斯鲁利单抗(Serplulimab) - 药物靶点：PD-1_在研适应症：食管鳞状细胞癌，ES-SCLC，鳞状非小细胞肺癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-PD-1 monoclonal antibody(Henlix Biotech)、Anti-PD-I mAb(Henlix Biotech)、HANSIZHUANG

+ [7]

靶点

PD-1

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

癌症消化系统疾病呼吸系统疾病+ [9]

在研适应症

食管鳞状细胞癌ES-SCLC鳞状非小细胞肺癌+ [25]

非在研适应症

晚期宫颈癌晚期肝细胞癌头颈部鳞状细胞癌

原研机构

汉霖生技股份有限公司

上海复宏汉霖生物技术股份有限公司

在研机构

PT Kalbio Global Medika上海复宏汉霖生物制药有限公司

上海复宏汉霖生物技术股份有限公司

+ [4]

非在研机构

Henlix, Inc.

最高研发阶段批准上市

首次获批日期

中国 (2022-03-22),

晚期胃癌结直肠癌MSI-H 实体瘤

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、附条件批准 (中国)

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序列信息

Sequence Code 431576801L

来源: *****

Sequence Code 431576802H

来源: *****

关联

114

项与斯鲁利单抗相关的临床试验

NCT06554535 / Not yet recruiting临床2期IIT

A Single-center, Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Platinum-based Chemotherapy and Bayer Aspirin in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.

Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Although platinum-based chemotherapy is the standard first-line treatment, median survival remains under one year, highlighting the need for improved outcomes. Recent studies have demonstrated that combining PD-1 inhibitors with chemotherapy can significantly improve survival in ES-SCLC patients. Serplulimab, a novel PD-1 inhibitor, has shown promising results in extending overall survival when combined with chemotherapy in a Phase III trial. Additionally, aspirin has been found to enhance the anti-tumor effects of immunotherapy by inhibiting immune checkpoint proteins and reducing adverse events such as thrombosis and fever. This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for patients with ES-SCLC.

开始日期2024-10-01

申办/合作机构

重庆市大坪医院

NCT06576921 / Not yet recruiting临床2期IIT

Efficacy and Safety of Serplulimab Combined With Nab-paclitaxel and SOX as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction: A Multicenter Randomized Controlled Trial

This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG.
The goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are:
Does serlulimab increase the pCR of participants with locally advanced AEG/GC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC.
Participants will:
Eligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg/m2 intravenously on days 1, OXA 130mg/ /m2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.

开始日期2024-09-01

申办/合作机构

西京医院第四军医大学

NCT06531291 / Not yet recruiting临床2期IIT

Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study

Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

开始日期2024-08-10

申办/合作机构

上海交通大学医学院附属仁济医院

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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388

项与斯鲁利单抗相关的文献（医药）

2024-04-01·Future oncology (London, England)

Nivolumab in unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma

Review

作者: Ikeda, Go ; Miyakoshi, Jun ; Kato, Ken ; Yamamoto, Shun

Esophageal cancer (EC) is the eighth most common cancer worldwide. In view of biology and anatomical restrictions, multimodality treatment strategies have been developed for EC. However, the prognosis of patients with advanced EC remains especially poor. Immunotherapy, such as PD-1/PD-L1 and CTLA-4/B7 blockade, has emerged as a potent treatment for many types of cancer and has been approved in many countries. Based on the results of the ATTRACTION-3 trial, nivolumab, an anti-PD-1 monoclonal antibody, was approved by the US FDA for patients with platinum-resistant, unresectable, recurrent or metastatic esophageal squamous cell carcinoma. The CheckMate 648 trial demonstrated that the combination of nivolumab with platinum-based fluoropyrimidine chemotherapy and combination immunotherapy with nivolumab and ipilimumab, an anti-CTLA-4 monoclonal antibody, showed a survival benefit in patients with advanced esophageal squamous cell carcinoma compared with doublet chemotherapy. This review focuses on nivolumab-containing treatments for patients with advanced esophageal squamous cell carcinoma.

