匹姆瑞妥单抗(上海复宏汉霖生物)(Pimurutamab(Shanghai Henlius Biotech, Inc.)) - 药物靶点：EGFR_在研适应症：皮肤鳞状细胞癌，鳞状非小细胞肺癌，鼻咽癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Cetuximab biobetter(Shanghai Henlius Biotech, Inc.)、Humanized anti-EGFR monoclonal antibody(Shanghai Henlius Biotech, Inc.)、Recombinant Anti-EGFR Humanised Monoclonal Antibody(Shanghai Henlius Biotech, Inc.)

+ [3]

靶点

EGFR

作用方式

拮抗剂

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)

治疗领域

肿瘤呼吸系统疾病消化系统疾病+ [3]

在研适应症

皮肤鳞状细胞癌鳞状非小细胞肺癌鼻咽癌+ [8]

非在研适应症

晚期肝细胞癌晚期鳞状非小细胞肺癌晚期肺非鳞状非小细胞癌+ [5]

原研机构

上海复宏汉霖生物技术股份有限公司

在研机构

上海复宏汉霖生物技术股份有限公司上海复宏瑞霖生物技术有限公司

上海复星医药产业发展有限公司

+ [1]

非在研机构

Henlix, Inc.

权益机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

Sequence Code 616724690H

来源: *****

Sequence Code 616724691L

来源: *****

关联

22

项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的临床试验

NCT06542588

/ Recruiting临床2期IIT

A Multicenter, Single-arm, Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07 and Serplulimab in the Treatment for RAS/BRAF Wild Type Locally Advanced Rectal Cancer

The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.

开始日期2024-07-19

申办/合作机构

华中科技大学同济医学院附属协和医院

NCT05360368

/ Unknown status临床1期

A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors

This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.

开始日期2023-03-30

申办/合作机构

上海复宏汉霖生物技术股份有限公司

NCT05354700

/ Unknown status临床2期

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)

This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

开始日期2023-03-29

申办/合作机构

上海复宏汉霖生物技术股份有限公司

100 项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的临床结果

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100 项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的转化医学

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100 项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的专利（医药）

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3

项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的文献（医药）

2024-12-01·Cancer Communications

HLX07 alone or combined with serplulimab, cisplatin and 5‐fluorouracil for advanced esophageal squamous cell carcinoma: A phase 2 study

Article

作者: Hu, Xuhui ; Wang, Lin ; Zhuang, Wu ; Yang, Mudan ; Li, Ning ; Liu, Bo ; Liu, Yun ; Zhu, Jun ; Wang, Ying ; Zhu, Yanrong ; Huang, Jing ; Chen, Jiayan ; Wang, Qingyu ; Wang, Yanfeng ; Zhou, Jin ; Wu, Tao ; Liu, Zhenyang ; Yuan, Yuan ; Tan, Zhenbo ; Yu, Haoyu

Abstract:

Background:

The combination of anti‐PD‐1 antibody serplulimab and chemotherapy is considered standard first‐line therapy for advanced esophageal squamous cell carcinoma (ESCC), but few later‐line treatments are available. Here we evaluated the therapeutic efficacy of the recombinant, humanized anti‐EGFR antibody HLX07 when used alone or together with serplulimab and chemotherapy against advanced ESCC.

Methods:

This open‐label, non‐randomized, two‐cohort, phase 2 trial involved patients 18‐75 years old with histologically or cytologically confirmed locally advanced, unresectable, or metastatic ESCC, and an Eastern Cooperative Oncology Group performance status of 0‐1. Patients who had failed first‐line immuno‐chemotherapy or at least two lines of other systemic therapy received HLX07 monotherapy intravenously at a dose of 1,000 mg once every 2 weeks (Q2W). Patients with no prior systemic therapy received HLX07 (1,000 mg, day 1) and serplulimab (200 mg, day 1) intravenously Q2W for up to 2 years, concurrently with cisplatin (50 mg/m2, day 1) for up to 8 cycles and 5‐fluorouracil (1,200 mg/m2, days 1‐2) for up to 12 cycles intravenously Q2W. The primary endpoints were progression‐free survival (PFS) and objective response rate (ORR).

Results:

Overall, 50 patients were enrolled. In the HLX07 monotherapy group, ORR was 15.0% (3/20), and the median PFS was 1.5 months (95% confidence interval [CI], 1.3 to 3.7). The median duration of response was not reached, and the rate of patients showing an objective response lasting at least 6 months was 66.7% (95% CI, 5.4 to 94.5). Two (10.0%, 2/20) patients experienced grade 3‐4 treatment‐related adverse events (TRAEs), including hypomagnesemia, hypocalcemia, and fatigue. No patient experienced grade 5 TRAEs. In the HLX07 combination group, the ORR was 60.0% (18/30), and the median PFS was 7.8 months (95% CI, 3.3 to 9.1). Fourteen (46.7%, 14/30) patients experienced grade 3‐4 TRAEs, and one (3.3%, 1/30) patient died due to serplulimab‐related pneumonitis.

Conclusions:

HLX07 monotherapy and its combination with serplulimab and chemotherapy showed manageable toxicity and promising antitumor activity in patients with recurrent or metastatic ESCC. Randomized controlled trials are warranted to further establish the safety and efficacy of HLX07 against ESCC.

