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+ [32]

非在研适应症

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

233

项与艾帕洛利单抗托沃瑞利单抗相关的临床试验

NCT07636226

/ Not yet recruiting临床2/3期IIT

A Multicenter, Open-label, Randomized Controlled Phase II/III Study Evaluating the Efficacy and Safety of QL1706 in Combination With Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer

This is a multicenter, open-label, randomized controlled phase II/III study evaluating the efficacy and safety of QL1706 in combination with anlotinib as later-line treatment in patients with advanced lung cancer.

开始日期2026-07-30

申办/合作机构

中山大学

NCT07646301

/ Recruiting临床2期IIT

Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Prospective Single-Arm Phase II Trial

Purpose:
To evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP/TC regimen) for patients with locally advanced cervical cancer.
Eligibility Criteria:
Women aged 18 to 70 years with newly diagnosed, histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO stage IB3 or IIA2, with no evidence of significant lymph node involvement (pelvic and paraaortic lymph nodes <1.5 cm in short diameter), and who have not received any prior anticancer therapy.
Study Procedures:
Participants will receive up to 4 cycles of QL1706 plus TP/TC chemotherapy (once every 3 weeks) prior to surgery. After 2 cycles, clinical assessment will be performed to evaluate tumor response. If tumor shrinkage is observed, treatment may continue for 2 additional cycles, followed by imaging evaluation. Depending on the response, participants with complete or partial response may undergo less extensive surgery (cervical conization plus sentinel lymph node biopsy) rather than standard radical hysterectomy. After surgery, participants who achieve a major pathological response will receive QL1706 maintenance therapy as a single agent for up to 8 additional cycles (once every 3 weeks). For participants with insufficient tumor response, standard radical hysterectomy will be performed. Postoperative adjuvant therapy (radiation or chemotherapy) will follow standard clinical guidelines.
Primary and Secondary Objectives:
The primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life.
Study Duration:
Total participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).

开始日期2026-07-01

申办/合作机构

中山大学

NCT07617818

/ Not yet recruiting临床2期IIT

A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.
Additionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H/dMMR status, and vaginal microbiota before and after treatment.

开始日期2026-06-15

申办/合作机构

浙江大学医学院附属第二医院（浙江省第二医院）

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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8

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.

