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，晚期宫颈癌_专利_临床

概要

基本信息

药物类型

双特异性抗体

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

作用方式

抑制剂

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+ [5]

在研适应症

转移性宫颈癌复发性宫颈癌晚期宫颈癌+ [31]

非在研适应症

HER2阳性乳腺癌残留肿瘤口腔鳞状细胞癌

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

Qilu Puget Sound Biotherapeutics Corp.

权益机构-

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 616720840L

当前序列信息引自: *****

关联

227

项与艾帕洛利单抗托沃瑞利单抗相关的临床试验

NCT07502027

/ Not yet recruiting临床4期IIT

A Multicenter, Single-arm, Exploratory Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma

This study is a domestic, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of heterogeneous radiotherapy (high and low dose) sequenced with iparomlimab and tuvonralimab plus SOX as a first-line treatment for unresectable locally advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

开始日期2026-06-01

申办/合作机构

华中科技大学

NCT07515469

/ Not yet recruiting临床2期IIT

A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With Iparomlimab and Tuvonralimab Injection, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).

开始日期2026-05-30

申办/合作机构

天津市肿瘤医院（天津医科大学肿瘤医院）

NCT07502014

/ Not yet recruiting临床2期IIT

A Randomized, Parallel, Open-Label, Multicenter Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer

This is a randomized, parallel, open-label, multicenter exploratory clinical study designed to investigate the efficacy and safety of iparomlimab and tuvonralimab in combination with fruquintinib plus heterogeneous radiotherapy, compared with fruquintinib monotherapy, as the third-line and subsequent-line treatment for patients with oligometastatic colorectal cancer.

开始日期2026-05-01

申办/合作机构

华中科技大学

[+1]

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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6

项与艾帕洛利单抗托沃瑞利单抗相关的文献（医药）

2026-02-01·EClinicalMedicine

Iparomlimab and tuvonralimab (QL1706) combined definitive chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma (QL1706-IIT-02): a single arm, phase 2 trial

Article

作者: Gao, Linrui ; Yan, Cihui ; Zheng, Zhunhao ; Cao, Fuliang ; Dong, Jie ; Chen, Xi ; Zhao, Gang ; Li, Zewei ; Zhang, Wencheng ; Bai, Na ; Pang, Qingsong ; Li, Jiacheng ; Wang, Ping ; Wang, Yufei ; Jiang, Shengpeng ; Zhang, Tian

Background:

Definitive chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal squamous cell carcinoma (ESCC). However, the prognosis for these patients remains poor. This study aimed to evaluate iparomlimab and tuvonralimab (QL1706), a novel PD-1/CTLA-4 dual inhibitor, combined with definitive chemoradiotherapy in patients with unresectable stage III-IVA ESCC.

Methods:

This single-arm, open-label phase 2 trial was conducted at a single center in China between August 2022 and September 2023. 39 patients with unresectable stage III-IVA ESCC were included. QL1706 is composed of iparomlimab (anti-PD-1 IgG4) and tuvonralimab (anti-CTLA-4 IgG1) in a fixed 2:1 ratio. Patients received radiotherapy (50.4 Gy/28 in fractions on 5 days per week), concurrent chemotherapy (paclitaxel 135 mg/m² d1+ cisplatin 25 mg/m² d1-3, q3w, 2 cycles), and QL1706 (5 mg/kg q3w for up to 1 year [total of 18 cycles]). The primary endpoint was progression-free survival (PFS). This study is registered with ClinicalTrials.gov (NCT05490719).

