帕博利珠单抗(Pembrolizumab) - 药物靶点：PD-1_在研适应症：输卵管癌，非肌层浸润性膀胱肿瘤，卵巢上皮癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Lambrolizumab、Pembrolizumab (Genetical Recombination)、Pembrolizumab (genetical recombination) (JAN)

+ [12]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤免疫系统疾病感染+ [12]

在研适应症

输卵管癌非肌层浸润性膀胱肿瘤卵巢上皮癌+ [321]

非在研适应症

肢端雀斑恶性黑色素瘤急性髓性白血病NPM1突变急性髓系白血病+ [128]

原研机构

Merck & Co., Inc.

在研机构

Merck Sharp & Dohme Corp.

默沙东研发（中国）有限公司Merck Sharp & Dohme BV

+ [17]

非在研机构

Merck Sharp & Dohme (Ireland) Ltd.

Turnstone Biologics Corp.

Eisai GmbH

+ [1]

权益机构

Nektar Therapeutics

NeoImmuneTech, Inc.

Canada Pension Plan Investment Board

+ [80]

最高研发阶段批准上市

首次获批日期

美国 (2014-09-04),

黑色素瘤

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (美国)、优先药物（PRIME） (欧盟)、孤儿药 (日本)、孤儿药 (澳大利亚)、突破性疗法 (中国)、优先审评 (澳大利亚)、优先审评 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 93660H

来源: *****

Sequence Code 93670L

来源: *****

关联

2,772

项与帕博利珠单抗相关的临床试验

NCT06093425

/ Not yet recruiting临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Pembrolizumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Gastric/GEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric/GEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin 18.2 (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.

开始日期2027-06-30

申办/合作机构

創勝醫藥集團有限公司

NCT04266730

/ Suspended临床1期

Phase I Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Administered Concurrently With Pembrolizumab

This is a single center, open-label phase I clinical trial designed to determine the safety of personalized and adjusted neoantigen peptide vaccine (PANDA-VAC) administered concurrently with pembrolizumab in subjects with advanced squamous non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (SCCHN).

开始日期2027-05-20

申办/合作机构

Lineberger Comprehensive Cancer Center

NCT07843550

/ Not yet recruiting临床1/2期

A Phase 1/2 Trial Of Larotrectinib And Pembrolizumab In Patients With Solid Tumors Previously Treated With Immune Checkpoint Inhibitor Monotherapy

This is a single-center, open-label Phase 1/2 trial evaluating the safety and efficacy of the combination of larotrectinib and pembrolizumab in patients with advanced/metastatic lung adenocarcinoma or melanoma.

开始日期2027-03-01

申办/合作机构

M.D. Anderson International España SA

100 项与帕博利珠单抗相关的临床结果

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100 项与帕博利珠单抗相关的转化医学

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100 项与帕博利珠单抗相关的专利（医药）

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10,744

项与帕博利珠单抗相关的文献（医药）

2026-12-31·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Focused ultrasound ablation surgery combined with immune checkpoint inhibition in driver-gene wild-type NSCLC with liver metastasis: a feasibility study

Article

作者: Wang, Ting ; Chen, Jinyun ; Ouyang, Bing ; Chen, Li ; Chen, Wenzhi

BACKGROUND:

This single-arm, open-label clinical trial aimed to evaluate the preliminary safety, efficacy and feasibility of focused ultrasound ablation surgery (FUAS) sequential with immune checkpoint inhibitors (ICIs) in patients with driver-gene wild-type non-small cell lung cancer (NSCLC) and liver metastases.

MATERIALS AND METHODS:

Ten eligible patients received two cycles of FUAS sequential with ICIs. The ICIs used include Camrelizumab (7/10), Pembrolizumab (3/10) and Serplulimab used for immune rechallenge (1/10). Follow-up was conducted every 6 weeks ± 3 days, including imaging and hematological assessments. Treatment-related adverse events (AEs) were documented anytime.

