维贝柯妥塔单抗(Becotatug vedotin) - 药物靶点：EGFR x Tubulin_在研适应症：鼻咽癌，转移性头颈部鳞状细胞癌，口腔鳞状细胞癌_专利_临床

概要

基本信息

药物类型

ADC

别名

MRG 003、MRG-003、MRG003

+ [1]

靶点

EGFR x Tubulin

作用方式

拮抗剂、抑制剂

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、微管蛋白抑制剂

治疗领域

肿瘤口颌疾病耳鼻咽喉疾病+ [2]

在研适应症

鼻咽癌转移性头颈部鳞状细胞癌口腔鳞状细胞癌+ [7]

非在研适应症

原研机构

在研机构

非在研机构

Panyu District Central Hospital

东曜药业有限公司

权益机构

乐普生物科技股份有限公司

上海美雅珂生物技术有限责任公司

最高研发阶段批准上市

首次获批日期

中国 (2025-10-28),

鼻咽癌

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)、突破性疗法 (中国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

使用我们的ADC技术数据为新药研发加速。

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Sequence Code 756146862L

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Sequence Code 756146864H

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关联

89

项与维贝柯妥塔单抗相关的临床试验

NCT07524413

/ Not yet recruiting临床2期IIT

A Multicenter, Prospective Study of Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade Guided by Dynamic Plasma Cell-Free EBV DNA in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to evaluate the efficacy and safety of a risk-adapted treatment strategy incorporating induction therapy with becotatug vedotin (MRG003) plus pucotenlimab, followed by treatment allocation based on post-induction plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic response in patients with locoregionally advanced nasopharyngeal carcinoma.
All participants will receive three cycles of induction therapy with becotatug vedotin (MRG003) plus the PD-1 inhibitor pucotenlimab. After induction therapy, participants with cfEBV DNA clearance and a complete or partial response will be classified as low risk and receive intensity-modulated radiotherapy alone, followed by adjuvant pucotenlimab. Participants without cfEBV DNA clearance or with stable or progressive disease will be classified as high risk and receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant pucotenlimab and capecitabine.
The primary objectives are to evaluate the post-induction therapy complete response rate in the overall study population and event-free survival in the high-risk group.

开始日期2026-12-01

申办/合作机构

中山大学

NCT07882940

/ Not yet recruiting临床2期IIT

Becotatug Vedotin Combined With Pucotenlimab and Platinum Induction Therapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable NSCLC: a Prospective, Single-arm Phase II Trial

This is a prospective, single-arm phase II clinical study enrolling patients with locally advanced unresectable non-small cell lung cancer. All enrolled patients receive induction therapy with Becotatug Vedotin combined with pucotenlimab and platinum-based regimens. Patients who complete the scheduled induction treatment will subsequently receive definitive concurrent chemoradiotherapy.

开始日期2026-11-15

申办/合作机构

中山大学

NCT07902713

/ Not yet recruiting临床2期IIT

A Single-Arm Phase II Clinical Trial of Becotatug Vedotin Combined With Gemcitabine and a PD-1 Inhibitor as Second-Line or Later Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior Platinum-Based Chemotherapy or PD-(L)1 Inhibitor Therapy

This is a single-center, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of becotatug vedotin combined with gemcitabine and a PD-1 inhibitor as second-line or later treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have experienced treatment failure following prior platinum-based chemotherapy or PD-(L)1 inhibitor therapy.
Patients with recurrent or metastatic NPC who are unsuitable for curative local treatment and meet the eligibility criteria will receive becotatug vedotin, gemcitabine, and a PD-1 inhibitor every 3 weeks for 4-6 cycles, followed by PD-1 inhibitor maintenance therapy until disease progression or unacceptable toxicity.
Approximately 30 patients will be enrolled. The primary objective is to evaluate the objective response rate (ORR) according to RECIST version 1.1. Secondary objectives include evaluating disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and treatment safety.
This study aims to explore a potential treatment option for patients with recurrent or metastatic NPC who have limited therapeutic options after failure of previous systemic therapy.

