依沃西单抗(Ivonescimab) - 药物靶点：PD-1 x VEGF-A_在研适应症：PD-L1阳性非小细胞肺癌，EGFR阳性非鳞状非小细胞肺癌，非小细胞肺癌_专利_临床

概要

基本信息

药物类型

双特异性抗体

别名

ivonescimab、AK 112、AK-112

+ [4]

靶点

PD-1 x VEGF-A

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)、VEGF-A抑制剂(血管内皮生长因子A抑制剂)

治疗领域

肿瘤呼吸系统疾病消化系统疾病+ [6]

在研适应症

PD-L1阳性非小细胞肺癌EGFR阳性非鳞状非小细胞肺癌非小细胞肺癌+ [56]

非在研适应症

可切除非小细胞肺癌

原研机构

中山康方生物医药有限公司

在研机构

康方赛诺医药有限公司Summit Therapeutics, Inc.

中山康方生物医药有限公司

+ [3]

非在研机构-

权益机构

上药控股有限公司

Virogin Biotech Ltd.

中山康方生物医药有限公司

+ [5]

最高研发阶段批准上市

首次获批日期

中国 (2024-05-21),

EGFR阳性非鳞状非小细胞肺癌

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、突破性疗法 (中国)、优先审评 (中国)

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结构/序列

Sequence Code 41637

来源: *****

Sequence Code 616715490

来源: *****

关联

133

项与依沃西单抗相关的临床试验

NCT07070466

/ Not yet recruiting临床2期IIT

A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas

This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.

开始日期2025-12-12

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT07038915

/ Not yet recruiting临床2期IIT

STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1

To learn if the drug combination of tiragolumab and ivonescimab can help to control LSCC that got worse after standard treatment with platinum doublets and anti-PD-1/PD-L1 therapy.

开始日期2025-12-03

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT07057791

/ Not yet recruiting临床2期IIT

Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Eligible untreated participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) who are ? 18 years of age will be randomized to receive ivonescimab 10 milligrams per kilogram (mg/kg) or ivonescimab 20 mg/kg in combination with carboplatin and etoposide.
Ivonescimab is a type of drug called a bispecific antibody. Antibodies are proteins that specifically recognize and bind to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Bispecific antibody, meaning it targets two different molecules at the same time.
Ivonescimab is a new drug that may help the immune system attack cancer cells and may also block certain pathways that cancer uses to grow and spread. This dual action of ivonescimab aims to help the immune system to fight the cancer and also disrupt tumor growth by blocking blood vessel formation that tumors use to grow.
Participants will receive induction with 4 cycles of ivonescimab (dose determined by randomization) with standard of care carboplatin and etoposide followed by maintenance therapy with ivonescimab at the same dose received during induction. Treatment will continue until disease progression, unacceptable toxicity or participant withdrawal.
The purpose of this study is to determine what dose of ivonescimab works best in combination with carboplatin and etoposide chemotherapy in ES-SCLC. We will also examine the side effects, good and bad, associated with ivonescimab.

开始日期2025-12-01

申办/合作机构

Summit Therapeutics, Inc.

100 项与依沃西单抗相关的临床结果

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100 项与依沃西单抗相关的转化医学

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100 项与依沃西单抗相关的专利（医药）

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28

项与依沃西单抗相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-08-01·Nature Reviews Clinical Oncology