RESULTS:

All participants demonstrated stable tolerability and safety in this trial. Immediate post-FUAS ablation rates ranged from 73% to 80%. The median follow-up time is 84 days (IQR, 42-127 days). From baseline to week 18, continuous shrinkage of both hepatic metastatic and target lesions was observed. The DCR of the tumor has reached 80% since the 2nd follow-up (12 weeks), and it remains at 50% until the 4th follow-up (24 weeks).

CONCLUSION:

FUAS sequential with ICIs suggests preliminary safety, activity and feasibility in treating driver-gene wild-type NSCLC patients with liver metastases, further validation is needed.

2026-12-31·Human Vaccines & Immunotherapeutics

Durable response of anaplastic thyroid cancer to pembrolizumab combined with chemotherapy: A case report

Article

作者: Zhuang, Yihan ; Chen, Qiongshan ; Lin, Wen ; Chen, Zipei

Anaplastic thyroid cancer is a notoriously aggressive malignancy with a dismal prognosis, typically associated with a median overall survival of less than one year. Therapeutic alternatives are particularly limited for patients without actionable driver mutations. Here, we report a case of BRAF V600E wild-type, PD-L1-positive (tumor proportion score of 80%) anaplastic thyroid cancer with residual/relapsed disease following surgery and subsequent progression on multi-targeted tyrosine kinase inhibitor therapy. The patient was thereafter treated with a combination of pembrolizumab, nab-paclitaxel and carboplatin, resulting in a sustained near-complete response lasting over 30 months, accompanied by a manageable safety profile. The favorable response in this case suggests that further evaluation of this triplet regimen could be considered for anaplastic thyroid cancer, though this remains a speculative premise requiring validation. Further studies are also needed to clarify the underlying mechanisms of this combination and to identify predictive biomarkers for patient selection.

2026-12-31·OncoImmunology

A mixed inflammatory peripheral signature defines clinical outcomes in a phase II trial combining pembrolizumab with paclitaxel and carboplatin in melanoma

Article

作者: Cocolakis, Eftihia ; Cailhier, Jean-François ; Lapointe, Réjean ; Thébault, Paméla ; Shechtman, Yelena ; Lepage, Stéphanie ; Letendre, Caroline ; Le, Huy ; Dionne, Jeanne ; Bélanger, Karl ; Jamal, Rahima ; Lambert, Caroline ; Miller Jr, Wilson H.

Checkpoint blockade of PD-1 with pembrolizumab provides long-term survival to a significant proportion of patients with metastatic melanoma. Pembrolizumab has been successfully used in combination with chemotherapy in non-small-cell lung cancer to increase the response rate. This phase II trial combined pembrolizumab with carboplatin/paclitaxel (CP) to assess its safety and efficacy, and to identify correlates of responses. Thirty patients without prior immunotherapy for unresectable/metastatic melanoma were treated with pembrolizumab and CP. Peripheral blood was collected at baseline and after 2 cycles to characterize systemic immune activity by multiplex assays and flow cytometry. Seventy percent of patients received all 4 cycles of CP; 87% received pembrolizumab for 2 y or until progression. Grade 3 and higher adverse events (AEs) occurred in 50% of the patients. The overall response rate (ORR) and disease control rate (DCR) by irRC criteria were 43% and 53%, respectively. Median overall survival (OS) was 23.8 months. Objective response was associated with a lower frequency of naive CD8 T cells and low plasma CCL3 at baseline, along with a larger proportion of mature NK cells and of CD4 T cells expressing BTLA or LAIR-1. Survival rate was higher for patients with lower baseline of IL-6, IL-8, and CD4⁺CD39⁺ T cells. Following treatment, pro-inflammatory soluble factors increased in both responders and non-responders. Addition of CP to pembrolizumab in this study did not appear to result in a response or survival advantage and was less tolerable than immunotherapy alone. Correlative data point to peripheral signals to investigate further as potential biomarkers. Trial registration: clinicaltrials.gov, NCT02617849, registered on December 1st, 2015.