2024-02-01·Cancer cell

A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004)

Article

作者: Luo, Feng ; Shi, Jianhua ; Pan, Yueyin ; Xu, Fei ; Cheng, Ying ; Kilickap, Saadettin ; Chen, Zhendong ; Zhu, Jun ; Zang, Aimin ; Kang, Wenying ; Lu, Ping ; Viguro, Maksym ; Wu, Lin ; Hu, Yanping ; Zhou, Caicun ; Makharadze, Tamta ; Sun, Hongmei ; Li, Jing ; Arkania, Ekaterine ; Yu, Haoyu ; Zhang, Ling ; Kuchava, Vladimer ; Wang, Qingyu ; Jia, Zhongyao ; Ying, Kejing ; Wang, Xiang

Combining immunotherapy with chemotherapy can provide improved survival in advanced squamous non-small-cell lung cancer (NSCLC) patients without targetable gene alterations. 537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC without targetable gene alterations were enrolled and randomized (2:1) to receive serplulimab 4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenously in 3-week cycles. The primary endpoint of progression-free survival (PFS) was met at the first interim analysis. At the second interim analysis, PFS benefit was maintained in serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.42-0.67). At the final analysis, serplulimab-chemotherapy significantly improved median OS compared to placebo-chemotherapy (HR 0.73, 95% CI 0.58-0.93; p = 0.010). Grade ≥3 serplulimab or placebo-related adverse events occurred in 126 (35.2%) and 58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimab to chemotherapy significantly improves survival in advanced squamous NSCLC patients, with manageable safety.

2023-12-31·mAbs

Development and pharmacokinetic assessment of a fully canine anti-PD-1 monoclonal antibody for comparative translational research in dogs with spontaneous tumors

Article

作者: Brillantes, Marc ; Siegel, Don L ; Gulendran, Gayathri ; Yoshimoto, Sho ; Xiong, Ailian ; Mason, Nicola J ; Chester, Nicholas ; Radaelli, Enrico ; Wang, Hong ; Glassman, Patrick

PD-1 checkpoint inhibitors have revolutionized the treatment of patients with different cancer histologies including melanoma, renal cell carcinoma, and non-small cell lung carcinoma. However, only a subset of patients show a dramatic clinical response to treatment. Despite intense biomarker discovery efforts, no single robust, prognostic correlation has emerged as a valid outcome predictor. Immune competent, pet dogs develop spontaneous tumors that share similar features to human cancers including chromosome aberrations, molecular subtypes, immune signatures, tumor heterogeneity, metastatic behavior, and chemotherapeutic response. As such, they represent a valuable parallel patient population in which to investigate predictive biomarkers of checkpoint inhibition. However, the lack of a validated, non-immunogenic, canine anti-PD-1 antibody for pre-clinical use hinders this comparative approach and prevents potential clinical benefits of PD-1 blockade being realized in the veterinary clinic. To address this, fully canine single-chain variable fragments (scFvs) that bind canine (c)PD-1 were isolated from a comprehensive canine scFv phage display library. Lead candidates were identified that bound with high affinity to cPD-1 and inhibited its interaction with canine PD-L1 (cPD-L1). The lead scFv candidate re-formatted into a fully canine IgG_D reversed the inhibitory effects of cPD-1:cPD-L1 interaction on canine chimeric antigen receptor (CAR) T cell function. In vivo administration showed no toxicity and revealed favorable pharmacokinetics for a reasonable dosing schedule. These results pave the way for clinical trials with anti-cPD-1 in canine cancer patients to investigate predictive biomarkers and combination regimens to inform human clinical trials and bring a promising checkpoint inhibitor into the veterinary armamentarium.