Findings:

20 patients (51.3%) completed the full cycles of QL-1706. Reasons for the premature cessation of QL1706 were disease progression (n = 7), COVID-19 infection (n = 2), pneumonia (n = 2), allergic reaction (n = 2), patient refusal (n = 4), rash (n = 1), and esophageal hemorrhage (n = 1). With a median follow-up of 21.1 months, the median progression-free survival (PFS) was 14.8 (95% CI: 11.2-NA) months. The median overall survival (OS) was immature. The 1-year PFS and OS rates were 58.6% (95% CI: 44.9-76.4) and 84.6% (95% CI: 74.0-96.7). The objective response rate and median duration of response were 84.6% (95% CI: 69.5-94.1) and 12.7 months (95% CI: 8.9-NA). Exploratory biomarker analyses identified several potential predictive biomarkers: 1) immunochemistry staining revealed that PD-L1 combined positive score ≥1 correlated with prolonged PFS (HR 0.37, p = 0.036); 2) Whole-exome sequencing detected high tumor mutation burden associated with better PFS (HR 0.24, p = 0.0066), while the mutated group (TNRC18/CAMSAP3/CARMIL2/ZFHX4 gene alterations) correlated with poor PFS (HR 6.40, p = 0.0002) and OS (HR 6.45, p = 0.0020); and 3) Olink plasma proteomics identified baseline levels of TWEAK and FASLG were both positively associated with PFS and OS (p < 0.05 for all). Grade ≥3 adverse events occurred in 89.7% (35/39) of the patients, predominantly lymphopenia (31/39, 79.5%).

Interpretation:

QL1706 combined with chemoradiotherapy demonstrated potential antitumor activity and manageable toxicity, supporting further investigation.

Funding:

National Natural Science Foundation of China, State Key Laboratory of Druggability Evaluation and Systematic Translational Medicine, Tianjin Key Medical Discipline Construction Project, and Tianjin Key Medical Discipline (Specialty) Construction Project.

2025-10-01·Cell Reports Medicine

Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors—A phase 1/1b study

Article

作者: Hongyun Zhao ; Yunpeng Yang ; Song Qu ; Yuxiang Ma ; Hui Li ; Fan Luo ; Xianling Liu ; Xiaoyan Kang ; Li Zhang ; Ying Cheng ; Dongyuan Zhu ; Zhan Huang ; Changbin Zhu ; Weiwei Li ; Chuanben Chen ; Zhendong Chen ; Qian Li ; Yi Ba ; Yan Huang ; Jinhui Xue ; Yiping Zhang ; Qun Chen ; Shaoyan Lin ; Wuyun Su ; Chuan Jin ; Jianbo He ; Aimin Zang ; Shilin Xue ; Qingshan Li ; Chao Wang ; Xiangcai Wang

QL1706 has shown promising efficacy in solid tumors in a phase 1/1b study. Here, we report updated long-term survival outcomes and biomarker analyses. Among 468 patients treated with QL1706 (5 mg/kg), median progression-free survival (mPFS) and overall survival (mOS) are 1.5 and 14.2 months for non-small cell lung cancer (NSCLC), 1.9 and 20.2 months for nasopharyngeal carcinoma (NPC), and 4.2 and 18.6 months for cervical cancer (CC), respectively. Liver metastasis is correlated with poor progression-free survival (PFS) and overall survival (OS) in NSCLC and poor OS in CC, while elevated lactate dehydrogenase is linked to shorter PFS and OS in NPC. CDK4/11q13 diploid or the expression of GZMK^high & MYC^low distinguishes NPCs with the most favorable PFS. In NSCLC, PD-L1⁺/TIL⁺ or a low ARG1:CXCL13 ratio indicates better outcomes. QL1706 offers long-term survival benefits in solid tumors, with identified molecular markers aiding in selecting suitable candidates. This study has been registered on clinicaltrials.gov (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.