20,153

项与帕博利珠单抗相关的新闻（医药）

16 小时之前

·抗体圈

数据泄露、预期落空，Mderna股价暴跌26%

当地时间10月22日，莫德纳经历了一个戏剧性的交易日。其与默沙东联合研发的个性化癌症疫苗Intismeran autogene部分数据在ESMO大会前泄露，MRNA盘中一度跌至180.80美元，较前收盘价低逾26%；收盘跌幅收窄至17.57%，报202.63美元。科学数据并不差，资本市场的反应却先给了“差评”。这正是创新药叙事里最耐人寻味的一幕。泄露数据来自黑色素瘤患者研究：与单用默沙东Keytruda相比，疫苗联合Keytruda可将癌症复发或死亡风险降低42%，将远处扩散或死亡风险降低38%。 MD安德森癌症中心专家Hussein Tawbi称，这对患者是“巨大的进展”，且额外疗效伴随的毒副作用更轻，如注射部位疼痛。默沙东研究实验室总裁Dean Li也直言，在Keytruda这类已很有效的疗法上再证明额外获益通常很难，“但在这里，我们完全没有遇到证明额外获益困难的问题”。问题恰恰在于：数据越积极，预期越昂贵。 BMO分析师Evan Seigerman认为，复发/死亡风险的相对下降具有临床意义，股价反应更像是在完整数据公布前，市场过高预期的一次释放，而非对联合疗法疗效的否定。瑞银同样称这是一组“非常强劲的数据”，并增强了对肾癌、膀胱癌后续研究的信心。换言之，市场惩罚的不是坏数据，而是“不够惊艳的好数据”。这款疫苗的独特之处，在于按患者肿瘤突变特征“量身设计”。若后续研究持续验证，它可能成为莫德纳管线中至关重要的商业化新增产品。目前公司收入仍主要依赖新冠、流感及RSV疫苗，癌症疫苗若能落地，意义不只是多一个产品，而是打开第二增长曲线。默沙东与莫德纳还在非小细胞肺癌、膀胱癌、肾细胞癌等方向布局，但Dean Li的比喻很清醒：可以梦想建造一座木屋，现在只是砍下一些木头、刚砍倒一棵树；砍倒一棵树，不等于拥有木屋，更谈不上村庄。这条新闻的看点不止股价。它提醒我们：第一，个性化癌症疫苗的临床价值正从概念走向数据，但“部分泄露数据”不能替代完整试验；第二，创新药投资越来越像预期管理游戏，科学利好与市场利空可以同时成立；第三，真正决定长期价值的，是后续头对头证据、适应症拓展和商业化执行力。莫德纳年内仍累涨超587%，默沙东涨超42%，短期暴跌并未改写长期叙事。只是这一次，市场用26%的盘中跌幅提醒所有人：在医药创新里，好数据只是砍倒第一棵树，离木屋还很远。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

17 小时之前

·PRNewswire

Rakuten Medical Presents Long-Term Follow-up Results of ASP-1929 Photoimmunotherapy in Combination with Pembrolizumab for R/M HNSCC at ESMO 2026

