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更新于：2025-05-14

Bevacizumab

贝伐珠单抗

更新于：2025-05-14

概要

基本信息

药物类型

单克隆抗体

别名

Bevacizumab(Genetical Recombination)、rhuMAb-VEGF、贝伐单抗

+ [17]

靶点

VEGF-A

作用方式

抑制剂

作用机制

VEGF-A抑制剂(血管内皮生长因子A抑制剂)、血管生成抑制剂

治疗领域

肿瘤神经系统疾病消化系统疾病+ [12]

在研适应症

不可切除的肝细胞癌肝细胞癌复发性胶质母细胞瘤+ [214]

非在研适应症

异戊酸血症急性嗜碱性粒细胞白血病急性嗜酸细胞白血病+ [276]

原研机构

Genentech, Inc.

在研机构

National Cancer InstituteRoche Pharma (Schweiz) AGRoche Registration GmbH

+ [28]

非在研机构

Hoffmann-La Roche Ltd.

Celgene Corp.

Eastern Cooperative Oncology Group

+ [45]

权益机构

Roche Korea Co., Ltd.

Immune-Onc Therapeutics, Inc.

Roche Holding AG

+ [5]

最高研发阶段批准上市

首次获批日期

美国 (2004-02-26),

结肠癌直肠癌

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、加速批准 (美国)、突破性疗法 (美国)

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结构/序列

Sequence Code 41632H

来源: *****

Sequence Code 41637L

来源: *****

关联

3,224

项与贝伐珠单抗相关的临床试验

NCT06543576

/ Not yet recruiting临床1/2期IIT

A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer

This phase I/II trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.

开始日期2026-01-31

申办/合作机构

Jonsson Comprehensive Cancer Center

[+1]

NCT06696768

/ Recruiting临床1期IIT

Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer

This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and/or effective in treating patients with metastatic colorectal cancer.

开始日期2026-01-23

申办/合作机构

National Cancer Institute

NCT05375708

/ Suspended临床2期IIT

A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer

A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.

开始日期2025-12-01

申办/合作机构

University Medical Center of Utrecht

100 项与贝伐珠单抗相关的临床结果

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100 项与贝伐珠单抗相关的转化医学

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100 项与贝伐珠单抗相关的专利（医药）

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23,228

项与贝伐珠单抗相关的文献（医药）

2026-04-01·DEN open

Long‐term results of palliative placement of very low‐axial force self‐expandable metallic stents for malignant colorectal obstruction

Article

作者: Moroi, Rintaro ; Kuwai, Toshio ; Yoshida, Shuntaro ; Enomoto, Toshiyuki ; Tomita, Masafumi ; Kyo, Rika ; Shiratori, Toshiyasu ; Saida, Yoshihisa ; Matsuzawa, Takeaki ; Isayama, Hiroyuki ; Sumida, Yorinobu ; Yamada, Tomonori ; Sasaki, Takashi

Abstract:

Objectives:

Stent placement is a standard option for palliative decompression in patients with malignant colorectal obstruction. Long‐term stent placement is associated with perforation, migration, and stent occlusion. Perforation is associated with life expectancy. Several studies have shown that stents with a high axial force (AF), which is defined as the force required to maintain the stent straight after it has bent, are associated with a higher perforation rate. Therefore, we evaluated the long‐term outcomes of using a very low AF stent (Niti‐S Enteral Colonic Uncovered stent D‐type) for palliative purposes.

Methods:

Eighty‐one consecutive patients with malignant colorectal obstruction in 33 medical institutions were evaluated. A stent with very low AF was placed using an endoscope system. We evaluated the adverse events (including perforation, migration, and stent occlusion), 1‐year survival rate, and cumulative patency rate. Univariate analysis was conducted using Fisher's exact test. The overall survival and cumulative patency rates were assessed using the Kaplan–Meier method.

Results:

The 1‐year cumulative survival rate was 37.8% after stent placement. The 3‐month, 6‐month, and 1‐year cumulative patency rates after stenting were 93.6%, 84.2%, and 75.8%, respectively. The major adverse events included stent migration (6.2%), stent occlusion (9.9%), and perforation (2.5%). Chemotherapy was administered in 26 cases (32.1%) after stenting, and bevacizumab was administered in five cases. However, no cases of perforation occurred following bevacizumab administration.

