Phase II Study of HRS-4642 in Combination With Nimotuzumab and Chemotherapy for Subjects With Borderline Resectable Pancreatic Cancer With KRAS G12D Mutation

This study is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and AG in borderline resectable pancreatic cancer. The study process includes a screening period (from the signing of the informed consent form until the first dose), a treatment period (from the first dose to the discontinuation of study treatment), and a follow-up period (safety follow-up and survival follow-up after the discontinuation of study treatment).

开始日期2026-02-15

申办/合作机构

浙江大学

NCT07310771

/ Not yet recruiting临床2期IIT

A Single-Arm Phase II Study of Sintilimab Plus Nimotuzumab and Chemotherapy Followed by Definitive Chemoradiotherapy With Nimotuzumab for Locally Advanced Head and Neck Squamous Cell Carcinoma

Although multiple immune-checkpoint inhibitors (ICIs) have demonstrated efficacy in recurrent or metastatic squamous-cell carcinoma of the head and neck (R/M-SCCHN), outcomes in the locally advanced (LA-SCCHN) setting remain suboptimal, and treatment continues to pose a major therapeutic challenge. Incremental improvements in efficacy are still required, necessitating the development of more effective regimens. Whether combining an ICI with chemotherapy and nimotuzumab can confer additional clinical benefit in LA-SCCHN remains to be determined. Against this backdrop, we designed a single-arm, phase II, single-centre clinical trial to evaluate the efficacy and safety of sintilimab plus chemotherapy and nimotuzumab for patients with LA-SCCHN.

开始日期2026-01-10

申办/合作机构

福建省肿瘤医院（福建省肿瘤研究所、福建省癌症防治中心、福建省生物医学与肿瘤转化研究中心）

NCT07333274

/ Recruiting临床3期IIT

An Open-label, Prospective, Randomized, Phase III, International Multicenter Clinical Study to Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),

开始日期2026-01-05

申办/合作机构-

100 项与尼妥珠单抗相关的临床结果

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100 项与尼妥珠单抗相关的转化医学

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100 项与尼妥珠单抗相关的专利（医药）

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338

项与尼妥珠单抗相关的文献（医药）

2026-03-01·NEUROSCIENCE

The efficacy of combination therapy versus monotherapy in patients with glioblastoma with abnormal epidermal growth factor receptor (EGFR) genes, a systematic review and network meta-analysis

Review

作者: Du, Yuejiao ; Xu, Songbai ; Che, Luhao ; Yan, Xiaokai ; Fan, Liding ; Wu, Hao ; Yu, Bo ; Li, Yanhua ; Zhang, Yi ; Feng, Junjie

The primary objective of this study is to evaluate the efficacy of various pharmaceuticals (combination therapy versus monotherapy) in patients with glioblastoma (GB) with abnormal epidermal growth factor receptor (EGFR) genes. Clinical trials to investigate the therapeutic effects of different therapy was searched by PubMed, Embase, Web of Science, Cochrane Library, and Google Scholar. The Cochrane Risk of Bias Assessment Tool and data analysis software will be applied. Data collection spanned from the earliest available date up to April 2025. Eight studies involving a total of 2,137 individuals were included, with 657 of these receiving combination therapies and 1,480 receiving monotherapies. The analysis revealed that combination therapies generally demonstrated superior efficacy compared to the single ones, while monotherapies exhibited greater potency than temozolomide (TMZ). In terms of median progression-free survival (PFS), the combinations of Afatinib plus TMZ (SUCRA: 62.28%), rindopepimut (CDX-110) plus TMZ (SUCRA: 62.27%), and depatuxizumab mafodotin (Depatux M) plus TMZ (SUCRA: 54.4%) ranked among the top tier. For median overall survival (OS), the combinations of CDX-110 plus TMZ (SUCRA: 68.8%), Depatux M plus TMZ (SUCRA: 68.3%), and Nimotuzumab plus TMZ (SUCRA: 52.5%) were positioned in the upper echelon. In terms of prolonging both median PFS and median OS in GB, CDX-110 plus TMZ and Depatux M plus TMZ have shown slightly better than comparable therapies. However, further clinical trials are needed to confirm the effectiveness of other drugs in this respect.