790

项与斯鲁利单抗相关的新闻（医药）

2024-09-13

·BioSpace

Roche Gains PD-1 Edge on Merck With FDA Nod for Subcutaneous Tecentriq

iStock, olli0815 Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy. The FDA on Friday signed off on the subcutaneous formulation of Roche ’s PD-1 blocker Tecentriq—which will carry the brand name Tecentriq Hybriza (atezolizumab and hyaluronidase-tqjs) to differentiate itself from the intravenous version—for the treatment of various cancers. According to Roche, Tecentriq Hybriza is the first and only PD-(L)1 blocker approved for subcutaneous use in the U.S. Tecentriq Hybriza is indicated for all cancers that its intravenous formulation is, including several different types of skin, liver, lung and soft-tissue cancers. Roche CMO Levi Garraway in a statement said that the approval of Tecentriq Hybriza “builds on the established safety and efficacy of intravenous Tecentriq.” The subcutaneous formulation “can treat patients faster and in more accessible settings” and “offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Garraway said. To enable subcutaneous administration, Tecentriq Hybriza leverages Halozyme Therapeutics’ Enhanze technology , which uses its patented recombinant hyaluronidase PH20 enzyme, which digests hyaluronan proteins beneath the skin to improve fluid flow in the subcutaneous space. In turn, this effect allows large volumes of fluids to be injected under the skin, while also boosting its dispersion and absorption. Through this technology, Tecentriq Hybriza takes approximately seven minutes to be administered, while an intravenous infusion of Tecentriq usually takes 30 minutes to 60 minutes. In the Phase Ib/III IMscin001 study, a subcutaneous injection of Tecentriq reached comparable levels of the drug in the blood as its intravenous formulation, with similar safety and efficacy pro Roche also included results from the Phase II IMscin002 study in its application, highlighting that 71% of patients preferred the Hybriza formulation versus intravenous treatment. Convenience—including less time in the clinic, comfort and lower emotional distress—was the most common reason for this preference. With Friday’s approval, Roche carves out a niche for its PD-1 inhibitor in a market dominated by Merck’s Keytruda (pembrolizumab). In 2023, Tecentriq generated approximately $4.45 billion , while Keytruda easily retained its PD-1 leadership with more than $25 billion in revenue. Roche has struggled to keep up with Keytruda in cancer, with a late-stage defeat in July 2024. Results from the Phase II/III SKYSCRAPER-06 showed that Tecentriq plus an investigational anti-TIGIT antibody tiragolumab had reduced efficacy in terms of progression-free survival, compared with Keytruda plus chemotherapy. The trial, which was testing Roche’s investigational regimen for the first-line treatment of non-small cell lung cancer, has since been discontinued. Merck is hot on Roche’s heels with a subcutaneous formulation of Keytruda in a Phase III study , which is scheduled for completion in late 2026.

临床结果临床3期临床2期上市批准免疫疗法

2024-09-12

·PRNewswire

HotSpot Therapeutics Presents First-in-Human Phase 1 Clinical Data on its Novel CBL-B Inhibitor, HST-1011, at ESMO Congress 2024

HST-1011 showed an encouraging early clinical profile demonstrating important linkages between exposure, target engagement, pharmacodynamics and initial signs of clinical activity, along with a generally manageable safety profile, in heavily pre-treated patients with advanced solid tumors Data represent the most comprehensive disclosure of clinical experience with a CBL-B inhibitor to date BOSTON, Sept. 12, 2024 /PRNewswire/ -- HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," today announced the presentation of initial clinical data for HST-1011, an investigational oral, selective inhibitor of Casitas B-lineage lymphoma proto-oncogene (CBL-B). Data from the Phase 1 monotherapy dose escalation portion of the study are being shared in a proffered oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024. "These initial data provide the first comprehensive insight into the clinical experience with a CBL-B inhibitor, a novel immuno-oncology mechanism with the potential to meaningfully transform the treatment paradigm for patients with solid tumors," said Timothy Reilly, Ph.D., Chief Development Officer of HotSpot. "Critically, HST-1011 demonstrated important linkages between drug exposures, target engagement, and proximal and distal measures of pharmacology, and we observed initial signs of clinical benefit, in a heavily pre-treated, advanced solid tumor patient population. We believe these data provide a strong foundation for the continued evaluation of HST-1011 in dedicated patient populations and for the further assessment of HST-1011 in combination with a PD-1 inhibitor, cemiplimab." The Phase 1/2 study of HST-1011 (NCT05662397) is an open-label clinical study designed to evaluate HST-1011 alone and subsequently in combination with Regeneron's anti-PD-1 therapy, Libtayo® (cemiplimab), in adult patients with advanced solid tumors that are relapsed on or are refractory to anti-PD(L)-1 or standard of care therapies. The results being presented at ESMO include data from 28 patients in the monotherapy dose escalation portion of the study. The presentation describes the following data: Patients had a diverse range of solid tumor types and were heavily pre-treated, with a median of four prior lines of therapy, including 89% who had been treated previously with immunotherapy. HST-1011 was generally well tolerated across a range of twice-weekly doses, with no dose-limiting toxicities. The most frequent adverse events were gastrointestinal in nature, which were generally mitigated by the adoption of a prophylactic pre-treatment regimen. Encouraging linkages were observed between pharmacokinetics (PK), target engagement, pharmacodynamics (PD) and initial signals of clinical activity. Despite the heavily pre-treated, advanced cancer patient population, indications of clinical benefit, including tumor stasis or shrinkage, were observed in 10 of the 28 patients across a range of tumor types and dose levels. These encouraging data provide support for the ongoing evaluation of HST-1011 (NCT05662397). Presentation details are as follows: Title: First-in-Human (FIH) Phase 1 Data of HST-1011, an Oral CBL-B Inhibitor, in Patients with Advanced Solid Tumors Speaker: Rachel E. Sanborn, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR Session Name: Proffered Paper session: Investigational immunotherapy Session Date and Time: Fri., Sep. 13, 2024, 16:00-17:30 CEST Presentation Time: 16:50-17:00 CEST Location: Burgos Auditorium – Hall 5, Fira Barcelona Gran Via Presentation Number: 991O About HotSpot Therapeutics, Inc. HotSpot Therapeutics, Inc. is a clinical-stage biotechnology company that is pioneering a new class of allosteric drugs that target certain naturally occurring pockets on proteins called "natural hotspots." These pockets are decisive in controlling a protein's cellular function and have significant potential for new drug discovery by enabling the systematic design of potent and selective small molecules with novel pharmacology. The Company's proprietary Smart Allostery™ platform combines computational approaches and AI-driven data mining of large and diverse data sets to uncover hotspots with tailored pharmacology toolkits and bespoke chemistry to drive the rapid discovery of novel hotspot-targeted small molecules. Leveraging this approach, HotSpot is building a broad pipeline of novel allosteric therapies for the treatment of cancer and autoimmune diseases. To learn more, visit . Investor & Media Contact: Natalie Wildenradt [email protected] SOURCE HotSpot Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期免疫疗法临床结果ASCO会议