Conclusions:

Our results suggest that very low AF stents are safe and effective. Therefore, they may be a suitable option for applications, such as palliation. (UMIN 000011304)

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

作者: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Yang, Min ; Marian, Marisca ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

作者: Bernauer, Mark ; Roth, Joshua A. ; Dorman, Stephanie ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

2,716

项与贝伐珠单抗相关的新闻（医药）

10 小时之前

·梅斯医学

手脚发麻、水肿浮肿、还以为是代谢差？35岁女白领被误当颈椎病，真相竟是罕见致命病！

35岁的小张是一位办公室职员，近一年总感觉手脚麻木发凉，走路没劲，还总爱出汗、胸闷乏力。她以为是颈椎出了问题，去做了几次理疗按摩就没再管。几个月后，问题越来越严重：双脚开始浮肿，鞋子越来越紧，甚至连脸都发胀，而且体毛变浓、声音变粗，月经也不规律了。她辗转几家医院，被怀疑是肾病、甲状腺问题，查了半天都没找出原因。直到某三甲医院的神经内科进一步检查，发现她有多发性神经病变、内分泌异常、肝脾肿大，加上血液中单克隆免疫球蛋白升高、VEGF显著升高，最终确诊为罕见的POEMS综合征。什么是POEMS综合征？POEMS综合征是一种病因和发病机制不清的、罕见的多系统疾病，主要表现（按照字母顺序）为：P：多发性神经病变（包括四肢麻木无力，以下肢远端无力为主）；O：器官肿大（包括肝脾大、淋巴结肿大，淋巴结活体组织病理检查常为Castleman病表现）；E：内分泌异常（包括性功能减退、甲状腺功能减退、肾上腺皮质功能不全、糖尿病等）；M：血清中存在M蛋白（经蛋白电泳或免疫固定电泳证实，一般都为IgG或IgA-λ型）；S：皮肤改变（皮肤颜色变黑变硬、体毛增多变硬）；其他表现还有腹腔积液、胸腔积液和水肿、肺动脉高压、视乳头水肿等。目前来自法国、美国、中国和日本的小样本的流行病学调查，显示该病患病率约为0.3/10万。临床表现1．多发性周围神经病：疾病初期常见为隐袭起病的渐进性的运动感觉周围神经病。为双下肢起病，逐渐向上发展。通常伴有麻木、刺痛和发凉感，随后出现无力症状，初期无力症状不重，主诉一般为难以上楼、难以站起。随病程进展，运动症状较感觉症状突出。除视乳头水肿外不累及脑神经。体检表现为双下肢远端为重的感觉周围神经病和上下肢远端无力及肌肉萎缩的周围神经病，通常对称存在。病程较为良性，但致残率高，患者生活质量较差。100%的POEMS综合征并发多发性周围神经病，这也是诊断POEMS的首个条件。2．其他表现：（1）脏器肿大，通常为肝脾肿大，淋巴结肿大；（2）内分泌异常，表现为甲状腺功能减退、性功能减退、肾上腺皮质功能不全、糖尿病等表现；（3）M蛋白，通常为λ型；（4）皮肤改变（皮肤颜色变黑变硬，体毛增多等）。诊断临床表现为亚急性或慢性进行性多发性运动感觉周围神经病的患者在经过电生理诊断后需要进行常规的周围神经病的病因筛查，如血清或尿免疫固定电泳发现游离轻链，则应进行骨髓检查，以除外浆细胞增殖性疾病。如患者伴有下列症状或体征即可考虑POEMS的诊断：（1）不明原因的肝脾肿大；（2）不明原因的腹腔积液、胸腔积液或水肿；（3）不明原因的性功能减退或伴有甲状腺功能减退；（4）不明原因的皮肤变黑。其中诊断的必要条件包括2条强制标准和至少1条主要标准和至少1条次要标准：治疗目前为止没有关于POEMS综合征治疗的随机双盲安慰剂对照研究报道，对治疗的推荐均来自病例报道系列。治疗原则包括仅有骨髓受累（2个以内病灶）而未发现克隆性浆细胞病的患者推荐观察并每3~6个月评估。单纯骨髓病变数目大于或等于3个，或已发现克隆性浆细胞病证据的患者进行系统治疗，可根据病情和实际医疗条件选择：马法兰联合地塞米松或糖皮质激素单独应用、环磷酰胺联合地塞米松、自体造血干细胞移植、沙利度胺联合地塞米松、硼替佐米、贝伐单抗等。对所有患者均需要血液科、神经科、康复科、内分泌科、肾内科、放射治疗科的多科协作。对患者除了治疗浆细胞病或骨髓瘤，还需要支持治疗，包括针对周围神经病的康复治疗和器械辅助、内分泌的替代治疗、浆膜渗出导致的水负荷过多应用利尿剂治疗以及针对血液高凝状态的抗血小板治疗等。参考资料：中华医学会神经病学分会，中华医学会神经病学分会周围神经病协作组，中华医学会神经病学分会肌电图与临床神经电生理学组,等. 中国POEMS综合征周围神经病变诊治专家共识. 中华神经科杂志，2019，52(11):893-897. DOI:10.3760/cma.j.issn.1006-7876.2019.11.005来源 | 梅斯医学编辑 | wanny神经系统罕见病交流群↓点击下方“阅读原文”，下载梅斯医学APP吧！