Trial registration:

This trial was registered at Clinicaltrials.gov (NCT05221658).

2021-11-02·Expert opinion on biological therapy3区 · 医学

Distinguishing features of a novel humanized anti-EGFR monoclonal antibody based on cetuximab with superior antitumor efficacy

3区 · 医学

Article

作者: Ho, Chieh-Hsin ; Jiang, Weidong ; Chen, Shih Chieh ; Liu, Eugene ; Cheng, Yun-Chih ; Issafras, Hassan ; Wang, Yanling ; Lin, Pei-Hua ; Tseng, Chi-Ling

BACKGROUND:

Cetuximab, the first approved EGFR targeting therapeutic antibody, is currently used to treat colorectal cancer and head and neck cancer. While effective, cetuximab is associated with a higher rate of skin rash, infusion reactions, and gastrointestinal toxicity, which was suggested to be linked to the presence of heterogeneous glycan contents on the Fab of the SP2/0-produced cetuximab.

OBJECTIVE AND METHODS:

To improve efficacy and minimize toxicity of EGFR inhibition treatment, we re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07.

RESULTS:

HLX07 binds to EGFR with similar affinity as cetuximab and shows better bioactivity compared to cetuximab in vitro. In vivo studies demonstrated that HLX07 significantly inhibited the growth of A431, FaDu, NCI-H292, and WiDr tumor cells and synergized them with chemotherapeutics and immune simulator agents such as anti-PD-1. In cynomolgus monkeys, 13-week repeat-dose GLP toxicokinetic studies showed minimal-to-mild toxicities in the dose range of up to 60 mg/kg/wk. In the preliminary phase 1 dose-escalation study, HLX07 had showed lower incidence of skin rashes with grade >2 severities.

CONCLUSION:

HLX07 is currently under phase 1/2 clinical development. We believe HLX07 would potentially be an alternative for patients who have been suffering from cetuximab-mediated toxicity.

2021-10-01·Investigational new drugs3区 · 医学

Phase I first-in-human study of HLX07, a novel and improved recombinant anti-EGFR humanized monoclonal antibody, in patients with advanced solid cancers

3区 · 医学

Article

作者: Zhu, Yunting ; Zhang, Xiaodi ; Hou, Ming-Mo ; Lin, Hsuan-Yu ; Ho, Ching-Liang

Summary:

Purpose This study aimed to evaluate the safety and pharmacokinetic (PK) profiles of HLX07, a novel, recombinant, humanized anti-epidermal growth factor receptor (EGFR) antibody, in patients with advanced solid cancers who had failed standard therapy or for whom no standard therapy was available. Methods In this prospective, open-label, Phase I dose escalation study, patients aged ≥18 years (≥20 years for patients in Taiwan) with histologically-confirmed metastatic or recurrent epithelial carcinoma that had no K-RAS or B-RAF mutations were enrolled in a ‘3 + 3’ escalation design. HLX07 was administered weekly by 2-h intravenous infusion at doses ranging from 50 to 800 mg. The primary endpoint was summary listing of participants reporting treatment-emergent adverse events (TEAEs). Secondary endpoints included PK analysis, serum anti-HLX07 antibody assessments and efficacy. Results In total, 19 patients were enrolled between 1 October 2016 and 16 July 2019 to receive HLX07 at doses of 50 (n = 3), 100 (n = 3), 200 (n = 3), 400 (n = 3), 600 (n = 3) and 800 (n = 4) mg per week. All patients experienced at least one TEAE, most commonly fatigue (68.4%), nausea (47.4%), paronychia (31.6%) and vomiting (31.6%). Serious TEAEs were reported in 11 patients but only one serious TEAE (dyspnea in 600 mg cohort) was regarded as possibly related to study treatment. No dose limiting toxicity (DLT) was reported. Systemic exposure to HLX07 increased proportionally with dose. Anti-HLX07 antibodies were not detected in any patients. Conclusion HLX07 was well tolerated (at dose levels up to 800 mg/week) and promising in patients with advanced solid cancers.Clinical Trial Registration: The study was registered at ClinicalTrials.gov: NCT02648490 (Jan 7, 2016).

