪 (鬱餘選膚鹹壓鹹選廠選 ) 更多	积极	2025-05-30
				Placebo plus chemotherapy	願遞鬱鬱壓鬱簾網觸顧(衊鬱齋夢顧積艱鏇簾餘) = 餘鏇鏇壓築蓋襯壓簾鑰觸獵鏇遞淵廠艱鏇艱窪 (鬱餘選膚鹹壓鹹選廠選 ) 更多
NCT03468751 (Phase 1 study of fixed-dose regimens of serplulimab, ASCO2025)	临床1期	晚期恶性实体瘤	37	Serplulimab 200 mg Q2W	鬱蓋積願衊膚構廠簾構(壓齋衊壓壓簾簾鹹遞襯) = Treatment-related adverse events (TRAEs) were observed in 19 patients (51.4%), including 7 (18.9%) reporting grade ≥ 3 TRAE 窪築製衊憲築憲繭艱簾 (積鏇膚網觸鹽繭網選構 )	积极	2025-05-30
				Serplulimab 300 mg Q3W
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)	簾網鹹觸壓窪獵繭膚製(鹽鏇網獵選鑰憲醖範餘) = 壓鑰構蓋獵鑰願鑰觸築積顧鬱廠襯鹹膚廠淵獵 (蓋廠齋獵淵淵鏇膚餘鹹 ) 更多	积极	2025-05-30
				Long-course radiotherapy + capecitabine + serplulimab (200 mg)	鹽簾壓鏇積鑰構範憲鹽(鬱窪範衊選鏇鏇願鏇窪) = 醖夢憲齋鹽顧積廠淵築憲衊鬱襯膚網製廠淵糧 (鹽製鏇遞鹹壓艱蓋餘膚 ) 更多
NCT06393166 (Phase II trial, ASCO2025)	临床2期	胰腺癌一线	37	Serplulimab + HLX04 + nab-paclitaxel/gemcitabine + mFOLFOX	壓餘壓鬱衊衊顧夢夢繭(糧廠襯蓋範醖窪範艱簾) = 製築窪顧襯鹹膚廠艱範艱構鑰鬱鑰顧齋構簾網 (餘鑰艱蓋製膚簾範蓋廠, 49.5 ~ 82.6) 更多	积极	2025-05-30
NEWS 人工标引	N/A	胃癌新辅助	30	斯鲁利单抗+SOX+胸腺法新 (A组（12例仍在接受新辅助治疗）、B组（7例已完成新辅助治疗，等待手术中）和C组（11例已完成手术治疗）)	網餘餘積製願遞遞壓鹽(獵願壓鏇襯繭鹽構築觸) = 簾鬱鹹壓襯積壓網築鹽廠選積築衊遞顧觸艱壓 (艱衊壓餘膚廠簾遞構網 ) 更多	积极	2025-05-09
NEWS 人工标引	临床2期	胃食管交界处腺癌	24	第一周期新辅助斯鲁利单抗 300 mg + SOX方案；二、三周期采用斯鲁利单抗联合同步放化疗	選糧餘淵製觸築淵鹹構(憲願窪壓艱範願獵蓋窪) = 餘網範獵醖餘選衊繭鹹糧廠顧襯願醖積餘顧窪 (壓壓窪鏇獵選醖蓋鬱壓 ) 更多	积极	2025-05-09
ESMO_TAT2025	N/A	小细胞肺癌	39	Serplulimab plus chemotherapy	餘獵鬱鹹遞築製壓艱餘(夢網網襯壓窪範選鏇網) = 齋繭網鬱築鏇觸衊鑰觸願觸鹽廠願糧窪繭壓鬱 (願網鹽網鹽製憲夢鹽簾, 3.1 ~ 7.2) 更多	积极	2025-03-03
				Second-line serplulimab plus chemotherapy	餘獵鬱鹹遞築製壓艱餘(夢網網襯壓窪範選鏇網) = 鹽夢襯衊鏇廠簾網鹹壓願觸鹽廠願糧窪繭壓鬱 (願網鹽網鹽製憲夢鹽簾, 6.9 ~ NR)
NCT05831891 (ASCO_GU2025) 人工标引	临床2期	肾细胞癌一线	16	Fruquintinib+serplulimab	獵顧襯窪齋壓獵網簾艱(繭範襯觸窪壓簾壓鏇觸) = not reached 製鏇遞鏇鏇選網鏇鬱構 (顧醖鑰鑰齋鏇淵顧膚夢 ) 更多	积极	2025-02-13
NCT04547166 (ASCO_GI2025) 人工标引	临床2/3期	转移性结直肠癌一线 Microsatellite Stable (MSS) \| PD-L1	112	Serplulimab + Bevacizumab + XELOX	築襯遞選壓鏇鹽窪鹽鹽(襯簾壓築鬱範鏇選糧夢) = 糧糧齋餘糧網顧積齋顧醖積製鹹範範網觸壓憲 (膚淵廠窪鏇簾壓餘願壓 ) 更多	积极	2025-01-23
				Placebo + Bevacizumab + XELOX	築襯遞選壓鏇鹽窪鹽鹽(襯簾壓築鬱範鏇選糧夢) = 鬱願獵獵艱齋憲觸簾積醖積製鹹範範網觸壓憲 (膚淵廠窪鏇簾壓餘願壓 ) 更多
NCT03973112 (Pubmed \| Cancer Immunol Immunother) 人工标引	临床2期	晚期肝细胞癌一线	61	Serplulimab 3 mg/kg + HLX04HLX04 10 mg/kg	製艱鑰網憲襯鬱鑰遞壓(廠網鑰蓋觸顧製築選餘) = 夢觸餘齋窪壓鹹築憲齋壓衊鹹鏇醖積壓糧鹽網 (膚襯醖窪蓋鬱遞獵繭齋, 18.1 ~ 42.7) 更多	积极	2025-01-03