2024-09-12

·复星医药

2024 CSCO | 复宏汉霖H药汉斯状多项研究入选

2024年9月25日至29日，第27届全国临床肿瘤学大会暨2024年CSCO学术年会将在厦门举办。复宏汉霖抗PD-1单抗H药汉斯状®（斯鲁利单抗）多项最新研究结果将在本次大会上发布，广泛覆盖肺癌、消化道肿瘤领域的治疗进展与前沿探索。其中，H药一线治疗鳞状非小细胞肺癌（sqNSCLC）III期临床研究（ASTRUM-004）的中国亚组数据、H药一线治疗广泛期小细胞肺癌（ES-SCLC）III期临床研究（ASTRUM-005）的亚洲人群数据以及H药联合贝伐珠单抗和化疗一线治疗转移性结直肠癌（mCRC）II期/III期临床研究（ASTRUM-015）的II期数据将以口头报告形式在本次大会上发布。 H药为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。目前，H药已在中国获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、sqNSCLC、ES-SCLC和食管鳞状细胞癌（ESCC），惠及患者约8万人。以临床需求为导向，公司就H药进行了差异化、多维度布局，广泛覆盖肺癌、消化道肿瘤等高发大癌种，在全球范围内累计入组逾4000名受试者。肺癌领域 ASTRUM-004：斯鲁利单抗联合化疗一线治疗晚期鳞状非小细胞肺癌的III期研究中国亚组数据牵头主要研究者：周彩存上海市东方医院汇报人：熊安稳上海市东方医院报告场次：非小细胞肺癌免疫治疗专场口头报告报告时间：2024年9月26日下午17:05-17:10 ASTRUM-005：斯鲁利单抗或安慰剂联合化疗一线治疗广泛期小细胞肺癌的国际多中心、随机、双盲III期研究亚洲人群数据牵头主要研究者：程颖，吉林省肿瘤医院汇报人：张爽吉林省肿瘤医院报告场次：小细胞肺癌专场2 口头报告报告时间：2024年9月28日上午11:10-11:20 消化道肿瘤领域斯鲁利单抗联合HLX04和XELOX对比安慰剂联合贝伐珠单抗和XELOX一线治疗转移性结直肠癌：一项II/III期研究牵头主要研究者&汇报人：徐瑞华中山大学肿瘤防治中心报告场次：结直肠癌专场2 口头报告报告时间：2024年9月28日下午15:31-15:39 斯鲁利单抗联合瑞戈非尼和肝动脉灌注碳酸氢盐三线治疗晚期肠癌肝转移患者: 一项单中心、单臂II期临床研究方案牵头主要研究者：袁瑛浙江大学医学院附属第二医院展示形式：壁报交流关于H药汉斯状® H药汉斯状®为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国和印度尼西亚获批上市。截至目前，H药已有4项适应症获批上市，2项适应症上市申请分别在中国和欧盟获受理，10余项临床试验同步在全球开展。 2022年3月，H药正式于中国获批上市，目前可用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）及食管鳞状细胞癌（ESCC）。H药联合化疗一线治疗非鳞状非小细胞肺癌（nsNSCLC）和一线治疗广泛期小细胞肺癌（ES-SCLC）的上市申请也分别获得中国NMPA和欧盟EMA受理。聚焦肺癌和消化道肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，在全球同步开展10余项肿瘤免疫联合疗法临床试验，于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超4000人。H药的4项关键性临床研究结果分别发表于知名期刊《美国医学会杂志》（JAMA）、《自然-医学》（Nature Medicine）、Cancer Cell和British Journal of Cancer。此外，H药还荣获《CSCO 小细胞肺癌诊疗指南》、《CSCO非小细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO结直肠癌诊疗指南》、《CSCO免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。海外方面，H药治疗SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国启动了一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。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，3款产品在国际获批上市，24项适应症获批，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50多个分子，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）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16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。