开始日期2026-11-01

申办/合作机构

中山大学

100 项与维贝柯妥塔单抗相关的临床结果

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100 项与维贝柯妥塔单抗相关的转化医学

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100 项与维贝柯妥塔单抗相关的专利（医药）

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550

项与维贝柯妥塔单抗相关的文献（医药）

2026-10-01·ANNALS OF ONCOLOGY

Becotatug vedotin for recurrent/metastatic nasopharyngeal carcinoma (Magic-M001): a multicenter, randomized trial

Article

作者: Pan, S M ; Li, Q ; Xu, M J ; Qu, S ; Yang, K Y ; Zhou, Y J ; Wang, F ; Xiang, Y Q ; Dou, Y W ; Wang, X H ; Dai, R ; Wei, Y ; Guo, Y ; Huang, S T ; Du, Y Q ; Xu, R H ; Li, J G ; Zhang, P ; Wu, W L ; Jin, Y S ; Lin, H M ; Shu, X L ; Xiao, S W ; Chen, X Z ; Qiu, S F ; Xu, G Q ; Wu, H ; Tang, L Q ; Huang, Y J ; Han, F

BACKGROUND:

Patients with recurrent/metastatic nasopharyngeal carcinoma (NPC) had limited treatment option and dismal prognosis after failure to programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors and chemotherapy.

PATIENTS AND METHODS:

This multicenter, open-label, randomized trial investigated the anti-epidermal growth factor receptor antibody-drug conjugate becotatug vedotin in patients with recurrent/metastatic NPC after failure to ≥2 lines of systemic therapies, including chemotherapy and PD-1/PD-L1 inhibitors. Eligible participants were randomly assigned 1:1 to receive becotatug vedotin 2.3 mg/kg every 3 weeks or chemotherapy (capecitabine or docetaxel). The coprimary endpoints were the independent review committee-confirmed objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).

RESULTS:

Between 6 April 2023 and 27 December 2023, a total of 173 patients were randomly assigned, with 86 assigned to becotatug vedotin and 87 to chemotherapy. As of 30 June 2024, the ORR was significantly higher with becotatug vedotin than with chemotherapy (30.2% versus 11.5%, P = 0.003). With a median follow-up of 7.39 months, becotatug vedotin was associated with a significantly reduced risk of disease progression or death compared with chemotherapy [median PFS, 5.82 versus 2.83 months; hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.43-0.91, log-rank P = 0.01]. As of 30 December 2024, the interim OS analysis showed a median OS of 17.08 months with becotatug vedotin and 11.99 months with chemotherapy (HR 0.73, 95% CI 0.48-1.12, log-rank P = 0.15), with a median follow-up of 13.47 months. The safety profiles were comparable between treatment groups.

CONCLUSIONS:

Among patients with heavily pretreated and immunotherapy-exposed recurrent or metastatic NPC, becotatug vedotin significantly improved ORR and PFS compared with chemotherapy, with comparable toxicity and encouraging but immature OS results.

2026-10-01·JOURNAL OF CLINICAL ONCOLOGY

Becotatug Vedotin Combined With Pucotenlimab in Platinum- and Immunotherapy-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma

Article

作者: Wu, Zheng ; Lin, Jinguan ; Guo, Ye ; Hou, Tao ; Ruan, Dan-Yun ; Zhou, Yujuan ; Wang, Feng-Hua ; Han, Fei ; Wu, Hai-Jun ; Qiu, Sufang ; Cui, Shuo ; Li, Zhi-Ming ; Qu, Song ; Wu, Yuan ; Li, Mengyun ; Xu, Rui-Hua ; Xiang, Yanqun ; Tang, Linquan ; Gao, Jin ; Liu, Lin ; Fang, Meiyu ; Chen, Qiuyan ; Ma, Yuxiang ; Zhao, Yanqiu ; Ma, Hongzhi ; Liu, Ping ; Han, Chen ; Hu, Man ; Zhao, Qiong ; Su, Fang

PURPOSE:

Patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) have limited therapeutic options after failing platinum and anti–PD-1/PD-L1 therapy. We investigated the efficacy and safety of an epidermal growth factor receptor (EGFR)–directed antibody-drug conjugate (ADC) becotatug vedotin (BV) combined with a PD-1 inhibitor pucotenlimab in this setting of patients.

