艾帕洛利单抗托沃瑞利单抗(Iparomlimab/Tuvonralimab) - 药物靶点：CTLA4 x PD-1_在研适应症：转移性宫颈癌，复发性宫颈癌，局限期小细胞肺癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-PD-1/CTLA-4 MabPair、Tuvonralimab/Iparomlimab、艾帕洛利托沃瑞利单抗

+ [5]

靶点

CTLA4 x PD-1

作用机制

CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂)、PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病消化系统疾病+ [4]

在研适应症

转移性宫颈癌复发性宫颈癌局限期小细胞肺癌+ [16]

非在研适应症-

原研机构

齐鲁制药有限公司

在研机构

齐鲁制药有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2024-09-26),

转移性宫颈癌复发性宫颈癌

最高研发阶段(中国)批准上市

特殊审评附条件批准 (中国)

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结构/序列

Sequence Code 616720839H

当前序列信息引自: *****

Sequence Code 616720840

当前序列信息引自: *****

关联

53

项与艾帕洛利单抗托沃瑞利单抗相关的临床试验

NCT06809530

/ Not yet recruiting临床1/2期IIT

Intrathecal Administration of Double Checkpoint Inhibition in Combination with Pemetrexed in Patients with Leptomeningeal Metastasis: a Monocentric Phase I/II

The objective of the present study is to evaluate the tolerability, feasibility, safety and therapeutic response of intrathecal administration of double checkpoint inhibition(QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.

开始日期2025-03-01

申办/合作机构

广州医科大学

NCT06787183

/ Not yet recruiting临床2期IIT

Efficacy and Safety of Short Course Radiotherapy Combined With CAPOX and PD-1/CTLA-4 Bispecific Antibody QL1706 in Patients With Liver Metastases From Rectal Cancer

To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.

开始日期2025-03-01

申办/合作机构

福建省肿瘤医院（福建省肿瘤研究所、福建省癌症防治中心）

NCT06829797

/ Not yet recruiting临床2期IIT

A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined with SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma(STAR-03)

To explore the efficacy of Iparomlimab and Tuvonralimab (QL1706) in combination with SOX chemotherapy versus chemotherapy alone for the neoadjuvant treatment of locally-progressed gastric/gastroesophageal union adenocarcinomas by evaluating the complete pathologic remission rate (pCR).

开始日期2025-02-28

申办/合作机构

山东华升医院有限公司

100 项与艾帕洛利单抗托沃瑞利单抗相关的临床结果

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100 项与艾帕洛利单抗托沃瑞利单抗相关的转化医学

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100 项与艾帕洛利单抗托沃瑞利单抗相关的专利（医药）

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3

项与艾帕洛利单抗托沃瑞利单抗相关的文献（医药）

2023-05-08·Journal of hematology & oncology

First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors.

Article

作者: Yan, Wei ; Zhu, Dongyuan ; Qu, Shenhong ; Zhang, Yiping ; Huang, Xian ; Yang, Yingying ; Zang, Aimin ; Zhang, Li ; Peng, Yufeng ; Yu, Zhuang ; Liang, Jin ; Hao, Yanrong ; Liu, Zhi ; Xue, Shilin ; Chen, Junmin ; Chen, Chuanben ; Feng, Weineng ; Liu, Baorui ; Ba, Yi ; Zhao, Yuanyuan ; Su, Wuyun ; Qu, Song ; Chen, Zhendong ; Fanslow, Bill ; Jin, Chuan ; Li, Qingshan ; Ma, Yuxiang ; Yang, Guihong ; Liu, Xianling ; Ouyang, Weiwei ; Zhang, Guoping ; Li, Yong ; He, Jianbo ; Wang, Xiangcai ; Cheng, Ying ; Kang, Xiaoyan ; Yang, Mengxiang ; Zhao, Hongyun

BACKGROUND:

QL1706 (PSB205) is a single bifunctional MabPair (a novel technical platform) product consisting of two engineered monoclonal antibodies (anti-PD-1 IgG4 and anti-CTLA-4 IgG1), with a shorter elimination half-life (t_1/2) for CTLA-4. We report results from a phase I/Ib study of QL1706 in patients with advanced solid tumors who failed standard therapies.