The next generation of immunotherapies for lung cancers

Review

作者: Yang, Weiwei ; Zhang, Li ; Zhao, Hongyun ; Zhao, Shen

Immunotherapies, specifically immune-checkpoint inhibitors (ICIs) targeting PD-(L)1 or CTLA4, have revolutionized the treatment of lung cancer; however, many patients do not have a response to ICIs and most of those with an initial tumour response eventually have disease progression owing to acquired resistance. Over the past few years, numerous therapeutic strategies have been explored to address the problems of intrinsic and acquired resistance to ICIs. In 2024, regulatory approvals of the bispecific PD-1 × VEGF antibody ivonescimab for the treatment of non-small-cell lung cancer in China and the bispecific DLL3 × CD3 T cell engager tarlatamab for patients with small cell lung cancer in the USA provided clinical proof-of-concept for overcoming the challenge of ICI resistance using novel immunotherapeutic agents, thereby increasing enthusiasm for the exploration of next-generation immunotherapies for lung cancer. A large variety of immunotherapies with diverse targets and mechanisms of action are currently being tested in clinical trials involving patients with lung cancer. In this Review, we provide an overview of these emerging immunotherapies in clinical development for non-small-cell lung cancer and/or small cell lung cancer, including novel immune-checkpoint modulators, immune cell engagers, adoptive cell therapies and therapeutic cancer vaccines. We describe the designs of these agents and the mechanisms by which they might overcome resistance to the current generation of ICIs. We also discuss hurdles impeding the clinical translation of each immunotherapeutic modality and potential strategies to address these challenges, using representative examples of agents that have entered the later phases of clinical testing.

2025-06-12·Antibody therapeutics

A novel bispecific antibody CVL006 superior to AK112 for dual targeting of PD-L1 and VEGF in cancer therapy

Article

作者: Shen, Xiaokun ; Huang, Hao ; Wu, Ziai ; Cao, Liang ; Pan, Junfang ; Li, Zhongyuan ; Song, Zeng ; Chen, XiaoBing ; Wang, Chunyan ; Huang, Jinwen

Abstract:

Background:

Preclinical and clinical studies highlight the enhanced anticancer efficacy of combining anti-VEGF/VEGFR drugs with immune checkpoint inhibitors (ICIs). PD-L1/VEGF bispecific antibodies outperform monotherapy or combined PD-L1 inhibitors and anti-VEGF antibodies by simultaneously blocking the PD-1/PD-L1 immune pathway and VEGF-driven angiogenesis, providing a dual mechanism for superior antitumor activity.

Methods:

We developed CVL006, a novel bispecific antibody, by fusing an anti-PD-L1 VHH domain with a humanized IgG1 anti-VEGF monoclonal antibody. CVL006 retains antibody-dependent cellular cytotoxicity (ADCC) functionality. Preclinical evaluations included binding affinity and specificity assessments, dual-pathway blockade testing, and in vivo efficacy comparisons to atezolizumab and PD-1/VEGF bispecific antibody AK112 (ivonescimab).

Results:

CVL006 demonstrated high affinity and specificity for human PD-L1 and VEGF. It effectively inhibited VEGF/VEGFR signaling and the PD-L1/PD-1 axis, suppressing VEGF-induced angiogenesis and reactivating T cells. This reactivation led to increased cytokine secretion critical for immune response. In vivo studies revealed CVL006’s superior antitumor efficacy, achieving greater tumor growth inhibition and angiogenesis suppression than atezolizumab. CVL006 also outperformed AK112 in preclinical models, showcasing robust antitumor activity.

Conclusions:

CVL006 integrates immune checkpoint inhibition and tumor vascularization disruption, offering a comprehensive anticancer strategy. Its superior preclinical performance compared to atezolizumab and AK112 underscores its therapeutic potential, paving the way for further development and clinical translation.

1,285

项与依沃西单抗相关的新闻（医药）

15 小时之前

·思齐俱乐部

花旗上调多家中国药企目标价，看好下一代免疫肿瘤疗法

花旗称，下一代免疫肿瘤疗法有望重塑相关治疗格局，上调康方生物、信达生物、三生制药等拥有免疫肿瘤研发管线的公司目标价，预计该领域将出现更多授权许可机会和数据催化剂。花旗表示，下一代免疫疗法药物的总市场规模(TAM)可能超过620亿美元，目前康方生物的ivonescimab及信达生物的IBI363数据表现亮眼。将康方生物的目标价从98港元上调至185港元，信达生物从90港元上调至105港元，三生制药从21港元上调至36港元，君实生物从17港元上调至32港元；中国生物制药从6.2港元上调至8.8港元。来源：金融界点击阅读原文了解更多