MATERIALS AND METHODS:

Magic-C001 (ClinicalTrials.gov identifier: NCT05688605 ) is an ongoing, open-label, multicohort, dose escalation (phase I) and expansion (phase II) study in patients with EGFR-positive solid tumors. Eligible patients received pucotenlimab 3.0 mg/kg and BV at 1.8-2.3 mg/kg (phase I) or 2.0 mg/kg (phase II for NPC) once every 3 weeks. The primary end point for phase II was objective response rate (ORR). Secondary end points included duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

Among 31 patients with NPC at the recommended phase II dose (RP2D) from phase I and II who had received anti–PD-1/PD-L1 and platinum-based therapy, the confirmed ORR was 71.0% (95% CI, 52.0 to 85.8); DCR was 93.5% (95% CI, 78.6 to 99.2). The median DoR and PFS were 14.0 months (95% CI, 5.7 to not estimated) and 12.0 months (95% CI, 6.8 to 15.4), respectively. Median OS was not mature. Most common treatment-related adverse events (TRAEs) were pruritus (71.9%), hypoesthesia (65.6%), anemia (59.4%), and rash (56.3%). TRAEs of ≥grade 3 occurred in 40.6% of patients. No TRAEs led to death.

CONCLUSION:

To our knowledge, we report the first trial combining an ADC with immunotherapy for platinum and anti–PD-1/PD-L1–resistant NPC. BV plus pucotenlimab yielded a notable ORR with exceptionally durable responses and substantially prolonged PFS, alongside manageable toxicities. This regimen may offer a promising anti–PD-1 rechallenge strategy in this population, which is being confirmed in an ongoing, multicenter, randomized controlled, phase III study.

2026-09-14·Future Oncology

MH-Penile-002: a phase II, prospective, single-arm trial of neoadjuvant anti-EGFR antibody-drug conjugate plus PD-1 inhibitor in penile cancer with challenging penile preservation or regional lymph node metastasis

Article

作者: Yang, Li-Li ; Shao, Yan-Xiang ; Li, Hong-Shuai ; Liu, Ji-Yan ; Zhang, Shuang ; Wang, Jia-Yao ; Li, Xiang ; Liu, Jia-Qi ; Liu, Rui-Zhi

Emerging evidence suggests that combinations of antibody-drug conjugates (ADCs) and immune checkpoint inhibitors (ICIs) may be effective for advanced penile squamous cell carcinoma (PSCC). These findings support the translation of this strategy into the neoadjuvant setting, offering a novel approach for patients with locally advanced or regionally metastatic disease who have limited treatment options. This single-center, prospective, single-arm, phase II trial evaluates the efficacy and safety of neoadjuvant Becotatug Vedotin plus Pucotenlimab in EGFR-expressing PSCC patients with challenging penile preservation or regional lymph node metastasis. Utilizing a Simon's two-stage design, the primary endpoint is the investigator-assessed R0 resection rate. Secondary endpoints include the downstaging rate, objective response rate (ORR), pathological complete response (pCR) rate, major pathological response (MPR) rate, tumor regression grade (TRG), event-free survival (EFS), disease-free survival (DFS), and organ‑sparing rate. The study plans to enroll 60 patients with EGFR-expressing PSCC. Clinical trial registration: www.clinicaltrials.gov identifier is NCT07518979.

