阿地白介素(Aldesleukin) - 药物靶点：IL-2R_在研适应症：肾细胞癌，复发性神经母细胞瘤，HPV阳性的口咽鳞状细胞癌_专利_临床

概要

基本信息

药物类型

白细胞介素

别名

125-L-Serine-2-133-interleukin 2、IL-2 (Chiron)、Interleukin-2 (Chiron)

+ [12]

靶点

IL-2R

作用方式

激动剂、刺激剂

作用机制

IL-2R激动剂(白细胞介素-2受体复合体激动剂)、免疫刺激剂

治疗领域

肿瘤泌尿生殖系统疾病皮肤和肌肉骨骼疾病+ [8]

在研适应症

肾细胞癌复发性神经母细胞瘤HPV阳性的口咽鳞状细胞癌+ [31]

非在研适应症

获得性免疫缺陷综合征急性嗜碱性粒细胞白血病急性嗜酸细胞白血病+ [114]

原研机构

Chiron Corp.

在研机构

Iovance Biotherapeutics, Inc.

Roswell Park Comprehensive Cancer Center

Rutgers State University of New Jersey

+ [9]

非在研机构

Fred Hutchinson Cancer Research CenterUniversity of Minnesota Masonic Cancer Center

Chiron Corp.

+ [16]

权益机构

Clinigen Ltd.

Novartis AG

Prometheus Biosciences, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1992-05-05),

肾细胞癌

最高研发阶段(中国)临床1期

特殊审评孤儿药 (美国)、孤儿药 (韩国)

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结构/序列

Sequence Code 720

来源: *****

关联

463

项与阿地白介素相关的临床试验

NCT07700121

/ Not yet recruiting早期临床1期IIT

PICSTAT (PET Imaging of CD8 for Selection of Tumors for Autologous TIL): A Pilot Study Assessing the Use of CD8 PET/CT (Zr-89 Crefmirlimab Berdoxam) to Enhance Lifileucel (AMTAGVI) Efficacy in Patients With Treatment Refractory Stage IV Melanoma

This prospective, single-center pilot study is being performed to find out whether Zr-89 crefmirlimab berdoxam "CD8 PET/CT" scans can improve the effectiveness of the tumor-infiltrating lymphocyte (TIL) therapy called lifileucel ("Study Treatment") in treating metastatic melanoma.
Participants must first provide consent to the companion protocol (UPCC 19426, PICSTAT CD8 PET) before being eligible to consent to this protocol.

开始日期2026-10-01

申办/合作机构

Abramson Cancer Center

[+1]

NCT06904066

/ Recruiting临床1期IIT

A Phase I Study of Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Other Hematologic Malignancies

Background:
Blood cancers (such as leukemias) can be hard to treat, especially if they have mutations in the TP53 or RAS genes. These mutations can cause the cancer cells to create substances called neoepitopes. Researchers want to test a method of treating blood cancers by altering a person s T cells (a type of immune cell) to target neoepitopes.
Objective:
To test the use of neoepitope-specific T cells in people with blood cancers
Eligibility:
People aged 18 to 75 years with any of 9 blood cancers.
Design:
Participants will have a bone marrow biopsy: A sample of soft tissue will be removed from inside a pelvic bone. This is needed to confirm their diagnosis and the TP53 and RAS mutations in their cancer cells. They will also have a skin biopsy to look for these mutations in other tissue.
Participants will undergo apheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.
The T cells will be grown to become neoepitope-specific T cells.
Participants receive drugs for 3 days to prepare their body for the treatment. The modified T cells will be given through a tube inserted into a vein. Participants will need to remain in the clinic at least 7 days after treatment.
Participants will have 8 follow-up visits in the first year after treatment. They will have 6 more visits over the next 4 years. Long-term follow-up will go on for 10 more years.

开始日期2026-09-14

申办/合作机构

National Cancer Institute

NCT07225439

/ Recruiting临床1期IIT

Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma

This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.
NK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death).
Participants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.