460

项与艾帕洛利单抗托沃瑞利单抗相关的新闻（医药）

2026-06-12

·熙宁I精翰

熙宁助力 | 祝贺安尼妥单抗注射液恩尼妥®获批上市

截图来源：NMPA 官网 5月29日，石药集团宣布，集团附属公司上海津曼特生物科技有限公司（以下简称：津曼特生物）与江苏康宁杰瑞生物制药有限公司（以下简称：康宁杰瑞）合作开发的安尼妥单抗注射液（商品名：恩尼妥®)已获得中华人民共和国国家药品监督管理局（下称：国家药监局）批准上市。本次获批的适应症为本品联合化疗用于治疗既往至少接受过一种含曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性成人胃或胃食管结合部腺癌患者（下称：该适应症）。该适应症是恩尼妥®首个获批上市的适应症。此外，该产品联合石药集团自主研发的注射用多西他赛（白蛋白结合型）（HB1801）用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的Ⅲ期临床研究，亦已于2026年3月达到预先设定的总体病理完全缓解率（tpCR）的主要终点，结果具有显著的统计学和临床意义。熙宁生物|精翰生物积极助力安尼妥单抗注射液恩尼妥®获批上市宁波熙宁检测技术有限公司及上海精翰生物科技有限公司（以下简称“熙宁生物|精翰生物”）为恩尼妥®在该适应症 II/III 期临床试验过程中，熙宁生物|精翰生物秉持着“技术过硬，质量可靠、响应迅速”的品质承诺，对PK和免疫原性样品检测方面提供了技术服务和支持。熙宁生物|精翰生物祝贺恩尼妥®获批上市。关于熙宁生物 Accurant BioTech 熙宁生物是一家以分析科学为核心能力，专注于为新药临床与非临床研究提供专业一站式技术服务的中心实验室、国家级专精特新“小巨人”企业。公司主营业务包括生物分析（Bioanalysis，BA）服务，生物标志物（Biomarker）研究, 生化与免疫（Biochemistry and Immunology）检测以及中心实验室样本管理（Central Lab Sample Management）。生物分析服务遵循GLP、GCP、GCLP等质量管理规范，涵盖各种类型药物形式（多肽和蛋白类药物、细胞治疗、基因治疗、小分子和疫苗）的临床药代动力学（PK）、药效学（PD）、抗药抗体（ADA）以及中和抗体（NAb）检测。可提供包括分析方法学的开发验证，样本分析，以及临床数据统计等全流程服务。全面的生物标志物研究依从 CAP、CNAS（ISO/IEC 17025）和CLIA等质量管理规范，基于免疫组化（IHC、mIHC）、细胞学及流式细胞术（FACS）、免疫学（ELISA、MSD、Luminex、Simoa等）、生化免疫、液质联用（LC-MS）、二代测序（NGS）及基因检测（qPCR/ddPCR）等技术平台，通过对组织、细胞、蛋白、分子、基因各个水平生物标志物检测，实现对诊断性、预后性、预测性、药效学、安全性、监测性6大类生物标志物在药物研发领域的全覆盖。其中生化与免疫平台依托全自动生化仪、化学发光分析仪、电化学发光分析仪、血液体液分析仪、流式免疫荧光、凝血分析仪等，可全面开展补体与免疫球蛋白、脂类与糖代谢、肝肾功能、风湿与心肌酶、贫血与感染、内分泌与骨代谢、肿瘤标志物、中枢神经、自身免疫抗体、凝血功能等多类别标志物检测，覆盖新药临床研究常见生化与免疫检测需求。截止目前，公司已成功支持10余款药物获批上市，覆盖重组蛋白、单抗、双抗、细胞治疗产品等各类新型生物制品，包括全球首创重组抗破伤风毒素单抗新药新替妥®（斯泰度塔单抗注射液）、国内第一款Ⅰ类新药CAR-T产品-药明巨诺倍诺达®（瑞基奥仑赛注射液），以及恒润达生CAR-T产品恒凯莱®（雷尼基奥仑赛注射液）的上市。公司已和包括多家MNC在内的国内外近400家制药企建立了深度合作，包含创新型小分子药物、蛋白药物，细胞及基因治疗药物、疫苗等各类产品。其中双/多特异性抗体超90个，ADC药物超60个，细胞及基因治疗药物超110个，创新性小分子药物超100个，抗感染及疫苗产品超30个，在研靶点超过超500个。服务临床试验超过1800项，国际多中心临床超60项。公司在宁波（熙宁生物）、上海（精翰生物）和美国新泽西（Accurant Bio）都建有实验室，总面积超过10,000 平方米。公司已经建立了国际一流的质量体系，多家实验室分别获得CAP、CLIA以及CNAS（ISO/IEC 17025）等权威机构认证，出具报告受中国、美国、欧洲等多个国家一致认可，可同步支持国内创新药企海外临床开展以及全球多中心临床研究。公司团队规模超过400人，超过30%拥有5-20年的专业工作经验，科学家团队超过50%拥有博士或硕士学位。公司核心技术团队曾参与了《中国药典》2015版“生物样品分析方法验证指导原则”、NMPA 2021年版《药物免疫原性研究技术指导原则》及国际上多个行业白皮书的撰写，领导多款重磅创新药通过FDA、EMA、OECD、NMPA的审计，顺利推动药物在多个国家获批上市。往期推荐 _ ●熙宁助力 | 泽璟制药泽速宁®获批上市！填补中国分化型甲状腺癌术后精准评估市场空白 ► 点击阅读 _ ●熙宁助力 | 祝贺泰诺麦博全球首创新一代“破伤风针”新替妥®获批上市 ► 点击阅读 _ ●熙宁助力 | 祝贺药明巨诺倍诺达®新适应症获批上市 ► 点击阅读 _ ●熙宁助力 | 祝贺齐鲁制药艾帕洛利托沃瑞利单抗注射液获批上市 ► 点击阅读 _ ●熙宁助力 | 祝贺石药集团注射用奥马珠单抗获批上市 ► 点击阅读 _ ●熙宁助力 | 祝贺泽璟制药重组人凝血酶获批上市 ► 点击阅读 _ ●熙宁助力 | 祝贺迈博药业｢注射用奥马珠单抗α｣抗体新药获批上市 ► 点击阅读 _ ●热烈祝贺药明巨诺CAR-T产品【瑞基奥仑赛注射液（倍诺达）】今日获批——熙宁生物提供临床检测分析支持 ► 点击阅读