46

项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的新闻（医药）

2025-07-25

·医药观澜

速递丨肺癌新突破！复宏汉霖多项创新管线亮相世界肺癌大会

复宏汉霖近日宣布，在即将举办的国际肺癌研究学会（IASLC）2025年世界肺癌大会（WCLC）上，复宏汉霖将就公司肺癌领域核心创新产品的10项中选研究进行报告，其中包括3项口头报告（oral），2项壁报导览（poster tour），涵盖靶向PD-L1的抗体偶联药物（ADC）HLX43 1期临床研究的更新数据，H药一线治疗晚期非鳞状非小细胞肺癌3期临床研究（首次发布），以及H药在肺癌治疗领域的广泛探索结果。2025年9月6日至9日，WCLC将在西班牙巴塞罗那举行。此次发表的具体信息如下：PD-L1 ADC HLX43：广谱抗肿瘤兼具IO疗效的潜在“best-in-class”ADCHLX43是一款靶向程序性死亡-配体1（PD-L1）的新型ADC候选药物，由全人源IgG1抗PD-L1抗体与创新连接子-拓扑异构酶抑制剂荷载偶联而成，其药物抗体比（DAR）约为8。HLX43兼具毒素精准杀伤和肿瘤免疫治疗的复合功能，其毒素不仅能够通过靶点内吞进入肿瘤细胞后进行释放，并在肿瘤微环境中释放后借助旁观者效应进入肿瘤细胞，阻断DNA复制，从而导致肿瘤细胞凋亡。此外，HLX43的PD-L1靶向抗体可激活免疫调节机制，发挥协同抗肿瘤效应。在2025美国临床肿瘤学会（ASCO）年会上，HLX43的1期临床数据首次发布，展现出令人鼓舞的初步疗效和安全性，对鳞状/非鳞状非小细胞肺癌（NSCLC），有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者都展现了优异的治疗潜力，且安全性良好。目前，HLX43已获得中国、美国、日本及澳大利亚药监机构的注册批准，开展一项针对晚期非小细胞肺癌（NSCLC）的国际多中心2期临床研究，并在中国境内完成首例受试者给药。此次WCLC大会上，HLX43自多款ADC分子中脱颖而出，其1期更新临床数据入选壁报导览环节（逾1500份壁报中，仅5%入选壁报导览）。H药：已获批治疗SCLC的抗PD-1单抗肺癌一线治疗全覆盖H药（通用名：斯鲁利单抗注射液）为抗PD-1单抗，已在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市，用于一线治疗小细胞肺癌。复宏汉霖持续深化该产品在肺癌治疗领域的多元布局，目前已全面覆盖肺癌一线治疗，获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、非鳞状非小细胞肺癌（nsNSCLC）三项肺癌适应症，同时正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心3期临床试验。此外，H药治疗SCLC也已获得美国FDA、欧盟委员会和瑞士Swissmedic授予的小细胞肺癌（SCLC）孤儿药资格。同时，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，探索免疫联合疗法在肺癌围术期患者、脑转移患者等广泛人群中的治疗潜力。本次H药获选口头报告，论文题目为：ASTRUM-002：斯鲁利单抗联合化疗（联合或不联合HLX04）用于晚期非鳞状非小细胞肺癌的一线治疗。H药更多研究信息还包括：HLX07联合斯鲁利单抗(联合或不联合化疗)用于鳞状非小细胞肺癌的一线治疗：一项2期研究；斯鲁利抗联合贝伐珠单抗和化疗治疗初治非鳞状非小细胞肺癌伴脑转移的2期研究；MRD动态监测在斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌的观察性研究；贝伐珠单抗联合斯鲁利单抗及化疗治疗EGFR-TKI耐药的非鳞状NSCLC患者2期研究；一项2期SPUR研究：多周期低剂量放射治疗重塑免疫化疗在广泛期小细胞肺癌中的应用；斯鲁利单抗新辅助治疗局晚期非小细胞肺癌的一项前瞻性单臂研究；PS评分≥2的广泛期小细胞肺癌患者的一线免疫联合化疗结果：来自ASTRUM-005R的真实世界证据；一线免疫化疗在广泛期小细胞肺癌中的荟萃分析：ECOG 体能状态评分≥2 是否影响生存结局？参考资料：[1]肺癌新突破！复宏汉霖ADC与IO管线3项口头报告及更多创新成果亮相2025 WCLC. From https://mp.weixin.qq.com/s/O7UCyhC6SfGyVvjnGmhPlg免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床结果抗体药物偶联物ASCO会议临床3期临床2期

2025-07-24

·医药代表

肺癌新突破！复宏汉霖WCLC“秀肌肉”