2026-02-01·ANTI-CANCER DRUGS

Adiponectin Receptor 1-vascular endothelial growth factor axis mediates resistance to epidermal growth factor receptor–targeted therapy in nasopharyngeal carcinoma

Article

作者: Li, Wanxia ; Wu, Shuting ; Liu, Xiong ; Zhang, Guohua ; Cheng, Zilu ; Peng, Xiaohong

Nasopharyngeal carcinoma (NPC) is highly prevalent in Southeast Asia and southern China, with most patients diagnosed at advanced stages. Although epidermal growth factor receptor (EGFR)–targeted therapies have shown clinical promise, their long-term efficacy is limited. This study explores the regulatory role of AdipoR1 in EGFR-targeted therapy response and evaluates adiponectin as a potential strategy to overcome treatment resistance. NPC cell lines (5-8F and CNE1) were treated with nimotuzumab for short (24 h) and long (72 h) durations. mRNA and protein expression of vascular endothelial growth factor (VEGF), AdipoR1/R2, and other pathway components were assessed using quantitative reverse transcription polymerase chain reaction (qRT-PCR) and western blotting. Adiponectin was applied to explore its regulatory role in VEGF expression and EGFR signaling. Prolonged treatment of NPC cells with nimotuzumab inhibited EGFR downstream signaling [protein kinase B, mammalian target of rapamycin (mTOR), extracellular signal-regulated kinase], reduced cell invasion and migration initially, but invasive capacity gradually recovered over time. VEGF expression remained unchanged at 24 h but significantly increased after 72 h, promoting angiogenesis in cocultured HUVECs. Long-term nimotuzumab exposure downregulated AdipoR1 expression, while adiponectin restored AdipoR1 and VEGF levels with decreased mTOR expression, not EGFR, indicating that the mTOR pathway may mediate this regulation. In addition, nimotuzumab elevated the expression of lipid metabolism-related genes, FABP4 and CD36, which was mitigated by A-PN cotreatment. Prolonged EGFR-targeted therapy in NPC upregulates VEGF via AdipoR1 downregulation, reducing treatment efficacy. Adiponectin restores AdipoR1, suppresses VEGF, and reverses this effect, possibly through mTOR inhibition, suggesting a potential strategy to improve long-term therapeutic outcomes.

2026-01-01·Journal of the Chinese Medical Association

Surgical margin assessment after neoadjuvant chemotherapy plus nimotuzumab in locally advanced oral squamous cell carcinoma

Article

作者: Bao, Yang ; Shi, Yaoyao ; Chen, Si ; Cui, Zifeng ; Zhang, Suxin ; Chai, Guochao ; Hao, Jiamei ; Peng, Shixiong

Background::

The surgical safety margin of the oral squamous cell carcinoma (OSCC) is not clear. We investigate the effect of nimotuzumab (N) combined with nab-paclitaxel, cisplatin, and fluorouracil (APF) neoadjuvant chemotherapy on the surgical margin.

Methods::

This was a single-center retrospective study, included 18 to 75 ages diagnosed newly histologically confirmed OSCC patients at the Fourth Hospital of Hebei Medical University between September 2019 and December 2021. Patients were divided into neoadjuvant chemotherapy and surgery group (G1 group, N + APF), chemotherapy and surgery group (G2 group, APF alone), and surgery group (G3 group). Tissue samples of the tumor core zone (P0), adjacent (P1, 3-5 mm from tumor), distal adjacent (P2, 7-10 mm from tumor), and surgical margin (P3, 15 mm from tumor) were collected. The main indicators of pathological evaluation were pathologic complete response (pCR) and major pathologic response (MPR). Chi-square or Fisher test was used for the pathological response rate of qualitative data, and t test or analysis of variance (ANOVA) was used for protein expression changes of quantitative data. A threshold value of p < 0.05 indicated statistical significance.

Results::

In the G1 (n = 15) and G2 (n = 20) groups, various degrees of degeneration and necrosis were observed in the tumor retraction area. Nine cases of MPR and four cases of pCR in the G1 group; eight cases of MPR and three cases of pCR in the G2 group. The expressions of p53, eIF4E, and EGFR in the samples of the three groups decreased from P0 to P2 ( p < 0.05). In the molecular tumor shrinkage area, the expression levels of p53, eIF4E, and EGFR in the shrinkage zone were lower than those in the negative margin.