22 小时之前

·今日头条

抗癌“肠”胜密码！粪菌移植组合拳让结直肠癌生存期延长近10个月

结直肠癌（CRC）是全球发病率位居前列的恶性肿瘤之一。目前，以氟尿嘧啶为基础的双药/三药化疗，联合抗血管内皮生长因子（VEGF）或抗表皮生长因子受体（EGFR）靶向治疗，已成为转移性结直肠癌（mCRC）一线和二线治疗的标准方案。然而，三线及以上治疗手段十分有限，仅有瑞戈非尼、TAS-102、贝伐单抗等少数选择，且普遍存在疾病控制率欠佳、治疗相关不良事件（TRAE）高发等问题，亟待创新疗法突破困境。近期，中国武汉开展的一项II期临床试验带来突破性进展，首次证实通过调控肠道菌群，联合免疫及抗血管生成治疗，有望成为转移性结直肠癌（mCRC）后线治疗的新方向，为晚期患者带来新的希望与选择！ ▲截图源自“THE LANCET” 粪菌移植联合疗法引爆突破，MSS结直肠癌疾病控制率狂飙至95%，无癌生存期延长近10个月本研究共纳入20例微卫星稳定型转移性结直肠癌（MSS mCRC）患者，中位年龄为62岁（范围：42-79岁）。患者基线特征显示：80%（16例）体能状态评分（ECOGPS）为1分；70%（14例）原发肿瘤位于左侧结肠或直肠；70%（14例）伴肝转移。所有患者均接受过至少二线全身治疗，其中55%（11例）接受过≥3线治疗；70%（14例）既往使用过抗VEGF/VEGFR药物（如贝伐单抗、瑞戈非尼等），45%（9例）接受过局部放疗。入组后，患者接受粪便菌群移植（口服定制胶囊）联合替雷利珠单抗及呋喹替尼作为三线及以上治疗方案，中位随访时间13.7个月（4.9-26.0个月）。结果显示：患者中位无进展生存期（PFS）达9.6个月（95%CI 4.1–15.1，详见下图A）。中位总生存期（OS）为13.7个月（95%CI 9.3–17.7，详见下图B）。中位治疗持续时间为7.5个周期（范围：3～18个周期）， 60%的患者出现靶病灶缩小。 ▲图源“eClinical Medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除在意向治疗（ITT）人群中，客观缓解率（ORR）为20%（95%CI5.7–43.7），疾病控制率（DCR）高达95%（95%CI 75.1-99.9），其中，4例患者达到部分缓解（PR）；15例患者达病情稳定（SD），中位缓解持续时间（DOR）为8.1个月（95%CI 1.7–10.6）。 ▲图源“eClinical Medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除其中，患者05的治疗效果尤为显著：经评估该患者达到部分缓解（PR），其影像学及血清肿瘤标志物动态变化详见附图，为该疗法的临床价值提供了直观例证。 ▲图源“eClinical Medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除肠道微生态成抗癌新战场，四大硬核手段帮助肿瘤患者重塑肠道菌群平衡肠道菌群与人体构建起复杂而精密的共生网络，不仅深度参与宿主的代谢调控，更在免疫系统与神经系统的塑造中发挥关键作用。对于癌症患者而言，调节肠道菌群平衡已成为提升治疗效果、改善生活质量的重要策略。目前，主要可通过饮食干预、益生菌补充、抗生素治疗及粪便微生物组移植（FMT）四大途径实现肠道菌群的优化。 1、饮食干预：从源头调节菌群生态生命早期增加膳食纤维与益生元摄入、减少红肉食用并维持健康体重，可有效降低肿瘤发生风险。研究表明，饮食结构的调整能在24-48小时内显著改变肠道微生物组成。然而，癌症患者常因口腔黏膜炎、味觉改变及厌食症等副作用，导致饮食干预的实施面临挑战。 2、益生菌补充：激活肠道健康防线益生菌作为“活的非病原性微生物”，足量摄入可显著改善健康状况。部分益生菌菌株被证实能调节肠道菌群，增强癌症免疫治疗效果，减轻放化疗不良反应。临床研究显示，益生菌在结直肠癌、肝癌、肺癌等多种癌症治疗中，有助于提升预后，也获得跨国癌症支持治疗协会等权威指南的推荐，对预防结肠感染、重建肠道微生态平衡具有积极意义。 3、粪便微生物组移植（FMT）：千年智慧的现代转化源自1700多年前中医理论的FMT，如今已成为前沿医学手段。该技术通过提取健康个体粪便中的菌群，制成菌液或胶囊，经内窥镜灌注、口服胶囊、结肠镜介入或灌肠等方式，将健康菌群移植至患者肠道，快速重建微生物多样性，用于治疗肠道内外疾病，为癌症患者提供了调节菌群的创新方案。 ▲图源“Front Immunol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语总之，上述研究证实，粪便菌群移植联合替雷利珠单抗与呋喹替尼，作为三线及以上治疗方案，在难治性微卫星稳定型转移性结直肠癌（MSS mCRC）中展现出显著的抗肿瘤活性与可控的安全性，有效延长患者生存期。这一创新疗法通过调节肠道菌群优化微生态，进一步增强抗PD-1免疫治疗效果，为晚期结直肠癌患者提供了极具前景的治疗新选择。不过，全球肿瘤医生网小编还要提醒广大癌友，一旦出现营养摄入不足或体重下降等问题，应及时寻求专业营养支持，可通过口服营养补充、肠外营养干预等方式改善机体状态。如需深入了解粪菌移植、肠道菌群调节或定制益生菌等前沿疗法，可将近期影像和病理检查结果、治疗经历等资料，提交至全球肿瘤医生网医学部，初步评估营养状况。参考资料 [1]Zhao W,et al.Fecal microbiota transplantation plus tislelizumab and fruquintinib in refractory microsatellite stable metastatic colorectal cancer: an open-label, single-arm, phase II trial (RENMIN-215)[J]. EClinicalMedicine, 2023, 66. https://www-thelancet-com.libproxy1.nus.edu.sg/journals/eclinm/article/PIIS2589-5370(23)00492-3/fulltext [2]Xu H,et al.Antitumor effects of fecal microbiota transplantation: Implications for microbiome modulation in cancer treatment. Front Immunol. 2022 Sep 13;13:949490. https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC9513044/ 本文为全球肿瘤医生网原创，未经授权严禁转载

