预约演示

更新于：2026-06-30

Atezolizumab

阿替利珠单抗

更新于：2026-06-30

概要

基本信息

药物类型

单克隆抗体

别名

Anti-PDL-1-Genentech/Roche、Atezolizumab (Genetical Recombination)、Atezolizumab (genetical recombination) (JAN)

+ [11]

靶点

PDL1

作用方式

抑制剂

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)

治疗领域

肿瘤免疫系统疾病消化系统疾病+ [10]

在研适应症

结外NK-T细胞淋巴瘤晚期非小细胞肺癌乳腺癌+ [151]

非在研适应症

大肠腺癌晚期胆管癌晚期胆道癌+ [102]

原研机构

Genentech, Inc.

Universitair Medisch Centrum Groningen

在研机构

Roche Registration GmbHRoche Pharma AG

罗氏（中国）投资有限公司

+ [21]

非在研机构

Kymab Ltd.

Sanofi

Pfizer Inc.

+ [12]

权益机构

NeoImmuneTech, Inc.

Harpoon Therapeutics, Inc.Novocure, Inc.

+ [26]

最高研发阶段批准上市

首次获批日期

美国 (2016-05-18),

尿路上皮癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、优先审评 (中国)

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结构/序列

Sequence Code 122091L

来源: *****

Sequence Code 4720027H

来源: *****

关联

919

项与阿替利珠单抗相关的临床试验

NCT07388524

/ Recruiting临床3期IIT

Evaluating Adjuvant Atezolizumab or Atezolizumab and Hyaluronidase-TQJS to Prevent Recurrence in Stage I Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase III Trial (AASI-NSCLC)

This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation or active surveillance, which involves closely watching a patient's condition but not giving treatment unless there are changes in test results. During active surveillance, patients are given certain exams and tests done on a regular schedule. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Atezolizumab and recombinant human hyaluronidase is a formulation of atezolizumab combined with an enzyme called hyaluronidase, which helps increase tissue absorption of the drug. Giving atezolizumab or atezolizumab and recombinant human hyaluronidase after resection may be effective for preventing NSCLC recurrence, and may be a better approach to treating patients with stage I NSCLC than the usual observation approach.

开始日期2027-03-02

申办/合作机构

National Cancer Institute

NCT07170592

/ Not yet recruiting临床1期

A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Combination With Hydroxyurea or Hydroxyurea/Atezolizumab in Treatment-refractory Solid Tumor Patients

This clinical trial aims to determine whether the administration of the investigational drug OTS-412, OTS-412 in combination with hydroxyurea or hydroxyurea/atezolizumab is safe and effective for patients with various types of cancer.

开始日期2027-01-01

申办/合作机构

Bionoxx, Inc.

NCT07322341

/ Not yet recruiting临床2期IIT

A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy

This phase II trial tests how well SX-682 and atezolizumab works for the treatment of non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic), and has come back after a period of improvement (recurrent). SX-682 blocks proteins that may be able to stimulate the immune system to kill and eliminate tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SX-682 and atezolizumab may be effective for the treatment of advanced or metastatic, recurrent NSCLC.

开始日期2026-09-01

申办/合作机构

University of Washington

[+3]

100 项与阿替利珠单抗相关的临床结果

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100 项与阿替利珠单抗相关的转化医学

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100 项与阿替利珠单抗相关的专利（医药）

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4,514

项与阿替利珠单抗相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of atezolizumab and bevacizumab as first-line systemic therapy in unresectable hepatocellular carcinoma in Malaysia

Article

作者: Chaiyakunapruk, Nathorn ; Patikorn, Chanthawat ; Sulaiman Shah, Audi Adawiah ; Wong, Yoke Fui ; Mohamed, Rosmawati

AIM:

This study aims to evaluate the cost-effectiveness of atezolizumab plus bevacizumab as first-line systemic therapy for unresectable hepatocellular carcinoma (uHCC) in Malaysia, compared with the current standard treatments in the Malaysian Ministry of Health (MOH) to inform public healthcare decision‑making.

MATERIALS AND METHODS:

A cost-effectiveness analysis was conducted from the MOH perspective, following the national pharmacoeconomic guidelines (2019). The study compared atezolizumab plus bevacizumab with sorafenib and lenvatinib, respectively, using a partitioned survival model to project health outcomes and costs over a lifetime horizon. Clinical efficacy data were sourced from published trials and network meta-analyses. Cost inputs reflected local healthcare resource use and prices, using 2024 Malaysian Ringgit values inflated via the Consumer Price Index for Health. Costs and outcomes were discounted at 3% annually. Deterministic and probabilistic sensitivity analyses were performed to assess the impact of key parameter uncertainties on the results.

RESULTS:

Atezolizumab plus bevacizumab provided the highest quality-adjusted life years (QALYs) and life years compared to sorafenib and lenvatinib. Sorafenib was dominated by lenvatinib due to lower QALYs and higher costs and excluded from further analysis. Compared to lenvatinib, atezolizumab plus bevacizumab yielded 0.873 additional QALYs and RM 44,863 additional cost, resulting in an incremental cost-effectiveness ratio (ICER) of RM 51,399 per QALY gained (∼0.906 GDP/capita at Malaysia's 2024 GDP/capita RM 56,734).

CONCLUSIONS:

Atezolizumab plus bevacizumab is cost-effective compared to lenvatinib and sorafenib across willingness-to-pay (WTP) values of one to three times Malaysia's GDP per capita. These findings provide evidence to inform public health policy that expanding funding and adoption of atezolizumab plus bevacizumab is likely to improve health outcomes cost-effectively.