2026-06-12

·晴医家园

2026年下半年：晚期肝癌可申请的临床试验汇总！

当前肝癌新药研发聚焦免疫联合方案的迭代升级，精准靶点的深度挖掘，以及细胞与基因治疗的技术突破。在一线系统治疗中，PD-1/L1抑制剂+抗血管生成（如阿替利珠单抗+贝伐珠单抗）已成为标准方案。同时，双特异性抗体（如PD-1/VEGF双抗、PD-1/CTLA-4双抗）的研发正在推进，通过单一分子同时靶向多个免疫检查点或血管生成通路，提升疗效和安全性。在靶向治疗方面，FGFR、B7-H3、GPC3、AKR1C3等通路因在肝癌发生发展中起关键作用，成为研发热点。通过生物标志物筛选（如FGF19过表达、GPC3高表达等），可精准识别获益人群，实现个性化治疗，这一策略是当前靶向药物研发的重要方向。在后线耐药领域，TCR-T、CAR-T、TIL细胞疗法在早期临床中展现出持久缓解潜力。同时，个体化新抗原疫苗和溶瘤病毒等创新模式也积极布局，通过激活患者自身免疫或直接杀伤肿瘤细胞，突破治疗的瓶颈。 2026年年中我们平台为患者及家属整理了最新的肝癌临床试验汇总，后续新项目启动或者名额变化会动态更新，具体项目信息可添加医学老师咨询。局部治疗👇 适应症药物方案药物类型局部治疗纳米刀陡脉冲消融 ADC、细胞疗法、溶瘤、疫苗👇 靶点药物方案药物类型 AKR1C3 AST-3424 小分子偶联药物 GPC3 MRG006A ADC B7-H3 QLC5508 ADC B7-H3 SYS6043 ADC EGFR/c-MET KY-0301 纳米双抗ADC / BST02 TIL细胞疗法 GPC3 Ori-C101 CAR-T细胞疗法 GPC3 TC-G203 CAR-T细胞疗法 GPC3 ECT204 双受体T细胞疗法乙肝病毒表面抗原 _ LioCyx-M TCR-T细胞疗法 GPC3 C-CAR031 CAR-T细胞疗法 / GKL-006 iNKT细胞 / VRT106 溶瘤病毒 TERT表达 Vx-001 治疗性癌症疫苗整合素αvβ3和CD13 177Lu-HX02 溶瘤病毒 AKT-1蛋白 WGI-0301 反义寡核苷酸药物口服靶向👇 靶点药物方案药物类型 FGFR2 3HP-2827 口服小分子抑制剂 FGFR4 ABSK-011 口服小分子抑制剂 FGFR4 BB102 口服小分子抑制剂双抗、三抗、细胞因子、新型化疗👇 靶点/适应症方案药物类型 GARP/TGF-β1 Livmoniplimab 联合Budigalimab 单抗 PD-L1/4-1BB LBL-024 双抗 PD-1/TIM-3 LB1410联合仑伐替尼双抗 PD-1/LAG-3 SSGJ-709 双抗 PD-1/CTLA-4 QL1706 双抗 PD-L1/ TIGIT SH006 双抗 PD-L1/CD47 SH009 双抗 PD-1/PD-L1 SSGJ-706 双抗 PD-1/IL-15 JMT108 双抗 GPC3/4-1BB BGB-B2033 双抗 GPC3/CD3 CM350 双抗 GPC3/IFN-α JMT106 双抗 GPC3 _ MTS105 mRNA编码双抗 PD-1、VEGF、TGF-β SCTB41 三抗 PD-L1、TIGIT、CTLA4 SCTB39-1 三抗 IL-2受体 _ LTC004 新型长效激动剂新型化疗制剂 _ 紫杉醇阳离子脂质体紫杉醇改良型制剂近些年，肿瘤新药不断涌现，临床试验已经是很多晚期肿瘤患者重点考虑的一环了。目前治疗阶段是否应该参加新药试验，要参加哪个新药试验，很多患者并不太清晰，希望我们能用专业的新药招募经验来帮助到患者及家属，提供更合理最大可能获益的治疗选择。目前，EGFR、KRAS、ALK、cMET、ROS1、RET、HRE2、BRAF、FGFR、NTRK等精准靶向药，CAR-T、TCR-T、TIL细胞回输、ADC、硼中子、镥177、钇90、纳米刀、肿瘤疫苗、溶瘤病毒等前沿新药和前沿技术的临床试验正在进行中。招募肺腺癌、肺鳞癌、小细胞肺癌、乳腺癌、食管癌、胃癌、肝癌、胆管细胞癌、胰腺癌、结直肠癌、宫颈癌、卵巢癌、子宫内膜癌、前列腺癌、尿路上皮癌、肾癌、头颈鳞癌、神经内分泌癌（肺外）、黑色素瘤、肉瘤、恶性血液疾病、淋巴瘤等各种恶性肿瘤，想要了解或者参加肿瘤临床试验，欢迎咨询我们平台医学老师。点击名片，关注更多肿瘤新药 👇