Median DOR of 44.3 months supports durability of response 4-year overall survival rate of 35.3% and median OS of 28.2 months suggest meaningful long-term survival Long-term survival of 42+ - 60+ months observed among complete responders SAN DIEGO, Oct. 23, 2026 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox® platform-based photoimmunotherapy, today announced the presentation of long-term follow-up results from the Phase 1b/2 ASP-1929-181 study (NCT04305795), which evaluated ASP-1929 photoimmunotherapy in combination with pembrolizumab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (r/m HNSCC), at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. The data were presented as an e-poster on October 23, 2026 at 8:00 a.m. (CET). Prior efficacy and safety findings from the ASP-1929-181 study showed durable clinical activity and a manageable safety profile after a median follow-up of 31.7 months. The current analysis extends follow-up by an additional 21.4 months to a median follow-up of 53.1 months and reports updated efficacy and safety outcomes, along with exploratory subgroup analyses by HPV status, PD-L1 CPS expression, and tumor size at baseline. ASP-1929-181 Study Presentation at ESMO 2026 Title: Long-Term Results of ASP-1929 Photoimmunotherapy with Pembrolizumab in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Poster: View/Download Poster [PDF] Key Findings (Data cutoff: February 10, 2026): The ASP-1929-181 study enrolled 19 patients with r/m HNSCC, and the long-term follow-up analysis included 17 efficacy-evaluable patients. Meaningful long-term survival was observed: Median overall survival (OS) was 28.2 months. Estimated OS rates were 47.1% at 36 months and 35.3% at 48 months. Among five (29%) patients who achieved a complete response (CR), four remained alive with follow-up ranging from more than 42 months to more than 60 months. Durability of response was suggested by: Median duration of response (DOR) was 44.3 months at the data cutoff. Four responders remained free from subsequent anticancer therapy following discontinuation of study treatment. Exploratory analyses showed generally consistent efficacy and safety findings across subgroups defined by baseline HPV status, PD-L1 CPS expression, and tumor size. No new safety signals were observed. Rakuten Medical is currently conducting the global Phase 3 ASP-1929-381 study (NCT06699212) evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC. These findings are exploratory and should be interpreted in light of the study's limitations, including the small sample size and limited patient numbers in some subgroup analyses. Nevertheless, the results support continued investigation of the ASP-1929-381 study. Following completion of this trial, Rakuten Medical aims to submit a Biologics License Application (BLA) for ASP-1929 to the U.S. FDA in 2028. About Alluminox® platform The Alluminox platform is Rakuten Medical's investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical's pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational. About ASP-1929 Rakuten Medical's first pipeline drug developed on its Alluminox® platform is ASP-1929, an antibody-dye conjugate comprised of the anti-epidermal growth factor receptor (EGFR) antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to EGFR, a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority. About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox® platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit our website, LinkedIn and YouTube. Investor Contact: Abhijit Bhatia Chief Operating Officer Tel: +1-619-650-1549 Email: [email protected] Media Contact: Ai Yoshikawa Associate Director, Global Corporate Communications Tel: +81-(0)70-4196-0845 Email: [email protected] Contact Us SOURCE Rakuten Medical, Inc. 21% more press release views with Request a Demo