METHODS:

In the phase I study, QL1706 was administered intravenously once every 3 weeks at one of five doses ranging from 0.3 to 10 mg/kg, and the maximum tolerated dose, recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of QL1706 were investigated. In the phase Ib study, QL1706 was administered at the RP2D intravenously every 3 weeks, and the preliminary efficacies in non-small cell lung cancer (NSCLC), nasopharyngeal carcinoma (NPC), cervical cancer (CC), and other solid tumors were evaluated.

RESULTS:

Between March 2020 and July 2021, 518 patients with advanced solid tumors were enrolled (phase I, n = 99; phase Ib, n = 419). For all patients, the three most common treatment-related adverse events (TRAEs) were rash (19.7%), hypothyroidism (13.5%), and pruritus (13.3%). The TRAEs and immune-related adverse events (irAEs) of grade ≥ 3 occurred in 16.0% and 8.1% of patients, respectively. In phase I, 2 of 6 patients in the 10mg/kg group experienced dose-limiting toxicities (DLTs) (grade 3 thrombocytopenia and grade 4 immune-mediated nephritis), so the maximum tolerated dose (MTD) was reached at 10 mg/kg. The RP2D was determined to be 5 mg/kg based on comprehensive analysis of tolerability, PK/PD, and efficacy. For all patients who received QL1706 at the RP2D, the objective response rate (ORR) and median duration of response were 16.9% (79/468) and 11.7 months (8.3-not reached [NR]), respectively; and the ORRs were 14.0% (17/121) in NSCLC, 24.5% (27/110) in NPC, 27.3% (15/55) in CC, 7.4% (2/27) in colorectal cancer, 23.1% (6/26) in small cell lung cancer. For immunotherapy-naive patients, QL1706 exhibited promising antitumor activities, especially in NSCLC, NPC, and CC, with ORRs of 24.2%, 38.7%, and 28.3%, respectively.

CONCLUSIONS:

QL1706 was well tolerated and demonstrated promising antitumor activity in solid tumors, especially in NSCLC, NPC, and CC patients. It is currently being evaluated in randomized phase II (NCT05576272, NCT05179317) and phase III (NCT05446883, NCT05487391) trials. Trial Registration ClinicalTrials.gov Identifier: NCT04296994 and NCT05171790.

Signal transduction and targeted therapy

QL1706 (anti-PD-1 IgG4/CTLA-4 antibody) plus chemotherapy with or without bevacizumab in advanced non-small cell lung cancer: a multi-cohort, phase II study

Article

作者: Xue, Shilin ; Zhang, Yaxiong ; Lu, Lu ; Zhao, Hongyun ; Zhang, Li ; Yang, Yunpeng ; Chen, Gang ; Zhou, Ting ; Kang, Xiaoyan ; Wu, Ting ; Fang, Wenfeng ; Huang, Yan ; Zhou, Ningning ; Zhao, Yuanyuan ; Chen, Likun

Abstract:

First-line chemoimmunotherapy (with or without bevacizumab) has improved outcomes in advanced non-small cell lung cancer (NSCLC). Here, this open-label, multi-cohort phase II study (NCT05329025) was done to investigate the safety and efficacy of QL1706 (a single bifunctional MabPair product against PD-1 and CTLA-4) and chemotherapy with or without bevacizumab in this population. Patients were enrolled into five different cohorts based on genotype (cohorts 1-4, epidermal growth factor receptor [EGFR] wild-type; cohort 5, EGFR-mutant and progressed on EGFR-tyrosine kinase inhibitors [TKIs]). Between June 11, 2021 and December 29, 2021, 91 patients were enrolled. Most frequent treatment-related adverse events (TRAEs) included decreased appetite (60 [65.9%]), anemia (60 [65.9%]), infusion-related reactions (48 [52.7%]), and pruritus (44 [48.4%]). Grade ≥ 3 TRAEs occurred in 30 (33.0%) patients. Twenty-seven (45%) patients with wild-type EGFR achieved partial response (PR) (objective response rate [ORR] = 45%) and had a median progression-free survival (mPFS) of 6.8 months (95% CI: 5.2-9.7). For 31 patients harboring mutated EGFR, 17 (54.8%) achieved PR (ORR = 54.8%), with an mPFS of 8.5 months (95% CI: 5.72-not evaluable). Overall, QL1706 plus chemotherapy, regardless of having bevacizumab, was generally tolerable and had promising antitumor activity for EGFR wild-type advanced NSCLC in first-line setting. Moreover, QL1706 plus chemotherapy and bevacizumab showed favorable antitumor activity for patients who had EGFR mutated NSCLC but failed in TKI therapy, demonstrating a potential for treating this population.