免疫疗法

17 小时之前

·PipelineReview

NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer

HONG KONG, China I July 28, 2025 I Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). This submission represents the third accepted application for ivonescimab in China, following previous filings for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC. PD-1 combined with chemotherapy has become a cornerstone in cancer therapy. The sNDA for ivonescimab’s new indication is based on the strong positive outcomes from its Phase III trial (AK112-306/HARMONi-6 study), which showed that ivonescimab combined with chemotherapy is superior to tislelizumab plus chemotherapy. Building on the success of its head-to-head comparison with pembrolizumab, ivonescimab’s ability to outperform PD-1 combination therapy marks a significant step forward in the evolution of global cancer immunotherapy. Currently, ivonescimab is involved in over 12 registrational/Phase III clinical trials worldwide, including six head-to-head studies with PD-1/L1 inhibitors. These trials span a diverse range of malignancies, such as various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others. Ivonescimab has established a broad and strategic footprint across key cancer immunotherapy indications. As part of the company’s “IO+ADC” 2.0 oncology strategy, ivonescimab is positioned as a cornerstone agent in immuno-oncology, being evaluated in combination with innovative therapies targeting novel mechanisms and pathways. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, “Akeso”) contains “forward-looking statements”. These statements reflect the current beliefs and expectations of Akeso’s management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso’s other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin . SOURCE: Akeso