2025年9月6日至9日，国际肺癌研究学会（IASLC）2025年世界肺癌大会（World Conference on Lung Cancer, WCLC）将在西班牙巴塞罗那举行。此次大会上，复宏汉霖将就公司肺癌领域核心创新产品的10项中选研究进行报告，其中包括3项口头报告（oral），2项壁报导览（poster tour），涵盖PD-L1 ADC HLX43 I期临床研究的更新数据，H药汉斯状®一线治疗晚期非鳞状非小细胞肺癌III期临床研究（首次发布），以及H药在肺癌治疗领域的广泛探索结果，成为此次入选口头报告数目最多的中国生物制药企业。此次发表的具体信息如下：PD-L1 ADC HLX43：广谱抗肿瘤兼具IO疗效的潜在同类最优ADCHLX43是一款靶向程序性死亡-配体1（PD-L1）的新型ADC候选药物，由全人源IgG1抗PD-L1抗体与创新连接子-拓扑异构酶抑制剂荷载偶联而成，其药物抗体比（drug-to-antibody ratio, DAR）约为8。HLX43兼具毒素精准杀伤和肿瘤免疫治疗的复合功能，其毒素不仅能够通过靶点内吞进入肿瘤细胞后进行释放，并在肿瘤微环境中释放后借助旁观者效应进入肿瘤细胞，阻断DNA复制，从而导致肿瘤细胞凋亡。此外，HLX43的PD-L1靶向抗体可激活免疫调节机制，发挥协同抗肿瘤效应。在2025 美国临床肿瘤学会（ASCO）年会上，HLX43的I期临床数据首次发布，展现出令人鼓舞的初步疗效和安全性，对鳞状/非鳞状非小细胞肺癌（NSCLC），有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者都展现了优异的治疗潜力，且安全性良好。目前，HLX43已获得中国、美国、日本及澳大利亚药监机构的注册批准，开展一项针对晚期非小细胞肺癌（NSCLC）的国际多中心II期临床研究，并在中国境内完成首例受试者给药。此次WCLC大会上，HLX43自多款ADC分子中脱颖而出，其I期更新临床数据入选壁报导览环节（逾1500份壁报中，仅5%入选壁报导览）。HLX43-FIH101研究论文题目：抗PD-L1 ADC HLX43在晚期/转移性实体瘤中的安全性、耐受性和初步有效性：I期研究展示形式：壁报导览场次：PT2.10-Metastatic Non-small Cell Lung Cancer - Antibody-Drug Conjugate and Cytotoxic Therapy摘要编号：1459牵头主要研究者：王洁中国医学科学院肿瘤医院展示时间：2025年9月8日下午2:31- 2:39（西班牙时间）H药汉斯状®：全球首个获批治疗SCLC的抗PD-1单抗肺癌一线治疗全覆盖H药汉斯状®（通用名：斯鲁利单抗注射液）为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，已在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市。复宏汉霖持续深化该产品在肺癌治疗领域的多元布局，目前已全面覆盖肺癌一线治疗，获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、非鳞状非小细胞肺癌（nsNSCLC）三项肺癌适应症，同时正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床试验。此外，H药治疗SCLC也已获得美国FDA、欧盟委员会和瑞士Swissmedic授予的小细胞肺癌（SCLC）孤儿药资格，英国创新许可与准入通道合作组织授予的创新通行证资格认定，以及韩国MFDS授予的广泛期小细胞肺癌（ES-SCLC）孤儿药资格，并在美国积极推进一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。同时，公司积极推进H药与公司其他产品的协同以及与创新疗法的联合，探索免疫联合疗法在肺癌围术期患者、脑转移患者等广泛人群中的治疗潜力。HLX10-002-NSCLC301研究论文题目：ASTRUM-002：斯鲁利单抗联合化疗（联合或不联合HLX04）用于晚期非鳞状非小细胞肺癌的一线治疗展示形式：口头报告场次：OA05-lmmunotherapy for Special Populations摘要编号：1454牵头主要研究者：石远凯中国医学科学院肿瘤医院展示时间：2025年9月7日下午4:46-4:56（西班牙时间）滑动查看更多H药在肺癌领域的研究信息HLX07HLX10-sqNSCLC201研究论文题目：HLX07联合斯鲁利单抗(联合或不联合化疗)用于鳞状非小细胞肺癌的一线治疗：一项II期研究展示形式：壁报场次：P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy摘要编号：1467牵头主要研究者：吴一龙广东省人民医院展示时间：2025年9月9日上午10:00-11:30（西班牙时间）论文题目：斯鲁利抗联合贝伐珠单抗和化疗治疗初治非鳞状非小细胞肺癌伴脑转移的II期研究展示形式：简短口头报告场次：MA10-Longer Follow Up and New IO Combinations摘要编号：2266牵头主要研究者：陈丽昆中山大学肿瘤防治中心展示时间：2025年9月9日下午1:02-1:07（西班牙时间）论文题目：MRD动态监测在斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌的观察性研究展示形式：简短口头报告场次：MA03 New Advances in circulating Biomarkers摘要编号：1217牵头主要研究者：马克威吉林大学第一医院展示时间：2025年9月7日下午3:17-3:22（西班牙时间）论文题目：贝伐珠单抗联合斯鲁利单抗及化疗治疗EGFR-TKI耐药的非鳞状NSCLC患者II期研究展示形式：壁报场次：P1.11-Metastatic Non-small Cell Lung Cancer -lmmunotherapy摘要编号：2217牵头主要研究者：王启鸣河南省肿瘤医院展示时间：2025年9月7日上午10:30-12:00（西班牙时间）论文题目：一项II 期SPUR研究：多周期低剂量放射治疗重塑免疫化疗在广泛期小细胞肺癌中的应用展示形式：壁报导览场次：PT2.13 - Small Cell Lung Cancer and Neuroendocrine Tumors摘要编号：2316牵头主要研究者：卢铀四川大学华西医院展示时间：2025年9月8日下午2:23-2:31（西班牙时间）论文题目：斯鲁利单抗新辅助治疗局晚期非小细胞肺癌的一项前瞻性单臂研究展示形式：壁报场次：P2.08 - Local-Regional Non-small Cell Lung Cancer摘要编号：1954牵头主要研究者：曾剑浙江省肿瘤医院展示时间：2025年9月8日上午10:30-12:00（西班牙时间）论文题目：PS评分≥2的广泛期小细胞肺癌患者的一线免疫联合化疗结果：来自ASTRUM-005R的真实世界证据展示形式：壁报场次：P3.13-Small Cell Lung Cancer and Neuroendocrine Tumors摘要编号：1534牵头主要研究者：邬麟湖南省肿瘤医院，胡成平中南大学湘雅医院展示时间：2025年9月9日上午10:00-11:30（西班牙时间）论文题目：一线免疫化疗在广泛期小细胞肺癌中的荟萃分析：ECOG 体能状态评分≥2 是否影响生存结局？展示形式：电子壁报摘要编号：1885牵头主要研究者：余新民浙江省肿瘤医院医药代表伴您成长！