Frontiers in oncology

Case Report: Immune checkpoint inhibitor-related vitiligo-like depigmentation in non-melanoma advanced cancer: A report of three cases and a pooled analysis of individual patient data

作者: Rao, Hui ; Wen, Xuejiao ; Wu, Longqiu ; Huang, Li ; Guo, Zheng ; Zeng, Xiaoli

Background:

Vitiligo-like depigmentation is a common skin adverse event in patients receiving immunotherapy for malignant melanoma, but has been rarely reported in patients with non-melanoma malignancies. To better understand this immune-related adverse event, we reviewed a series of cases of immunotherapy induced vitiligo-like depigmentation in patients with cancers other than malignant melanoma.

Case presentation:

We report three cases of vitiligo-like depigmentation after immune checkpoint inhibitor treatment in gastric adenocarcinoma, lung adenocarcinoma, and squamous cell carcinoma. The first case was treated with camrelizumab, the second was treated with QL1706 injection and sintilimab, and the third was treated with tislelizumab. Pembrolizumab, nivolumab, and ipilimumab caused the majority of vitiligo-like depigmentation, and all three of our patients experienced similar vitiligo-like depigmentation after taking other immune checkpoint inhibitors.

Methods:

Three patients who presented with vitiligo-like depigmentation after treatment with immune checkpoint inhibitors were selected. The clinical features, including radiological and histological examination, and the treatment process were reviewed. Eighteen previously published cases of vitiligo-like depigmentation were also used to analyze the results. The severity of vitiligo-like depigmentation in these cases was graded according to the Common Terminology Criteria for Adverse Events, version 5.0.

Results:

Vitiligo-like depigmentation occurred in 13 men (61.90%) and 8 women (38.10%), aged from 46 to 79 years, with an average age of 69.9 years. Of the 21 reviewed cases, vitiligo-like depigmentation was described in lung cancer (13/21, 61.90%), clear cell renal cell carcinoma (2/21, 9.52%), acute myeloid leukemia (1/21, 4.76%), cholangiocarcinoma (1/21, 4.76%), urothelial carcinoma (1/21, 4.76%), oral squamous cell carcinoma (1/21, 4.76%), esophageal squamous cell carcinoma (1/21, 4.76%), and gastric adenocarcinoma (1/21, 4.76%). The severity of vitiligo-like depigmentation after immunotherapy was unrelated to sex, age, cancer type, previous autoimmune diseases, and medication.

Conclusions:

Vitiligo-like depigmentation is a non-specific skin adverse event in melanoma immunotherapy, but arises as a direct result of treatment with immune checkpoint inhibitors. Vitiligo-like depigmentation has an irregular location, is not limited to direct sunlight cracks, and has also been reported on hair on the head, eyelashes, and eyebrows. People without any skin or autoimmune diseases can also experience vitiligo-like depigmentation after immunotherapy; the incidence of which is irrespective of sex, age, cancer type, previous autoimmune diseases, and medication.