免疫疗法临床3期上市批准

22 小时之前

·康方生物Akeso

依沃西联合化疗1L治疗sq-NSCLC的上市申请获NMPA受理

2025年7月28日，国家药品监督管理局药品审评中心（CDE）官网显示，康方生物（9926.HK）独立自主研发的PD-1/VEGF双特异性抗体依达方®（依沃西单抗注射液），联合化疗一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）的新药上市许可申请（sNDA）已被受理。PD-1/L1抑制剂联合化疗是NSCLC领域当前全球最优SOC，依沃西联合方案有望成为广大sq-NSCLC患者一线治疗的全新选择。一线治疗sq-NSCLC，是继EGFR-TKI治疗进展的nsq-NSCLC和一线治疗PD-L1表达阳性的NSCLC适应症获批后，依沃西在中国申报的第3项NSCLC适应症。该新适应症将推动依沃西在NSCLC领域实现一线和后线，鳞癌、非鳞癌人群治疗更全面的布局。PD-1联合化疗是免疫抑制剂疗法在全球获得巨大临床突破和商业价值的核心疗法。此次依沃西新适应症的sNDA，则正是基于依沃西联合化疗“头对头”替雷利珠单抗联合化疗的III期临床（AK112-306/HARMONi-6研究）强阳性结果。继单药头对头帕博利珠单抗之后，战胜PD-1联合化疗，是依沃西方案推动全球肿瘤免疫治疗成功实现更广泛的迭代升级的重要一步，展现了依沃西疗法在全球范围内巨大的临床突破性价值和商业价值。当前，依沃西在全球范围内已经开展了超过12项注册性/III期临床研究（其中6项与PD-1/L1疗法头对头研究），覆盖多种类型肺癌、一线结直肠癌、一线头颈鳞癌、一线胆道癌、一线胰腺癌、一线三阴性乳腺癌等等，在肿瘤免疫治疗的核心适应症领域实现了全面布局。在公司推动的肿瘤治疗“IO+ADC”2.0战略下，依沃西正作为IO端的基石药物之一，与全球各种创新机制/创新靶点药物进行强强联合探索，持续升级肿瘤治疗格局。说明：本文作为康方生物的新闻发布，用于披露公司最新进展，并非产品推广广告，不构成康方生物的信息披露或投资建议。关于依达方®（PD-1/VEGF双抗，依沃西）依达方®（依沃西单抗注射液）是康方生物自主研发的、全球首创PD-1/VEGF双特异性肿瘤免疫治疗药物。依达方®于2024年5月获得中国国家药品监督管理局批准上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，成为全球首个获批上市的“肿瘤免疫+抗血管生成“协同抗肿瘤机制的双特异性抗体新药；同年11月，依达方®及该适应症被纳入2024年国家医保目录。依达方®单药对比帕博利珠单抗单药一线治疗PD-L1表达阳性的晚期NSCLC的III期研究在期中分析中达到了无进展生存期的主要研究终点，获得决定性胜出阳性结果。基于此项研究，依达方®单药一线治疗PD-L1表达阳性的晚期NSCLC适应症获优先审评，并于2025年4月获批上市。基于头对头替雷利珠单抗联合化疗的III期研究强阳性结果，依达方®联合化疗一线治疗晚期sq-NSCLC（HARMONi-6研究）的上市申请已获NMPA受理。同时，由合作伙伴Summit主导开展的依达方®联合化疗联合化疗用于经第三代EGFR-TKI治疗进展的EGFR突变、局晚期或转移性nsq-NSCLC的国际多中心III期临床研究（HARMONi研究）、依达方®联合化疗对比帕博利珠单抗联合化疗一线治疗鳞状和非鳞状NSCLC的国际多中心III期研究（HARMONi-3研究）和依达方®单药对比帕博利珠单抗一线治疗PD-L1高表达晚期NSCLC的国际多中心临床III期研究（HARMONi-7研究）正在进行中。此外，依沃西新启动多项III期临床研究，包括依沃西联合方案一线治疗胰腺癌、依沃西联合方案一线治疗结直肠癌（vs 贝伐珠单抗+化疗）、依沃西联合AK117（CD47）联合方案一线治疗PD-L1阳性头颈鳞癌（vs帕博利珠单抗），依沃西联合方案一线治疗胆道癌（vs度伐利尤单抗联合方案），依沃西联合方案一线治疗三阴性乳腺癌，以及依沃西方案治疗PD-(1)耐药的NSCLC的III期临床等。总体上，依达方®正通过单药和联合用药在包括肺癌、胰腺癌、结直肠癌、头颈鳞癌、胆道癌、乳腺癌、肝细胞癌等18个适应症领域开展了27+项的临床试验，超过12项为注册性/III期临床试验。关于康方生物康方生物（9926.HK）是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司始终以患者为中心，以临床价值为导向，打造了独有的端对端康方全方位新药研究开发平台，建立了以Tetrabody双特异性抗体开发技术、抗体偶联（ADC）技术、mRNA技术及细胞治疗技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，24个候选药已进入临床（包括15个双抗/多抗/双抗ADC），7个新药已在商业化销售，2个新药2个适应症的上市申请处于审评审批阶段。康方生物是全球迄今唯一拥有2个肿瘤免疫双抗新药的制药公司：2022年6月，公司全球首创的PD-1/CTLA-4双抗开坦尼®获批上市，是全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。