2026-09-01·COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY C-TOXICOLOGY & PHARMACOLOGY

Toxic effects of acute atrazine exposure on the physiological functions and transcriptional levels in non-targeted marine invertebrates (Chlamys nobilis)

Article

作者: Sun, Jing ; Zheng, Huaiping ; Liu, Yaoting ; Yan, Beiyu ; Lin, Qing ; Wang, Weili ; Zhang, Hongkuan

Atrazine (ATZ), the second most widely used pesticide globally, poses potential risks to non-target aquatic organisms. However, its toxicological impacts on the economically valuable Chlamys nobilis remain unknown. This study investigates the toxicological effects of ATZ on the economically important C. nobilis. We assessed tissue integrity, physiological functions, and transcriptional profiles following ATZ exposure. Mortality in C. nobilis was observed to be time- and dose-dependent. Gill tissue damage was first noted at 5 μg/L ATZ, with severity increasing at higher concentrations. Superoxide dismutase (SOD) and catalase (CAT) activities were significantly elevated at 5 μg/L and 50 μg/L compared to controls but declined at 500 μg/L (P < 0.05). Glutathione S-transferase (GST) activity increased in all exposed groups except at 500 μg/L, peaking at 5 μg/L (P < 0.05). Malondialdehyde (MDA) levels rose significantly at 0.5 μg/L and further increased with higher ATZ concentrations (P < 0.05). RNA-seq analysis revealed 167 and 282 differentially expressed genes (DEGs) at 0.5 μg/L and 50 μg/L, respectively, enriched in pathways related to the endocrine, sensory, and digestive systems. Our findings highlight the toxic effects of ATZ on C. nobilis and contribute to the environmental risk assessment of this pesticide.

2026-09-01·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Synthesis and preclinical evaluation of 89Zr-DFO-atezolizumab for immuno-PET imaging in colorectal cancer

Article

作者: Hao, Siqi ; Rojsitthisak, Pornchai ; Vajragupta, Opa ; Chen, Qian ; Zhu, Hua ; Zhang, Qian ; Sriwongta, Soontaree ; Jiang, Yang ; Zhang, Yan ; Yang, Zhi

The immune checkpoint programmed ligand 1 (PD-L1) is expressed in various solid tumors and is associated with immunotherapy prognosis. Dynamic assessment of PDL1 expression levels helps identify patients who may benefit from immunotherapy. Atezolizumab is a monoclonal antibody that targets PD-L1 and is used in the treatment of various hematologic malignancies and solid tumors. However, research on colon cancer is lacking. Approximately 85% of colorectal cancer (CRC) patients have the MSS/pMMR (Microsatellite Stable/proficient Mismatch Repair) subtype, which lacks ideal biomarkers for precise and dynamic screening of potential immune-responsive subpopulations and for predicting combination therapy strategies. Currently, the assessment of PD-L1 is limited to biopsy samples. Molecular immuno-PET imaging can provide an effective solution for guiding clinical immunotherapy selection. This study describes the development of ⁸⁹Zr-DFO-atezolizumab, a PD-L1-targeted immuno-imaging agent, and its evaluation in terms of in vitro and in vivo specificity as well as pharmacokinetics. Tumor uptake and heterogeneity were quantified in mouse models via immuno-PET imaging. PET/CT scans using ⁸⁹Zr-DFO-atezolizumab revealed a significant difference in tumor uptake between the MC38^hPD-L1 model and the MC38 model, and cold anti-atezolizumab effectively blocked this uptake. The preliminary dosimetry study indicated that the organs receiving higher doses are the spleen and the liver. Preclinical PET/CT imaging with ⁸⁹Zr-DFO-atezolizumab reveals its potential for the non-invasive detection of PD-L1-positive CRC tumors, which holds potential significance for understanding tumor heterogeneity and monitoring early PD-L1 expression changes induced by therapy.

3,600

项与阿替利珠单抗相关的新闻（医药）

21 小时之前

·PRNewswire

EirGenix Showcases Dual-Track Biosimilars and CDMO Strategy in U.S. Market Push at BIO 2026