391

项与艾帕洛利单抗托沃瑞利单抗相关的新闻（医药）

2026-05-06

·药研苑

3期试验强生古塞奇尤单抗显著改善克罗恩病肛瘘

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年5月5日，强生Johnson & Johnson公布古塞奇尤单抗用于活动性克罗恩病肛瘘3期临床试验TREMFYA的研究结果。 TREMFYA研究为多中心、随机、双盲、安慰剂对照3期临床研究，纳入既往一线或最多两种克罗恩病后线治疗反应不佳的克罗恩病肛瘘患者。入组患者按2:2:1比例随机分配进入古塞奇尤单100mg组（古塞奇尤单抗200mg静脉注射，第0、4、8周后改为每8周一次100mg皮下注射）、古塞奇尤单200mg组（古塞奇尤单抗200mg静脉注射，第0、4、8周后改为每4周一次200mg皮下注射）、或安慰剂组。研究结果显示，至第24周，古塞奇尤单100mg组、200mg组和安慰剂组达到复合肛瘘缓解（MRI显示瘘管完全闭且无积液）的比例分别为28.3%、27.0%和10.3%（p=0.007和p=0.013）。在安全性方，古塞奇尤单抗的安全性特征与既往研究一致。克罗恩病（CD）是一种病因及发病机制尚不清楚的慢性非特异性肠道炎性疾病，近年来在我国的发病率明显上升。25%~80%的成人克罗恩病患者合并肛周病变，其中克罗恩病肛瘘，约占17%~43%。古塞奇尤单抗（Guselkumab）为抗IL-23单克隆抗体。通过与IL-23p19亚基特异性结合，阻止IL-23作用于IL-23受体发挥抗炎作用。国内获批的抗IL-23单克隆抗体包括古塞奇尤单抗（Guselkumab）、替瑞奇珠单抗（Tildrakizumab）、匹康奇拜单抗（Picankibart ）、利生奇珠单抗（Risankizumab）和米吉珠单抗（Mirikizumab）。古塞奇尤单抗皮下注射剂在国内获批的适应症为：适用于于适合系统性治疗的中重度斑块状银屑病成人患者。静脉注射剂在国内获批的适应症为：适用于治疗对传统治疗或生物制剂应答不充分、失应答或不耐受的中度至重度活动性克罗恩病成人患者；以及适用于治疗对传统治疗或生物制剂应答不充分、失应答或不耐受的中度至重度活动性溃疡性结肠炎成人患者。除了古塞奇尤单抗外，利生奇珠单抗与米吉珠单抗，均已在国内获批用于克罗恩病和溃疡性结肠炎。 IL-23为IL-23p19和IL-12p40组成的二聚体。IL-12p40是IL-23和IL-12的共同亚单位。但IL-12在克罗恩病中的作用不如IL-23重要。古塞奇尤单抗、米吉珠单抗和利生奇珠单抗均已取得优于抗IL-23/IL-12单克隆抗体乌司奴单抗（Ustekinumab ）的临床试验证据。推荐指数：★★ 推荐原因：古塞奇尤单抗、米吉珠单抗和利生奇珠单抗国内获批用于炎症性肠病的时间均不长。TREMFYA研究使古塞奇尤单抗率先获得缓解克罗恩病肛瘘的试验证据，有利于古塞奇尤单抗在炎症性肠病中占据更有利的治疗地位。相关阅读：击穿地板价？华道生物CAR-T药物万基奥仑赛申请上市先声药业申请IL-4Rα单抗乐德奇拜上市用于特应性皮炎齐鲁制药艾帕洛利托沃瑞利单抗申请一线治疗转移性宫颈癌鞍石生物安达艾替尼获批治疗EGFR ex20ins突变非小细胞肺癌邦顺制药JAK2抑制剂贝泽昔替尼获批治疗骨髓纤维化 FDA批准强生卢美哌隆用于预防精神分裂症复发首家，恩华药业申请抗抑郁药物右美沙芬安非他酮缓释片上市晟斯生物申请上市长效重组凝血因子Ⅷ（FRSW117）拜耳凝血因子ⅩⅠa抑制剂Asundexian国内申请用于预防卒中 FDA批准阿斯利康布地格福吸入气雾剂用于哮喘三生艾曲泊帕乙醇胺干混悬剂新增重型再生障碍性贫血适应症艾尔建美学注射用A型肉毒毒素获批改善中重度额纹 3期试验勃林格殷格翰Gcg/GLP-1双激动剂索弗度肽减重16.6% 首仿，华阳制药第二代JAK抑制剂乌帕替尼缓释片获批独家剂型，和泽医药甲苯磺酸艾多沙班口崩片获批上市相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