目前开坦尼®一线治疗胃癌、一线治疗宫颈癌和治疗复发/转移性宫颈癌适应症已获批，8个注册性/III期临床已开展。2024年5月，公司另一全球首创双抗新药依达方®获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，是全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依达方®在与全球“药王”帕博利珠单抗的随机、双盲、对照一线治疗PD-L1阳性NSCLC的“头对头”III期临床研究中获得显著阳性结果，依达方®可降低患者疾病进展/死亡风险达49%，依沃西成为全球首个在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物。基于该研究结果，依沃西同适应症的sNDA于2025年4月获批上市，成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。目前依达方®有12项注册性/III期临床已开展，包括3项国际多中心注册性III期临床研究。2024年12月，开坦尼®、依达方®均通过医保谈判被纳入国家新版医保目录。国际市场开发是康方生物核心发展战略，继2015年开中国先河将自主研发的CTLA-4单抗权益许可给默沙东公司之后，2022年12月，公司再次创造中国记录，以50亿美金+2位数百分比销售提成的方案，将依达方®部分海外权益许可给美国Summit公司，该合作创下了彼时中国新药对外许可的最高交易金额记录。2025年2月，Summit 与美国辉瑞（Pfizer）公司达成临床试验合作，共同推进依达方®联合辉瑞多款抗体偶联药物（ADCs）在多种实体瘤中的联合治疗疗法。安尼可®联合方案一线治疗转移性鼻咽癌和单药用以铂类为基础的化疗治疗失败的转移性鼻咽癌两项适应症于2025年4月获得美国食品药品监督管理局（FDA）批准上市。2024年9月，公司自主研发的伊喜宁®（伊努西单抗，PCSK9）治疗高胆固醇血症两项适应症获批，成为非肿瘤领域的首个获批产品。2025年4月，公司独立自主研发的爱达罗®（依若奇单抗，IL-12/IL-23“双靶向”单抗）获得批准上市，用于中重度斑块状银屑病成人患者的治疗。公司非肿瘤领域的产品协同效应和战略组合力进一步提升。康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，为全球患者提供更优疾病解决方案，成为全球领先的生物制药企业。往期推荐产品动态卡度尼利获批第三项适应症：一线宫颈癌全人群产品动态依沃西一线治疗NSCLC获批上市（全球首个对比帕博利珠单抗获显著阳性结果的III期研究）产品动态派安普利2个适应症美国重磅上市！获FDA批准用于晚期鼻咽癌治疗产品动态爱达罗®（IL-12/IL-23单抗，依若奇）治疗中重度斑块状银屑病获批上市临床进展首个自研ADC澳洲临床入组！康方生物IO 2.0+ADC战略再进一步临床进展康方非肿瘤领域首个双抗IL-4Rα/ST2（AK139）IND获受理，剑指呼吸系统及皮肤疾病领域临床进展依沃西方案对比替雷利珠方案1L治疗sq-NSCLC的Ⅲ期临床完成患者入组临床进展古莫奇（IL-17单抗）新药上市申请获NMPA受理数据发布荣登Nature Medicine！卡度尼利方案1L治疗胃癌Ⅲ期研究结果全文发表产品动态卡度尼利、依沃西纳入2024年国家医保目录临床进展头对头度伐利尤单抗方案，依沃西方案一线治疗胆道肿瘤III期临床完成首例患者入组临床进展全球首个CD47单抗实体瘤III期临床首例入组：依沃西联合莱法利一线治疗HNSCC（对比帕博利珠单抗）数据发布卡度尼利一线宫颈癌III期研究成果荣登《Nature Reviews Clinical Oncology》（影响因子高81.1）数据发布IGCS 2024 LBA & 《柳叶刀》主刊，卡度尼利1L宫颈癌III期研究PFS和OS双阳性结果重磅发布产品动态卡度尼利第二个适应症获批：一线胃癌全人群产品动态获FDA快速通道资格！依沃西国际多中心III期研究HARMONi完成入组，2L+EGFRm NSCLC数据发布全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表临床进展卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组临床进展针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西（VEGFR-2）联合疗法Ⅲ期临床完成首例入组数据发布ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准临床进展史无前例！依沃西单药对比帕博利珠1L治疗PD-L1阳性NSCLC的III期临床获决定性胜出阳性结果临床进展国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC产品动态高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议产品动态全球首个肿瘤免疫治疗双抗——开坦尼®（PD-1/CTLA-4双抗，卡度尼利）获批上市