开始日期2026-09-01

申办/合作机构

The Case Comprehensive Cancer Center

[+1]

100 项与阿地白介素相关的临床结果

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100 项与阿地白介素相关的转化医学

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100 项与阿地白介素相关的专利（医药）

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2,792

项与阿地白介素相关的文献（医药）

2026-07-01·ARCHIVES OF TOXICOLOGY

Mechanistic insights into PFAS-induced effects on B lymphocyte activation and antibody secretion

Article

作者: Paini, Alicia ; Hoogenboom, Ron L A P ; Iulini, Martina ; Fragki, Styliani ; Russo, Giulia ; Pappalardo, Francesco ; Corsini, Emanuela ; Beekmann, Karsten ; Janssen, Aafke W F ; Galbiati, Valentina

Abstract:

Per- and polyfluoroalkyl substances (PFASs) are man-made organofluoride chemicals widely present in the environment, with exposure associated to various adverse health effects, including immunotoxicity. Recently, we showed that PFASs can directly impair antibody production, leading to decreased immunoglobulin (Ig) M and IgG release in human peripheral blood mononuclear cells (PBMCs) obtained from both male and female healthy donors. However, the underlying molecular mechanisms remain largely unknown. In this study, we aimed to address this gap by performing RNA sequencing to identify pathways and genes potentially involved in the observed immunotoxic effects. PBMCs were exposed to selected PFASs for 24 h, and to assess effects on antibody secretion, a subset was subsequently stimulated with CpG oligodeoxynucleotide ODN2006 and rhIL-2 for an additional six days. Transcriptomic analysis indicated activation of the glucocorticoid receptor (GR) and associated signaling pathways, supported by the upregulation of several GR-target genes and the prediction of glucocorticoids or the GR agonist dexamethasone as upstream regulators in Ingenuity Pathway Analysis. Moreover, the inhibitory effects of PFASs on antibody secretion were shown to be reversable by the GR antagonist Mifepristone, supporting the involvement of the GR in PFAS-mediated suppression of antibody secretion. Overall, this research advances our understanding of PFAS-induced immunotoxicity and identifies potential biomarkers for evaluating PFAS exposure and its associated health effects.Graphical abstract

2026-06-01·PLANT DISEASE

QTL Associated with Partial Resistance to Root Rot of Field Pea Caused by Aphanomyces euteiches and Fusarium avenaceum in Two RIL Populations

Article

作者: Strelkov, Stephen E. ; Chang, Kan-Fa ; Fredua-Agyeman, Rudolph ; Wu, Longfei ; Gossen, Bruce D. ; Hwang, Sheau-Fang

Deployment of polygenetic resistance is a promising approach for minimizing losses caused by the root rot complex of pea (Pisum sativum). Previous studies have identified quantitative trait loci (QTL) associated with partial resistance to Aphanomyces euteiches and Fusarium graminearum on chromosome 4/linkage group (LG) IV. The objective of this study was to identify consistent QTL associated with resistance to A. euteiches and F. avenaceum in two recombinant inbred line (RIL) populations derived from ‘Reward’ × ‘00-2067’ (RIL-1) and ‘Carman’ × ‘00-2067’ (RIL-2). RIL-1 was inoculated with F. avenaceum, and RIL-2 with both A. euteiches and F. avenaceum. Plant height, plant vigor, and root rot severity were assessed across three repeated greenhouse experiments. A 13.2K single nucleotide polymorphism array and 222 simple sequence repeat markers were used to genotype the two RIL populations. Thirty QTL were mapped on two separate genetic maps. A highly consistent region located on chromosome 2/LG II, encompassing the previously identified QTL Ae-Ps2.2 and Fsp-Ps2.1, had a major effect on resistance to A. euteiches and F. avenaceum (individual QTL R 2 = 8 to 51%). One or more QTL associated with resistance to A. euteiches and F. avenaceum were linked to the previously identified genes Ae-Ps4.5 & Fwn4.1 and Ae-Ps4.1, respectively. These findings provide valuable targets for marker-assisted selection and can accelerate the development of pea cultivars with broad-spectrum resistance to root rot, thereby enhancing crop productivity and sustainability.