136

项与艾帕洛利单抗托沃瑞利单抗相关的新闻（医药）

2025-03-04

·摩熵医药

两大重磅新药上市申请遭驳回，齐鲁制药和乐普生物双双受挫！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。根据国内现行的新药审批流程，如果药物顺利获批，则会受到“药品批准证明文件送达信息”，如果收到的是“药品通知件”，则表示此次申请暂未成功获批。当然，收到“药品通知件”，也并不意味着药物上市的彻底失败，理论上存在着完善补充数据之后，继续申报流程的可能性。 2025年3月3日，国家药监局网站公布当日药品通知件送达信息，涉及两大重磅药物品种。截图来源：NMPA官网其中一个产品是齐鲁制药的艾帕洛利单抗注射液，为PD-1单抗，2023年9月17日，其上市申请获得CDE受理，适应症为不可切除或转移性DNA错配修复缺陷（dMMR）或高度微卫星不稳定（MSI-H）实体瘤。 2024年9月30日，齐鲁制药的艾帕洛利托沃瑞利单抗注射液获批上市，其为艾帕洛利单抗（PD-1）和托沃瑞利单抗（CTLA-4）的复方制剂，用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。齐鲁制药复方获批而单方被否，猜测CMC原因的可能性较低，临床原因概率较大。毕竟抗PD-1单抗获批上市的品种众多，审评机构对于后来者临床优势有更高的要求。据摩熵医药-中国药品审评库显示，国内已有16个品种被批准生产/进口，竞争非常激烈。截图来源：摩熵医药中国药品审评数据库第二个产品为乐普生物的注射用维贝柯妥塔单抗，研发代号MRG003，为靶向EGFR的ADC，在研适应症为二线或以上NPC（鼻咽癌）或HNSCC（头颈部鳞状细胞癌）。其中鼻咽癌适应症上市申请于2024年9月获得受理，并获优先审评资格。在晚期鼻咽癌的治疗上，其 II 期研究结果显示，61 例既往经铂类和 / 或 PD-(L) 1 抑制剂治疗失败的患者接受治疗后，2.0mg/kg 队列的客观缓解率（ORR）达到 39.3%，2.3mg/kg 队列的 ORR 更是高达 55.2%，疾病控制率（DCR）分别为 71.4% 和 86.2% 。该产品被寄予了很高的期望，各种荣誉加持：FDA突破性疗法，国内有优先审评和突破性治疗。今天乐普生物最新公告称，出现通知件原因为CDE要求补充相关资料，所以企业撤回申请，并于今天重新递交上市申请。公司股价盘中一度跌了17.85%，收盘跌幅缩窄至4.82%。截图来源：企业公告据摩熵医药-全球药物研发数据库显示，针对EGFR靶点的ADC药物中，MRG003在全球位于领先的位置。全球仅有MRG003处于申请上市阶段，临床III期阶段除了该药的头颈部鳞状细胞癌适应症外，还有百利天恒的BL-B01D1（EGFR×HER3 双靶点ADC）单药用于既往含铂化疗及抗PD-1/PD-L1单抗治疗失败的复发性小细胞肺癌；石药集团SYS6010（EGFR ADC）单药用于治疗经EGFR-TKI和含铂化疗治疗失败的EGFR突变阳性晚期非小细胞肺癌，已获得国家药品监督管理局的突破性治疗认定。截图来源：摩熵医药全球药物研发数据库小结新药研发面临多重风险，涵盖从临床前研究到上市后的全生命周期。法规政策变化（如审批标准提升）和市场需求波动（如竞品上市或治疗手段革新）显著影响研发回报。为应对这些风险，需实时跟进竞品进度，识别潜在的市场窗口期。同时，动态调整申报策略，根据竞品数据优化试验设计（如调整入组标准或终点指标）。通过整合风险管理工具（如风险评估矩阵）与实时数据分析，企业可提升决策效率，降低研发不确定性。 END 本文为原创文章，转载请留言获取授权近期热门资源获取 CGT产业现状与未来趋势蓝皮书-202406 中药行业现状与未来趋势白皮书-202407 2023年医药企业综合实力排行榜-202408 跨越国界，引领创新：中国药企出海的布局实践-202408 专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409 中国放射性药物市场现状分析报告-202410 合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410 中国合成生物学创投市场分析报告-202410 中国糖尿病临床诊疗与药物多渠道市场数据分析-202411 基于剂型改良的复杂注射剂分析--微球篇-202411 2024医美注射材料市场发展分析报告-20241213 国家药品集采跟踪报告-前9批次集采回顾与展望-202411 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