SAN DIEGO, June 30, 2026 /PRNewswire/ -- At BIO 2026, EirGenix presented its comprehensive HER2-positive breast cancer biosimilar portfolio and highlighted its integrated one-stop contract development and manufacturing organization (CDMO) service platform. The company actively pursued U.S. market opportunities through business matchmaking and global partnership discussions. While antibody-drug conjugates, other oncology and immunology biologics, and biosimilars continue to drive growth, CDMOs are gaining strategic importance amid ongoing global supply chain restructuring. Continue Reading EirGenix showcases its complete HER2-positive breast cancer biosimilar product portfolio and one-stop integrated CDMO platform at BIO 2026. Image: GeneOnline In an industry shifting from single-product competition toward platform-based and combination-therapy strategies amid geopolitical uncertainty, EirGenix addresses the challenge of finding new growth engines in mature markets through its dual-track approach. By combining targeted biosimilar development with a flexible CDMO model, the company captures high-potential oncology opportunities while helping partners accelerate global commercialization. Breast Cancer Remains a Core Battlefield in Oncology Innovation According to the World Health Organization (WHO), approximately 2.3 million women were diagnosed with breast cancer in 2022, making it the second most commonly diagnosed cancer worldwide. The large patient population and steadily rising treatment demand continue to drive sustained pharmaceutical investment in the field. Market research from Grand View Research projects that the global breast cancer drug market will expand from USD 36.6 billion in 2024 to USD 69.7 billion by 2033, representing a compound annual growth rate (CAGR) of 7.1%. HER2-positive breast cancer accounts for approximately 15% to 20% of all breast cancer cases. Historically, this subtype was associated with aggressive tumor biology and poor prognosis. However, the introduction of trastuzumab validated HER2 as a therapeutic target and reshaped the treatment paradigm. Since then, innovation in HER2-positive therapy has accelerated. Dual-target regimens, subcutaneous formulations, and antibody-drug conjugate (ADC)-based approaches have reshaped the competitive landscape. Today, differentiation extends beyond efficacy, increasingly focusing on treatment convenience and patient experience. Biosimilars for HER2-Positive Breast Cancer Drive EirGenix's Next Growth Phase The global biopharmaceutical industry is entering a major patent cliff, as approximately $300 billion of biologics are expected to lose patent protection over the next decade. This transition is creating significant opportunities for biosimilar developers across major therapeutic areas, especially in oncology and immunology. This is unlocking a vast market potential for biosimilars. While 118 biologics are set to lose exclusivity by 2034, a striking 106 of them currently have no biosimilars in development. At the same time, global regulatory frameworks are becoming increasingly harmonized. Agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are aligning expectations for biosimilar approval pathways. Development requirements are increasingly focused on in vitro comparability and on pharmacokinetic bioequivalence data, reflecting a more streamlined regulatory approach. This shift is reducing reliance on large-scale Phase III clinical trials, ultimately shortening development timelines while lowering costs and clinical risk. Against this backdrop, EirGenix has strategically prioritized HER2-positive breast cancer within its biosimilar portfolio. The company's pipeline spans multiple modalities, including trastuzumab and pertuzumab, as well as subcutaneous combination formulations designed to improve treatment convenience and administration efficiency. In parallel, EirGenix is advancing development efforts in next-generation ADC biosimilars. Beyond single-agent development, EirGenix is also exploring combination therapy strategies to address mechanisms of resistance in oncology treatment. These include potential co-development approaches involving ADC biosimilars alongside immune checkpoint inhibitors such as atezolizumab, as well as other targeted therapies including daratumumab. As additional oncology biologics approach patent expiration, the company continues to evaluate and prioritize future targets across its development pipeline. This proactive portfolio strategy is designed to strengthen its positioning in the rapidly evolving immuno-oncology biosimilar landscape. Supply Chain Restructuring Elevates the Strategic Role of CDMO Partners Beyond biosimilars, CDMO services represent a second core pillar of EirGenix's business strategy. Global supply chain restructuring, the rapid rise of biotech startups, and increasing demand for biologics are reshaping outsourcing models across the pharmaceutical industry. In the United States, companies of all sizes are increasingly relying on external partners to support both development and manufacturing activities. This shift is driven by the need to reduce capital expenditure while improving R&D efficiency and operational flexibility. With demonstrated leadership in commercial-scale GMP biologics manufacturing, EirGenix provides integrated CDMO services across the full product lifecycle. Unlike development-focused CDMOs with limited scale and late-stage capabilities, EirGenix operates a fully integrated, commercially scaled platform spanning cell line engineering, process and analytical development, technology transfer, and GMP manufacturing. This delivers strong performance across the entire value chain from early-stage development through commercialization. Its service scope covers monoclonal antibodies, bispecific antibodies (BsAbs), and other complex biologics. By integrating these capabilities, EirGenix expands cross-border collaboration opportunities and reinforces its positioning in the global biologics outsourcing market. EirGenix Advances Dual-Track Growth in Biosimilars and CDMO Services at BIO Convention The United States remains the largest pharmaceutical market globally. At BIO 2026, EirGenix strengthened its international visibility by showcasing its R&D capabilities and engaging in active partnering discussions and industry networking. The company reiterated its commitment to expanding its global footprint, with a strategic focus on capturing opportunities from biosimilar patent expirations and increasing global demand for CDMO partnerships. EirGenix highlighted its long-term dual-track growth strategy: advancing high-value biosimilar assets while leveraging its commercial-scale development and manufacturing platform to support global clients across the entire product lifecycle. This integrated approach is designed to accelerate development timelines for partners while improving commercialization efficiency. Ultimately, it positions EirGenix as an integrated enabler within the rapidly growing global biologics ecosystem. Contact: Press GeneOnline [email protected] +886-225140360 SOURCE EirGenix 21% more press release views with Request a Demo

临床3期抗体药物偶联物

2026-06-29

·研发客

艾科联与罗氏达成合作，评估EXP011用于DLL3阳性实体瘤联合治疗潜力 | 新闻稿

• 罗氏将提供阿替利珠单抗（泰圣奇®），用于艾科联生物科技后续研究中探索EXP011（CTM012）与阿替利珠单抗联合治疗DLL3阳性实体瘤的疗效 • 初始研究将聚焦小细胞肺癌（SCLC），并有望扩展至神经内分泌肿瘤（NET）等其他肿瘤类型 2026年6月29日，专注于实体瘤和自身免疫性疾病下一代T细胞衔接器（TCE）疗法的艾科联生物科技（Excalipoint Therapeutics），宣布与罗氏（Roche）达成临床合作，探索艾科联核心在研产品EXP011（CTM012）与罗氏阿替利珠单抗（atezolizumab）对于各类表达 DLL3 抗原的实体肿瘤的联合治疗方案。EXP011是一款靶向DLL3、CD3及4-1BB的三特异性T细胞衔接器。根据合作协议，罗氏将为计划中的临床研究提供阿替利珠单抗。该合作项下的临床研究旨在评估EXP011联合阿替利珠单抗治疗小细胞肺癌（SCLC）的安全性、耐受性及初步抗肿瘤活性，并有望扩展至神经内分泌肿瘤（NET）等其他肿瘤类型。 “我们很高兴与罗氏合作，共同探索EXP011与阿替利珠单抗联合用于SCLC及其他难治性实体瘤患者的治疗潜力。”艾科联生物科技联合创始人、董事长兼首席执行官方磊博士表示，“此次合作使我们能够评估一种差异化的免疫肿瘤联合治疗策略，以突破现有治疗方案的局限性，为患者带来更好的临床获益。” “与罗氏的此次临床合作将进一步彰显EXP011在实体瘤领域的临床价值，并加速这一高度差异化资产的全球开发进程。”艾科联生物科技联合创始人、首席财务官兼首席商务官朱杰伦先生表示，“这一合作也是对EXP011潜力的有力认可——该产品有望突破现有疗法的治疗壁垒，实现更持久的应答，提升患者治疗效果。” EXP011是艾科联生物科技基于其自主EXCOPIA™共刺激平台（前身为TOPABody）开发的核心三特异性T细胞衔接器，旨在选择性靶向DLL3（在SCLC和NET中高表达的肿瘤特异性抗原），同时结合CD3和4-1BB，实现强效、可控且协同的T细胞激活与抗肿瘤活性。泰圣奇®（阿替利珠单抗）是罗氏集团成员基因泰克（Genentech）的注册商标。关于艾科联生物科技艾科联生物科技是一家临床阶段的生物技术企业，致力于开发下一代创新型 T 细胞衔接器（TCE）疗法，以满足全球范围未被满足的治疗需求。公司以EXCOPIA™共刺激平台、EXiShield™免疫护盾平台及EXPROMA™前药平台等多项自主T细胞治疗技术为核心，专注于研发具有差异化与临床潜力的新型T细胞疗法，攻克现有疗法面临的技术壁垒。公司管线涵盖肿瘤与免疫领域的6款候选药物，核心产品 EXP011已进入针对实体瘤的I/II期临床试验阶段。了解更多信息，敬请访问公司官网：www.excalipoint.com。 PR & IR 合作联系邮箱：info@excalipoint.com