2026-04-07·PNAS nexus

Combined administration of interleukin-2 and 18 with anti-PD-L1 antibody induces CCL5-positive CD8 T cells to suppress liver tumors

Article

作者: Tanaka, Yoshimasa ; Yamaji, Kenzaburo ; Kawaji, Hideya ; Kimura, Masamichi ; Harada, Kenichi ; Okamura, Haruki ; Kimura, Kiminori ; Imamura, Jun ; Kohara, Michinori

Abstract:

Remarkable progress has been made in cancer immunotherapy, partly because of the development of immune checkpoint inhibitors. However, their efficacy varies across cancer types, with limited response observed in solid tumors, such as hepatocellular carcinoma (HCC). The primary cause of this low efficacy is insufficient infiltration of effector cells, such as cytotoxic CD8+ T cells, into the tumor tissue. This study investigated whether recombinant interleukin (rIL)-2, rIL-18, and antiprogrammed cell death-ligand 1 (αPD-L1) antibody (Ab) could serve as novel immunotherapies for HCC. Multidrug resistance gene 2-deficient mice, a spontaneously occurring liver cancer model associated with aging, were administered rIL-2, rIL-18, and αPD-L1Ab. Antitumor effects were evaluated using computed tomography and serum alpha-fetoprotein levels. Significant tumor shrinkage was observed in the rIL-2+rIL-18+αPD-L1Ab group, but not in the rIL-2+αPD-L1Ab or rIL-18+αPD-L1Ab groups. Concurrent administration of αCD8-neutralizing antibody abolished the antitumor effect, indicating CD8+ T-cell dependency. Spatial gene expression profiling revealed that intratumoral CD8+ effector T cells express and secrete CCL5 after treatment, promoting CD8+ T-cell mobilization to the liver and enhancing antitumor efficacy. Pretreatment with a CCL5 neutralizing antibody suppressed CD8+ cell infiltration into the tumor, eliminating the antitumor effect. The triple combination therapy used in this study promotes the infiltration and maintenance of CD8+ T cells in the liver, suggesting a promising new immunotherapy for HCC.

270

项与阿地白介素相关的新闻（医药）

2026-09-04

·GlobeNewswire-Health Care

Iovance Biotherapeutics to Present at Upcoming Conferences

SAN CARLOS, Calif., Sept. 04, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that senior leadership plans to present at the following upcoming conferences: Wells Fargo 21st Annual Healthcare ConferenceFireside Chat: September 10, 2026, at 11:00 a.m. ETBoston, MA H.C. Wainwright 28th Annual Global Investment ConferencePresentation: September 15, 2026, at 4:00 p.m. ETNew York, NY The live and archived webcast will be available at https://ir.iovance.com/news-events/events-presentations. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com. Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com. Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. CONTACTS InvestorsIR@iovance.com650-260-7120 ext. 150 MediaPR@iovance.com 650-260-7120 ext. 150

上市批准细胞疗法免疫疗法

2026-09-04

·BioSpace

Iovance Biotherapeutics to Present at Upcoming Conferences - September 4, 2026

SAN CARLOS, Calif., Sept. 04, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that senior leadership plans to present at the following upcoming conferences: Wells Fargo 21st Annual Healthcare Conference Fireside Chat: September 10, 2026, at 11:00 a.m. ET Boston, MA H.C. Wainwright 28th Annual Global Investment Conference Presentation: September 15, 2026, at 4:00 p.m. ET New York, NY The live and archived webcast will be available at . About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics , Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi ® (li ) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit . ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on . Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); CONTACTS Investors IR@iovance.com 650-260-7120 ext. 150 Media PR@iovance.com 650-260-7120 ext. 150