优先审批突破性疗法申请上市上市批准抗体药物偶联物

2025-03-04

·抗体圈

上市双双受挫！齐鲁PD-1、乐普EGFR ADC未获批

据国家药品监督管理局（NMPA）最新药品通知件送达信息，齐鲁制药艾帕洛利单抗注射液（受理号：CXSS2300077，注册分类：1类）和乐普生物注射用维贝柯妥塔单抗（受理号：CXSS2400102，注册分类：1类，适应症：既往经至少二线系统化疗和PD-1/PD-L1抑制剂治疗失败的复发/转移性鼻咽癌）在列。一般来说，出现在通知件中通常意味着两种可能：一是该药物的上市申请可能被不予批准，二是企业可能主动撤回了申请。然而，目前尚无法确定具体是哪种情况。不过，不管何种原因均表明两家药企相应新药无法如期上市。 1、齐鲁PD-1单抗公开信息显示, 艾帕洛利单抗注射液(研发代码:QL1604)为齐鲁制药研发的全球首个PD-1/CTLA-4双功能组合抗体。该药物由靶向PD-1的艾帕洛利单抗和靶向CTLA-4的托沃瑞利单抗组成，具有同时阻断PD-1和CTLA-4两条免疫检查点通路的协同作用机制。 2023年12月，齐鲁制药在2023年ESMO大会中公布其单药治疗DNA错配修复缺陷（dMMR）或高度微卫星不稳定（MSI-H）实体瘤的II期临床研究结果。 2020年6月至2023年1月，共纳入120例dMMR/MSI-H实体瘤患者，其中结直肠癌80例（66.7%），胃癌18例（15.0%），其它实体瘤22例（18.3%）；97.5%患者入组时疾病分期IV期，中位治疗线数为2.0（范围：0–6）。有效性方面，截至2023年7月20日，中位随访时间13.6个月，11例患者完全缓解（CR），44例部分缓解（PR），ORR为45.8%（95%CI: 36.7%–55.2%），疾病控制率（DCR）为77.5%（95%CI: 69.0%–84.6%）。结直肠癌患者ORR和DCR分别为42.5%（95%CI: 31.5%–54.1%）和77.5%（95%CI: 31.5%–54.1%）。中位缓解持续时间（DoR）尚未达到，6个月和12个月DoR率分别为100%和97.4%；中位无进展生存期（PFS）和中位总生存期（OS）未达到。在安全性方面，治疗期间发生不良事件（TEAEs）的发生率为97.5%。最常见的治疗相关不良事件发生率为25.8%，3级以上TRAEs发生率为5.0%；无治疗药物相关性死亡事件发生。 2024年9月30日，艾帕洛利托沃瑞利单抗注射液曾获得NMPA附条件批准上市，用于治疗既往接受含铂化疗失败的复发或转移性宫颈癌患者。此次艾帕洛利单抗注射液出现在NMPA的通知件待领取信息中，可能与后续的补充申请或其他适应症的审批有关。不过，目前无法确定具体原因是否与药物的审批状态有关，这个还需等待齐鲁的官方回应。 2、乐普EGFR ADC 注射用维贝柯妥塔单抗（研发代码：MRG003）为乐普生物的靶向表皮生长因子受体（EGFR）的ADC，其由EGFR靶向单克隆抗体与强效的微管抑制有效载荷一甲基澳瑞他汀E分子通过缬氨酸－瓜氨酸链接体偶联而成。以高亲和力特异性地结合肿瘤细胞表面的EGFR，通过内吞及溶酶体蛋白酶裂解后释放强效的有效载荷，从而导致肿瘤细胞死亡。其在研适应症为二线或以上NPC（鼻咽癌）或HNSCC（头颈部鳞状细胞癌）。其鼻咽癌适应症2024年向CDE递交上市申请（受理号：CXSS2400102），并获优先审评资格。对于收到药品通知件送达信息，今天乐普生物最新公告进行了回应，出现通知件原因为CDE要求补充相关资料，所以企业撤回申请，并于今天重新递交上市申请。对于之前投资者最担心的，上市未获批准是否是临床数据不佳、CMC问题等，乐普生物也针对大众关心的内容在2025年3月4日上午主动召开了沟通会，详细阐述。根据会议上内容，针对MRG003的相关内容以及乐普生物后续新药计划与近期成果，大致可总结为以下几点： MRG003此次未获批准，并非临床试验数据问题，不影响上市，主要为此次申报材料的错误导致，内部已对团队做出了惩罚。 MRG003此次重新提交上市申请，对产品整体进度影响大致为1-3个月（从2025年底到2026年初），但整体进度上，不影响2026年的医保谈判。 2025年下半年，针对MRG003联合PD-1的相关疗法，会有初期临床数据解读。多抗平台目前已筛选出全新抗体，有望在2025年上半年提交IND。乐普生物业绩正增长，2025年将是收获大年。总结而言，此次MRG003的上市申请提交对产品整体上市与上市进度的影响不大，对关键节点时间（医保谈判）的影响并不大，且由于采用eCTD格式递交注册文件，在审批进度上也可能存在加速，更关键的是对公司后续新药产品的相关审批有着积极影响。本文综合整理自药讯随说、博药速递、一度医药等。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！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。