2026-05-06

·药研苑

减重19.3%，博瑞公布GLP-1/GIP双激动剂BGM0504三期数据

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年5月5日，博瑞生物宣布BGM0504注射液在用于超重或肥胖3期临床试验BGM0504-III-WL中，取得积极顶线结果。 BGM0504-III-WL研究为随机、双盲、安慰剂对照的3期临床试验，共纳入652例超重或肥胖患者。入组患者随机接受GM0504注射液5mg、10mg和15mg或安慰剂，一周一次，共52周。研究结果显示，BGM0504注射液5mg、10mg、15mg和安慰剂组体重较基线平均分别降低14.3%、17.3%、19.2%和3.1%。BGM0504注射液5mg、10mg和15mg组体重较基线降低≥5%的比例分别为84.7%、89.8%和94.6%。BGM0504注射液15mg组，体重较基线降低≥15%人比例为67.3%，体重较基线降低≥20%人比例为48.9%。腰围较基线平均减少16.5cm。安慰剂组腰围平均减少3.3cm。在血压方面，基线合并高血压且血压未达标的受试者，至第36周，收缩压和舒张压较基线平均分别降低22.9mmHg和12.9mmHg，其中92.9%的受试者实现血压达标。BGM0504注射液组全部患者，收缩压和舒张压较基线平均分别降低12.8mmHg和6.8mmHg。研究期间未观察到低血压事件。在其他心血管代谢风险因素方面，至第52周，BGM0504注射液组高密度脂蛋白胆固醇平均升高7.3%，低密度脂蛋白胆固醇平均降低12.7%，甘油三酯平均降低33.6%，总胆固醇平均降低7.4%，尿酸平均降低70.7μmol/L。在骨代谢方面，BGM0504注射液组全身骨密度/腰椎骨密度/髋关节骨密度等相对基线分别增加0.3%、1.4%和3.9%，骨密度未随着体重下降而降低。在安全性方面，BGM0504注射液整体耐受性良好，不良反应类型与GLP-1受体激动剂类药物已知安全性特征一致。常见胃肠道不良反应多为轻度至中度，可在短时间内自行缓解。研究期间未发生低血糖事件，未观察到新的安全性信号。52周治疗期间，BGM0504注射液各剂量组因不良事件导致终止治疗的比例分别为1.7%、1.2%和0.7%。 BGM0504为肽类GLP-1/GIP受体双重激动剂，目前正在开发注射和口服剂型，目标适应症包括2型糖尿病和体重管理。临床前研究显示BGM0504对GLP-1和GIP受体的激动作用是替尔泊肽的2-3倍（ED50：0.031和0.182nM与ED50：0.086和0.441）（Jiandong Yuan., 2024）。2025年博瑞生物与华润三九达成GM0504注射液在中国大陆地区（不包含香港、澳门及台湾地区），共同开发和商业化协议。推荐指数：★★ 推荐原因：尽管减肥市场被认为市场潜力巨大，但随着更多参与者进入，竞争会趋于激烈。3期试验BGM0504的减重数据未能超过20%，也未能超过替尔泊肽的历史研究数据，对BGM0504来说，算是缺憾。相关阅读：击穿地板价？华道生物CAR-T药物万基奥仑赛申请上市先声药业申请IL-4Rα单抗乐德奇拜上市用于特应性皮炎齐鲁制药艾帕洛利托沃瑞利单抗申请一线治疗转移性宫颈癌鞍石生物安达艾替尼获批治疗EGFR ex20ins突变非小细胞肺癌邦顺制药JAK2抑制剂贝泽昔替尼获批治疗骨髓纤维化 FDA批准强生卢美哌隆用于预防精神分裂症复发首家，恩华药业申请抗抑郁药物右美沙芬安非他酮缓释片上市晟斯生物申请上市长效重组凝血因子Ⅷ（FRSW117）拜耳凝血因子ⅩⅠa抑制剂Asundexian国内申请用于预防卒中 FDA批准阿斯利康布地格福吸入气雾剂用于哮喘三生艾曲泊帕乙醇胺干混悬剂新增重型再生障碍性贫血适应症艾尔建美学注射用A型肉毒毒素获批改善中重度额纹 3期试验勃林格殷格翰Gcg/GLP-1双激动剂索弗度肽减重16.6% 首仿，华阳制药第二代JAK抑制剂乌帕替尼缓释片获批独家剂型，和泽医药甲苯磺酸艾多沙班口崩片获批上市相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