免疫疗法临床结果临床3期上市批准

19 小时之前

·医药健闻

私募巨头近百亿欧元收购凯杰；默沙东癌症疫苗III期数据不及此前试验；西门子医疗与英伟达达成战略合作 | 日报

全球医疗行业每日重点资讯企业动态瑞典私募股权巨头EQT与荷兰分子诊断企业凯杰（QIAGEN N. V.）公布已签署业务合并协议，且计划以全现金的自愿公开收购要约方式将其私有化。根据公告内容，该交易对凯杰的股权估值大约为96亿欧元（约合108亿美元），在计入净债务之后，企业价值约为108亿欧元、折合121亿美元。这起收购由EQT旗下EQT XI基金间接控制的收购主体Crown NL Bidco B. V.来执行，其将以每股46.50欧元（约52.22美元）的现金，买下凯杰全部流通股。预计能够在2027年年中完成交割。西门子医疗宣布，与英伟达（NVIDIA）宣布达成战略合作，双方将共同探索人工智能技术，以优化患者就医体验、支撑个体化治疗、简化放射治疗流程，并扩大医疗服务的可及性。合作将聚焦AI赋能自适应放疗，依托瓦里安硬件底座与英伟达加速计算、大模型、数字孪生技术，试图破解全球放疗资源供给缺口难题。埃斯特维ESTEVE CDMO正通过搬迁、扩建和现代化升级其在中国的现有生产业务，进一步巩固其在亚洲的业务地位，相关投资超过8,000万美元。于绍兴的新基地将更大的产能与先进技术、高度自动化和数字化相结合，标志着埃斯特维CDMO在中国制造能力建设迈出了重要一步。新生产基地设有三个生产车间，一期总反应体积达250立方米，并预留了额外超过150立方米的扩建空间。随着生产需求变化，总反应容积未来可扩展至超过400立方米。先进制造技术、自动化系统和数字化解决方案贯穿整个工厂设计与运营，以提升运营效率、生产灵活性和规模化能力。同时，基地基础设施也已在设计中预留未来扩建和持续发展所需的空间。深圳柏垠生物科技有限公司完成超2亿元人民币A轮系列融资。本轮投资方包括广药资本、欧莱雅、广新基金、富华资本、君联资本、基石资本、中科先进、沃博联、星博生辉、君科丹木。本轮融资将主要用于生物材料研发AI平台升级、创新生物材料研发、规模化生产、产品开发及市场拓展。北京大学与普洛药业股份有限公司共建“北京大学—普洛药业核酸药物与生物制造联合实验室”签约揭牌。双方将围绕小核酸原料药化学与生物合成开展产学研协同攻关，推动高校基础研究优势与企业产业化转化能力深度融合，为普洛药业CDMO业务在核酸药物与生物制造领域拓展提供技术支撑。爱朋医疗与上海商汤善萃医疗科技有限公司（商汤医疗）达成战略合作，并通过股权投资进一步深化战略合作。根据规划，双方将以专病数据与人工智能技术的融合为主线，链接诊中与诊后场景。优先围绕疼痛管理、围术期脑状态监测、睡眠障碍诊疗、注意缺陷多动障碍（ADHD）行为管理与诊疗、鼻腔及上气道疾病管理等专病场景展开，聚焦医疗大语言模型、多模态模型、医疗世界模型及医疗智能体等技术方向，推进技术研发、数据与算法、产品与市场、科研与学术、海外市场等五个方面的合作。三生国健发布2026年第三季度报告。2026年前三季度，三生国健营业收入13.92亿元，同比增长24.77%，归母净利润5.87亿元，同比增长47.29%，扣非归母净利润4.42亿元，同比增长25.55%。在保持收入、利润高增长的同时，公司持续加码创新研发投入，前三季度研发费用同比增长35.68%。