免疫疗法临床申请细胞疗法临床研究突破性疗法

2026-06-29

·法迈医讯

什么是随机、双盲、安慰剂对照：为何它们构成临床试验设计的“金标准”？

在临床试验中，“随机、双盲、安慰剂对照”通常被称为金标准设计（Gold Standard Design），代表着最高水平的科学严谨性和结果可靠性。IMpower133试验作为一项支持药品注册的关键性III期研究，其结果获得了FDA的认可并支持了atezolizumab在该适应症的批准，该研究完整采用了这一设计框架。理解这一设计为何重要，不仅是学习临床研究的基本功，更是掌握生物统计实践的基石。本文将深入拆解这三大核心设计元素的原理、意义与在IMpower133中的应用。一、随机（Randomization）：确保组间可比性1. 什么是随机？随机化是指将受试者分配至各治疗组的过程完全依赖于预设的概率机制，而非人为判断。在IMpower133中，研究人员通过交互式语音/网页应答系统（IxRS）实现了1:1的中央随机分配。2. 为什么随机？核心目的是防止选择偏倚（selection bias），确保组间在基线特征上的可比性。在一个没有随机化的研究中，即使两个治疗组在人数上相等，它们在年龄、疾病严重程度、合并症等方面可能存在系统性差异，进而影响疗效评价。而随机化通过概率机制，使得所有潜在混杂因素（已知与未知）在组间分布趋于一致，从而增强因果推断的可信度。3. IMpower133的分层随机为了进一步提高组间平衡性，IMpower133引入了分层随机化（stratified randomization），按下列三项进行分层：性别（male vs female） ECOG体力评分（0 vs 1）脑转移状态（yes vs no）这种设计有助于确保各治疗组在关键预后因素上的平衡，从而提高整体比较的精确度和统计效能，并为后续可靠的亚组分析提供基础。二、双盲（Double-Blind）：防止观察与评估偏倚1. 什么是双盲？双盲指的是在研究过程中，既不让研究对象知道其所接受的治疗是哪一组，也不让研究医生（或评估者）知道。这在IMpower133中体现为：患者不知自己接受的是atezolizumab还是安慰剂；医生和评估员也不知患者所属组别。2. 为什么双盲？目的是避免主观偏倚干扰治疗效果的评估（performance bias, assessment bias）。例如，患者知道自己服用的是新药可能更积极配合，而医生若知患者接受实验治疗，在主观症状打分、影像解释时也可能存在倾向性。这在免疫治疗领域尤其关键——因为免疫药物常伴随“迟发效应”和“伪进展”等现象，评估标准更依赖观察者的专业判断。3. 如何实现盲法？ IMpower133采用了外观一致的注射制剂和统一的给药频次，确保实验组与对照组在“形式上”完全一致，从而有效维持盲态。三、安慰剂对照（Placebo-Controlled）：设立科学对照基线1. 什么是安慰剂？安慰剂是一种外形、味道和使用方式与试验药一致，但不含有效成分的物质。在IMpower133中，对照组患者接受的“安慰剂 + 化疗”组合与试验组的“atezolizumab + 化疗”在给药方式上完全一致。2. 为什么使用安慰剂？为了确保组间在非治疗因素上的体验一致，使得观察到的差异唯一归因于试验药物的作用。若使用“无处理”组作为对照，则患者体验上的差异可能引入心理预期差异，影响依从性、主观评分等，从而扭曲结果。 IMpower133采用的是安慰剂对照的附加设计（add-on design），即在标准背景化疗的基础上，一组加用atezolizumab，另一组加用安慰剂，这是当前在已有标准治疗情况下评估新疗法时推荐的设计之一。3. 安慰剂的伦理挑战与解答很多人会问：在严重疾病如广泛期SCLC中，使用安慰剂是否违背伦理？关键点在于：所有患者均接受标准治疗（carboplatin + etoposide）；安慰剂仅作为是否添加atezolizumab的掩饰工具；不存在剥夺标准疗法的问题。因此，IMpower133中的安慰剂对照设计在伦理上是可接受且合规的。四、三者结合为何构成“金标准”？设计要素控制偏倚类型举例说明随机选择偏倚、混杂因素分层随机可避免某组恰好脑转移比例较高双盲观察者偏倚、行为偏倚医生盲态评估影像，避免刻意放宽评估标准安慰剂对照安慰剂效应、心理/依从性差异患者不知道是否使用新药，主观感受趋于一致三者联用的最大价值在于：使临床试验的结果接近真实药效而非人为或系统性偏差产生的差异。这就是FDA、EMA、NMPA等全球监管机构最信任此类设计的原因所在。五、结语：精确设计是“科学之锚” IMpower133能最终成为全球首个改变SCLC一线治疗标准的免疫药物试验，其基础不只是药物本身，更是设计严谨、执行规范、偏倚最小的研究方法学。 “随机、双盲、安慰剂对照”不是老调重弹，而是历经实证考验的真理。未来不论是你参与设计研究、解读结果，还是阅读一篇文献，都应首先问：这个研究控制了哪些偏倚？它的设计靠得住吗？从这一问题出发，你就开始具备专业思维了。行业福音：efreeshare线上版免费，企业级本地部署正式开放预约！自 efreeshare 系统发布以来，我们收到了行业同仁的热烈反馈。为了回馈大家的支持，我们决定将 Web 线上版全面升级——取消个人版限制，所有功能面向全行业【免费】开放！同时，针对药企对数据安全和内网合规的刚需，efreeshare 企业级本地化部署方案（私有云/内网版）现已正式商用落地！更强悍的性能、更严密的安全防护、更深度的定制服务，欢迎有需求的企业咨询对接。问题一：efreeshare 到底是干什么的？简单来说，efreeshare是一个专注于临床试验数据全流程的、智能化的SaaS平台。它的核心使命是解决临床数据在新药研发过程中面临的三大挑战：合规性 (Compliance): 确保您的临床数据处理和递交过程，严格符合全球主流监管机构（NMPA, FDA, PMDA）的最新标准和技术要求。效率 (Efficiency): 通过自动化和智能化工具，将数据处理人员从大量重复、繁琐的手动操作中解放出来，将数周的工作缩短至数天甚至数小时。