2026-05-06

·药研苑

阿斯利康雌激素受体降解/拮抗剂申请一线治疗晚期乳腺癌受挫

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年4月30日阿斯利康AstraZeneca发布公告，指出美国食品药品监督管理局（FDA）肿瘤药品咨询委员会（ODAC）以3票对6票的投票结果，未能通过Camizestrant联合CDK4/6抑制剂，用于激素受体（HR）阳性、表皮生长因子受体2（HER2）阴性晚期乳腺癌患者的一线治疗。 2025年6月阿斯利康发表了Camizestrant一线治疗晚期乳腺癌随机、双盲、阳性对照3期临床试验SERENA-6研究中期分析结果。该中期分析共纳入315名HR+、HER2-、ESR1突变晚期乳腺癌患者。入组患者在CDK4/6抑制剂（哌柏西利Palbociclib、瑞波西利Ribociclib 或阿贝西利Abemaciclib）的基础上随机接受Camizestrant或芳香化酶抑制剂（AI，来曲唑Letrozole或阿那曲唑Anastrozole）。中期分析显示，Camizestrant组或芳香化酶抑制剂组中位无进展生存期分别为16.0个月和9.2个月，Camizestrant组降低56%的疾病进展或死亡风险（HR 0.44; 95% CI, 0.31–0.60; P<0.0001）。患者报告的整体健康状况和生活质量恶化的中位时间为分别为21.0个月和6.4个月（HR, 0.54; 95% CI, 0.34–0.84）。Camizestrant组和芳香化酶抑制剂组由于因不良事件导致停药的比例分别为1.3%和1.9%（François-Clément Bidard., 2025）。 Camizestrant为选择性雌激素受体降解剂（SERD）和雌激素受体完全拮抗剂。Camizestrant通过作用于雌激素受体（ER），引起ER构象发生变化，暴露出泛素连接酶E3结合位点，使ER泛素化，介导泛素化的ER被蛋白酶体降解。此外Imlunestrant与ER结合后，还能够阻断雌激素作用于雌激素受体，拮抗雌激素激活ER。Camizestrant的同类药物Imlunestrant已获得FDA批准用于在至少一种内分泌治疗（ET）后进展的，ER+、HER2-、ESR1突变的成人晚期或转移性乳腺癌。本次Camizestrant未能通过ODAC的投票，主要是未能证明其用于一线治疗与用于后线治疗相比，更能够让患者从中受益。推荐指数：☆ 推荐原因：阿斯利康寄希望于Camizestrant治疗前移，使其在与其他SERD类药物竞争中，快速前进。尽管ODAC的投票结果不具有法律效力，但Camizestrant一线用于晚期乳腺，如最终未能获得FDA批准，将会使Camizestrant面对更加复杂的竞争局面。相关阅读：击穿地板价？华道生物CAR-T药物万基奥仑赛申请上市先声药业申请IL-4Rα单抗乐德奇拜上市用于特应性皮炎齐鲁制药艾帕洛利托沃瑞利单抗申请一线治疗转移性宫颈癌鞍石生物安达艾替尼获批治疗EGFR ex20ins突变非小细胞肺癌邦顺制药JAK2抑制剂贝泽昔替尼获批治疗骨髓纤维化 FDA批准强生卢美哌隆用于预防精神分裂症复发首家，恩华药业申请抗抑郁药物右美沙芬安非他酮缓释片上市晟斯生物申请上市长效重组凝血因子Ⅷ（FRSW117）拜耳凝血因子ⅩⅠa抑制剂Asundexian国内申请用于预防卒中 FDA批准阿斯利康布地格福吸入气雾剂用于哮喘三生艾曲泊帕乙醇胺干混悬剂新增重型再生障碍性贫血适应症艾尔建美学注射用A型肉毒毒素获批改善中重度额纹 3期试验勃林格殷格翰Gcg/GLP-1双激动剂索弗度肽减重16.6% 首仿，华阳制药第二代JAK抑制剂乌帕替尼缓释片获批独家剂型，和泽医药甲苯磺酸艾多沙班口崩片获批上市相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