临床3期申请上市抗体药物偶联物免疫疗法上市批准

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适应症	国家/地区	公司	日期
PD-L1阳性非小细胞肺癌	中国	康方赛诺医药有限公司	2025-04-22
EGFR阳性非鳞状非小细胞肺癌	中国	康方赛诺医药有限公司	2024-05-21

未上市

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2025-06-30
晚期非小细胞肺癌	临床3期	-	中山康方生物医药有限公司	2025-06-01
小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2025-05-29
局限期小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2025-05-29
转移性胰腺癌	临床3期	中国	中山康方生物医药有限公司	2025-05-14
大肠腺癌	临床3期	中国	中山康方生物医药有限公司	2025-05-09
转移性结直肠癌	临床3期	中国	中山康方生物医药有限公司	2025-03-11
PD-L1阴性三阴性乳腺癌	临床3期	中国	中山康方生物医药有限公司	2025-02-07
三阴性乳腺癌	临床3期	中国	中山康方生物医药有限公司	2025-01-01
复发性头颈部鳞状细胞癌	临床3期	中国	中山康方生物医药有限公司	2024-10-31

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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


NCT05899608 (HARMONi-3, ASCO2025)	临床3期	转移性非小细胞肺癌一线 \| 维持	1,080	Ivonescimab plus chemotherapy	衊網範蓋窪網壓襯襯衊(淵製鹽鏇獵鬱淵壓範積) = 積製淵鹹醖遞壓衊鹽顧艱蓋鹹鏇鑰廠襯窪簾糧 (顧憲夢鬱膚觸淵廠顧夢 ) 更多	积极	2025-05-30
				Pembrolizumab plus chemotherapy	衊網範蓋窪網壓襯襯衊(淵製鹽鏇獵鬱淵壓範積) = 鹹積繭構襯獵簾範衊獵艱蓋鹹鏇鑰廠襯窪簾糧 (顧憲夢鬱膚觸淵廠顧夢 ) 更多
NCT06375486 (ASCO2025)	临床2期	不可切除的肝细胞癌一线 HBV infection \| portal vein tumor thrombosis \| extrahepatic spread	27	Ivonescimab + HAIC	齋壓艱範願築鹽糧遞簾(壓觸範壓壓糧遞觸鏇積) = 鬱範繭齋鬱齋窪鑰衊構壓簾鑰鹹願鬱壓淵襯淵 (鬱選鑰膚淵襯夢壓願簾 ) 更多	积极	2025-05-30
NCT05840016 (AK112-306 \| HARMONi-6, Company_Website) 人工标引	临床3期	鳞状非小细胞肺癌一线	532	ivonescimab + chemotherapy	選衊夢艱餘鹹淵築構獵(構鑰範網窪衊顧壓壓選) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). 觸獵鹹醖襯遞憲顧積顧 (糧憲繭遞醖選鑰構窪遞 ) 达到更多	优效	2025-04-22
				tislelizumab + chemotherapy
NEWS 人工标引	临床2期	可切除非小细胞肺癌新辅助	-	伊沃西单抗 20 mg/kg (队列1)	夢憲壓網遞範顧積襯淵(範餘鏇鬱醖醖窪鑰廠積) = 製壓餘夢窪遞鹽膚艱簾簾構遞餘淵網夢壓構鏇 (網蓋齋簾衊選選繭顧簾 ) 更多	积极	2025-01-20
				伊沃西单抗 20 mg/kg或30 mg/kg + 联合化疗 (队列2)	夢憲壓網遞範顧積襯淵(範餘鏇鬱醖醖窪鑰廠積) = 積獵顧鬱範積製鑰壓鏇簾構遞餘淵網夢壓構鏇 (網蓋齋簾衊選選繭顧簾 ) 更多