Conclusion::

There is no significant statistical difference between APF plus nimotuzumab or APF alone in the pathological remission rate. The surgical margin was defined to 1.5 cm clinical margin after tumor regression.

项与尼妥珠单抗相关的新闻（医药）

2026-02-25

·亦庄有能量

百泰生物：中国单抗药物领军者，以“生物导弹”重塑癌症治疗格局

——春节不停产背后的创新密码与产业雄心一、企业画像：中古合作典范，23年深耕抗体赛道百泰生物药业有限公司（以下简称“百泰生物”）成立于2000年8月，是中国与古巴在生物医药领域规模最大、技术最深远的合作项目，总部位于北京经济技术开发区。作为国内首个实现人源化单克隆抗体产业化的企业，公司拥有中国首个抗体人源化技术平台和全自动大规模哺乳动物细胞培养生产线，填补了国内肿瘤治疗性抗体药物的空白。 23年来，百泰生物以“让中国患者用上国际水平的创新药”为使命，累计承担国家863计划、重大新药创制专项等国家级科研项目20余项，荣获北京市科学技术一等奖、中国专利金奖等荣誉，并于2022年入选北京市专精特新“小巨人”企业。二、核心产品：尼妥珠单抗——改写鼻咽癌治疗史的“中国智造” 百泰生物的拳头产品尼妥珠单抗注射液（泰欣生®），是中国首个治疗恶性肿瘤的单克隆抗体药物，于2008年获批上市，至今仍是国内唯一获批用于局部晚期鼻咽癌治疗的靶向药物。其核心技术突破体现在：人源化程度达95%：通过基因重组技术改造鼠源抗体，大幅降低免疫原性，副作用仅为传统化疗的1/3；精准靶向EGFR通路：特异性结合表皮生长因子受体，阻断肿瘤细胞增殖信号，被《NCCN头颈肿瘤临床实践指南》推荐为一线治疗方案；多适应症拓展：已获批鼻咽癌、胰腺癌、头颈部肿瘤三大适应症，食管癌适应症完成临床核查即将上市，累计服务超15万患者。三、技术壁垒：全球领先的连续灌流工艺百泰生物的核心竞争力源于两大技术突破： 4000L连续灌流培养系统国际最大规模产线：单批次产能达4000升，年产能180万支，较传统工艺效率提升5倍；生产周期压缩30%：通过无血清培养基和自动化控制，实现哺乳动物细胞连续稳定生产，单抗表达量突破5g/L。全流程质量管控体系从细胞株构建到制剂灌装全程实现GMP标准，关键工艺参数（CPP）实时监控；建立百万级具身智能数据集，优化工艺稳定性，产品纯度达99.9%以上。四、产能布局：亦庄“超级工厂”冲刺18亿产值为应对泰欣生®市场需求激增（2025年销售额预计突破18亿元），百泰生物在北京亦庄启动“三车间投产、四车间筹建”计划：现有产能：2个原液车间满负荷运转，年产180万支；新增产能：2026年第三个车间投产后，总产能将达360万支，支撑年产值突破25亿元；技术升级：引入AI驱动的智能生产系统，实现从发酵参数到质检结果的全流程数字化管控。五、研发管线：从单抗到多抗，构建肿瘤治疗生态百泰生物正从单一品种向多元化产品矩阵转型，在研管线覆盖10余个靶点：临床阶段：3款新药进入Ⅱ/Ⅲ期试验，包括抗CD6单抗（银屑病）、抗CD3单抗（器官移植排斥）；技术储备：开发双特异性抗体、抗体偶联药物（ADC），布局EGF疫苗等新型疗法；国际化布局：与古巴分子免疫学中心共建联合实验室，推动泰欣生®在拉美、东南亚市场的注册。六、未来蓝图：打造“亦庄智造”全球标杆 “到2027年，我们要实现三个目标：建成亚洲最大抗体生产基地、推动5个新药上市、跻身全球生物医药TOP50。”百泰生物董事长白先宏表示。依托北京经开区“新药创制-临床试验-产业化”全链条支持政策，公司将加速推进三大战略：产能倍增：2026年底前完成第四车间建设，总产能突破500万支；临床突围：拓展泰欣生®在食管癌、宫颈癌等领域的适应症，覆盖人群扩大至30万/年；技术出海：通过FDA认证，推动中国单抗药物进入欧美市场。结语：从“跟跑”到“领跑”的中国方案从2000年中古技术合作到2026年全球产能前三，百泰生物的崛起印证了中国生物医药产业的跨越式发展。其以“生物导弹”精准打击肿瘤的创新实践，不仅为患者带来生的希望，更树立了“引进—消化—创新”的产业标杆。正如车间里永不停歇的发酵罐，这家“亦庄智造”企业正以澎湃动能，书写着中国创新药的新篇章。欢迎朋友们咨询以下内容：北京工业科技旅游研学~ 参观大厂：小米、北京奔驰、京东方、视源、盛通等亦庄企业参访交流、亦庄产业园区需求、写字楼等亦庄各类资源需求亦庄企业品宣、市场推广，上下游产业链链接加小编微信对接