产业动态 Moderna和默沙东(Merck)两家公司联合研发的个性化mRNA癌症疫苗III期临床试验数据遭到提前披露，引发投资者对疫苗实际疗效的担忧。随后，默沙东与Moderna提前公布主要疗效数据，确认此前流出的核心数字属实：该疫苗与默沙东畅销抗癌药Keytruda联合使用，可使黑色素瘤患者的癌症复发或死亡风险降低42%。尽管这一结果达到统计学显著性，但低于此前IIb期研究显示的49%风险降幅，引发市场对其商业前景的重新评估强生宣布，国家药品监督管理局已批准泰立珂（特立妥单抗注射液）新增适应症，用于既往至少接受过一线治疗（包括抗CD38单克隆抗体和来那度胺）的复发或难治性多发性骨髓瘤成人患者。此次获批使泰立珂治疗前移至首次复发阶段，为中国复发或难治性多发性骨髓瘤患者带来全球范围内同类首创的免疫治疗新选择。由阿斯利康和第一三共共同开发与商业化的优赫得（英文商品名：Enhertu，通用名：注射用德曲妥珠单抗）于2026年10月20日正式获得中国国家药品监督管理局（NMPA）批准，单药适用于治疗既往接受过治疗或无满意替代治疗方案的不可切除或转移性HER2表达为IHC 3+的成人实体瘤患者。该适应症是基于单臂临床试验的结果给予的附条件批准。卫材中国仑卡奈单抗皮下全自动注射笔中国首张处方在上海交通大学医学院附属瑞金医院海南医院开出。一名早期阿尔茨海默病患者于当日完成首次给药，成为该剂型在中国的首位使用者。这也是该药物剂型在美国以外全球范围内的首次应用。金赛药业宣布其与全球最大的脱敏治疗药企ALK-Abelló A/S合作的GenSci171（即ACARIZAX尘螨变应原舌下免疫治疗片剂），在12–65岁伴或不伴哮喘的尘螨过敏性鼻炎/鼻结膜炎中国参与者中开展的Ⅲ期临床试验达到了主要终点，在仅接受24-28周治疗后显示与既往试验一致的疗效结果。试验结果显示，ACARIZAX具有良好的安全性和耐受性，与此前十余年的海外临床试验数据一致。派诺生物宣布，其三款多阶段新型U-VLP疟疾候选疫苗的I期首次人体临床试验（NCT07831226）已于2026年10月19日获得Bellberry人类研究伦理委员会批准。其中，LYB014针对恶性疟原虫（Plasmodium falciparum）生命周期中的三个关键阶段；LYB017针对间日疟原虫（Plasmodium vivax）生命周期中的三个关键阶段；而LYB027则同时针对恶性疟原虫和间日疟原虫生命周期中的上述三个关键阶段。这些候选疫苗将联合派诺生物自研的A02佐剂进行评估。和铂医药宣布，中国国家药品监督管理局（NMPA）已批准恩力达（巴托利单抗注射液，皮下给药，170 mg (1 mL)/瓶）上市，用于治疗抗乙酰胆碱受体（AChR）抗体阳性的成人全身型重症肌无力（gMG）患者。歌礼制药宣布，其战略合作伙伴Sagimet Biosciences Inc.已完成其地尼法司他（ASC40）关键性美国III期临床试验AURORA的首例患者给药，该试验在患有中重度痤疮的成人和12岁及以上的青少年中开展。Therakos Development Limited宣布，其THERAKOS CELLEX光分离治疗系统已依据欧盟《医疗器械法规》（MDR）获得扩展适应证认证。该系统现已在欧洲获准用于治疗对皮质类固醇反应不足的成年患者因免疫检查点抑制剂（ICI）治疗而出现的免疫相关不良事件（irAE）。这是全球首个、也是唯一获批用于这一用途的疗法。联系美通社 +86-10-5953 9500 info@prnasia.com