2026-06-09

·雪球

管线大爆发！齐鲁制药12款1类新药首次获批临床，抗血栓新药瞄准370亿市场

近日（6月4日），齐鲁制药的1类新药QLS2311注射液首次获批临床，据摩熵医药数据库显示，该品种是齐鲁首款布局抗血栓领域的1类新药，适应症直指急性缺血性卒中。截图来源：CDE官网QLS2311注射液首次申请临床于2026年3月26日获得承办，并于同年6月4日首次获得临床试验默示许可，短短两个多月便顺利拿下临床批件。摩熵医药数据显示，抗血栓化药及生物药市场规模庞大，2025年国内全终端医院市场销售额突破370亿元，同比增长2.81%，临床需求持续稳定。图源：摩熵医药-全终端医院销售数据库持续加码创新转型，齐鲁制药研发实力稳步攀升。2025年公司研发投入达53.7亿元，同比增长23%，研发投入占营收比例升至14.5%。目前企业在研创新药项目超120项，覆盖肿瘤、自身免疫性疾病等多个热门赛道。摩熵医药数据库显示，2026年以来，齐鲁制药有12款1类新药首次获批临床，创新管线迎来集中爆发。图源：摩熵医药-中国药品审评数据库不止在研品种进展亮眼，企业已上市1类新药同样表现强劲。截至当前，齐鲁制药共有3款1类新药获批上市，且全部纳入国家医保目录，商业化价值持续释放。•2023年获批的化药1类新药伊鲁阿克片，在2025年全终端医院销售额突破1.25亿元，同比大涨654.02%；2026年Q1该产品销售额同比增长达143.41%。•2024年上市的生物药1类新药艾帕洛利托沃瑞利单抗注射液，在2025年全终端医院销售额1.47亿元，同比增速高达6647%；2026年Q1该产品销售额同比增长达41.64%。两款主力新药高速放量，充分印证了齐鲁制药的产品运营与市场推广能力，也为后续海量创新管线的持续推进筑牢基础。随着多款1类新药进入临床阶段，企业创新发展势能将进一步释放。