临床3期免疫疗法细胞疗法

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
晚期宫颈癌	申请上市	中国	齐鲁制药有限公司	2026-04-24
大肠腺癌	临床3期	中国	齐鲁制药有限公司	2025-08-19
转移性结直肠癌	临床3期	-	齐鲁制药有限公司	2025-07-01
晚期鼻咽癌	临床3期	中国	齐鲁制药有限公司	2025-05-04
鼻咽癌	临床3期	中国	齐鲁制药有限公司	2025-05-04
局限期小细胞肺癌	临床3期	-	齐鲁制药有限公司	2025-02-01
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
非鳞状非小细胞肺癌	临床3期	中国	齐鲁制药有限公司	2023-02-15
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

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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


NCT05490719 (QL1706-IIT-02, Pubmed) 人工标引	临床2期	局部晚期食管鳞状细胞癌	39	QL1706 + chemoradiotherapy	簾獵鬱廠蓋構憲齋糧襯(觸衊遞製淵壓顧構鹽顧) = 衊糧遞糧醖築淵鏇壓鏇獵糧網選簾簾獵範積膚 (夢襯壓膚壓膚夢簾鏇網, 44.9 ~ 76.4) 更多	积极	2026-01-21
NCT06801665 (FTM-JSNO-03, ESMO2025)	临床2期	结肠癌肝转移一线 microsatellite-stable (MSS)	30	FMT plus QL1706 plus bevacizumab plus XELOX	築範遞鑰淵簾淵積獵鬱(鹹製簾範鬱鬱獵選願壓) = The most common treatment-related adverse events were hand-foot syndrome (63.2%), diarrhea (43.8%), and rash(35.5%). 選鑰繭觸窪艱積夢鏇鬱 (艱築鹽壓鹽獵鬱膚襯夢 )	积极	2025-10-17
NCT05976568 (DUBHE-H-308, ESMO2025)	临床2期	晚期肝细胞癌一线	120	QL1706 7.5 mg/kg + bev 15 mg/kg + chemo (oxaliplatin 85 mg/m + capecitabine 1000 mg/m)	餘選積膚範範鏇艱鹽窪(獵淵鹹選憲獵醖壓壓醖) = 製顧鏇壓鬱製網餘範鑰構衊糧積範淵顧襯壓鬱 (鑰艱鹽遞壓鹹鑰衊醖齋, 22.7 ~ 59.4) 更多	积极	2025-10-17
				QL1706 + bev	餘選積膚範範鏇艱鹽窪(獵淵鹹選憲獵醖壓壓醖) = 鏇繭網顧獵繭艱製淵顧構衊糧積範淵顧襯壓鬱 (鑰艱鹽遞壓鹹鑰衊醖齋, 22.7 ~ 59.4) 更多
NCT05171790 \| NCT04296994 (Pubmed \| Cell Rep Med)	临床1期	晚期恶性实体瘤 \| 非小细胞肺癌 \| 鼻咽癌 ... CDK4 \| 11q13 diploid \| GZMK high & MYC low ... 更多	468	QL1706 (5 mg/kg) (NSCLC)	鑰構獵齋鏇齋壓獵膚願(築構夢餘襯廠積壓衊觸) = 鹹鑰願蓋獵衊鹹鬱範壓積鑰築鑰網鑰構艱顧壓 (網鬱廠鑰範鏇淵簾範壓 ) 更多	积极	2025-10-01