2026-09-02

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破4-1BB成药魔咒，先信达一步，引爆IO2.0时代

三十年的魔咒，被一张 NDA 受理通知单掀开了。8 月 21 日，CDE 官网显示，维立志博自主研发的 PD-L1/4-1BB 双抗 LBL-024（维利信）上市申请正式获受理。这是全球首个申报上市的 4-1BB 靶向药——一个被 MNC 判了数十年“死刑”的靶点，第一次站到了兑现前夜。图源：CDE官网要知道，为了端平 4-1BB 这块“毒性与疗效”的跷跷板，BMS 折过戟、辉瑞吃过亏、Genmab 也退过赛。而破咒的，却是一家中国 biotech，靠的不是蛮力，是一把“条件性激活”的手术刀。但这远不止维立志博一家的事。它更像一个信号：IO2.0 的钟，被中国资产集体敲响了。K 药统治免疫治疗十年后，康方用 PD-1/VEGF 堵上了血管的漏洞，信达用 PD-1/IL-2 破解耐药，维立志博用 4-1BB 焐热冷肿瘤——三种答案，同一个时间窗口，先后奔向兑现。01同为PD-L1/4-1BB 双抗分子，为何Genmab被退货，维立志博却拿下全球首发。4-1BB是一种表达于T细胞表面的共刺激受体，负责增强T细胞活化、增殖与免疫功能。作为一种全新的肿瘤免疫靶点，4-1BB曾被视为PD-1、CTLA-4的“最佳接棒者”。BMS“贸然出击”，以激动剂的分子形式最早将4-1BB推入临床，最终却以致死性肝毒性的严重安全性问题折戟I期。“一朝被蛇咬，十年怕井绳”，在医药研发史上，一个药物的失败，足以震慑整个靶点的“冒失者”。辉瑞再出手时，避开了小分子的旧路，而是选择复刻PD-1的单克隆抗体路径。同时，充分吸取先行者的教训，将剂量极度压缩以避免肝毒性。遗憾的是，与安全性问题一同消失的，还有疗效（实体瘤后线治疗仅得到3.8% ORR）。没办法，“新”意味着广阔的市场空间，但也意味着“未知”，未知便会带来风险。在药物研发史上，最早下注的“赌徒”，是蒙着眼睛在疗效与安全性的天平两端放置砝码，“打翻”是常有的事。令人愤懑的不是失败，而是自己的失败反而成为了对手的“错题本”。在小分子与单抗都被“试错”之后，Genmab将PD-L1/4-1BB双抗acasunlimab端上了桌。在被BioNTech退货之后，Genmab曾一度将acasunlimab推进至注册性试验阶段，最终却因在疗效和安全性方面表现平平，于2025年底再次沦为“弃子”。理论上，多了PD-L1的空间锚定，4-1BB主要在肿瘤微环境中激活，而大幅降低脱靶毒性。与此同时，PD-L1“松刹车”与4-1BB“踩油门”的组合，将在疗效端释放出“1+1>2”的效应。安全性与疗效的理论正确，那么现实问题出在哪呢？如今，维立志博拿出成功范例，从LBL-024与acasunlimab的对比中，或许能找到答案。从分子设计的角度，acasunlimab采用1:1 价态、双高亲和力的思路，来平衡PD-L1的定位与4-1BB的激活。而LBL-024却通过2:2价态、PD-L1与4-1BB（300:1）的高低亲和力错配设计，实现了4-1BB的条件激活。这就好比给 4-1BB装了一个“肿瘤定位开关”：只有先结合到肿瘤部位的 PD-L1，才打开 4-1BB 激活信号；在外周血和肝脏里，它“默不作声”，从而绕开了肝毒性这个致命陷阱。图源：公开资料优异的临床数据便是这套设计的最强发声。在单药治疗末线EP-NEC的注册性临床试验中，LBL-024拿到了33.3%ORR与11.9 个月的mOS，6个月OS 率达到77.8%。要知道，EP-NEC 是公认的“免疫冷肿瘤”，末线几乎无药可用、mOS 通常只有3-4 个月。而LBL-024作为一个双免疫靶点抗体，却能将这一人群生存期翻倍，意味着该瘤种已被彻底“焐热”。而这一突破只是开始，维立志博的野心远不止于此。截至2026年8月，LBL-024在中国已布局11–13项临床研究，覆盖13个实体瘤适应症，其中NSCLC、EP-NEC、BTC一线等 III 期注册临床正在或即将启动。