CSCO会议临床3期上市批准临床2期临床结果

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
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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
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
食管鳞状细胞癌	中国	上海复宏汉霖生物技术股份有限公司	2023-09-19
ES-SCLC	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	上海复宏汉霖生物技术股份有限公司	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
非鳞状非小细胞肺癌	申请上市	中国	上海复宏汉霖生物制药有限公司	2023-12-12
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
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	2022-05-11
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	2022-05-11
小细胞肺癌	临床3期	澳大利亚	上海复宏汉霖生物技术股份有限公司	2022-05-11
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	2022-05-11
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	2022-05-11

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临床结果

适应症

分期

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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


NCT04033354 (ASTRUM-004, ESMO2024)	临床3期	鳞状非小细胞肺癌一线 TP53 \| LRP1B \| KMT2D ... 更多	537	Serplulimab plus chemotherapy	構構壓鹹獵顧願鹹齋衊(築衊積窪夢膚遞獵範顧) = 構網鑰壓壓鏇範鏇夢衊範壓積膚壓膚壓鑰鏇膚 (糧憲淵製齋艱鹹鑰選膚 )	积极	2024-09-15
				Placebo plus chemotherapy	構構壓鹹獵顧願鹹齋衊(築衊積窪夢膚遞獵範顧) = 獵鹽築鏇衊遞齋鹽選壓範壓積膚壓膚壓鑰鏇膚 (糧憲淵製齋艱鹹鑰選膚 )
ESMO2024	N/A	ES-SCLC	-	Serplulimab	網獵糧築鬱範鏇蓋衊衊(壓憲壓鹹鹹襯艱範壓網) = 製獵鬱顧淵醖鏇積廠築餘齋餘積壓夢襯夢艱襯 (衊鑰觸範製選窪網積糧 ) 更多	-	2024-09-14
				Chemotherapy	網獵糧築鬱範鏇蓋衊衊(壓憲壓鹹鹹襯艱範壓網) = 鹹窪積夢鹹餘壓願繭築餘齋餘積壓夢襯夢艱襯 (衊鑰觸範製選窪網積糧 ) 更多
NCT04063163 (ASTRUM-005, WCLC2024) 人工标引	临床3期	ES-SCLC 一线	538	Serplulimab combined with chemotherapy	衊衊齋鑰鬱襯膚糧築憲(範選鏇糧壓齋窪齋製選) = 餘醖壓範選顧鏇獵夢遞鏇鹽糧顧範願獵膚蓋鹽 (鹽簾顧齋夢壓鬱衊襯鏇 ) 更多	积极	2024-09-08
				Serplulimab combined with chemotherapy (the Asian)	衊衊齋鑰鬱襯膚糧築憲(範選鏇糧壓齋窪齋製選) = 簾積築憲網觸壓遞築選鏇鹽糧顧範願獵膚蓋鹽 (鹽簾顧齋夢壓鬱衊襯鏇 ) 更多