100 项与帕博利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10574	帕博利珠单抗	L01FF02	DB09037

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
输卵管癌	澳大利亚	Merck Sharp & Dohme (Australia) Pty Ltd.	2026-07-23
非肌层浸润性膀胱肿瘤	澳大利亚	Merck Sharp & Dohme (Australia) Pty Ltd.	2026-07-23
浸润性膀胱癌	欧盟	Merck Sharp & Dohme BV	2026-07-01
浸润性膀胱癌	冰岛	Merck Sharp & Dohme BV	2026-07-01
浸润性膀胱癌	列支敦士登	Merck Sharp & Dohme BV	2026-07-01
浸润性膀胱癌	挪威	Merck Sharp & Dohme BV	2026-07-01
铂耐药性输卵管癌	中国	Merck Sharp & Dohme LLC	2026-06-23
铂类耐药性原发性腹膜癌	欧盟	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	冰岛	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	列支敦士登	Merck Sharp & Dohme BV	2026-04-22
铂耐药上皮性卵巢癌	欧盟	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	冰岛	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	列支敦士登	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	挪威	Merck & Co., Inc.	2026-04-02
错配修复缺陷或微高卫星不稳定性结肠癌	美国	Merck Sharp & Dohme Corp.	2026-02-10
错配修复缺陷或微高卫星不稳定性结肠癌	美国	Merck Sharp & Dohme LLC	2026-02-10
肿瘤	美国	Merck Sharp & Dohme Corp.	2026-02-10
肿瘤	美国	Merck Sharp & Dohme LLC	2026-02-10
卵巢癌	美国	Merck Sharp & Dohme LLC	2026-02-10
卵巢癌	美国	Merck Sharp & Dohme Corp.	2026-02-10