上市批准

2026-02-19

·澎湃新闻

春节“细胞工厂”不打烊，百泰生物今年将冲刺18亿产值

2月19日大年初三，位于北京经济技术开发区（北京亦庄）的百泰生物药业有限公司（以下简称“百泰生物”）的抗体原液生产车间一片忙碌，身穿蓝色洁净服的操作人员各司其职，开展细胞培养和产物纯化工作。这条春节“不打烊”的生产线上，正培育着关系许多癌症患者生命的“希望种子”。百泰生物副总经理林峰说：“随着新适应症的获批，市场需求持续攀升，我们今年产值有望突破18亿元，同比增长预计近30%” “目前车间主要进行尼妥珠单抗注射液（泰欣生®）的细胞培养。”林峰指着运转中的4000L发酵罐告诉记者。百泰生物是国内最早从事肿瘤抗体药物研发、生产的企业之一，早在2008年便实现了国内首个人源化抗体药物——尼妥珠单抗注射液（泰欣生®）的产业化，到现在仍是国内唯一获批用于局部晚期鼻咽癌治疗的靶向药物，率先填补了国内在肿瘤治疗性抗体药物领域的空白。百泰生物的抗体原液生产车间内操作人员们正在工作。目前，尼妥珠单抗注射液（泰欣生®）已陆续获批3个临床适应症，分别是鼻咽癌、胰腺癌和头颈部肿瘤。对癌症患者而言，抗体药物治疗就像“生物导弹”，能精准狙杀肿瘤细胞，而不伤害患者自身的其他细胞。林峰透露，尼妥珠单抗注射液（泰欣生®）的第4个适应症——食管癌的临床试验已经结束，并于今年1月底完成临床现场核查，距离上市又近了一步。面对同比增长近30%的全年生产任务指标，抗体药物生产的连续性要求，让春节不停产成为必然选择。林峰解释，因为生产工艺的特殊性，一个完整批次生产周期长达3个月，涵盖发酵、纯化、制剂三大环节。其中，发酵阶段需持续培养哺乳动物细胞以产生抗体，一旦中断再重启，重新解冻细胞直至恢复生产需多耗费30余天。他说：“时间紧、任务重，连续生产为全年目标的实现抢出宝贵时间。” 百泰生物的抗体原液生产车间内操作人员们正在工作。在紧张生产的同时，产能扩充也在紧锣密鼓推进。据林峰介绍，百泰生物已在北京亦庄建成两个原液生产车间，年产能达180万支，预计今年将投用第三个车间，并启动第四个车间的筹建。值得关注的是，百泰生物掌握的4000L连续灌流工艺，是目前国际同类工艺应用的最大规模产线，曾荣获北京市科学技术一等奖。这一生产规模优势，加上对连续工艺条件下抗体质量的精准把控，构成了百泰生物难以复制的核心竞争力。 “未来，我们将在北京亦庄产业政策、生态等支持下，从研发、扩产、临床适应症等方面发力，让更多‘亦庄造’创新药惠及患者。”林峰描绘着发展蓝图。在研发端，百泰生物在研新药十余种，3款已进入临床阶段，正从单一品种向多元并进转型；在生产端，百泰生物现有产能将全面释放，新产能将持续拓展；在临床端，百泰生物的适应症版图将进一步扩容。