836

项与维贝柯妥塔单抗相关的新闻（医药）

2026-11-03

·万泰生物

医学前沿丨《CSCO鼻咽癌诊疗指南（2026）》更新解读：P85-Ab进入分子辅助诊断Ⅰ级推荐

Medical Frontiers 《CSCO鼻咽癌诊疗指南（2026）》由中国临床肿瘤学会指南工作委员会组织编写、人民卫生出版社出版,现已正式发布[1]，在延续2025版整体框架的基础上完成年度更新：全书由13章增至14章，新增“老年鼻咽癌的诊疗”独立章节，第2章2.2节由“病理学诊断”更名为“病理与分子诊断”[2]。本次更新“没有改变分期和治疗的基本框架，但大幅提高了各个环节的准入门槛”，并正着力构建“筛查一诊断一治疗一监测”的全流程闭环体系。诊断: P85-Ab升级为分子辅助诊断Ⅰ级推荐本版诊断部分最重要的更新，是将P85-Ab（抗BNLF2b总抗体）由筛查标志物升级为分子辅助诊断Ⅰ级推荐，标志着P85-Ab从“筛查优选”迈入“诊断标配”。2025版Ⅰ级推荐仅泛称“血清EB病毒抗体与血浆EBV DNA拷贝数可协助鼻咽癌的诊断”；2026版则明确改写为“血清EB病毒抗体（VCA-IgA、EBNA1-IgA和P85-Ab）与血浆EBV DNA拷贝数可协助鼻咽癌的筛查与早期诊断”，并新增“血浆EBV DNA全程动态监测”条目。这三处调整各有其针对性：第一条把2025版泛称的“血清EB病毒抗体”落实为明确的抗体谱系（VCA-IgA、EBNA1-IgA和P85-Ab），并将推荐定位由“协助诊断”拓展为“协助筛查与早期诊断”；第二条把EBV DNA从“单次检测”升级为“全程动态监测”；第三条把落脚点由“诊断价值”转向“质量规范”。循证支撑可按“抗体标志物”与“EBV DNA”两层分别梳理。抗体标志物：从“筛查优选”到“诊断标配” 支撑P85-Ab进入Ⅰ级推荐的是两条顶级期刊证据，分别证实了P85-Ab在筛查和门诊场景的临床应用价值。筛查端，2023年《NEJM》在约2.5万人前瞻性队列中“头对头”比较P85-Ab与EB病毒双抗体的性能。结果显示，P85-Ab灵敏度97.9%（双抗72.3%）、特异度98.3%（双抗97.0%）、阳性预测值10.0%（双抗4.3%），对早期鼻咽癌灵敏度高达97.4%，联合双抗可将筛查阳性预测值由4.3%提升至44.6%[3]。诊断端，2026年《JAMA Oncology》纳入3777例门诊疑似鼻咽癌患者，所有受检者均经内镜与病理确诊，检测者对临床信息设盲。结果显示，P85-Ab灵敏度93.0%、特异度97.3%，显著优于VCA-IgA、EA-IgA和EBNA1-IgA；并提出分层鉴别策略——无症状或非特异性症状者首选P85-Ab单项，鼻咽癌特异性症状者采用“P85-Ab + VCA-IgA + EBNA1-IgA”三联抗体可将灵敏度提升至95.9%[4]。专家点评尽管2026版CSCO指南已将P85-Ab列入Ⅰ级推荐，但在不同场景中应当选用哪种标志物或组合，目前仍不明确。中山大学肿瘤防治中心唐林泉教授提出以下推荐：高发区无症状社区人群筛查首选P85-Ab。不具备P85-Ab检测条件的机构，可选EBNA1-IgA+VCA-IgA；两者任一阳性者，可进一步接受鼻咽镜检查。门诊疑似人群无症状或非特异性症状者，单测P85-Ab即可；有鼻咽癌特异性症状者，P85-Ab+EBNA1-IgA+VCA-IgA同测，但不应依据抗体结果决定是否进行鼻咽镜检查。唐林泉教授同时强调，以上仅为基于当前证据的个人推荐。未来仍需开展真实世界研究，探索各场景下的最佳应用路径与随访策略。随着P85-Ab进入相关检验项目目录并获CSCOⅠ级推荐，预计将有更多筛查项目、体检机构与医疗机构将其纳入检测流程；随着真实世界数据积累，对P85-Ab、双抗体与EBV DNA的使用方式也将形成更清晰的认识。 EBV DNA：从“单次检测”到“全程动态+标准化质控” 支撑EBV DNA两条新条款的证据，分别对应“动态”与“规范”。全程动态监测方面，2024年《Cancer Cell》发表的EP-SEASON研究证实，动态追踪治疗中的血浆EBV DNA可实现对治疗响应性与复发转移风险的实时监测[5]；2026年《Nature》发表的EP-STAR研究进一步证实，基于EBV DNA动态变化进行风险分层并调整后续治疗可显著降低疾病进展风险[6]。