安全性与协作 (Security & Collaboration): 提供企业级的安全保障（特别是通过本地化部署），并打破不同职能团队（数据、统计、医学、监查等）之间的数据壁垒，提升协作效率。问题二：它的功能到底有哪些？够不够专业？ efreeshare提供了一套完整、专业的功能组合，覆盖了从数据审阅到最终递交包创建的全链路。以下是核心功能的详细解读： 1. 多格式数据在线浏览器与转换器 (Multi-Format Data Viewer & Converter) 核心价值：打破技术壁垒，让团队中每一位成员都能轻松访问和审阅临床数据。详细说明：无需安装SAS：用户可以直接在网页浏览器中打开并浏览 .xpt (SAS Transport Format) 和 .sas7bdat (SAS Dataset) 格式的文件，彻底摆脱了对本地SAS软件的依赖。便捷的数据审阅：对于数据管理员、医学监查、生物统计师等非编程背景的角色，此功能提供了直观的表格化数据视图，支持在线进行数据筛选、排序和基础审核。一键格式转换：用户可以轻松地将在线浏览的数据集一键下载为通用的 Excel (.xlsx) 或 CSV 格式，方便进行进一步的数据处理、分享或报告制作。 2. 全球多中心合规验证引擎 (Global Multi-Center Compliance Validation Engine) 核心价值：以全球统一标准，确保您的临床数据包在任何主流监管机构面前都经得起最严格的审阅。详细说明：多标准支持：内置了针对中国NMPA、美国FDA、日本PMDA三大主流监管机构的验证规则配置，用户可根据递交目标一键切换。 SDTM验证：全面支持SDTM-IG 3.1.2, 3.1.3, 3.2, 3.3等多个版本，能对数据集结构、变量属性、受控术语、域间逻辑关系等进行上千项规则的自动化检查。 ADaM验证：支持ADaM-IG 1.1, 1.2, 1.3等版本，确保分析数据集的合规性、可追溯性以及与统计分析计划的一致性。 Define.xml验证：支持Define.xml 2.0及2.1版本，检查其结构、内容、链接的有效性，确保递交的元数据准确无误。交互式报告：生成详细、可交互的验证报告，清晰列出每一个Error、Warning或Notice，并提供规则来源和问题定位，极大方便了程序员的调试工作。 3. 智能化Define.xml全流程解决方案 (Intelligent Define.xml End-to-End Solution) 核心价值：将繁琐、易错的Define.xml创建工作变为一个高效、智能、可协作的自动化流程。详细说明：模板化创建：提供标准的Define.xml 2.0/2.1模板，用户只需导入数据集即可启动创建流程。元数据高度自动化填充：系统能自动读取SDTM/ADaM数据集的元数据，并智能填充其中的数据集/变量属性、数据类型、长度、标签等信息，准确率和效率远超手动填写。智能关联：自动处理复杂的元数据关系，包括受控术语 (Controlled Terminology) 的绑定、值级别元数据 (Value Level Metadata - VLM) 的定义、以及计算方法 (Computation Methods) 的关联。在线协作与管理：支持团队成员在线协同编辑和审阅Define.xml草稿，所有修改都有版本记录，便于协作和项目管理。 4. 一体化递交文档协作平台 (Integrated Submission Document Collaboration Platform) 核心价值：将分散的文档工作整合到统一平台，消除版本混乱，提升团队协作效率和递交文档质量。详细说明： Metadata管理：支持在线编辑和管理SDTM、ADaM的Mapping Specifications（数据映射规范）编程模版，团队成员可基于统一的模板和版本进行工作。审阅者指南 (SDRG/ADRG) 智能创建：提供在线创建cSDRG和ADRG的功能，系统能根据已有的数据集和元数据，智能化填充大部分内容，将原本耗时数天的文档撰写工作缩短至数小时。 5. PDF文档双书签制作工具 (PDF Dual Bookmark Tool) 核心价值：轻松解决eCTD递交中aCRF等PDF文档的双书签制作难题。详细说明：针对监管机构对aCRF（带注释的病例报告表）等PDF文档的特定要求，本工具支持线上或通过导入文件的方式，为PDF文档自动或半自动地创建符合递交标准的双层书签结构，无需使用复杂的第三方PDF编辑软件。 6. eCTD m5文件夹一键构建 (One-Click eCTD m5 Folder Builder) 核心价值：告别递交前的手动打包，一键生成完整、合规、可存档的递交文件包。详细说明：在项目的所有数据和文档（如数据集、Define.xml、审阅者指南、程序等）经过最终确认后，用户可使用此功能一键在线自动创建符合eCTD规范的m5文件夹结构。系统会自动将所有相关文件精准地放置到对应的子文件夹中，生成一个完整的、可直接用于递交的压缩包，并支持存档和下载，极大地降低了递交前手动整理出错的风险。问题三：哪些人可以使用efreeshare？ efreeshare的设计初衷是服务于整个临床研发数据链条上的每一位专业人士。只要您的工作与临床数据打交道，efreeshare就能为您提供价值。统计程序员 (Statistical Programmer) / SAS程序员 / 临床程序员：你们是efreeshare的核心用户。平台能将你们从繁琐的数据验证、Define.xml创建、递交包整理等重复性工作中解放出来，让你们更专注于核心的分析编程。数据管理员 (Data Manager): 利用在线数据浏览器审阅EDC导出的数据，检查数据一致性，并参与Mapping Spec的协作。生物统计师 (Biostatistician): 轻松查阅SDTM/ADaM数据集，验证分析结果的可追溯性，并参与审阅者指南的撰写。医学监查 (Medical Monitor) / 临床研究协调员 (CRA): 无需SAS，即可在线查看最新的临床数据，进行医学审核，发现潜在问题。