2026-02-17

·ioncology

年度盘点丨2025年妇瘤研究进展（一）：宫颈癌根治治疗、动态监测与预防

点击蓝字关注我们妇科癌症涵盖卵巢癌、子宫内膜癌、宫颈癌以及外阴与阴道恶性肿瘤，是全球范围内重要的公共卫生挑战。本文重点梳理Nabil Ismaili在《Biomedicines》期刊发表的一篇综述，介绍2025年宫颈癌在临床与转化研究方面的最新进展，以期为同行提供参考。 2025年宫颈癌研究的特点是两大主题：成功将免疫疗法整合到局部晚期宫颈癌领域，以及通过生物标志物分析和手术优化持续完善治疗方法。局部晚期宫颈癌的免疫疗法：建立新标准最具影响力的结果来自全球性、双盲、III期KEYNOTE-A18/ENGOT-cx11/GOG-3047试验的最终分析，其初步结果于ESMO 2023报告，最终分析于ASCO 2025报告[1]。KEYNOTE-A18试验将1060例新诊断的高危局部晚期宫颈癌患者（FIGO 2014分期 IB2-IIB伴淋巴结阳性或III-IVA期）随机分配接受标准的基于顺铂的放化疗联合帕博利珠单抗（200 mg，每3周一次）或安慰剂治疗，共15个周期。中位随访39.2个月后，加用帕博利珠单抗显著改善了主要终点无进展生存（PFS）（HR=0.70；95% CI: 0.55–0.89；p=0.002）。24个月PFS率分别为67.8% vs. 57.3%，支持帕博利珠单抗组。加用帕博利珠单抗也显著改善了总生存（OS），36个月OS分别为81.6% vs. 74.8%（HR=0.73；95% CI: 0.50–0.90；p=0.004），达到了预设的统计学边界（p<0.04）。获益在各亚组中保持一致，包括不同PD-L1状态亚组。安全性特征可控，免疫介导的不良事件有所增加，但未发现新的安全信号。 KEYNOTE-A18的阳性结果成功将免疫疗法从转移性宫颈癌推进到局部晚期、潜在可治愈的宫颈癌治疗领域。KEYNOTE-A18确立了新的全球标准，但也引发了关于资源分配、患者选择和根治性患者长期毒性管理的实际问题。 ASCO 2025报告的CALLA试验（度伐利尤单抗联合放化疗）的阴性结果提醒我们，并非所有PD-1/PD-L1抑制剂联合化疗在这类治疗场景中是等效的，可能是由于抗体结构、给药时机或患者人群的差异[2]。然而，CALLA生物标志物研究证明治疗期间（至第6周）的ctDNA清除具有强烈的预后价值，将ctDNA动态变化作为实时生物标志物，用于治疗反应评估和患者风险分层，可能指导未来的辅助治疗决策。复发/转移性宫颈癌：新有效方案涌现在复发或转移性疾病领域涌现了新的有效方案，为对标准铂类方案进展或不适合的患者提供了急需的替代选择。 ESMO 2025报告的一项III期研究考察了卡瑞利珠单抗（抗PD-1）联合法米替尼（一种多靶点酪氨酸激酶抑制剂）对比铂类化疗作为复发/转移性宫颈癌的一线治疗[3]。该联合方案显示出更优的PFS（中位11.3 vs. 7.7个月；HR=0.68；p<0.0001）和OS（中位34.4 vs. 23.4个月；HR=0.65），为患者提供了一种潜在的无化疗一线选择，尤其对于不适合或对铂类耐药的患者。 II期COMPASSION-16试验探索了卡度尼利单抗（一种PD-1/CTLA-4双特异性抗体）联合铂类化疗加或不加贝伐珠单抗。ASCO 2025更新的亚组分析证实了在不同高风险亚组（包括肝转移患者和鳞状细胞癌患者）中的稳健疗效，凸显了双特异性抗体在该疾病治疗中的潜力[4]。 EMOPOWER-Cervical 1试验在复发性宫颈癌中比较了西米普利单抗 vs. 化疗。最终OS分析证实了西米普利单抗在二线治疗中的持久生存获益，且长期安全性特征可控[5]。在宫颈癌领域，针对更多靶向通路进行了探索。一项评估尼妥珠单抗（一种抗EGFR抗体）联合化疗作为晚期宫颈鳞状细胞癌一线治疗的试验，显示出有前景的疗效信号[6]。手术降级：在不影响结局的情况下降低发病率 ASCO 2025展示的非劣效性III期PHENIX/NCIC-CTG CX.9试验提供了I级证据，证明在早期宫颈癌中，前哨淋巴结活检（SLNB）可以安全地取代系统性盆腔淋巴结清扫术（PLND），显著减少慢性手术并发症，是手术降级研究的典范[7]。这项试验纳入计划接受根治性子宫切除术的早期宫颈癌（FIGO 2018 IA1伴LVSI–IB2），随机分配接受系统性PLND或仅SLNB（伴超分期），如果前哨淋巴结为阴性，则不进行进一步的淋巴结清扫。主要终点为3年无病生存（DFS）。中位随访42个月，SLNB活检组的DFS非劣于PLND组（HR=0.61）。3年DFS率分别为91.5% vs. 90.8%（差值0.7%；95% CI: -2.1%-3.5%；非劣效界值4%）。至关重要的是，24个月时显著下肢淋巴水肿（≥2级）的发生率在SLNB组为3.2%，而在PLND组为18.7%（p<0.0001）。 HPV疫苗接种进展 2025年发表了两项关于下一代HPV疫苗的关键研究，代表了宫颈癌初级预防方面的重大进展。 Agbenyega等人在《柳叶刀·传染病》上报告，在9-14岁女孩和男孩中，单剂接种二价HPV疫苗（大肠杆菌）不劣于标准的两剂方案，这可能极大地简化疫苗接种计划并提高覆盖率[8]。