一项回顾性研究为“全程监测”的临床价值提供了直接数据：血浆EBV DNA对初治后远处转移的诊断灵敏度、特异度、准确率分别为91.1%、80.0%和92.8%（对肺外转移的准确率高于肺转移），对区域复发为80.2%、80.0%和85.9%[7]。标准化质控方面，指南以Ⅲ级推荐要求“采用统一的标准化EBV DNA检测方案、结果溯源至国际参考品”[1]，其依据包括对PCR法EBV DNA检测现状的系统性综述[8]，以及2025年CSCO年会“EBV DNA检测标准化”专题报告[9]。放疗: 靶区命名标准化，证据边界收紧放疗章有两处改动。其一，3.1节删除“必要时可考虑质子或重离子射线”后半句，使推荐表与注释中仅光子调强放疗的随机证据范围一致[1]。其二，3.3节靶区分层与命名标准化——由2025版“PTVp/CTVp1/CTV2”改为2026版“CTVp_High / CTVp_Mid / CTVp_Low”三级命名，PTV外放边界（GTVp+3mm、+8mm、+13mm）与三档剂量不变；需说明的是，“按诱导化疗后肿瘤体积勾画GTV、缩小高剂量照射范围”并非本轮新增，2025版即已推荐[1-2]。转移性治疗：一线新增派安普利单抗，后线两个ADC落地转移性鼻咽癌推荐表是治疗板块变化最集中的部分。一线Ⅰ级推荐新增“吉西他滨+顺铂或卡铂+派安普利单抗（1A类）”——Ⅲ期AK105-304研究显示，其联合GP较安慰剂联合GP延长中位无进展生存（9.63 vs. 7.00个月，HR=0.45），使推荐表内PD-1单抗联合GP方案扩至五种（卡瑞利珠、特瑞普利、替雷利珠、塔戈利、派安普利）[1]。局部放疗由2025版Ⅱ级推荐的“5-FU+顺铂+局部放疗”改写为Ⅰ级推荐“全身治疗后+局部放疗（2A类）”，并限定为“全身治疗后获得缓解、且经评估可能获益者”——位置上调、证据降级、条件收紧，强调局部放疗应作为缓解后巩固，不应推迟或削弱全身治疗[1]。三线及以上首次出现两个ADC后线选择：伦康依隆妥单抗（iza-bren，靶向EGFR/HER3双特异性ADC）对照标准化疗缓解率为54.6% vs. 27.0%、中位无进展生存为8.38 vs. 4.34个月（HR=0.44）；维贝柯妥塔单抗（MRG003，靶向EGFR）对照卡培他滨或多西他赛缓解率为30.2% vs. 11.5%（HR=0.63）[1]。老年鼻咽癌：新增章节，按功能状态分层新增的“老年鼻咽癌的诊疗”章节按老年综合评估（CGA）分层：功能良好者尽量根治（根治性IMRT，剂量参照一般人群66~70Gy，不因年龄减量）；功能受限者保留根治性放疗、减少治疗中断（根治性IMRT+一个阶段系统治疗，不常规推荐同期化疗）；功能衰弱者以安全性与生活质量优先（短程姑息放疗或最佳支持治疗）[1]。CGA覆盖功能状态、合并症、器官功能、营养与肌少症、认知心理与用药、社会支持六个维度，并建议MDT同时报告TNM分期、CGA分层与顺铂适合性[1]。筛查与质控：双抗体12年随访死亡风险降低 + EBV DNA检测标准化筛查评价终点由早诊率推进至死亡率。双抗体筛查使早诊率由20.6%提高到79.0%、五年总生存率由64.5%提高到95.7%（2025版已有）；2026版新增12年随访结果——筛查组鼻咽癌特异性死亡率8.2/1000人年、对照组12.5/1000人年，校正后RR=0.70，鼻咽癌特异性相对死亡风险降低约30%[10] 。EBV DNA检测标准化则补齐参数空白：高敏试剂（检测下限低于50 IU/ml）、溯源至国际参考品、以国际单位报告，并优化样本流程（血浆、磁珠提取、800 μL、6小时内检测），与诊断章Ⅲ级推荐“表提要求、正文给参数”互为表里。其他增补：支持治疗、人工智能与疗效监测不良反应与营养支持：富勒烯外用制剂使≥2级放射性皮炎相对下降48.5%；莫匹罗星鼻用软膏去定植使≥3级口腔黏膜炎由47.7%降至22.7%；晚期损伤新增高压氧；营养对低碳水的表述改为“适当限制”[1]。人工智能：新增鼻咽内镜诊断系统，多读者研究中基层医师准确率由83.4%升至91.2%[1]。疗效监测与随访：按诱导化疗期间血浆EBV DNA清除速度分层的风险适应治疗，即指南所引EP-STAR研究，进展或死亡风险显著降低[6]。