抗体药物偶联物临床结果上市批准临床2期申请上市

2025-02-21

·求实药社

齐鲁制药PD-1&CTLA-4组合抗体启动食管癌II/III期临床研究

来源：药讯随说 2月19日，齐鲁制药在中国药品审评中心（CDE）临床试验登记平台注册了“一项评价QL1706（艾帕洛利托沃瑞利单抗注射液，商品名：齐倍安）围术期治疗联合新辅助化疗（紫杉醇+卡铂）用于局部晚期可切除食管鳞癌的随机、双盲、安慰剂对照的Ⅱ/Ⅲ期临床研究（CTR20250570）”。研究主要目的为：1、评估QL1706围术期治疗联合新辅助化疗用于局部晚期可切除食管鳞癌的病理完全缓解率（pathology CR，pCR）（Ⅱ期阶段）；2、比较QL1706围术期治疗联合新辅助化疗对比安慰剂联合新辅助化疗用于局部晚期可切除食管鳞癌的无事件生存期（Event-free survival，EFS）（Ⅲ期阶段）。研究以北京肿瘤医院（PI：沈琳&陈可能）和四川肿瘤医院（PI：韩泳涛）为组长单位，另有8家医院参与，计划招募30例患者。 QL1706（艾帕洛利托沃瑞利单抗注射液）是由靶向人程序性死亡受体-1（PD-1）的艾帕洛利单抗与靶向人细胞毒性T淋巴细胞相关蛋白-4（CTLA-4）的托沃瑞利单抗组成的双功能组合抗体。可特异性结合PD-1和CTLA-4受体，阻断PD-1与PD-L1以及CTLA-4与B7-1/B7-2两条免疫检查点信号通路，同时解除两条通路对T淋巴细胞的抑制作用，促进肿瘤特异性的T细胞免疫活化，进而发挥抗肿瘤作用。 2024年10月，中国NMPA附条件批准上市，商品名：齐倍安，用于既往接受含铂化疗失败的复发或转移性宫颈癌的治疗，全球首创PD-1/CTLA-4组合抗体！齐鲁艾帕洛利托沃瑞利单抗获批准。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。联系我们 I-RNA 2025 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！

临床3期上市批准免疫疗法

100 项与艾帕洛利单抗托沃瑞利单抗相关的药物交易

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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
转移性宫颈癌	中国	齐鲁制药有限公司	2024-09-26
复发性宫颈癌	中国	齐鲁制药有限公司	2024-09-26