临床2期临床结果临床3期

2025-05-12

·BiG生物创新社

罗氏祭出「后手棋」

作者｜momo罗氏曾凭借肿瘤“三驾马车”叱咤市场，却在核心专利到期后遭遇生物类似药的猛烈冲击。面对收入断崖与竞争白热化，罗氏以眼科突破、肿瘤迭代和自免创新三线并进，试图在行业变局中重构护城河。 01 专利悬崖和市场挑战作为全球制药巨头，罗氏凭借1990年起对基因泰克的两次战略性收购，构建了以利妥昔单抗（Rituxan）、贝伐珠单抗（Avastin）和曲妥珠单抗（Herceptin）为核心的肿瘤药物矩阵。这三款被誉为“三驾马车”的重磅产品，曾贡献罗氏处方药收入的半壁江山，并在全球肿瘤治疗领域长期占据主导地位。其中，曲妥珠单抗作为HER2阳性乳腺癌治疗的基石药物，自1998年上市以来累计销售额超970亿瑞士法郎，年销售峰值突破70亿瑞士法郎，奠定了罗氏在靶向治疗领域的标杆地位。然而，随着核心产品专利相继到期（利妥昔单抗2018年、贝伐珠单抗与曲妥珠单抗2019年），生物类似药的冲击正迅速瓦解其市场壁垒。后续，三大产品的全球市场迅速被生物类似药分食。以利妥昔单抗为例，其全球销售额从2017年峰值74亿瑞士法郎锐减至2024年的11.16亿瑞士法郎（图1），中国市场更因复宏汉霖、信达生物等本土企业的仿制药竞争而持续承压。图1.利妥昔单抗（Rituxan）、贝伐珠单抗（Avastin）和曲妥珠单抗（Herceptin）为核心的肿瘤药物矩阵历年销售额为应对市场萎缩，罗氏于2025年将利妥昔单抗在中国的独家推广权移交百洋医药（图2），这一策略性外包旨在借助本土企业的渠道优势应对医保控费与集采压力，但亦折射出原研药在低价竞争中的被动局面。图2.罗氏将利妥昔单抗在中国的独家推广权移交百洋医药与此同时，曲妥珠单抗面临双重夹击。一方面，生物类似药以价格优势抢占基层市场；另一方面，HER2靶向治疗领域的技术迭代正在重构竞争格局，单纯依赖传统单抗的商业模式已显疲态。更为严峻的是，作为肿瘤免疫治疗领域的核心靶点，PD-(L)1抑制剂的市场竞争已进入白热化阶段（图3）。图3.中国已上市PD-(L)1产品罗氏旗下PD-L1抑制剂阿替利珠单抗（Tecentriq）虽在非小细胞肺癌、三阴性乳腺癌等适应症中占据重要地位，但其面临的生物类似药冲击即将显现。随着原研药专利到期临近（Tecentriq核心专利预计2030年后陆续到期），全球已有超过20家药企布局PD-(L)1生物类似药，直接威胁罗氏在中国这一全球第二大医药市场的份额。 02 巩固眼科拓宽肿瘤面对专利悬崖引发的市场冲击，罗氏以“巩固眼科优势”和“拓宽肿瘤版图”的双轨战略展开突围。其在眼科领域的突破性进展集中体现于双抗药物法瑞西单抗（Vabysmo）。该药物自2022年1月在美国获批以来，凭借“每4个月一次”的长周期给药方案和显著疗效，迅速抢占眼底病市场。至2024年，其上市第三年全球销售额已达44亿美元，同比增长68%，成为罗氏增长最快的单品之一（图4）。Vabysmo已覆盖新生血管性年龄相关性黄斑变性（nAMD）、糖尿病性黄斑水肿（DME）及视网膜静脉阻塞（RVO）三大适应症，且暂无直接竞品威胁。图4.Vabysmo正在成为罗氏的增长支柱2024年7月，FDA批准其6.0mg单剂量预充式注射器上市，进一步优化给药便捷性，为患者依从性与市场渗透率提升注入新动能。与此同时，在肿瘤领域，罗氏通过迭代升级与管线整合，逐步完成从传统单抗到创新疗法的过渡。帕妥珠单抗（Perjeta）、恩美曲妥珠单抗（Kadcyla）及阿替利珠单抗（Tecentriq）构成的新“三驾马车”，2024年合计贡献超105亿美元收入，成功接棒老牌产品（图5）。图5.罗氏肿瘤领域新三驾马车此外，罗氏在乳腺癌领域的深度布局进一步巩固其领导地位。针对PIK3CA突变导致的耐药难题，PI3K α 抑制剂Itovebi（inavolisib）于2024年10月获批，联合CDK4/6抑制剂与氟维司群治疗HR+/HER2-乳腺癌，临床数据显示其将患者中位无进展生存期（PFS）从7.3个月延长至15个月，疾病进展风险降低57%。更值得关注的是，针对乳腺癌的口服选择性雌激素受体降解剂Giredestrant的关键III期数据将于2025年公布；恩美曲妥珠单抗（Kadcyla）也在持续拓展早期乳腺癌辅助治疗适应症。为弥补研发短板，罗氏近两年密集开展肿瘤领域BD合作，38项交易中15项聚焦肿瘤创新疗法。2024年与锐格医药合作引进CDK抑制剂RGT-419B，补全CDK4/6抑制剂拼图；后续以15亿美元收购Poseida Therapeutics，更是强化了CAR-T细胞疗法在血液瘤与实体瘤的布局（图6）。图6.