综观全篇，《CSCO鼻咽癌诊疗指南（2026）》在“分期与治疗基本框架不变”的前提下，完成了四个推荐表层面的实质修订——P85-Ab晋级分子辅助诊断Ⅰ级推荐、放疗靶区命名标准化、转移性一线扩充与后线ADC落地、老年诊疗独立成章，并大幅提升了筛查、质控与随访各环节的准入门槛。其中，P85-Ab从“筛查优选”到“诊断标配”的跨越，是“生物标志物驱动”理念落地的标志性一步。随着标准化国产标志物与精准分层策略协同推进，鼻咽癌的诊疗全流程闭环正加速成形，将让更多患者从“早期发现、精准干预”中获益。本文仅供学术交流，诊疗决策以指南原文及药品说明书为准。往期回顾医学前沿 | 循证筑基：P85-Ab重塑鼻咽癌防治路径医学前沿 | 《鼻咽癌标志物临床应用专家共识2025版》发布，重磅推荐万泰生物P85-Ab 参考文献： [1] 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会（CSCO）鼻咽癌诊疗指南2026[M]. 北京: 人民卫生出版社, 2026. [2] 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会（CSCO）鼻咽癌诊疗指南2025[M]. 北京: 人民卫生出版社, 2025. [3] Li TD, Li FG, Guo XY, et al. Anti-Epstein-Barr virus BNLF2b for mass screening for nasopharyngeal cancer[J]. N Engl J Med, 2023, 389(9): 808-819. [4] Li SC, Li FG, Wu SJ, et al. Diagnostic performance of anti-Epstein-Barr virus BNLF2b in suspected nasopharyngeal carcinoma[J]. JAMA Oncol, 2026, 12(5): 478-487. [5] Lv J, Xu LX, Li ZX, et al. Longitudinal on-treatment circulating tumor DNA as a biomarker for real-time dynamic risk monitoring in cancer patients: the EP-SEASON study[J]. Cancer Cell, 2024, 42(8): 1401-1414. [6] Lv J, Zheng DX, Liang JH, et al. Risk-adaptive therapy guided by dynamic ctDNA in nasopharyngeal carcinoma[J]. Nature, 2026, 652(8110): 731-739. [7] Chen FP, Huang XD, Lv JW, et al. Prognostic potential of liquid biopsy tracking in the posttreatment surveillance of patients with nonmetastatic nasopharyngeal carcinoma[J]. Cancer, 2020, 126(10): 2163-2173. [8] Kim KY, Le QT, Yom SS, et al. Current state of PCR-based Epstein-Barr virus DNA testing for nasopharyngeal cancer[J]. J Natl Cancer Inst, 2017, 109(4): 761-763. [9] 杜紫明. EBV DNA检测标准化[C]//第28届中国临床肿瘤学会学术年会. 济南: 中国临床肿瘤学会(CSCO), 2025. [10] Chen WJ, Yu X, Lu YQ, et al. Impact of an Epstein-Barr virus serology-based screening program on nasopharyngeal carcinoma mortality: a cluster-randomized controlled trial. J Clin Oncol. 2025;43(1):22-31.