NCT04547166 (Literature) 人工标引	临床2/3期	转移性结直肠癌一线	114	Serplulimab plus HLX04 and XELOX	繭鹽膚範壓鑰窪夢積遞(觸夢夢齋鏇醖範觸顧鏇) = 蓋醖觸觸築膚鬱鹹膚蓋鹽鑰膚鏇願鹹窪襯選鹹 (鏇遞蓋積觸衊積範窪鹹 ) 更多	积极	2024-07-24
				Placebo plus bevacizumab and XELOX	繭鹽膚範壓鑰窪夢積遞(觸夢夢齋鏇醖範觸顧鏇) = 願壓鑰窪構膚鬱窪壓觸鹽鑰膚鏇願鹹窪襯選鹹 (鏇遞蓋積觸衊積範窪鹹 ) 更多
NCT04547166 (Phase 2/3 trial, Pubmed)	临床2期	转移性结直肠癌一线 pMMR \| MSS	114	Serplulimab + HLX04 + XELOX	製鑰範鬱鏇淵壓鹹齋壓(鏇積壓窪觸築廠夢壓遞) = 鹹鑰鏇築顧願襯醖糧壓獵憲夢獵襯夢觸範壓遞 (繭鹹糧餘艱窪顧製築餘 )	积极	2024-06-09
				Placebo + Bevacizumab + XELOX	製鑰範鬱鏇淵壓鹹齋壓(鏇積壓窪觸築廠夢壓遞) = 齋顧艱範醖衊餘憲積繭獵憲夢獵襯夢觸範壓遞 (繭鹹糧餘艱窪顧製築餘 )
ASCO2024 人工标引	N/A	食管癌一线	57	serplulimab combined with chemotherapy	構鬱積獵鏇襯構構廠遞(構襯願壓鹽願遞壓夢鑰) = 觸構餘網顧艱製範鹽鹽醖窪憲鏇獵繭鏇廠膚鏇 (鑰積衊憲餘膚選窪齋構 ) 更多	积极	2024-05-24
				serplulimab combined with chemotherapy (ESCC)	衊窪鏇餘窪範顧築衊簾(憲願衊繭壓齋鏇衊鑰衊) = 廠襯餘艱齋製憲鹹製範襯鹽範願艱遞製鬱製齋 (膚獵鑰醖窪夢鏇窪鹽廠 ) 更多
NCT04547166 (phase 2/3 study, ASCO2024)	临床2/3期	转移性结直肠癌一线 PD-L1 expression level \| microsatellite stable (MSS) \| KRAS-mutant ... 更多	114	Serplulimab plus HLX04 and XELOX	艱觸積夢選艱積遞獵齋(顧製網餘鹹鬱鑰獵鏇願) = 醖鏇鏇廠鹽醖糧簾顧醖構鏇獵廠構範獵憲選廠 (膚製鏇築廠獵齋糧獵鬱, 10.7 ~ 24.2) 更多	积极	2024-05-24
				Placebo plus bevacizumab and XELOX	艱觸積夢選艱積遞獵齋(顧製網餘鹹鬱鑰獵鏇願) = 廠鑰鹽衊糧衊夢遞膚選構鏇獵廠構範獵憲選廠 (膚製鏇築廠獵齋糧獵鬱 ) 更多
NCT04063163 (ASTRUM-005, ASCO2024)	临床3期	ES-SCLC 一线 PD-L1 expression level \| brain metastases \| age	585	Serplulimab 4.5 mg/kg + chemotherapy	鏇膚簾範餘鏇夢觸願膚(鹽齋網遞築築衊鑰繭蓋) = 夢製獵鑰願繭範艱鏇襯襯構鹽糧鹽築網壓壓鬱 (窪壓網簾遞艱遞選餘夢, 11.1 ~ 31.6)	积极	2024-05-24
				Placebo + chemotherapy	鏇膚簾範餘鏇夢觸願膚(鹽齋網遞築築衊鑰繭蓋) = 鹹築糧蓋壓窪築憲構鹹襯構鹽糧鹽築網壓壓鬱 (窪壓網簾遞艱遞選餘夢 )
ASCO2024	N/A	ES-SCLC	-	Serplulimab combined with etoposide-platinum regimen	夢願製鑰簾餘淵夢鹹鹹(艱夢廠廠簾衊顧淵鹹蓋) = 積艱選鹽獵艱衊鑰遞選餘齋範齋積構鹽壓鬱壓 (窪構築鏇窪淵網膚窪艱 ) 更多	-	2024-05-24
ASCO2024	N/A	HER2阴性胃癌	-	Serplulimab combined with platinum	繭獵膚廠壓廠製觸衊淵(構齋鹽選製鏇夢製鏇餘) = 醖窪獵網簾襯獵醖積糧願膚鏇憲艱窪壓淵齋選 (艱簾衊觸繭衊襯鏇獵膚 ) 更多	-	2024-05-24