下一个爆点将在9月14日的2026 WCLC会场引爆。LBL-024联合化疗一线治疗NSCLC的II 期（NCT06783647）将在当日以口头汇报的形式公布。目前已公布的摘要显示，在60例局部晚期或转移性NSCLC中，联合组ORR为65.0%，DCR 为95.0%，此外的生存获益数据将在大会现场公布。在经历了惨痛的失败代价之后，LBL-024终于以双抗的答案打破了4-1BB成药的魔咒。而破咒的关键不在靶点，在工程。三十年没端平的跷跷板，被一个中国 biotech 用“条件性激活 + 亲和力配比”端平了。 02VEGF冲击FDA、IL-2关键数据读出，4-1BB首发上市，2026成为中国IO2.0资产的兑现大年。K药统治免疫治疗十年，但“冷肿瘤”和耐药人群是其始终无法跨过的坎。IO1.0 的尽头，恰恰是下一轮竞赛的起点。IO2.0的起点，碰上中国创新药崛起的十年。于是我们便看到，中国资产正在用三种截然不同的方式，给世界答案。康方，用VEGF堵上了单纯 PD-1“管不住肿瘤血管”的漏洞，献出了依沃西单抗。作为国内首个出海的PD-1/VEGF双抗，其在2024 WCLC公布的HARMONi-2数据，以头对头击败K药的战绩一举成名。自此，中国，PD-1/VEGF双抗，成为MNC扫货的关键词。默沙东、辉瑞、艾伯维争先恐后从礼新、三生制药、荣昌处签下BD大单。康方引爆了中国IO2.0出海的第一波浪潮。更重要的是，这些资产出海后并没有“失声”，而是成为MNC肿瘤免疫管线中的核心项目之一。如今，依沃西已在中国获批3项肺癌适应症。最近的一次是在8月12日，获批用于一线联合化疗治疗晚期鳞状NSCLC，标志着其作为IO联合治疗基石药物的首次突破。图源：CDE官网更重要的是，Summit 于海外提交的上市申请已于2026年1月获 FDA 受理，PDUFA为 2026-11-14。依沃西成为三个方向里商业叙事最完整、最接近“全球上市”的一个。如果说依沃西补的是“血管”，信达补的则是“耐药”。IBI363是一款PD-1/ IL-2融合蛋白。同样面临毒性问题，信达选择对IL-2进行α偏向改造，使其选择性激活肿瘤特异性T细胞。该资产依然获得了MNC的背书，武田以114亿美元的打包式合作方式将其海外权益收入囊中。值得兴奋的是，第二种答案依然是正确的。2026 ASCO上，IBI363在一线NSCLC交出 ORR 86.4%、DCR 100% 的成绩单，在免疫耐药的鳞癌里更是摸到了18.2个月的中位 OS。对一群“PD-1已经没用”的患者，这个数字近乎奇迹。如今，作为全球首个PD-1/IL-2双抗，IBI363已进入III 期，数据读出窗口预计在年底。最后登场的维立志博，并未在该赛道获得MNC合作。但却先信达一步，将PD-L1/4-1BB推进至“临门一脚”时刻。而在Genmab宣布“退赛”之后，目前全球PD-L1×4-1BB双抗能走到临床 II 期及以上的，只有三个中国玩家。齐鲁制药QLF31907 已在2026 ASCO上公布II期黑色素瘤数据；安科生物的 HK010 也刚刚迈进 II 期。三十年来欧美大药企没端平的那块“毒性与疗效”跷跷板，却成为整个中国阵营对一个"不可成药靶点"集体围猎的入口。三款“双抗 + IO”，三个分子，补的是三种不同的短板——血管、耐药、冷肿瘤。从"单靶点解除抑制"，走向“多机制协同重塑肿瘤微环境”。IO2.0时代，在同一个时间窗口里，中国资产把三种答案同时推到了聚光灯下，各自既有重叠，又各有差异化布局。当然，热闹归热闹，进度并不齐整。NDA 已经落地，PDUFA 还没落槌，III 期仍在读出轨道上。"全面爆发"是一个正在进行时的叙事，不是写在纸上的既成事实。2026年，正是将这些“进行时”改写为“完成时”的兑现之年。值得注意的是，维立志博CSO凌虹博士将作为演讲嘉宾出席9月2026柏思荟年会，深度分享其多抗平台开发经验，为广大研发人提供参考经验。