注册与递交专员 (Regulatory Affairs): 利用平台确保递交包的完整性和合规性，并通过m5文件夹构建功能简化最终的打包工作。质量保证 (QA) 人员：方便地进行数据和文档的审计追踪，确保所有流程符合SOP。项目经理 (Project Manager): 实时了解数据处理和文档准备的进度，更好地进行项目管理。问题四：怎么使用efreeshare？我们提供了两种灵活、安全的使用方式，全部免费： SaaS在线注册使用 (最快捷): 步骤：访问官网 www.efreeshare.com，使用您的邮箱或手机号即可在30秒内完成注册。优势：无需任何本地安装和维护，登录即可使用，并能自动获得最新的功能和标准更新。本地化部署 (最安全): 步骤：如果贵公司对数据安全有最高级别的要求，可以联系我们进行免费的本地化部署。我们会提供详细的部署手册和远程支持。优势：将efreeshare完全部署在您公司的私有服务器内，数据100%不出内网，实现绝对的数据安全和自主可控。【联系我们】如果您在使用 Web 版时遇到问题，或者您的企业对本地化部署、数据安全定制有采购意向，欢迎联系我们的官方商务助理“团团”。 👇 扫码添加小编老师微信，获取： Web版使用操作手册企业级本地部署方案与报价加入行业大咖交流群小编团团官方邮箱：info@efreeshare.com 苏州蓝点呼吸科技有限公司 (Blue Dot Breath) 关于我们企业定位：苏州蓝点呼吸科技有限公司，是一家由资深临床研发与大数据专家联合创立的科技企业。我们深耕生命科学领域，专注打破数据孤岛，为新药研发提供从数据标准化、云端协同到自动化递交的系统级解决方案。市场认可：凭借硬核的技术壁垒与对临床业务的深刻洞察，efreeshare 平台已深度渗透国内外市场。我们的客户及合作伙伴涵盖众多国内外上市创新药企、头部 Biotech 及知名 CRO 机构。我们致力于将繁琐的合规要求转化为高效的数字生产力。欢迎加入1502+人的中国临床试验千人通讯录精品课程推荐国际临床研究系列课程十套课已全部更新完毕！现购课福利多多！一期和二三期临床试验设计实操训练营多终点设计实操训练营联合用药研究设计实操训练营 ADC临床试验设计实操训练营 Protocol撰写实操训练营期中分析设计实操训练营生存分析实操训练营《AI赋能Protocol撰写Workshop》训练AI按要求帮你完成专业的protocol撰写,附课程试听！统计师必看：从实际案例系统学习临床试验前沿设计方法好课推荐| 生物统计学方法讲解与应用系列培训课程好课推荐|SAS程序员统计编程技能系列录播课程推荐|临床试验标准化提交辅导系列培训统计程序员TFLs编程系列录播课程，42节课程干货满满！学习|SAS 绘图系列课程！！！生翼计划:临床SAS程序员实战项目训练营开营啦！真实临床试验项目数据练手,模拟工作环境,体验工作日常！推荐|药物警戒系列课程模块一二三四好课推荐|CRA系列课程好课推荐|临床试验数据管理系列录播课程推荐|CRA能力提升系列培训课程药物警戒体系全套SOPs：符合国家局核查标准！符合B证现场检查！关于举办“2025定量药理学建模与模拟基础（NONMEM软件）培训班”的通知 21节SAS初级编程系列课程在线免费观看【重磅推出】FDA483报告与警告信典型案例解读系列课程推荐|AI撰写Protocol训练营详细课表更新-学员反馈很棒的活动！精品资料包推荐真实世界研究全套资料包！临床试验贝叶斯设计资料包：17本书籍+14篇文献干货满满！ FDA药物警戒资料包领取|临床研究统计方法必看的15本知名书籍！领取| 临床SAS编程和数据管理全套干货资料包！药物警戒全套精华资料包收藏|知名书籍：临床试验的贝叶斯自适应方法法规|ICH-GCP中英文对照（最完整版）收藏|E9：临床试验统计原则（另附中英文对照词汇表）免费公开课|21节SAS Base初级编程系列课程限时领取|杜克临床研究所的临床试验手册汇总|临床试验十七个相关知识点免费领取|临床研究几本经典书籍！最全汇总：Define-XML 2.1指导原则讲解视频分享|专属生物统计师的几本经典书籍汇总|电子版CDISC-SDTM基本理论及实践系列文章限时领取|8.72G临床试验精华资料包(共180个文件）送给临研人的福利！限时领取|符合国际标准的全套临床SOP资料包,651个文件供你参考学习！汇总帖：CDISC标准干货文章和资料精选汇总帖：生物统计系列干货文章和资料精选汇总帖：SDTM干货文章和资料精选免费领取|ADC(抗体药物偶联物)知名书籍：研发,临床,注册及市场发展领取|生物等效性试验（BE试验）比较全面的知名书籍！汇总|CDE ICH指导原则全系列培训视频必看|学习生物制药CMC必看的23本书籍！限时免费|书籍: 临床数据管理实用指南第三版收藏|抗肿瘤药物创新研发必看16本书籍！福利|专属CRC的全套资料包免费领取收藏|547页CDASHIG v2.3 FINAL 领取知名书籍:新临床试验人员的基本概念&药物开发中的定量决策汇总|生物统计系列十五篇干货文章！收藏|临床研究设计与方案撰写资料包！！汇总|生物统计系列十五篇干货文章！汇总|生物统计学常用统计分析方法系列文章汇总|SAS编程应用及相关知识分享系列文章收藏|药物临床试验必备文件及相关管理要求限时领取|CRA应看的5本知名书籍！ >>>> 公众号推荐欢迎关注法迈新媒体更多，更及时的干货内容，请加我们的微信公众号：法迈医讯，诚邀业内人士及机构向我们投稿。投稿邮箱：bellama@pharmanews.cn 【免责声明】文章为网络整理，不代表“法迈医讯”立场。如因作品内容、版权等存在问题，请于本文刊发30日内联系法迈医讯进行删除或洽谈版权使用事宜。法迈医讯作为法迈新媒体微信公众号矩阵之一，法迈新媒体是国内一家面向制药行业供应链综合服务平台，致力于服务全球制药行业从业人员。以创新的互网+模式服务于行业用户，形成以“资源整合，知识共享”为核心，微信公众号矩阵、社群矩阵为分支的新媒体模式，力争打造国内活跃和具影响力的专业化平台！