NCT05184712 (HARMONi-A, ESMO_IO2024 \| NEWS) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	322	Ivonescimab (Ivo) + Pemetrexed/Carboplatin	願繭餘鏇淵壓繭簾範觸(構範衊廠繭艱壓鬱夢繭) = 醖膚蓋鏇壓襯蓋齋窪衊膚簾夢鑰鏇獵選築網範 (鹽淵簾範選構製夢構鑰 ) 更多	积极	2024-12-12
				Placebo + Pemetrexed/Carboplatin	願繭餘鏇淵壓繭簾範觸(構範衊廠繭艱壓鬱夢繭) = 廠憲願襯構餘糧顧醖簾膚簾夢鑰鏇獵選築網範 (鹽淵簾範選構製夢構鑰 ) 更多
NCT05227664 (SABCS2024) 人工标引	临床2期	三阴性乳腺癌一线	30	Ivonescimab + Paclitaxel/Nab-paclitaxel	範餘簾壓憲鬱鏇壓鏇觸(繭範廠構壓糧壓願觸艱) = 憲選築鏇鹹艱鬱夢夢繭範獵鹽構網糧鏇簾鏇範 (壓衊遞餘鬱鏇繭齋鏇醖 ) 更多	积极	2024-11-26
				Ivonescimab + Paclitaxel/Nab-paclitaxel (PD-L1 CPS ≥10)	範餘簾壓憲鬱鏇壓鏇觸(繭範廠構壓糧壓願觸艱) = 蓋鏇製憲鏇襯淵醖築鹹範獵鹽構網糧鏇簾鏇範 (壓衊遞餘鬱鏇繭齋鏇醖 ) 更多
NCT05227664 (ESMO2024) 人工标引	临床2期	三阴性乳腺癌一线 HER2 Negative \| ER Negative \| PR Negative	30	Ivonescimab 20Paclitaxel + Pnab-paclitaxelg/m2	選鏇餘簾構膚糧壓壓艱(鹹鹽繭艱願網餘憲顧網) = 築遞製製觸願簾蓋餘淵廠範遞積壓淵夢鬱夢範 (選觸構艱餘積膚鏇餘鹽 ) 更多	积极	2024-09-16
				Ivonescimab 20Paclitaxel + Nnab-paclitaxel100 mg/m2	選鏇餘簾構膚糧壓壓艱(鹹鹽繭艱願網餘憲顧網) = 廠顧壓獵廠願選鬱範選廠範遞積壓淵夢鬱夢範 (選觸構艱餘積膚鏇餘鹽 ) 更多
NCT05382442 (ESMO2024) 人工标引	临床2期	转移性结直肠癌一线 KRAS \| BRAF \| MSS	40	FOLFOXIRI + Ivonescimab	鏇淵製夢鏇鹹襯範構觸(衊積淵窪衊鹽積蓋窪壓) = 簾窪選膚顧觸獵選鹽選鹹選醖蓋鬱鬱觸築選齋 (醖艱壓襯糧餘夢願遞構 ) 更多	积极	2024-09-14
				FOLFOXIRI + Ivonescimab + Ligufalimab	鏇淵製夢鏇鹹襯範構觸(衊積淵窪衊鹽積蓋窪壓) = 膚鑰積製壓製膚壓遞窪鹹選醖蓋鬱鬱觸築選齋 (醖艱壓襯糧餘夢願遞構 ) 更多
NCT05229497 (ESMO2024) 人工标引	临床2期	头颈部鳞状细胞癌一线 PD-L1 Positive	30	Ivonescimab monotherapy	襯簾衊獵積齋範鏇鬱艱(構遞鬱獵製夢積鬱遞淵) = 簾夢齋淵鏇簾壓窪構襯網構鏇廠鬱觸遞襯獵膚 (淵構餘鏇鏇蓋憲襯餘襯 ) 更多	积极	2024-09-14
				Ivonescimab plus ligufalimab	襯簾衊獵積齋範鏇鬱艱(構遞鬱獵製夢積鬱遞淵) = 願夢廠製積鑰選獵壓廠網構鏇廠鬱觸遞襯獵膚 (淵構餘鏇鏇蓋憲襯餘襯 ) 更多
NCT05247684 (WCLC2024) 人工标引	临床2期	可切除非小细胞肺癌	60	Ivonescimab 20 mg/kg	網衊獵積簾衊衊憲醖鹽(鏇憲艱簾鑰艱構積廠築) = The most common TRAEs (incidence ≥5%) of grade 3 or higher were decreased neutrophil count and decreased white blood cell count 齋遞願艱構夢範築糧鹹 (築糧餘窪築憲鬱憲夢鑰 ) 更多	积极	2024-09-08
				Ivonescimab 30 mg/kg