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
局限期小细胞肺癌	临床3期	-	齐鲁制药有限公司	2025-02-01
鼻咽癌	临床3期	中国	齐鲁制药有限公司	2024-12-19
错配修复缺陷或微高卫星不稳定性结肠癌	临床3期	中国	齐鲁制药有限公司	2024-12-12
晚期肝细胞癌	临床3期	中国	齐鲁制药有限公司	2023-08-07
局部晚期非小细胞肺癌	临床3期	中国	齐鲁制药有限公司	2023-02-10
转移性非小细胞肺癌	临床3期	中国	齐鲁制药有限公司	2023-02-10
非鳞状非小细胞肺癌	临床3期	-	齐鲁制药有限公司	2023-02-01
非小细胞肺癌IIIB期	临床3期	中国	齐鲁制药有限公司	2022-12-08
食管鳞状细胞癌	临床2期	中国	齐鲁制药有限公司	2025-02-19
子宫内膜癌	临床2期	中国	齐鲁制药有限公司	2025-02-01

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临床结果

适应症

分期

评价

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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


NCT05179317 (DUBHE-C-204, ESMO_ASIA2024) 人工标引	临床2期	宫颈癌	60	QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (without bevacizumab)	網網鏇餘夢衊築壓衊衊(網獵繭遞築齋襯遞鹹願) = 齋簾蓋壓廠顧廠簾鏇廠鏇範簾夢構襯襯淵選艱 (窪願獵範遞鏇餘壓膚艱 ) 更多	积极	2024-12-09
				QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (with bevacizumab)	夢鹹觸築網獵襯餘獵鬱(築醖製餘窪鹹膚顧積壓) = 觸窪膚鏇窪襯糧襯夢齋積積遞積糧廠積簾鹹鏇 (簾選齋鑰鑰構鹽糧夢選 ) 更多
NCT05799820 (ESMO_ASIA2024) 人工标引	临床2期	转移性结直肠癌一线 MSI-Low \| Microsatellite Stable (MSS) \| MSI-High	59	QL1706 5 mg/kg (MSI-high)	製膚淵衊積網顧窪鬱廠(膚衊壓繭範鑰遞範繭獵) = 齋繭範衊衊夢顧艱鹽憲網餘襯選範餘襯願獵淵 (選衊獵製範窪遞壓壓壓 ) 更多	积极	2024-12-07
				QL1706 5 mg/kg + Bevacizumab + Oxaliplatin + Capecitabine (MSS/MSI-low and wild-type RAS/BRAF)	製膚淵衊積網顧窪鬱廠(膚衊壓繭範鑰遞範繭獵) = 鏇築簾構獵廠範獵鹽廠網餘襯選範餘襯願獵淵 (選衊獵製範窪遞壓壓壓, 56.2 ~ 82.5) 更多
NCT05329025 (DUBHE-L-201, ESMO_ASIA2024) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	31	QL1706 (5 mg/kg) + Carboplatin + Pemetrexed + Bevacizumab	簾繭鹹憲繭製艱鏇範築(壓淵醖築膚餘鏇願襯襯) = 構糧鬱構艱範構衊鑰鹽構網鑰醖願範積壓窪餘 (鏇膚製夢糧鬱廠願築鹽, 36.0 ~ 72.7) 更多	积极	2024-12-07
NCT05490719 (ESMO2024) 人工标引	临床2期	局部晚期食管鳞状细胞癌一线 PD-L1-positive	39	Paclitaxel, CisplatinQL170606	鬱糧鬱獵餘餘鏇觸鹹鹹(觸鏇範餘齋壓鏇襯糧製) = 簾齋夢夢鏇窪夢襯鬱鬱繭製餘選襯願製衊遞膚 (廠簾廠觸觸蓋夢憲夢糧 ) 更多	积极	2024-09-16