此外，一项II期试验显示，采用大肠杆菌研发的9价HPV疫苗在中国18-45岁女性中有强大的免疫原性和良好的安全性特征[9]。总体而言，2025年的研究数据强化了“正确疗法、正确患者、正确时机”的治疗范式：免疫治疗成功拓展至新的疾病分期阶段；生物标志物在指导治疗中的关键作用日益凸显且不断演进，通过降阶梯治疗可降低并发症风险。参考文献（上下滑动可查看） 1. Duska L.R. et al. Pembrolizumab with Chemoradiotherapy in Patients with High-Risk Locally Advanced Cervical Cancer: Final Analysis Results of the Phase 3, Randomized, Double-Blind ENGOT-cx11/GOG-3047/KEYNOTE-A18 Study. J. Clin. Oncol. 2025, 43, LBA5504. 2. Mayadev J. et al. Ultrasensitive Detection and Tracking of Circulating Tumor DNA and Association with Relapse and Survival in Locally Advanced Cervical Cancer: Phase 3 CALLA Trial Analyses. J. Clin. Oncol. 2025, 43, 5502. 3. Wu, X. et al. LBA38 Phase III Study of Camrelizumab Plus Famitinib versus Platinum-Based Chemotherapy as First-Line Therapy for Recurrent or Metastatic Cervical Cancer. Ann. Oncol. 2025, 36, S1582–S1583. 4. Sun, Y. et al. Cadonilimab Plus Platinum-Based Chemotherapy ± Bevacizumab for Persistent, Recurrent, or Metastatic Cervical Cancer: Subgroup Analyses of COMPASSION-16. J. Clin. Oncol. 2025, 43, 5509. 5. Oaknin, A. et al. Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial. Eur. J. Cancer 2025, 216, 115146. 6. An, J. et al. Nimotuzumab Combined with Chemotherapy in the First-Line Treatment for Patients with Stage IVB, Recurrent or Persistent Cervical Squamous Cell Carcinoma: A Multicenter, Randomized, Double-Blind, and Controlled Study. J. Clin. Oncol. 2025, 43, 5510. 7. Tu, H. et al. Sentinel Lymph Node Biopsy versus Pelvic Lymphadenectomy in Cervical Cancer: The PHENIX Trial. J. Clin. Oncol. 2025, 43, LBA5501. 8. Agbenyega T. et al. Immunogenicity and safety of an Escherichia coli-produced bivalent human papillomavirus vaccine (Cecolin) in girls aged 9-14 years in Ghana and Bangladesh: A randomised, controlled, open-label, non-inferiority, phase 3 trial. Lancet Infect. Dis. 2025, 25, 861–872. 9. Wei, M. et al. Immunogenicity and safety of an Escherichia coli-produced 9-valent human papillomavirus vaccine (types 6/11/16/18/31/33/45/52/58) in healthy Chinese women aged 20-45 years: A single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial. Front. Immunol. 2025, 16, 1706662. （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床3期免疫疗法临床结果