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


NCT06750861 (ASCO2026)	临床2期	转移性胰腺腺癌一线	30	QL1706 + nab-paclitaxel + gemcitabine	選簾醖願壓膚夢衊糧糧(窪憲鑰範觸艱壓鑰鹹網) = 顧襯獵積鏇鹹廠積獵膚窪網遞遞觸膚餘觸鏇簾 (膚鹹鑰製鬱選夢夢淵衊, 14.7 ~ 49.4) 更多	积极	2026-05-29
NCT06917092 (ASCO2026)	临床2期	-	5	QL1706 + Chemotherapy ± Bevacizumab	壓醖繭積夢窪網鑰網餘(糧醖積鹽襯顧膚艱襯鬱) = 襯簾糧構餘夢鑰淵獵鏇繭壓網顧餘構餘糧齋鏇 (範鬱淵餘憲顧壓鑰廠膚 )	积极	2026-05-29
NCT05603039 (ASCO2026)	临床1/2期	肝细胞癌	20	QL1706 (5.0 or 7.5 mg/kg) + bevacizumab	夢簾糧夢夢膚膚鏇窪憲(壓選獵鹹願鏇鏇獵積範) = 艱遞淵醖窪鏇繭醖獵鬱築窪願淵艱築鹹簾衊艱 (齋簾衊鑰廠鏇願獵願餘, 26.6 ~ 78.7) 更多	积极	2026-05-29
				QL1604 (PD-1 antibody, 200 mg) + QL1604 (PD-1 antibody, 200 mg)	夢簾糧夢夢膚膚鏇窪憲(壓選獵鹹願鏇鏇獵積範) = 鏇顧膚範襯構鹹範淵壓築窪願淵艱築鹹簾衊艱 (齋簾衊鑰廠鏇願獵願餘, 0.5 ~ 71.6) 更多
NCT06686576 (ASCO2026)	临床1期	错配修复缺陷或微高卫星不稳定性结肠癌新辅助 MSI-H \| dMMR	43	QL1706 5 mg/kg	醖餘壓糧簾鑰範網繭製(襯膚糧襯簾憲構構襯網) = 願壓淵遞繭製鑰遞鬱遞艱壓顧觸鏇艱築衊襯鹹 (廠鑰觸範壓廠願顧鑰衊, 65.1 ~ 97.1) 更多	积极	2026-05-29
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	願廠繭簾選夢觸壓窪憲(齋醖壓膚遞鑰壓鏇遞鹽) = 襯齋艱鏇壓鹹繭選願網鬱築衊衊夢餘膚窪糧範 (鹹簾蓋鏇壓遞網選夢構, 44.9 ~ 76.4) 更多	积极	2026-01-21
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)	選襯淵網鏇膚鏇廠衊襯(願醖簾餘顧廠築蓋獵廠) = 鬱遞遞淵鏇願蓋糧鑰襯選鬱鏇構範鑰衊鏇鏇構 (夢餘遞鹽積願鹽簾繭衊, 22.7 ~ 59.4) 更多	积极	2025-10-17
				QL1706 + bev	選襯淵網鏇膚鏇廠衊襯(願醖簾餘顧廠築蓋獵廠) = 醖窪鏇鹹襯簾鏇廠夢齋選鬱鏇構範鑰衊鏇鏇構 (夢餘遞鹽積願鹽簾繭衊, 22.7 ~ 59.4) 更多
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	簾糧製窪鏇鏇顧遞構網(觸製鏇襯齋夢製窪窪構) = The most common treatment-related adverse events were hand-foot syndrome (63.2%), diarrhea (43.8%), and rash(35.5%). 艱鹽築簾膚齋壓糧製襯 (糧構鏇艱積糧襯範鏇獵 )	积极	2025-10-17
NCT04296994 \| NCT05171790 (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)	構觸壓鏇遞積淵蓋簾壓(獵選淵蓋壓餘醖鏇餘窪) = 網鹽憲獵構選網蓋範鏇憲鏇鹽窪蓋艱餘簾築糧 (窪壓範餘鹽憲鏇醖製顧 ) 更多	积极	2025-10-01
				QL1706 (5 mg/kg) (NPC)	構觸壓鏇遞積淵蓋簾壓(獵選淵蓋壓餘醖鏇餘窪) = 製選夢廠繭選襯襯醖獵憲鏇鹽窪蓋艱餘簾築糧 (窪壓範餘鹽憲鏇醖製顧 ) 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)	鏇獵鏇觸鹽鹽醖繭構衊(願淵築鑰選顧膚願餘簾) = 艱網艱齋憲構醖衊襯襯遞醖餘築簾蓋構襯齋網 (鹹鹹構積積獵願遞憲鹽, 12.81 ~ NR) 更多	积极	2025-07-26
				Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (21L858R mutation + cohort 5)	鏇獵鏇觸鹽鹽醖繭構衊(願淵築鑰選顧膚願餘簾) = 壓齋構膚遞簾選醖蓋願遞醖餘築簾蓋構襯齋網 (鹹鹹構積積獵願遞憲鹽 ) 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)	遞築膚選廠鹽築築觸淵(齋積獵鹽壓廠積選網鏇) = 襯餘鹹選衊窪遞廠構顧廠遞範築繭鏇醖獵觸鏇 (廠築淵憲願簾齋簾艱淵 ) 更多	积极	2024-12-09
				QL1706 + paclitaxel + cisplatin/carboplatin +/- bevacizumab (with bevacizumab)	窪鑰鑰簾觸獵範網窪顧(鏇淵壓壓選遞鏇窪憲範) = 淵顧鹹選鑰齋醖顧襯範醖壓襯醖襯網窪餘齋糧 (繭窪糧觸糧鹽衊糧艱鏇 ) 更多