罗氏收购Poseida Therapeutics面对专利到期带来的收入危机，罗氏一手抓眼科新药快速变现，一手重构肿瘤产品生态，初步化解了专利悬崖引发的收入断层风险。 03 自免祭出后手棋与此同时，近年来，罗氏在自免领域悄然落子，以CD20单抗为矛、新兴靶点为盾，构建起抵御市场侵蚀的第二增长曲线。罗氏在CD20靶点的深耕印证了其战略韧性。初代产品利妥昔单抗（美罗华）虽在血液瘤领域创造72亿美元销售峰值，但专利到期后遭遇生物类似药围剿，2024年销售额已不足15亿美元。面对困局，罗氏通过适应症迁移实现价值重生。奥瑞利珠单抗（Ocrevus）转向多发性硬化症（MS）治疗，凭借半年一次的静脉输注方案，2024年以76.8亿美元销售额登顶自免领域Top5（表1），超越美罗华巅峰表现。表1.2024年全球自免药物销售额TOP 10这款第二代CD20单抗不仅将治疗领域从肿瘤转向自免，更通过剂型革新持续拓展生命周期，2024年9月FDA批准其皮下注射剂型Ocrevus Zunov，将年治疗次数缩减至2次、单次注射时间压缩至10分钟，患者依从性显著提升。（相关阅读：从自免到肿瘤，风卷残云的皮下制剂开发逻辑）第三代CD20单抗奥妥珠单抗（Gazyva）的布局更具深意。2024年9月，Gazyva在狼疮性肾炎的III期REGENCY试验中达到主要终点，标志着罗氏正式将CD20靶点战场延伸至系统性红斑狼疮（SLE）领域（图7）。图7.Gazyva在狼疮性肾炎的III期REGENCY试验中达到主要终点与此同时，其开发的CD3/CD19双抗RG6382和CD3/CD20双抗RG7828（Lunsumio）均正在开展针对系统性红斑狼疮的临床1期，罗氏正在构建覆盖B细胞通路的立体化治疗网络。此外，为突破CD20单抗的单一依赖，罗氏通过自主研发与并购加速新兴靶点布局。2023年71亿美元收购Telavant获得的抗TL1A抗体RG6631（RVT-3101），成为其攻占炎症性肠病（IBD）490亿美元市场的关键筹码。2025年启动的特应性皮炎与代谢相关脂肪性肝炎（MASH）试验，将进一步释放靶点价值。（相关阅读：TL1A靶点：两全其美的自免炎症通路放大器能否通过成药性考验？）2025年4月罗氏与Repertoire Immune Medicines达成协议，开发T细胞靶向免疫药物，进一步直指自免疾病根源性治疗（图8）。图8.罗氏与Repertoire Immune Medicines达成合作在神经免疫领域，口服BTK抑制剂Fenebrutinib的进展也尤为关键。2024年9月公布的II期FENopta研究显示，复发性多发性硬化症（RMS）患者接受治疗1年后疾病活动水平持续受控，残疾零进展。相较于现有注射疗法，其口服给药方式与中枢神经渗透优势，有望重塑治疗标准。纵观全局，罗氏以CD20为锚点、新兴靶点为支点的自免战略，展现出传统巨头转型的典型路径。若TL1A抗体和BTK抑制剂能如期兑现临床潜力，辅以CD20产品的持续迭代，其或将在2030年前构筑起500亿美元级自免防线，真正实现从“肿瘤依赖”到“双轮驱动”的跨越。结语罗氏这一系列“后手棋”，或将撬动医药行业的下一个黄金十年。参考资料[1]https://mp.weixin.qq.com/s/ApKIWyq49QH9Aw49-JkWrQ[2]https://mp.weixin.qq.com/s/DKId2oAq4UFowJEZ5pNcEw[3]https://assets.roche.com/f/176343/x/15cb053605/irp250130-a.pdf[4]https://www.roche.com/media/releases/med-cor-2024-11-26b[5]https://www.businesswire.com/news/home/20240925225486/en/Positive-Phase-III-Results-for-Genentechs-Gazyva-Show-Superiority-to-Standard-Therapy-Alone-in-People-With-Lupus-Nephritis[6]https://www.repertoire.com/about/press-releases/repertoire-immune-medicines-enters-into-collaboration-and-license-agreement-with-genentech-for-the-development-of-t-cell-targeted-therapies-for-an-autoimmune-disease共建Biomedical创新生态圈！如何加入BiG会员？