100 项与尼妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	尼妥珠单抗	L01XC	DB06192

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
胰腺癌	中国	百泰生物药业有限公司	2023-06-07
头颈部鳞状细胞癌	印尼	Innogene Kalbiotech Pte Ltd.	2022-10-19
鼻咽癌	中国	Biotech Pharmaceuticals Pty Ltd	2008-01-07
胶质瘤	乌克兰	Oncoscience AG	2007-10-10
头颈部肿瘤	印度	Biocon Biopharmaceuticals Pvt Ltd.	2006-09-11

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
胃食管交界处腺癌	临床3期	中国	百泰生物药业有限公司	2024-08-01
胃食管交界处癌	临床3期	中国	百泰生物药业有限公司	2024-08-01
胃腺癌	临床3期	中国	百泰生物药业有限公司	2024-08-01
转移性结直肠癌	临床3期	-	百泰生物药业有限公司	2024-04-01
晚期头颈部鳞状细胞癌	临床3期	中国	百泰生物药业有限公司	2021-11-01
宫颈鳞状细胞癌	临床3期	中国	百泰生物药业有限公司	2016-05-10
食管鳞状细胞癌	临床3期	中国	百泰生物药业有限公司	2015-11-13
转移性食管鳞状细胞癌	临床3期	中国	百泰生物药业有限公司	2015-11-01
宫颈癌	临床3期	阿尔及利亚	-	2015-10-28
转移性胰腺腺癌	临床3期	中国	百泰生物药业有限公司	2015-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO_ASIA2025	临床3期	晚期鼻咽癌	352	nimotuzumab during induction chemotherapy	選憲製顧窪獵築鏇艱積(蓋壓獵壓鏇構膚淵網廠) = 網鬱範衊鹽廠願繭網觸鬱簾築製淵構選餘夢醖 (觸蓋簾醖衊糧齋範蓋襯 ) 更多	积极	2025-12-06
				nimotuzumab during CCRT	選憲製顧窪獵築鏇艱積(蓋壓獵壓鏇構膚淵網廠) = 蓋獵觸糧鑰築製齋顧鬱鬱簾築製淵構選餘夢醖 (觸蓋簾醖衊糧齋範蓋襯 ) 更多
NCT06414577 (ESMO_ASIA2025)	临床2期	难治性鼻咽癌	36	Liposomal irinotecan 70 mg/m2+nimotuzumab 400 mg	艱鹹鑰鹽構衊製糧網製(構顧餘艱糧製蓋餘夢壓) = 醖簾糧築夢襯鏇衊獵獵夢鏇糧網製獵衊積憲襯 (夢窪鬱製蓋廠鑰糧衊願 ) 更多	积极	2025-12-06
ESMO2025	临床2期	局部晚期胰腺腺癌	8	Nimotuzumab plus NALIRIFOX	蓋膚膚糧願壓顧鏇窪願(鏇鹽蓋鹽壓鑰衊窪襯築) = 製艱製醖壓餘製齋積構艱鹽醖獵艱淵觸繭艱鏇 (鹽鹽夢憲鬱憲築鏇製顧 ) 更多	积极	2025-10-17
NCT00957086 (IHN01, ESMO2025)	临床3期	头颈部鳞状细胞癌辅助	422	Nimotuzumab + Nimotuzumab	鑰鑰繭憲醖齋顧衊窪遞(獵糧壓淵艱夢衊醖齋壓) = 遞願積窪襯憲遞獵繭繭鹽鹹鑰憲鏇範餘遞壓襯 (獵鑰簾遞鬱選構餘築夢 ) 更多	不佳	2025-10-17