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KEGG	Wiki	ATC	Drug Bank
D10773	阿替利珠单抗	L01XC32	DB11595

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
结外NK-T细胞淋巴瘤	日本	Chugai Pharmaceutical Co., Ltd.	2025-09-19
晚期非小细胞肺癌	欧盟	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	冰岛	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	列支敦士登	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	挪威	Roche Registration GmbH	2024-07-25
乳腺癌	加拿大	F. Hoffmann-La Roche Ltd.	2024-03-13
肺泡软组织肉瘤	美国	Genentech, Inc.	2022-12-09
PD-L1阳性非小细胞肺癌	日本	Chugai Pharmaceutical Co., Ltd.	2022-05-26
BRAF V600 突变阳性黑色素瘤	美国	Genentech, Inc.	2020-07-30
PD-L1阳性三阴性乳腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2018-01-19
晚期肝细胞癌	欧盟	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	冰岛	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	列支敦士登	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	挪威	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	欧盟	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	冰岛	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	列支敦士登	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	挪威	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	欧盟	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	冰岛	Roche Registration GmbH	2017-09-20

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
错配修复缺陷或微高卫星不稳定性结肠癌	申请上市	澳大利亚	Roche Products Pty Ltd.	2026-04-08
肌层浸润性膀胱癌	申请上市	日本	Chugai Pharmaceutical Co., Ltd.	2026-01-28
膀胱癌	申请上市	中国	Roche Holding AG	2019-02-25
淋巴组织增生性疾病	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
黑色素瘤	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
MSI-H 癌症	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
Turcot综合征	临床3期	英国	Hoffmann-La Roche Ltd.	2023-10-25
局部晚期乳腺癌	临床3期	美国	Roche Diagnostics GmbH	2021-03-29
局部晚期乳腺癌	临床3期	美国	罗氏（中国）投资有限公司	2021-03-29
局部晚期乳腺癌	临床3期	美国	F. Hoffmann-La Roche Ltd.	2021-03-29

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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