抗体药物偶联物临床3期临床结果ASCO会议上市批准

2025-07-24

·复宏汉霖

肺癌新突破！复宏汉霖ADC与IO管线3项口头报告及更多创新成果亮相2025 WCLC

2025年9月6日至9日，国际肺癌研究学会（IASLC）2025年世界肺癌大会（World Conference on Lung Cancer, WCLC）将在西班牙巴塞罗那举行。此次大会上，复宏汉霖将就公司肺癌领域核心创新产品的10项中选研究进行报告，其中包括3项口头报告（oral），2项壁报导览（poster tour），涵盖PD-L1 ADC HLX43 I期临床研究的更新数据，H药汉斯状®一线治疗晚期非鳞状非小细胞肺癌III期临床研究（首次发布），以及H药在肺癌治疗领域的广泛探索结果，成为此次入选口头报告数目最多的中国生物制药企业。此次发表的具体信息如下：PD-L1 ADC HLX43：广谱抗肿瘤兼具IO疗效的潜在同类最优ADCHLX43是一款靶向程序性死亡-配体1（PD-L1）的新型ADC候选药物，由全人源IgG1抗PD-L1抗体与创新连接子-拓扑异构酶抑制剂荷载偶联而成，其药物抗体比（drug-to-antibody ratio, DAR）约为8。HLX43兼具毒素精准杀伤和肿瘤免疫治疗的复合功能，其毒素不仅能够通过靶点内吞进入肿瘤细胞后进行释放，并在肿瘤微环境中释放后借助旁观者效应进入肿瘤细胞，阻断DNA复制，从而导致肿瘤细胞凋亡。此外，HLX43的PD-L1靶向抗体可激活免疫调节机制，发挥协同抗肿瘤效应。在2025 美国临床肿瘤学会（ASCO）年会上，HLX43的I期临床数据首次发布，展现出令人鼓舞的初步疗效和安全性，对鳞状/非鳞状非小细胞肺癌（NSCLC），有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者都展现了优异的治疗潜力，且安全性良好。目前，HLX43已获得中国、美国、日本及澳大利亚药监机构的注册批准，开展一项针对晚期非小细胞肺癌（NSCLC）的国际多中心II期临床研究，并在中国境内完成首例受试者给药。此次WCLC大会上，HLX43自多款ADC分子中脱颖而出，其I期更新临床数据入选壁报导览环节（逾1500份壁报中，仅5%入选壁报导览）。HLX43-FIH101研究论文题目：抗PD-L1 ADC HLX43在晚期/转移性实体瘤中的安全性、耐受性和初步有效性：I期研究展示形式：壁报导览场次：PT2.10-Metastatic Non-small Cell Lung Cancer - Antibody-Drug Conjugate and Cytotoxic Therapy摘要编号：1459牵头主要研究者：王洁中国医学科学院肿瘤医院展示时间：2025年9月8日下午2:31- 2:39（西班牙时间）H药汉斯状®：全球首个获批治疗SCLC的抗PD-1单抗肺癌一线治疗全覆盖H药汉斯状®（通用名：斯鲁利单抗注射液）为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，已在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市。复宏汉霖持续深化该产品在肺癌治疗领域的多元布局，目前已全面覆盖肺癌一线治疗，获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、非鳞状非小细胞肺癌（nsNSCLC）三项肺癌适应症，同时正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床试验。此外，H药治疗SCLC也已获得美国FDA、欧盟委员会和瑞士Swissmedic授予的小细胞肺癌（SCLC）孤儿药资格，英国创新许可与准入通道合作组织授予的创新通行证资格认定，以及韩国MFDS授予的广泛期小细胞肺癌（ES-SCLC）孤儿药资格，并在美国积极推进一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。同时，公司积极推进H药与公司其他产品的协同以及与创新疗法的联合，探索免疫联合疗法在肺癌围术期患者、脑转移患者等广泛人群中的治疗潜力。HLX10-002-NSCLC301研究论文题目：ASTRUM-002：斯鲁利单抗联合化疗（联合或不联合HLX04）用于晚期非鳞状非小细胞肺癌的一线治疗展示形式：口头报告场次：OA05-lmmunotherapy for Special Populations摘要编号：1454牵头主要研究者：石远凯中国医学科学院肿瘤医院展示时间：2025年9月7日下午4:46-4:56（西班牙时间）滑动查看更多H药在肺癌领域的研究信息HLX07HLX10-sqNSCLC201研究论文题目：HLX07联合斯鲁利单抗(联合或不联合化疗)用于鳞状非小细胞肺癌的一线治疗：一项II期研究展示形式：壁报场次：P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy摘要编号：1467牵头主要研究者：吴一龙广东省人民医院展示时间：2025年9月9日上午10:00-11:30（西班牙时间）论文题目：斯鲁利抗联合贝伐珠单抗和化疗治疗初治非鳞状非小细胞肺癌伴脑转移的II期研究展示形式：简短口头报告场次：MA10-Longer Follow Up and New IO Combinations摘要编号：2266牵头主要研究者：陈丽昆中山大学肿瘤防治中心展示时间：2025年9月9日下午1:02-1:07（西班牙时间）论文题目：MRD动态监测在斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌的观察性研究展示形式：简短口头报告场次：MA03 New Advances in circulating Biomarkers摘要编号：1217牵头主要研究者：马克威吉林大学第一医院展示时间：2025年9月7日下午3:17-3:22（西班牙时间）论文题目：贝伐珠单抗联合斯鲁利单抗及化疗治疗EGFR-TKI耐药的非鳞状NSCLC患者II期研究展示形式：壁报场次：P1.11-Metastatic Non-small Cell Lung Cancer -lmmunotherapy摘要编号：2217牵头主要研究者：王启鸣河南省肿瘤医院展示时间：2025年9月7日上午10:30-12:00（西班牙时间）论文题目：一项II 期SPUR研究：多周期低剂量放射治疗重塑免疫化疗在广泛期小细胞肺癌中的应用展示形式：壁报导览场次：PT2.13 - Small Cell Lung Cancer and Neuroendocrine Tumors摘要编号：2316牵头主要研究者：卢铀四川大学华西医院展示时间：2025年9月8日下午2:23-2:31（西班牙时间）论文题目：斯鲁利单抗新辅助治疗局晚期非小细胞肺癌的一项前瞻性单臂研究展示形式：壁报场次：P2.08 - Local-Regional Non-small Cell Lung Cancer摘要编号：1954牵头主要研究者：曾剑浙江省肿瘤医院展示时间：2025年9月8日上午10:30-12:00（西班牙时间）论文题目：PS评分≥2的广泛期小细胞肺癌患者的一线免疫联合化疗结果：来自ASTRUM-005R的真实世界证据展示形式：壁报场次：P3.13-Small Cell Lung Cancer and Neuroendocrine Tumors摘要编号：1534牵头主要研究者：邬麟湖南省肿瘤医院，胡成平中南大学湘雅医院展示时间：2025年9月9日上午10:00-11:30（西班牙时间）论文题目：一线免疫化疗在广泛期小细胞肺癌中的荟萃分析：ECOG 体能状态评分≥2 是否影响生存结局？