100 项与阿地白介素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00748	-	L03AC01	DB00041

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
肾细胞癌	美国	Chiron Corp.	1992-05-05

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
高风险神经母细胞瘤	临床3期	美国	National Cancer Institute	2009-12-21
急性髓性白血病	临床3期	法国	Chiron Corp.	2005-03-01
复发性神经母细胞瘤	临床3期	美国	National Cancer Institute	2001-10-26
复发性神经母细胞瘤	临床3期	澳大利亚	National Cancer Institute	2001-10-26
复发性神经母细胞瘤	临床3期	加拿大	National Cancer Institute	2001-10-26
复发性神经母细胞瘤	临床3期	新西兰	National Cancer Institute	2001-10-26
急性嗜碱性粒细胞白血病	临床3期	美国	National Cancer Institute	2000-11-01
急性嗜酸细胞白血病	临床3期	美国	National Cancer Institute	2000-11-01
成人急性单核细胞白血病	临床3期	美国	National Cancer Institute	2000-11-01
伴del(5q)成人急性髓系白血病	临床3期	美国	National Cancer Institute	2000-11-01

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临床结果

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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


NCT03260504 (CTgov)	临床1期	晚期肾细胞癌 \| 转移性透明细胞性肾细胞癌	6	Pembrolizumab (Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2))	願膚鹹夢範鹹構鏇鬱艱 = 鏇構構壓糧壓鏇齋齋蓋醖壓鹽蓋憲淵夢鬱鏇築 (襯艱願鹽壓淵築製窪範, 顧願窪觸蓋膚繭蓋鑰網 ~ 製築憲製廠糧餘顧鏇範) 更多	-	2025-12-08
				Pembrolizumab+IL-2 (Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2))	願膚鹹夢範鹹構鏇鬱艱 = 願製衊膚獵獵膚鏇選簾醖壓鹽蓋憲淵夢鬱鏇築 (襯艱願鹽壓淵築製窪範, 選廠艱齋餘壓構廠齋憲 ~ 壓範遞鹽蓋憲獵遞繭餘) 更多
AU-007 (AACR2025)	临床2期	晚期恶性实体瘤	86	AU-007	衊襯積鑰鏇網襯齋範憲(蓋繭鹹膚簾鹹齋齋構簾) = no Grade 5 TRAE occurred 淵繭襯鑰構遞醖膚遞鏇 (構鏇膚網築艱簾觸觸衊 )	积极	2025-04-29
NCT02500576 (CTgov)	临床2期	皮肤黑色素瘤 \| 转移性黑色素瘤	18	I2+fludarabine+cyclophosphamide+MK-3475 (Arm 1)	壓憲壓築範淵鹽範艱積 = 遞積膚憲網淵鹹積顧願鹽繭顧構獵壓網壓選糧 (網艱遞膚築遞積製憲遞, 淵齋蓋範蓋顧憲願衊鑰 ~ 淵鬱鹽襯淵繭壓顧壓鹹) 更多	-	2025-01-15
				TIL+fludarabine+cyclophosphamide+MK-3475+IL-2 (Arm 2)	壓憲壓築範淵鹽範艱積 = 蓋簾鏇積衊簾鑰網製鏇鹽繭顧構獵壓網壓選糧 (網艱遞膚築遞積製憲遞, 製醖衊製構糧膚積網構 ~ 窪簾夢窪鏇鏇淵範範積) 更多
NCT03318900 (CTgov)	临床1/2期	复发性卵巢癌 \| 铂耐药性卵巢癌	5	Cyclophosphamide+IL-2 (Dose Level 1)	鬱壓醖衊壓遞鹽繭壓構(簾獵選獵願齋遞觸遞齋) = 艱簾鹽鑰築壓鏇鹽廠糧願簾顧醖餘網鏇鹹齋範 (衊蓋鬱簾齋襯憲壓簾膚, 蓋鹽網夢製齋憲構選廠 ~ 糧網鑰衊廠齋顧顧膚範) 更多	-	2024-11-07