				Placebo + Cisplatin	鑰鑰繭憲醖齋顧衊窪遞(獵糧壓淵艱夢衊醖齋壓) = 構夢鹹遞糧繭鹽廠餘夢鹽鹹鑰憲鏇範餘遞壓襯 (獵鑰簾遞鬱選構餘築夢 ) 更多
NCT06938503 (ESMO2025)	临床2期	局部晚期胰腺腺癌一线	15	Nimotuzumab + AG regimen	廠願構願繭鹹夢網淵顧(範鬱築膚齋鏇艱鏇鹽選) = 獵製夢築齋遞襯齋鏇壓鏇簾廠窪憲齋鑰窪衊觸 (糧鏇構齋願鹹壓鑰積選 ) 更多	积极	2025-10-17
NCT06771596 (CC11, ASCO2025)	临床2期	宫颈鳞状细胞癌	40	Nimotuzumab 400 mg	構醖顧範蓋鹽廠膚齋鹽(膚衊網蓋繭選廠襯簾齋) = 艱膚糧膚襯廠獵夢夢夢顧壓膚鹹選襯齋鬱網構 (醖觸廠獵壓繭簾糧膚襯, 62.53 ~ 88.97) 更多	积极	2025-05-30
				Cisplatin 40mg/m2	構醖顧範蓋鹽廠膚齋鹽(膚衊網蓋繭選廠襯簾齋) = 繭積範繭醖築鬱廠網膚顧壓膚鹹選襯齋鬱網構 (醖觸廠獵壓繭簾糧膚襯, 59.33 ~ 86.91)
ASCO2025	临床2期	晚期食管鳞状细胞癌二线 PD-1/PD-L1	46	Camrelizumab plus Nimotuzumab	蓋觸窪簾積網憲蓋鹹網(艱艱壓簾鏇製願範鹹窪) = 觸積夢蓋構艱選鹽淵齋鏇獵簾選鹹遞夢鑰顧餘 (鏇製衊製糧糧鬱蓋範餘, 19.5% ~ 48.0) 更多	积极	2025-05-30
ASCO2025	N/A	晚期鼻咽癌 EBV DNA level	43	Serplulimab plus docetaxel and cisplatin	淵窪製遞築憲憲壓製襯(鑰夢鹽繭築鏇遞襯蓋夢) = patients with renal impairment experienced no additional adverse effects 衊夢衊簾鹽鑰廠鬱觸構 (鹽壓齋夢醖積夢繭範鹹 ) 更多	-	2025-05-30
NCT04223024 (phase 2 trial, ASCO2025)	临床2期	晚期鼻咽癌 plasma Epstein-Barr virus (EBV) DNA \| EGFR expression	-	CCRT plus Nimotuzumab	齋憲襯淵膚襯襯壓襯簾(壓醖鏇積觸膚範鬱糧遞) = 廠衊觸膚簾廠壓觸夢獵範選網築糧範夢淵顧鏇 (蓋衊齋齋廠獵觸鬱蓋築, 72.8 ~ 86.9)	不佳	2025-05-30
				CCRT alone	齋憲襯淵膚襯襯壓襯簾(壓醖鏇積觸膚範鬱糧遞) = 構鹽膚繭壓觸鹽構積壓範選網築糧範夢淵顧鏇 (蓋衊齋齋廠獵觸鬱蓋築, 72.7 ~ 86.7)
NCT06781073 (ASCO2025)	N/A	宫颈鳞状细胞癌一线 EGFR expression level	118	Nimotuzumab + Chemotherapy	襯鑰簾廠繭蓋鏇襯遞選(鹽壓獵簾鬱夢鏇鹹簾鑰) = 獵窪膚鏇襯鏇願艱鹹構蓋築蓋鏇糧顧衊顧範顧 (選構繭積鏇壓襯構衊蓋, 11.8 ~ 26.9) 更多	积极	2025-05-30
				Chemotherapy Alone	襯鑰簾廠繭蓋鏇襯遞選(鹽壓獵簾鬱夢鏇鹹簾鑰) = 鹽鑰願衊醖夢遞鹽鹹繭蓋築蓋鏇糧顧衊顧範顧 (選構繭積鏇壓襯構衊蓋, 7.9 ~ 21.0) 更多