				Paclitaxel+Cisplatin+QL1706 (PD-L1–positive (TPS ≥ 5%))	-
NCT05976568 (DUBHE-H-308, ESMO2024) 人工标引	临床2/3期	晚期肝细胞癌一线	120	QL1706+bev+chemo	築顧顧觸壓糧鑰鑰衊齋(蓋齋壓繭鹽艱艱範餘網) = 顧鬱淵艱壓蓋齋網鹹糧鑰網鏇衊襯齋廠觸醖顧 (艱艱範鏇憲簾憲簾顧憲, 19.2 ~ 54.6) 更多	积极	2024-09-13
				QL1706+bev	築顧顧觸壓糧鑰鑰衊齋(蓋齋壓繭鹽艱艱範餘網) = 衊遞餘願糧蓋糧鑰顧製鑰網鏇衊襯齋廠觸醖顧 (艱艱範鏇憲簾憲簾顧憲, 19.9 ~ 56.1) 更多
NCT05976568 (DUBHE-H-308, NEWS) 人工标引	临床2/3期	晚期肝细胞癌一线	-	QL1706 + Bevacizumab + chemotherapy	鏇築淵獵積鹹鑰艱鏇繭(齋餘網獵膚襯簾艱壓醖) = 艱願膚構醖顧齋鏇觸簾繭製蓋鹽壓積鏇憲鏇餘 (蓋觸餘蓋築簾齋鬱網願 ) 更多	积极	2024-09-13
				QL1706 + Bevacizumab	鏇築淵獵積鹹鑰艱鏇繭(齋餘網獵膚襯簾艱壓醖) = 夢築餘鏇鏇繭築窪艱獵繭製蓋鹽壓積鏇憲鏇餘 (蓋觸餘蓋築簾齋鬱網願 ) 更多
NCT05557565 (DUBHE-C-206, ESGO2024) 人工标引	临床2期	宫颈癌二线	148	QL1706	蓋壓範襯夢顧鬱築積襯(襯觸築築簾構獵憲糧糧) = 鏇觸糧齋衊簾憲糧鹹選築製顧築鬱製簾構築齋 (窪顧鹹齋築築夢繭夢齋, 26.2 ~ 42.0) 更多	积极	2024-03-08
NCT05329025 (Literature) 人工标引	临床2期	晚期非小细胞肺癌一线	91	QL1706+paclitaxel+carboplatin (Squamous non-small cell lung cancer + Cohort 1)	鏇襯觸願鑰艱夢選積憲(鑰鏇淵鏇範廠構齋遞鹽) = Most frequent treatment-related adverse events (TRAEs) included decreased appetite (60 [65.9%]), anemia (60 [65.9%]), infusion-related reactions (48 [52.7%]), and pruritus (44 [48.4%]). 壓膚範鹹築齋憲淵觸廠 (憲淵淵鑰獵鹽壓衊觸獵 ) 更多	积极	2024-01-29
				QL1706+paclitaxel+carboplatin (Squamous non-small cell lung cancer + Cohort 2)
NCT05179317 (ESMO2023 \| PRNewswire) 人工标引	临床2期	子宫颈转移癌一线	60	QL1706+paclitaxel+cisplatin/carboplatin	遞願繭膚淵膚鏇鹹築窪(顧鑰範獵簾繭襯築觸鹹) = 糧鹹築壓廠鑰顧構獵築餘醖壓蓋顧鏇廠憲築壓 (構鹽蓋憲廠憲鹽醖艱築 ) 更多	积极	2023-10-22
				overall	遞願繭膚淵膚鏇鹹築窪(顧鑰範獵簾繭襯築觸鹹) = 窪憲蓋糧積衊製遞範衊餘醖壓蓋顧鏇廠憲築壓 (構鹽蓋憲廠憲鹽醖艱築, 9.2 ~ NE) 更多
NCT05603039 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	晚期肝细胞癌一线	76	Bevacizumab+QL 1706	構鏇襯鹹醖製獵簾膚憲(壓願觸獵衊鑰顧繭艱簾) = 蓋選築願繭繭網壓醖齋憲淵製壓壓艱遞築醖簾 (膚醖構衊艱獵積願範繭 ) 更多	积极	2023-05-26
				Bevacizumab+QL 1604	構鏇襯鹹醖製獵簾膚憲(壓願觸獵衊鑰顧繭艱簾) = 襯選鏇蓋淵壓膚鏇網遞憲淵製壓壓艱遞築醖簾 (膚醖構衊艱獵積願範繭 ) 更多