CSCO会议

2026-11-02

·搜狐新闻

乐普生物（02157.HK）：11月2日南向资金增持288.4万股

证券之星消息，11月2日南向资金增持288.4万股乐普生物（02157.HK）。近5个交易日中，获南向资金增持的有5天，累计净增持2308.1万股。近20个交易日中，获南向资金增持的有11天，累计净增持267.91万股。截至目前，南向资金持有乐普生物（02157.HK）5.49亿股，占公司已发行普通股的30.44%。乐普生物科技股份有限公司是一家主要从事医药产品销售及新药研发的公司。该公司聚焦于肿瘤治疗领域，尤其是靶向治疗及免疫治疗。该公司致力于通过抗体药物偶联物（ADC）技术开发平台开发创新型ADC。该公司的临床阶段候选药物涵盖靶向疗法药物和一种免疫治疗药物，具体包括MRG003、MRG002、CMG901、MRG004A、CG0070、MRG006A、MRG007、CTM012等。本文数据来源于香港交易所，仅供参考不构成投资建议。返回搜狐，查看更多

抗体药物偶联物免疫疗法

2026-11-02

·搜狐新闻

乐普生物（02157.HK）11月2日收盘平盘，主力资金净流入89.73万港元

证券之星消息，截至2026年11月2日收盘，乐普生物(02157.HK)报收于3.15港元，与上一交易日持平，成交量806.2万股，成交额2526.69万港元。资金流向数据方面，11月2日乐普生物主力资金净流入89.73万港元，超大单资金净流入56.2万港元，大单资金净流入33.53万港元，中单资金净流入177.16万港元，小单资金净流入31.73万港元。乐普生物科技股份有限公司是一家主要从事医药产品销售及新药研发的公司。该公司聚焦于肿瘤治疗领域，尤其是靶向治疗及免疫治疗。该公司致力于通过抗体药物偶联物（ADC）技术开发平台开发创新型ADC。该公司的临床阶段候选药物涵盖靶向疗法药物和一种免疫治疗药物，具体包括MRG003、MRG002、CMG901、MRG004A、CG0070、MRG006A、MRG007、CTM012等。以上内容为证券之星据公开信息整理，仅供参考不构成投资建议。返回搜狐，查看更多

抗体药物偶联物

100 项与维贝柯妥塔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
鼻咽癌	中国	乐普生物科技股份有限公司	2025-10-28

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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
转移性头颈部鳞状细胞癌	临床3期	中国	乐普生物科技股份有限公司	2023-04-04
晚期头颈部鳞状细胞癌	临床3期	中国	上海美雅珂生物技术有限责任公司	2023-03-29
下咽癌	临床2期	中国	Panyu District Central Hospital	2026-10-01
喉肿瘤	临床2期	中国	Panyu District Central Hospital	2026-10-01
口腔肿瘤	临床2期	中国	Panyu District Central Hospital	2026-10-01
口咽肿瘤	临床2期	中国	Panyu District Central Hospital	2026-10-01
口腔鳞状细胞癌	临床2期	中国	乐普生物科技股份有限公司	2026-09-01
局部晚期恶性实体瘤	临床2期	中国	乐普生物科技股份有限公司	2026-08-01
阴茎鳞状细胞癌	临床2期	中国	乐普（北京）医疗器械股份有限公司	2026-07-22
皮肤鳞状细胞癌	临床2期	中国	乐普生物科技股份有限公司	2026-01-09

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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