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适应症	国家/地区	公司	日期
不可切除的肝细胞癌	日本	Chugai Pharmaceutical Co., Ltd.	2020-09-25
肝细胞癌	美国	Genentech, Inc.	2020-05-29
复发性胶质母细胞瘤	美国	Genentech, Inc.	2020-05-29
复发性原发性腹膜癌	美国	Genentech, Inc.	2014-11-14
卵巢癌	日本	Chugai Pharmaceutical Co., Ltd.	2013-11-22
胶质瘤	日本	Chugai Pharmaceutical Co., Ltd.	2013-06-14
乳腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2011-09-26
结直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2009-09-18
转移性肾细胞癌	美国	Genentech, Inc.	2009-07-31
胶质母细胞瘤	美国	Genentech, Inc.	2009-05-05
转移性结直肠癌	美国	Genentech, Inc.	2009-05-05
节细胞神经胶质瘤	日本	Chugai Pharmaceutical Co., Ltd.	2007-04-18
非鳞状非小细胞肺癌	美国	Genentech, Inc.	2006-10-11
输卵管癌	欧盟	Roche Registration GmbH	2005-01-12
输卵管癌	冰岛	Roche Registration GmbH	2005-01-12
输卵管癌	列支敦士登	Roche Registration GmbH	2005-01-12
输卵管癌	挪威	Roche Registration GmbH	2005-01-12
转移性乳腺癌	欧盟	Roche Registration GmbH	2005-01-12
转移性乳腺癌	冰岛	Roche Registration GmbH	2005-01-12
转移性乳腺癌	列支敦士登	Roche Registration GmbH	2005-01-12