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
复发性铂耐药性卵巢癌	申请上市	美国	Merck & Co., Inc.	2025-10-20
小肠癌	申请上市	欧盟	Merck Sharp & Dohme Corp.	2022-03-25
非小细胞肺癌Ⅰ期	临床3期	美国	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	日本	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	巴西	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	加拿大	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	智利	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	哥伦比亚	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	法国	Merck Sharp & Dohme LLC	2026-05-04

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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


NCT02617849 (Pubmed \| Oncoimmunology)	临床2期	黑色素瘤	30	Pembrolizumab and Carboplatin/ Paclitaxel	鬱繭觸鬱襯襯顧廠鑰衊(餘繭築衊壓觸簾窪範觸) = 網窪壓願鹽醖鹽鑰憲積顧鏇鹹鬱蓋積淵遞網範 (積築夢衊顧窪壓觸鹹衊 ) 更多	不佳	2026-12-31
ACR2026	N/A	肾细胞癌	27,394	ICI (RA)	壓製衊鑰鏇網積餘鹽選(壓糧襯範製觸蓋衊膚襯) = 淵膚繭醖膚遞繭糧膚獵選衊衊膚鏇襯繭築衊蓋 (夢鑰遞鹹蓋構觸壓廠築 ) 更多	积极	2026-11-06
				ICI (non-RA)	壓製衊鑰鏇網積餘鹽選(壓糧襯範製觸蓋衊膚襯) = 醖觸繭艱觸廠願膚醖壓選衊衊膚鏇襯繭築衊蓋 (夢鑰遞鹹蓋構觸壓廠築 ) 更多
NCT03598608 (MK-4280-003, Pubmed \| Blood Neoplasia)	临床1/2期	难治性经典霍奇金淋巴瘤 PD-1	34	Favezelimab 800 mg plus Pembrolizumab 200 mg	網鏇襯鏇壓壓獵製簾築(獵糧鏇餘範鑰糧壓餘鏇) = 1 of 21 participants experienced a dose-limiting toxicity (grade 4 autoimmune hepatitis) 艱衊廠積鹽構壓觸壓糧 (襯膚餘壓夢衊鹹顧壓鬱 ) 更多	积极	2026-11-01
NCT06031233 (MINUTE, ESMO2026)	临床4期	肿瘤	228	Pembrolizumab (10-minute infusion)	餘範鹽範壓繭餘觸廠艱(衊鹽網繭淵鑰憲積廠憲) = 醖襯獵積夢淵鑰願遞窪衊願餘壓艱觸壓襯鏇鬱 (襯選壓壓廠範壓繭願襯, 0.1 ~ 3.1) 更多	积极	2026-10-23
NCT03275506 (GINECO NeoPembrOV, ESMO2026)	临床2期	卵巢浆液性肿瘤	87	PembrolizumabBevacizumababbevacizumabpembrolizumab + PembrolizumabBevacizumabve chemotherapybevacizumabpembrolizumab + PembrolizumabBevacizumabbevacizumabpembrolizumab (Perioperative chemotherapy + pembrolizumab, followed by bevacizumab maintenance + pembrolizumab)	-	不佳	2026-10-23
				PembrolizumabBevacizumababpembrolizumabbevacizumab + PembrolizumabBevacizumabve chemotherapypembrolizumabbevacizumab + PembrolizumabBevacizumabpembrolizumabbevacizumab (Perioperative chemotherapy + pembrolizumab, followed by bevacizumab maintenance + pembrolizumab)	襯鏇廠夢壓鏇壓艱膚鑰(顧鑰窪範築醖範艱糧膚) = 積窪襯繭夢範醖鹹鹹夢餘繭構構繭簾窪壓齋鹹 (鏇範鏇鬱糧蓋範齋簾遞 )
ESMO2026	N/A	肿瘤	111	Immune checkpoint inhibitor therapy (<70 years)	鬱鏇選範膚觸願窪製製(壓壓顧糧廠網製築鹽鹽) = 願醖鏇廠顧艱蓋餘簾襯憲糧繭廠壓蓋製淵積顧 (鏇襯鬱糧廠鑰夢淵憲鹹 ) 更多	积极	2026-10-23
				Immune checkpoint inhibitor therapy (≥70 years)	鬱鏇選範膚觸願窪製製(壓壓顧糧廠網製築鹽鹽) = 衊觸餘襯夢襯鹹遞範淵憲糧繭廠壓蓋製淵積顧 (鏇襯鬱糧廠鑰夢淵憲鹹 ) 更多
NCT07349303 (NEOPRIME, ESMO2026)	临床2期	黑色素瘤新辅助	30	Pembrolizumab 400 mg	選製顧積繭製醖廠艱積(憲窪衊網襯簾繭廠糧築) = occurred in 12% (1 case of anemia, 1 case of hyperbilirubinemia, 2 cases of hyponatremia) of patients treated with pembrolizumab and in 25% (2 cases of hyperbilirubinemia, 2 cases of elevated liver enzymes) of patients treated with placebo. 獵鏇網獵顧醖鏇廠選壓 (壓鏇艱廠願餘觸製鏇鬱 )	积极	2026-10-23
ESMO2026	N/A	晚期宫颈癌	54	IO	積範鏇憲襯艱網鹽構鏇(築齋選鹽獵壓窪鏇構鑰) = 顧窪襯衊選窪鹹鑰憲構願廠製簾襯窪願鏇鬱鏇 (夢範膚鏇鑰膚糧積膚襯, 13.1 ~ NR) 更多	积极	2026-10-23
				IO (progression LT)	積範鏇憲襯艱網鹽構鏇(築齋選鹽獵壓窪鏇構鑰) = 鑰製襯蓋範願簾觸積鹹願廠製簾襯窪願鏇鬱鏇 (夢範膚鏇鑰膚糧積膚襯, 15.2 ~ NR)
ESMO2026	N/A	新辅助	560	Neoadjuvant pembrolizumab	願鹹艱願膚鑰範鑰齋積(齋衊蓋選膚衊糧繭艱構) = 憲製醖範顧願築願膚憲夢觸繭範壓製襯鹹夢積 (範醖鬱齋願襯顧淵選獵, 67.3 ~ 80.4) 更多	积极	2026-10-23
				Neoadjuvant ipilimumab-nivolumab	願鹹艱願膚鑰範鑰齋積(齋衊蓋選膚衊糧繭艱構) = 夢衊選齋鏇觸膚顧範選夢觸繭範壓製襯鹹夢積 (範醖鬱齋願襯顧淵選獵, 73.9 ~ 84.1) 更多
ESMO2026	N/A	三阴性乳腺癌	30	Standard anthracycline-taxane chemotherapy (AC→T) combined with pembrolizumab	齋壓選鹽夢網壓顧憲壓(積糧鬱範鑰壓積廠膚簾) = 壓選繭夢夢齋簾選積衊廠鹹齋鹽蓋夢願醖築襯 (繭遞構鬱製窪膚鏇醖繭 ) 更多	积极	2026-10-23
				Platinum-based regimen (taxane plus cisplatin or carboplatin weekly) combined with pembrolizumab	齋壓選鹽夢網壓顧憲壓(積糧鬱範鑰壓積廠膚簾) = 遞餘願製衊憲餘齋觸鹽廠鹹齋鹽蓋夢願醖築襯 (繭遞構鬱製窪膚鏇醖繭 ) 更多