NCT05537402 (LOST-B, CTgov)	临床2期	肝细胞癌	1	Atezolizumab+Bevacizumab (Arm A: Atezolizumab and Bevacizumab)	簾餘簾觸遞鬱蓋廠願遞(鏇鬱網蓋壓觸醖簾構糧) = 夢積衊鏇衊積淵鬱選遞廠壓築構顧鹽鏇糧構獵 (膚鹽鏇積膚憲窪齋構醖, 餘齋衊選積齋構膚繭夢 ~ 鏇範獵願廠壓鬱醖襯糧) 更多	-	2026-06-18
				transarterial chemoembolization (TACE) or transarterial radioembolization (TARE (Arm B: Locoregional Therapy With TACE or TARE)	簾餘簾觸遞鬱蓋廠願遞(鏇鬱網蓋壓觸醖簾構糧) = 鏇鏇鬱壓憲餘窪蓋廠願廠壓築構顧鹽鏇糧構獵 (膚鹽鏇積膚憲窪齋構醖, 憲艱獵鬱蓋壓繭鏇範鑰 ~ 淵網壓築憲願製遞壓餘) 更多
NCT04829383 (BTCRC-GI20-457 \| AB7, CTgov)	临床2期	不可切除的肝细胞癌	6	Atezolizumab+Bevacizumab	積觸襯淵齋鑰鏇醖壓夢 = 鹽憲淵網鏇窪鹽觸積窪願糧憲築繭淵製遞選獵 (積鹹築簾淵餘觸醖蓋繭, 範醖遞鑰鹹艱繭蓋網醖 ~ 願構簾衊醖膚選壓憲膚) 更多	-	2026-06-16
NCT04984811 (CTgov)	临床2期	非小细胞肺癌 \| 非小细胞肺癌 III期 \| 转移性非小细胞肺癌	33	Atezoliaumab+NT-I7	築積鑰衊鏇蓋構膚獵齋 = 範餘鑰築製蓋繭窪淵鏇壓積壓夢網壓夢糧製蓋 (築觸鬱糧夢鏇繭夢醖鏇, 衊餘壓鑰壓鹹淵顧鏇鑰 ~ 膚遞築夢艱簾窪繭蓋簾) 更多	-	2026-06-11
NCT04619797 (SKYSCRAPER-06, CTgov)	临床2/3期	晚期肺非鳞状非小细胞癌	542	Pembrolizumab+Placebo (Placebo + Pembrolizumab + Chemotherapy)	壓蓋築夢網網簾憲憲糧(鬱獵鑰蓋衊鹹鏇齋壓襯) = 醖遞築獵願觸憲網構網襯鹹餘積膚膚遞網憲鹽 (艱蓋糧襯鬱淵齋齋淵積, 衊壓築醖簾衊鏇夢夢壓 ~ 構衊糧積艱鹽鹹繭醖糧) 更多	-	2026-06-03
				Atezolizumab+Tiragolumab (Tiragolumab + Atezolizumab + Chemotherapy)	壓蓋築夢網網簾憲憲糧(鬱獵鑰蓋衊鹹鏇齋壓襯) = 膚齋憲襯獵餘鹽夢膚製襯鹹餘積膚膚遞網憲鹽 (艱蓋糧襯鬱淵齋齋淵積, 鑰簾夢鹽構鑰襯鏇觸淵 ~ 構齋膚簾艱構蓋醖蓋膚) 更多
NCT04513925 (SKYSCRAPER-03, CTgov)	临床3期	局部晚期非小细胞肺癌	829	Durvalumab (Durvalumab)	鹽廠獵窪鹹鏇齋積願範(願夢鬱餘繭憲憲夢積醖) = 膚遞觸夢鏇膚顧醖範齋衊衊構蓋鹹顧鑰衊夢壓 (鹹獵憲願鹹繭艱製積鬱, 鏇膚膚簾衊糧鑰繭鏇膚 ~ 鑰淵積願襯築壓餘醖選) 更多	-	2026-06-03
				Atezolizumab+Tiragolumab (Atezolizumab + Tiragolumab)	鹽廠獵窪鹹鏇齋積願範(願夢鬱餘繭憲憲夢積醖) = 襯衊遞蓋淵壓糧築壓淵衊衊構蓋鹹顧鑰衊夢壓 (鹹獵憲願鹹繭艱製積鬱, 糧壓鹽艱範餘鹹獵顧繭 ~ 窪獵網簾範鬱餘蓋網衊) 更多
NCT03698461 (Pubmed \| Genome Med)	临床2期	结肠癌肝转移新辅助	60	ABFOLFOX treatment	築製遞遞積獵繭蓋鹹廠(淵鏇鬱製鹹築壓餘淵鑰) = 構鹽鹹顧遞網淵積簾網膚憲簾廠鹹淵艱窪鹽衊 (觸鹹觸蓋顧構淵艱鑰獵 )	积极	2026-05-30
ASCO2026	N/A	膀胱癌 IED172	814	atezolizumab	鑰鑰蓋膚窪窪網膚網夢(餘構窪觸糧糧淵築網鑰) = 壓淵艱鏇築簾衊範膚鹹網簾衊襯淵獵夢鏇夢網 (夢築鏇選製衊顧網壓選 ) 更多	积极	2026-05-29
				atezolizumab (low IED-PI)	鑰鑰蓋膚窪窪網膚網夢(餘構窪觸糧糧淵築網鑰) = 壓鬱願夢鏇糧糧顧廠鏇網簾衊襯淵獵夢鏇夢網 (夢築鏇選製衊顧網壓選 ) 更多
ASCO2026	N/A	不可切除的肝细胞癌一线	91	Atezolizumab + Bevacizumab + Transarterial Therapies (Baseline AFP >25 ng/mL and normalized after treatment + Unresectable Hepatocellular Carcinoma)	膚鹹顧鑰醖艱遞糧壓觸(願築鑰壓網衊獵鑰鑰獵) = 廠鹹艱範積網簾構鬱獵鬱願顧網網範範網蓋憲 (範簾簾鏇範觸選齋顧鏇 ) 更多	积极	2026-05-29
ASCO2026	N/A	肝细胞癌一线	39	Atezolizumab + Bevacizumab (CPA)	鏇齋構窪鬱壓遞餘遞選(獵鹽壓觸鹹糧遞製鹹餘) = 鹹夢廠艱鏇憲壓廠淵襯築壓襯鑰鬱衊構鏇襯蓋 (夢遞衊壓鬱襯壓淵淵鑰, 5.3 ~ not estimable) 更多	积极	2026-05-29
				Atezolizumab + Bevacizumab (CPB)	鏇齋構窪鬱壓遞餘遞選(獵鹽壓觸鹹糧遞製鹹餘) = 鏇壓觸淵鑰獵鑰餘廠醖築壓襯鑰鬱衊構鏇襯蓋 (夢遞衊壓鬱襯壓淵淵鑰, 4.8 ~ 15.7) 更多
ASCO2026	N/A	肝细胞癌一线	140	GLP-1RA group	廠顧艱蓋鏇夢廠獵艱鹽(鑰壓餘觸廠鹹膚鬱衊獵): HR = 0.51 (95.0% CI, 0.32 ~ 0.82) 更多	积极	2026-05-29
				non-GLP-1RA group