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适应症	最高研发状态	国家/地区	公司	日期
晚期头颈癌	临床3期	美国	National Cancer Institute	2023-03-13
头颈部皮肤鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
头颈癌转移	临床3期	美国	National Cancer Institute	2023-03-13
鼻咽癌	临床3期	美国	National Cancer Institute	2023-03-13
鼻咽鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
口咽肿瘤	临床3期	美国	National Cancer Institute	2023-03-13
复发性咽部鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
复发性头颈部鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
早产儿视网膜病变	临床3期	美国	National Eye Institute	2022-04-27
早产儿视网膜病变	临床3期	加拿大	National Eye Institute	2022-04-27

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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


NCT02521051 (CTgov)	临床1/2期	ALK阳性非小细胞肺癌	11	Alectinib+bevacizumab (Phase I Dose Level 1: Alectinib 600 mg + Bevacizumab 15 mg/kg)	鹽憲鏇蓋廠顧鹽範獵遞 = 憲範憲艱艱鬱襯鏇繭餘鬱夢選醖鑰範積鹽壓鏇 (遞夢觸鹹餘築夢鹹襯糧, 顧積糧鬱艱艱簾襯鬱夢 ~ 夢鏇淵構襯網遞鏇選齋) 更多	-	2025-05-13
				Alectinib+Bevacizumab (Phase II: RP2D)	夢齋膚艱選壓獵艱選壓 = 齋簾憲願選遞糧顧糧範範衊醖廠製顧鹹鬱餘遞 (夢膚觸鹽鏇選獵網鹹網, 壓醖築膚齋糧網襯廠餘 ~ 鑰膚窪鹽鹹糧築鹹糧膚) 更多
NCT04732286 (CTgov)	临床3期	肝细胞癌	100	Atezolizumab+Bevacizumab (Atezolizumab + Bevacizumab)	製壓鑰糧餘襯糧鏇築壓 = 製衊廠餘製齋製遞鹹蓋遞鹹鹽獵餘憲艱壓壓襯 (醖鹹獵選鏇蓋構齋鹽顧, 鑰構網簾構餘襯選憲築 ~ 鑰範遞顧鬱艱廠範觸範) 更多	-	2025-05-08
				Atezolizumab+Bevacizumab (Atezolizumab + Bevacizumab:)	糧艱遞艱鹹鹹鑰願鬱鑰(鹽獵遞鏇餘鑰鹽築願繭) = 簾積網廠繭顧醖餘簾獵齋壓構窪蓋遞壓簾繭膚 (壓鑰築壓齋鑰艱製壓獵, 淵築鏇窪窪顧壓願淵鏇 ~ 範膚衊壓蓋網襯糧夢餘) 更多
NCT04512430 (CTgov)	临床2期	非小细胞肺癌	4	Carboplatin+Pemetrexed+Atezolizumab+Bevacizumab	顧淵壓鏇願積膚遞鹽醖 = 獵壓憲鹹鏇淵蓋選積膚築選觸鏇窪獵積膚膚築 (壓鹹膚網衊構膚夢鏇鹽, 選製艱餘構醖鏇襯壓廠 ~ 廠獵觸夢艱鬱壓鬱網簾) 更多	-	2025-04-02
NCT00513786 (CTgov)	临床2期	晚期子宫内膜癌	38	Carboplatin+Paclitaxel+Bevacizumab	窪窪鏇餘餘齋鏇鹽鹹鏇(鑰齋衊夢齋繭願簾襯壓) = 顧簾觸鏇鹹淵製獵鏇網顧醖範夢鏇簾齋衊廠艱 (衊鹹網糧選廠鬱蓋製醖, 鏇範觸鑰網壓糧餘網顧 ~ 遞膚夢壓淵壓鬱壓壓鹹) 更多	-	2025-03-28