展示形式：电子壁报摘要编号：1885牵头主要研究者：余新民浙江省肿瘤医院关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。Henlius to Present Latest Results on ADC and IO Therapies in Lung Cancer at 2025 WCLC2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer(IASLC)  will be held from September 6-9 in Barcelona, Spain‌. At the conference, Henlius will showcase 10 latest results from its innovative products on lung cancer, which includes 3 oral presentations and 2 poster tours, covering updated phase 1 clinical data‌ for PD-L1 ADC HLX43, the results(first release) from ASTRUM-002, a phase 3 clinical trial of serplulimab (anti-PD-1 monoclonal antibody) in the first line treatment of advanced non-squamous non small cell lung cancer (NSCLC) as oral presentation, along with further research findings on serplulimab in lung cancer, making it the Chinese biopharmaceautical with most oral presentations.Details of the release are as follows:PD-L1 ADC HLX43HLX43 is a novel PD-L1-targeting ADC, composed of a fully humanized anti-PD-L1 IgG1 antibody, a novel tripeptide linker and topoisomerase inhibitor payload. The drug to antibody ratio (DAR) is around 8. Its mechanisms of action integrates targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1 blockade. Upon binding to PD-L1-expressing tumor cells, HLX43's cytotoxic payload can be delivered into tumor cells via dual mechanisms—First, the ADC undergoes receptor-mediated endocytosis, releasing the cytotoxic payload intracellularly via linker cleavage, and the payload further diffuses into neighboring tumor cells via bystander effect, thereby blocking DNA replication and triggering tumor cell apoptosis. Meanwhile, the anti-PD-L1 antibody of HLX43 activates immune modulation and blocks immune checkpoints, driving synergistic antitumor efficacy. At WCLC 2025, HLX43 stands out among multiple ADC molecules, with its updated phase 1 clinical data selected for poster tour session.(only 5% were chosen for this session from over 1500 posters)The results from the phase 1 clinical trial of HLX43 has been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC, including squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative patients. To date, HLX43 has been approved by the China NMPA, the U.S. FDA, Australia TGA and Japan's PMDA to initiate phase 2 multi-regional clinical trial in patients with advanced non-small cell lung cancer (NSCLC). Additionally, the first patient dosing has been completed in China. HLX43-FIH101Title: Safety, Tolerability and Preliminary Efficacy of Anti-PD-L1 ADC HLX43 in Advanced/Metastatic Solid Tumors: A Phase I studyForm: Poster TourSession: PT2.10-Metastatic Non-small Cell Lung Cancer - Antibody-Drug Conjugate and Cytotoxic TherapyAbstract Number: 1459Leading PI: Jie Wang, Cancer Hospital Chinese Academyof Medical SciencesTime: Sep 8, 2025 2:31 PM-2:39 PM (CEST)HANSIZHUANG（serplulimab, anti-PD-1 mAb）HANSIZHUANG is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer. It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India. Henlius continues to expand the layout of HANSIZHUANG in the field of lung cancer. Up to date, it has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). In additon, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC).The product was granted orphan drug designations from the FDA, the EC and Swissmedic for the treatment of SCLC, as well as