				QL1706 (5 mg/kg) (NPC)	鑰構獵齋鏇齋壓獵膚願(築構夢餘襯廠積壓衊觸) = 簾顧顧衊觸獵繭廠齋積積鑰築鑰網鑰構艱顧壓 (網鬱廠鑰範鏇淵簾範壓 ) 更多
DUBHE-L-201 (Pubmed \| J Hematol Oncol) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	31	Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (cohort 5)	齋糧壓鹹遞襯製積夢醖(鏇醖選選網襯艱憲鏇衊) = 遞衊觸構襯積蓋顧鏇築製壓襯築艱鹹顧憲憲願 (艱築蓋憲築範鹹遞積觸, 12.81 ~ NR) 更多	积极	2025-07-26
				Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (21L858R mutation + cohort 5)	齋糧壓鹹遞襯製積夢醖(鏇醖選選網襯艱憲鏇衊) = 淵鹹廠淵簾範遞鹽鏇簾製壓襯築艱鹹顧憲憲願 (艱築蓋憲築範鹹遞積觸 ) 更多
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)	醖餘衊鬱艱遞鏇積鹽鏇(蓋憲膚膚蓋襯糧網膚淵) = 淵窪襯築鹹廠窪獵繭構鬱觸繭襯廠願餘遞壓獵 (夢衊選衊醖鹹醖鹹鹹構 ) 更多	积极	2024-12-09
				QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (with bevacizumab)	餘醖齋願蓋鏇構願壓製(築壓願憲鬱襯願壓願醖) = 網鏇鏇廠遞廠壓願繭網醖餘廠製壓憲襯範蓋襯 (廠淵醖糧蓋鹽膚醖襯範 ) 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)	壓鏇製艱觸憲鑰選廠艱(夢廠簾憲齋衊餘選窪憲) = 選遞積廠艱鏇餘遞製膚顧憲範餘願觸衊餘顧鹹 (艱顧選鬱糧艱醖壓範憲 ) 更多	积极	2024-12-07
				QL1706 5 mg/kg + Bevacizumab + Oxaliplatin + Capecitabine (MSS/MSI-low and wild-type RAS/BRAF)	壓鏇製艱觸憲鑰選廠艱(夢廠簾憲齋衊餘選窪憲) = 襯夢鏇艱窪網窪齋衊壓顧憲範餘願觸衊餘顧鹹 (艱顧選鬱糧艱醖壓範憲, 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	淵獵壓鹽憲鏇憲艱壓顧(齋襯鏇鑰選觸顧觸鬱願) = 膚淵醖願顧糧壓艱鏇糧衊艱築築糧製繭淵簾築 (築願繭簾網簾願夢衊鑰, 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	淵遞糧獵積範鑰夢膚選(選願構艱網襯遞繭願網) = 鑰餘齋範襯膚鹹顧鑰窪襯網壓鬱網簾鹽遞憲觸 (廠選糧餘鹹構網願襯顧 ) 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	遞網艱遞餘鏇壓壓襯鏇(觸襯醖鹹顧衊衊獵衊糧) = 窪窪蓋廠構繭憲壓獵窪鏇鬱選憲網窪鏇遞簾鹹 (鹽簾壓淵鏇選構簾膚繭, 19.2 ~ 54.6) 更多	积极	2024-09-13
				QL1706+bev	遞網艱遞餘鏇壓壓襯鏇(觸襯醖鹹顧衊衊獵衊糧) = 夢襯鏇夢餘壓鏇網網蓋鏇鬱選憲網窪鏇遞簾鹹 (鹽簾壓淵鏇選構簾膚繭, 19.9 ~ 56.1) 更多