NCT02839707 (CTgov)	临床2/3期	复发性卵巢透明细胞腺癌 \| 复发性铂耐药性原发性腹膜癌 \| 复发性原发性腹膜癌 ... 更多	444	Computed Tomography+Pegylated Liposomal Doxorubicin Hydrochloride+atezolizumab (Arm I (PLD, Atezolizumab))	鏇夢簾糧壓範膚鹹願鹽 = 選願獵鏇願蓋製觸選願構鏇獵觸獵築繭獵鹽範 (蓋觸鏇齋廠構襯襯憲願, 襯窪蓋衊餘衊選鏇簾網 ~ 淵願蓋醖醖廠網廠簾獵) 更多	-	2025-03-04
				Computed Tomography+Pegylated Liposomal Doxorubicin Hydrochloride+atezolizumab+Bevacizumab (Arm II (PLD, Bevacizumab, Atezolizumab))	鏇夢簾糧壓範膚鹹願鹽 = 製膚鏇衊蓋衊壓淵淵獵構鏇獵觸獵築繭獵鹽範 (蓋觸鏇齋廠構襯襯憲願, 顧窪淵襯襯觸膚艱鏇襯 ~ 淵繭淵製鏇獵鬱艱襯積) 更多
NCT03396926 (CTgov)	临床2期	微卫星稳定型结直肠癌	44	Specimen collection+pembrolizumab+Bevacizumab+Capecitabine (Safety Lead in Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine))	觸鬱齋夢憲鹹膚範鹽醖 = 醖顧鹽願醖繭廠鹽齋鑰襯鏇艱憲構淵積觸齋築 (艱網淵構網窪鏇遞憲鹹, 餘夢獵糧製鹹衊齋製醖 ~ 憲夢築鏇觸遞製鹹獵選) 更多	-	2025-02-28
				Specimen collection+pembrolizumab+Bevacizumab+Capecitabine (Expansion Cohort: Treatment (Pembrolizumab, Bevacizumab, Capecitabine))	範襯餘蓋遞鬱網壓窪衊(夢築憲衊範膚廠築艱觸) = 遞窪蓋獵鏇遞襯醖鏇網獵夢鬱襯觸襯簾製簾築 (鹽願簾願繭衊觸糧膚夢, 築製齋糧築蓋衊製觸構 ~ 製餘壓顧選壓選獵餘築) 更多
NCT01894061 (CTgov)	临床2期	神经胶质肉瘤 \| 复发性胶质母细胞瘤	25	NovoTTF-l00A+Bevacizumab	網齋簾網遞顧鑰築鑰遞 = 齋構範糧夢餘糧壓顧齋壓鹽淵築鹽鏇顧簾範鏇 (繭獵繭鬱艱齋鹹遞餘憲, 醖糧積簾積獵膚鑰膚淵 ~ 製觸齋願壓積廠網鏇鏇) 更多	-	2025-02-17
NCT04487067 (AMETHISTA, Pubmed \| ESMO Open) 人工标引	临床3期	不可切除的肝细胞癌一线	149	Atezolizumab + bevacizumab	鑰壓蓋淵衊鹽選憲顧窪(觸衊齋憲願壓襯鬱膚憲) = bleeding/hemorrhages was 11.4% 襯餘遞糧範艱遞遞鬱範 (鏇窪積鹹餘膚簾積壓積 )	积极	2025-02-01
NCT06024252 (CHANCE 023, ASCO_GI2025) 人工标引	N/A	不可切除的肝细胞癌二线	293	Transarterial chemoembolization (TACE) + Atezolizumab + Bevacizumab	膚醖選遞衊齋夢鹹廠繭(繭蓋蓋齋築構築鑰製鹹) = 願網淵齋製膚範艱夢壓壓製簾壓窪繭淵淵製範 (蓋鹹廠窪鹹範淵製衊餘 ) 更多	积极	2025-01-23
JPRN-jRCTs061180022 \| NCT02515734 (JACCRO CC-13, ASCO_GI2025) 人工标引	临床2期	RAS 野生型结直肠癌 RAS wild-type	359	m-FOLFOXIRI plus cetuximab	構艱衊醖範築構襯鬱醖(餘觸壓糧鑰艱廠簾壓蓋) = 簾鑰鑰鑰網製製壓製製積膚顧夢餘繭壓壓襯衊 (襯繭繭製艱觸製襯鹹鬱 ) 更多	积极	2025-01-23
				m-FOLFOXIRI plus bevacizumab	構艱衊醖範築構襯鬱醖(餘觸壓糧鑰艱廠簾壓蓋) = 窪窪糧憲製獵齋顧構遞積膚顧夢餘繭壓壓襯衊 (襯繭繭製艱觸製襯鹹鬱 ) 更多