from the Korean Ministry of Food and Drug Safety (MFDS) for the treatment of ES-SCLC. Its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way. Focusing on lung cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted to explore the therapeutic potential of immunotherapy in a wide range of populations, including the perioperative setting for patients with NSCLC and patients with brain metastases.HLX10-002-NSCLC301Title: ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung CancerForm: OralSession: OA05-lmmunotherapy for Special PopulationsAbstract Number: 1454Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy of Medical SciencesTime: Sunday Sep 7, 2025 4:46 PM-4:56 PM (CEST)click to view more research information about serplulimabHLX07HLX10-sqNSCLC201Title: First-line HLX07 plus serplulimab with or without chemotherapy in squamous non-small cell lung cancer: a phase 2 studyForm: PosterSession: P3.12-Metastatic Non-small Cell Lung Cancer - Targeted TherapyAbstract Number: 1467Leading PI: Yilong Wu, Guangdong Provincial People's HospitalTime: Sep 9, 2025 10:00 AM-11:30 AM (CEST)Title: Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naive Non-Squamous NSCLC with Brain Metastases(SUPER BRAIN)Form: Mini OralSession: MA10-Longer Follow Up and New IO CombinationsAbstract Number: 2266Leading PI: Likun Chen, Sun Yat-Sen University Cancer CenterTime: Sep 9,2025 1:02 PM-1:07 PM (CEST)Title: Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive-Stage Small Cell Lung CancerForm: Mini OralSession: MA03 New Advances in circulating BiomarkersAbstract Number: 1217Leading PI: Kewei Ma, Jilin University the First HospitalTime: Sep 7,2025 3:17 PM - 3:22 PM (CEST)Title: Bevacizumab Plus Serplulimab and Chemotherapy for EGFR-TKI-Resistant Non-squamous Non-small-cell Lung Cancer: A Phase 2 StudyForm: PosterSession: P1.11-Metastatic Non-small Cell Lung Cancer -lmmunotherapyAbstract Number: 2217Leading PI: Qiming Wang, Henan Cancer HospitalTime: Sep 7,2025 10:30 AM-12:00 AM (CEST)Title: Multi-Cycle Low-Dose Radiotherapy Reshapes lmmunochemotherapy forES-SCLC: The SPUR Phase II TrialForm: Poster TourSession: PT2.13 - Small Cell Lung Cancer and Neuroendocrine TumorsAbstract Number: 2316Leading PI: You Lu, West China School of Medicine/West China Hospital of Sichuan UniversityTime: Sep 8, 2025 2:23 PM-2:31 PM (CEST)Title: Serplulimab in Neoadjuvant Therapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Single-Arm StudyForm: PosterSession: P2.08 - Local-Regional Non-small Cell Lung CancerAbstract Number: 1954Leading PI: Jian Zeng, Zhejiang Cancer HospitalTime: Sep 8, 2025 10:30 AM-12:00 AM (CEST)Title: First-Line Immunochemotherapy in ES-SCLC Patients with ECOG PS ≥2: Real-World Evidence from the ASTRUM-005R TrialForm: PosterSession: P3.13-Small Cell Lung Cancer and Neuroendocrine TumorsAbstract Number: 1534Leading PI: Lin Wu, Hunan Cancer Hospital | Chengping Hu, Xiangya Hospital of Central South UniversityTime: Sep 9,2025 10:00 AM-11:30 AM (CEST)Title: Meta-Analysis of First-Line Immunochemotherapy in ES-SCLC: Does ECOG PS ≥2 Affect Survival Outcomes?Form: E-PosterAbstract Number: 1885Leading PI: Xinmin Yu, Zhejiang Cancer HospitalAbout HenliusHenlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.联系方式媒体：PR@Henlius.com投资者：IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