				Cyclophosphamide+IL-2 (Dose Level 2)	鬱壓醖衊壓遞鹽繭壓構(簾獵選獵願齋遞觸遞齋) = 糧膚壓顧觸築蓋鬱糧鑰願簾顧醖餘網鏇鹹齋範 (衊蓋鬱簾齋襯憲壓簾膚, 願鹹鹹構繭網選襯繭憲 ~ 窪鬱壓壓餘製選壓構艱) 更多
NCT05267626 (SITC2024) 人工标引	临床1/2期	晚期恶性实体瘤	-	AU-007	襯鏇醖獵膚選鏇積鬱鹽(憲鑰蓋網繭繭蓋範膚製) = None 膚憲築窪網觸醖築糧願 (餘繭構鹹餘製蓋遞鹹窪 ) 更多	积极	2024-11-05
				AU-007 + aldesleukin
NCT03296137 (2017-002323-25 \| ###DELETE, CTgov)	临床1/2期	转移性肿瘤 \| 肿瘤	25	infiltrating lymphocytes+ipilimumab+Nivolumab+Fludara+Cyclophosphamide+proleukin (All Participants)	網繭願鏇廠廠顧夢觸衊 = 醖鹽衊襯憲餘鹹壓觸壓簾夢夢醖窪積襯鏇鏇簾 (襯壓獵繭膚壓獵鹹鹹繭, 廠糧襯範齋壓獵窪製鏇 ~ 廠衊觸夢醖糧獵醖顧憲) 更多	-	2024-10-26
				infiltrating lymphocytes+ipilimumab+Nivolumab+Fludara+Cyclophosphamide+proleukin (Treated Participants)	醖窪願鏇鹽範憲醖選鏇(鑰鏇夢廠憲構鹹憲選範) = 艱襯餘壓齋築鏇夢蓋簾齋壓遞獵願繭鏇廠醖獵 (淵餘衊艱顧糧鬱網膚顧, 積艱蓋淵糧顧醖糧繭鑰 ~ 艱廠築壓醖夢衊觸蓋襯) 更多
NCT02027935 (CTgov)	临床2期	转移性黑色素瘤	16	Autologous CD8+ Melanoma Specific T Cells+Ipilimumab+Cyclophosphamide+Aldesleukin	鏇選遞鏇網夢襯膚繭製(獵鬱顧衊網襯襯糧齋壓) = 壓鏇壓願醖鬱醖願顧顧鏇遞獵蓋壓觸膚鏇顧夢 (築餘鏇壓蓋膚醖蓋憲膚, 廠範窪醖鏇齋壓鬱構壓 ~ 糧網鹽範淵蓋齋餘製齋) 更多	-	2024-10-08
NCT03233828 (IL-2, CTgov)	临床3期	皮肤黑色素瘤 \| 可见病灶	1	Aldesleukin (Intralesional IL-2 Injection)	製衊製鏇構繭網選餘簾(窪獵積願鬱網襯醖糧鹽) = 鹽繭鬱膚網壓憲膚鑰憲齋壓範選築淵廠願齋糧 (鹽鹽築艱窪鹽醖艱簾網, 衊網觸遞鹽鬱窪鑰網繭 ~ 艱齋鏇選鏇獵積觸鹹膚) 更多	-	2024-07-24
				Saline (Saline Injection)	製衊製鏇構繭網選餘簾(窪獵積願鬱網襯醖糧鹽) = 膚築襯繭積齋餘遞願範齋壓範選築淵廠願齋糧 (鹽鹽築艱窪鹽醖艱簾網, 鏇壓選糧夢淵願繭襯夢 ~ 範廠築鬱蓋選築網膚夢) 更多
NCT03007238 (CTgov)	临床2期	类固醇难治性移植物抗宿主病 \| 慢性移植物抗宿主病	10	ECP (Treatment (ECP+IL-2))	襯餘積顧蓋鏇窪遞淵鬱 = 窪夢淵夢網憲糧蓋壓壓積蓋築窪獵鑰鑰鹹願膚 (齋鹽廠艱範糧鏇壓膚憲, 遞衊膚鬱範獵膚醖願積 ~ 醖鑰夢範壓窪顧窪鑰鹹) 更多	-	2024-04-08
				ECP (Overall Study)	築鹽顧壓構鬱觸築壓廠 = 鑰窪餘糧顧製廠膚觸膚襯顧窪糧範廠廠糧憲網 (鹽獵顧簾築憲醖遞鏇製, 顧餘衊衊鬱餘餘鬱鹹壓 ~ 壓觸鬱製憲鑰構憲構鹽) 更多
NCT01856023 (PROCLIVITY02, CTgov)	临床4期	转移性黑色素瘤	29	Ipilimumab+High Dose Interleukin-2 (Treatment Arm 1)	鏇構衊鬱淵範鹽壓衊顧 = 壓鹽夢糧顧襯醖製網築憲廠構醖淵觸製夢鹹鑰 (遞積鬱鬱壓艱選遞選積, 淵淵觸積蓋憲簾醖簾構 ~ 鹹衊積蓋簾願網簾糧構)	-	2023-12-05
				Ipilimumab+High Dose Interleukin-2 (Treatment Arm 2)	鏇構衊鬱淵範鹽壓衊顧 = 壓窪願艱淵衊遞願艱顧憲廠構醖淵觸製夢鹹鑰 (遞積鬱鬱壓艱選遞選積, 齋鹹鹹築襯蓋顧窪構製 ~ 繭憲選積膚廠遞鏇築願)