NCT07235566 (ESMO2026)	临床2期	EGFR阳性肿瘤 EGFR-positive	30	Becotatug vedotin+pucotenlimab	製醖遞獵衊廠簾鹽簾廠(顧廠蓋齋鏇遞夢憲鹹壓) = 積鑰憲餘窪壓範夢範鏇網製築構築製網餘鹽築 (廠鹹構鬱願齋夢鹽鏇構, 26.7 ~ 62.9) 更多	积极	2026-10-23
NCT07235566 (ESMO2026)	临床2期	EGFR阳性肿瘤 EGFR-positive	30	Becotatug vedotin+pucotenlimab (BRAF mutant)	製醖遞獵衊廠簾鹽簾廠(顧廠蓋齋鏇遞夢憲鹹壓) = 廠艱膚鏇構鬱糧範獵夢網製築構築製網餘鹽築 (廠鹹構鬱願齋夢鹽鏇構, 24.8 ~ 69.9)	积极	2026-10-23
NCT06959108 (IDEAL, ESMO2026)	临床2期	局部晚期头颈部鳞状细胞癌	49	pucotenlimab (HX008) + becotatug vedotin (MRG003)	糧鑰窪鹽餘醖鑰襯選觸(鑰範醖築窪獵鑰餘積觸) = One death occurred in Arm B (post-gastrostomy, after 1 cycle ADC), deemed unrelated to study treatment. 襯簾築夢構鑰構構憲積 (襯糧鏇鹹糧襯構範憲壓 ) 更多	积极	2026-10-23
NCT06959108 (IDEAL, ESMO2026)	临床2期	局部晚期头颈部鳞状细胞癌	49	becotatug vedotin (MRG003)		积极	2026-10-23
NCT05688605 (Magic-C001, Pubmed \| J Clin Oncol)	临床1/2期	复发性鼻咽癌 EGFR-positive	31	Becotatug Vedotin + Pucotenlimab	繭簾夢襯餘憲顧衊遞簾(艱鑰網醖憲壓鑰鏇築範) = 製願顧顧範鑰鹹醖鹽憲夢齋衊襯糧觸憲願齋壓 (憲壓鏇膚蓋鑰鹽蓋觸鑰, 52.0 ~ 85.8) 更多	积极	2026-10-01
NCT07381075 (ASCO2026)	临床2期	局部晚期头颈部鳞状细胞癌新辅助	60	Becotatug Vedotin + Ivonescimab	夢選壓積繭憲簾範獵壓(鹹膚遞觸獵膚襯鬱憲積) = 鬱選鹽鏇窪構衊構築鹹獵蓋夢膚積築廠鹽糧鑰 (繭壓淵窪餘蓋積繭壓積 )	积极	2026-05-29
NCT04868162 (Pubmed \| Literature)	临床2期	头颈部鳞状细胞癌	67	Becotatug Vedotin	築範範醖鬱艱積鹽鏇網(壓鬱壓糧鏇鹽膚淵顧顧) = 壓網構廠衊糧鬱繭製糧襯築繭構糧獵艱夢簾繭 (簾淵鑰鏇淵鹹構憲窪鏇, 11.9 ~ 32.6) 更多	积极	2026-04-15
NCT05688605 (HX008/MRG003-C001, ESMO2025) 人工标引	临床2期	转移性头颈部鳞状细胞癌 \| 复发性头颈部鳞状细胞癌一线	37	Becotatug vedotin 2.0 mg/kg + pucotenlimab	築遞憲觸鏇遞鏇構衊獵(糧鏇餘構獵範遞簾願顧) = 築齋鹹艱艱艱鹹鏇糧壓鏇鑰糧廠網鬱鑰餘觸獵 (築餘艱繭鑰遞鬱網窪淵 ) 更多	积极	2025-10-17
NCT05688605 (HX008/MRG003-C001, ESMO2025) 人工标引	临床2期	转移性头颈部鳞状细胞癌 \| 复发性头颈部鳞状细胞癌一线	37	Becotatug vedotin 2.3 mg/kg + pucotenlimab	築遞憲觸鏇遞鏇構衊獵(糧鏇餘構獵範遞簾願顧) = 衊壓繭醖醖餘衊鏇選艱鏇鑰糧廠網鬱鑰餘觸獵 (築餘艱繭鑰遞鬱網窪淵 ) 更多	积极	2025-10-17
NCT05688605 (HX008/MRG003-C001, ESMO2025) 人工标引	临床2期	复发性鼻咽癌二线	30	becotatug vedotin (HX008)pucotenlimab (MRG003)	壓製鹽淵鹽築壓鹽膚夢(網網觸顧鑰顧夢衊憲鏇) = 網醖構鹹蓋衊鏇衊襯觸選窪齋範網鏇遞窪廠觸 (衊簾淵壓鹽簾獵範遞鹽 ) 更多	积极	2025-10-17
NCT05126719 (ASCO2025) 人工标引	临床2期	晚期鼻咽癌三线	173	MRG003	選廠簾顧積選窪願窪淵(廠鹽製憲鬱壓襯積窪鏇) = 積憲齋醖糧觸夢獵繭獵廠遞鏇餘廠鏇醖鹹觸窪 (糧醖齋鬱窪獵餘夢鏇鏇, 11.4 ~ NE) 更多	积极	2025-05-30
NCT05126719 (ASCO2025) 人工标引	临床2期	晚期鼻咽癌三线	173	Chemotherapy	選廠簾顧積選窪願窪淵(廠鹽製憲鬱壓襯積窪鏇) = 壓鑰衊選鑰願鏇觸窪築廠遞鏇餘廠鏇醖鹹觸窪 (糧醖齋鬱窪獵餘夢鏇鏇, 9.7 ~ 15.4) 更多	积极	2025-05-30
NCT05688605 (HX008/MRG003-C001, ESMO_ASIA2024) 人工标引	临床2期	鼻咽癌	30	Pucotenlimab (HX008) 3.0 mg/kg + EGFR-ADC (MRG003) 2.0 mg/kg	壓繭艱願願鬱顧壓網積(窪齋膚夢鑰襯餘製衊鑰) = 廠壓淵鹹壓鏇窪鹽鑰網衊蓋鏇簾壓餘網齋簾廠 (齋蓋鑰壓遞糧觸範醖築, 59.7 ~ 73.7) 更多	积极	2024-12-07
NCT05688605 (Phase I/II study, ASCO2024) 人工标引	临床1/2期	EGFR 突变实体瘤 EGFR-positive	33	Pucotenlimab(HX008) + MRG003	構艱餘艱顧壓獵範觸襯(醖夢遞構築築淵簾鹹觸) = 壓糧鏇製構鏇鑰艱築蓋膚遞艱遞觸鬱窪鹽艱築 (顧鏇獵積餘廠鹹鏇艱襯 ) 更多	积极	2024-05-24