抗体药物偶联物ASCO会议临床结果临床1期临床3期

100 项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
皮肤鳞状细胞癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
鳞状非小细胞肺癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
晚期肺非鳞状非小细胞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2023-04-10
晚期鳞状非小细胞肺癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2023-02-01
鼻咽癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-12-14
转移性食管鳞状细胞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-08-25
食管鳞状细胞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-08-18
食管腺鳞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-08-18
晚期肝细胞癌	临床2期	-	上海复宏汉霖生物技术股份有限公司	2022-08-01
转移性结直肠癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-04-14

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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


NCT05513573 (ESMO_ASIA2024) 人工标引	临床2期	鼻咽肿瘤一线	75	HLX07 + Serplulimab + gemcitabine + cisplatin	鏇鹹窪願繭構餘糧顧廠(艱襯選鹹簾鬱鹽憲網淵) = 糧範網網餘蓋夢獵觸齋衊獵鹽積遞獵餘積築醖 (衊觸觸觸餘艱願範廠憲 ) 更多	积极	2024-12-07
				Placebo + Serplulimab + gemcitabine + cisplatin	鏇鹹窪願繭構餘糧顧廠(艱襯選鹹簾鬱鹽憲網淵) = 糧築壓簾齋齋顧醖鹹獵衊獵鹽積遞獵餘積築醖 (衊觸觸觸餘艱願範廠憲 ) 更多
NCT05238363 (ESMO_ASIA2024) 人工标引	临床2期	皮肤鳞状细胞癌末线	31	HLX07 1500 mg	簾淵觸廠鹹壓願鹽遞獵(鏇齋衊夢簾鏇艱製顧顧) = 觸壓顧築鬱鹽鬱鏇願鑰鏇範簾簾遞鏇鑰構糧餘 (願夢選鬱襯醖願醖憲鹽, 5.5 ~ 41.9) 更多	积极	2024-12-07
				HLX07 1000 mg	簾淵觸廠鹹壓願鹽遞獵(鏇齋衊夢簾鏇艱製顧顧) = 糧夢繭顧窪鹽糧膚網觸鏇範簾簾遞鏇鑰構糧餘 (願夢選鬱襯醖願醖憲鹽, 26.2 ~ 87.8) 更多
NCT05221658 (Pubmed \| Cancer Commun (Lond)) 人工标引	临床2期	晚期食管鳞状细胞癌	50	HLX07HLX07 monotherapy	醖夢鹹襯築顧憲襯夢鏇(壓繭鑰獵艱遞遞鹹積願) = 獵壓襯觸窪膚鑰壓鹹願鏇鹽鹹齋鹽蓋構膚鏇膚 (築醖鹹糧繭膚構簾簾艱 ) 更多	积极	2024-10-24
				HLX07+serplulimab+chemotherapy	醖夢鹹襯築顧憲襯夢鏇(壓繭鑰獵艱遞遞鹹積願) = 壓範觸淵積窪艱糧選憲鏇鹽鹹齋鹽蓋構膚鏇膚 (築醖鹹糧繭膚構簾簾艱 ) 更多
NCT05238363 (ESMO_ASIA2023)	临床2期	皮肤鳞状细胞癌 EGFR expression	31	HLX07 1500 mg	選遞顧糧蓋蓋齋鏇鑰淵(艱夢積鹽鏇襯網衊糧糧) = 積鑰築蓋蓋夢夢獵繭顧膚淵鬱淵遞齋觸鹹醖鬱 (簾窪鑰鹽艱獵鹹憲觸夢, 8.2 ~ 47.2) 更多	积极	2023-12-02
				HLX07 1000 mg	選遞顧糧蓋蓋齋鏇鑰淵(艱夢積鹽鏇襯網衊糧糧) = 膚憲蓋鹹積鹹簾繭範壓膚淵鬱淵遞齋觸鹹醖鬱 (簾窪鑰鹽艱獵鹹憲觸夢, 24.5 ~ 91.5) 更多
NCT03577704 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	56	gemcitabine+Cisplatin+HLX07	糧鏇遞簾窪鏇糧鬱廠繭(選簾淵夢蓋構壓蓋網鏇) = 製繭襯餘餘鹹簾選願鏇簾艱淵觸製鏇蓋願窪獵 (獵衊範範衊築糧齋鑰積 ) 更多	积极	2023-05-26
				Paclitaxel+Carboplatin+HLX07	糧鏇遞簾窪鏇糧鬱廠繭(選簾淵夢蓋構壓蓋網鏇) = 廠鑰醖鏇壓簾襯衊鹹簾簾艱淵觸製鏇蓋願窪獵 (獵衊範範衊築糧齋鑰積 ) 更多
NCT05221658 (ASCO 12023 \| ASCO 22023) 人工标引	临床2期	食管鳞状细胞癌一线	49	chemotherapy+HLX07+Serplulimab (Patients with no prior systemic antitumor therapy + group A)	醖範廠襯夢鹹醖鑰簾齋(選壓壓鬱艱範製鹹選廠) = 衊廠糧廠淵膚壓製鹽願鏇鬱壓鏇鬱鬱窪夢繭壓 (衊願繭構鹹壓蓋繭壓鹽, 35.7 ~ 73.6) 更多	积极	2023-05-26
				HLX07 (Patients who had failed first-line immuno-chemotherapy combination or at least two lines of other systemic antitumor therapy + group B)	醖範廠襯夢鹹醖鑰簾齋(選壓壓鬱艱範製鹹選廠) = 憲齋壓醖鬱鏇憲顧構繭鏇鬱壓鏇鬱鬱窪夢繭壓 (衊願繭構鹹壓蓋繭壓鹽, 5.0 ~ 53.8) 更多
NCT02648490 (Pubmed \| Invest New Drugs) 人工标引	临床1期	实体瘤末线	19	HLX07	獵範淵糧構壓齋襯鬱蓋(壓構願齋選衊鹹襯夢醖) = fatigue 68.4%, nausea 47.4%, paronychia 31.6% and vomiting 31.6% 積廠積餘觸顧構憲醖構 (蓋築窪鏇鏇餘壓願選網 ) 更多	积极	2021-10-01
NCT02648490 (ASCO2017)	临床1期	卵巢上皮癌	19	HLX07	鑰製構積觸製壓鹹顧膚(網遞鹽夢網製簾範艱鏇) = 獵選網獵壓廠廠壓鏇淵網衊築鬱夢簾鹹繭願選 (範鬱鬱醖繭夢憲蓋襯積 )	-	2017-05-30
				Cetuximab	鑰製構積觸製壓鹹顧膚(網遞鹽夢網製簾範艱鏇) = 鹽齋簾簾醖積蓋範衊鏇網衊築鬱夢簾鹹繭願選 (範鬱鬱醖繭夢憲蓋襯積 )