A Phase 2 Study of Venetoclax + Obinutuzumab Followed by Epcoritamab in Previously Untreated Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (LonGEVity)

This phase II trial tests the effect of venetoclax and obinutuzumab followed by epcoritamab in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have not previously received treatment. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody 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). Epcoritamab, a bispecific monoclonal antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. The combination of venetoclax and obinutuzumab is a standard treatment for CLL/SLL and has been found to be safe and effective. Adding epcoritamab to standard treatment with venetoclax and obinutuzumab may lead to deeper and longer-lasting responses in patients with untreated CLL/SLL.

开始日期2025-12-09

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07003295

/ Not yet recruiting临床2期IIT

A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy

This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody 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 glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.

开始日期2025-10-31

申办/合作机构

National Cancer Institute

NCT06649812

/ Recruiting临床2期IIT

A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

开始日期2025-10-07

申办/合作机构

National Cancer Institute

100 项与奥妥珠单抗相关的临床结果

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100 项与奥妥珠单抗相关的转化医学

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100 项与奥妥珠单抗相关的专利（医药）

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1,134

项与奥妥珠单抗相关的文献（医药）

2025-12-01·Blood Research

Hepatitis B virus reactivation in patients with hematologic malignancies treated with Bruton tyrosine kinase inhibitors

Article

作者: Yoon, Sang Eun ; Choi, Yunsuk ; Park, Hyunkyung ; Kim, Seok Jin ; Park, Han-Seung ; Lee, Jung-Hee ; Hur, Joon Young ; Won, Young-Woong ; Choi, Jung Hye ; Lee, Je-Hwan ; Kim, Won Seog

Abstract:

Purpose:

Bruton tyrosine kinase inhibitors (BTKis) are effective and well-tolerated treatments for chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Here, we describe the clinical characteristics of hepatitis B virus (HBV) reactivation in patients with hematological malignancies treated with BTKis.

Methods:

Patients were required to have a pathologically confirmed diagnosis of CLL or MCL, receive at least one cycle of ibrutinib or zanubrutinib, and have either positive hepatitis B surface antigen or hepatitis B core antibody at diagnosis. Patients were excluded if they had received rituximab or obinutuzumab within the previous 12 months.

Results:

We identified five patients with CLL and one with MCL who had resolved HBV infections and received BTKis during the study period. None of the patients received anti-HBV prophylaxis after CLL diagnosis. The patient with MCL who received zanubrutinib was confirmed to have HBV reactivation even after prophylactic entecavir administration followed by tenofovir. All five patients with CLL received ibrutinib as second-line therapy. A 62-year-old man died of hepatorenal syndrome associated with HBV reactivation despite entecavir treatment.

Conclusion:

To the best of our knowledge, this is the first description of HBV-related death in patients receiving BTKis from HBV-endemic areas, and the first case of HBV reactivation associated with zanubrutinib despite previous entecavir prophylaxis. Further prospective studies are warranted to develop useful guidelines for monitoring HBV DNA and antiviral prophylaxis to prevent HBV reactivation after BTKi therapy.

2025-11-01·KIDNEY INTERNATIONAL

Childhood-onset lupus nephritis: unique aspects and challenges in management

Review

作者: Chan, Eugene Yu-Hin ; Marks, Stephen D

Childhood-onset lupus nephritis is an important glomerular disease that requires safe and effective treatments to reduce the incidence of chronic kidney disease and kidney failure. Novel treatments have become available for adults in the last decade, notably belimumab, obinutuzumab, and voclosporin. In contrast, most children with lupus nephritis are treated with conventional immunosuppression, and treatment recommendations are extrapolated from adult data because pediatric patients have historically been rarely included in clinical trials. However, children are not small adults with evolving immune systems, and there is a significant role of genetics contributing to the complex disease pathogenesis. In this mini review, we will highlight several unique aspects in managing childhood-onset lupus nephritis, including the optimal definition of disease remission, prevention of relapse, the delicate balance between treatment efficacy and side effects, and monogenic forms of lupus nephritis. We will also discuss how treatment adherence and dedicated transition care can affect treatment outcomes.

2025-11-01·Clinical Lymphoma Myeloma & Leukemia

Cardiac Events in Three Phase 3 Randomized Trials Including Acalabrutinib in Chronic Lymphocytic Leukemia

Article

作者: Bajwa, Naghmana ; Brown, Jennifer R ; Corry, Anthony J ; Jannuru, Suman ; Chen, Hong ; O'Quinn, Rupal ; Miranda, Paulo

BACKGROUND:

The first-generation Bruton tyrosine kinase (BTK) inhibitor ibrutinib is effective in patients with CLL but is associated with considerable cardiac toxicity. The more selective second-generation BTK inhibitor acalabrutinib has demonstrated a more favorable cardiovascular safety profile with fewer atrial fibrillation events versus ibrutinib. We performed a comprehensive analysis of cardiac outcomes with acalabrutinib versus active comparators, including ibrutinib, in patients with and without baseline cardiovascular disorders.

MATERIALS AND METHODS:

Data from three phase 3 trials in CLL (ELEVATE-RR, ELEVATE-TN, ASCEND) were used. Exposure-adjusted incidence rates (EAIR; events/100 person-months) were reported for system organ class "cardiac disorders" in patients overall and by number of baseline cardiovascular disorders. All analyses were descriptive. No statistical comparisons were performed.

RESULTS:

In total, 1362 patients were included; 404 (29.7%) had ≥1 baseline cardiovascular disorder. The overall EAIR of any-grade cardiac disorder events was lower for acalabrutinib versus active comparator in each trial, and acalabrutinib did not increase cardiac events in patients with ≥1 baseline cardiovascular disorder. The EAIR of de novo cardiac disorder events (ie, among patients without baseline cardiovascular disorders) was also lower for acalabrutinib versus active comparator across trials (ELEVATE-RR: 0.34 vs. 0.67 [acalabrutinib vs. ibrutinib], ELEVATE-TN: 0.28 and 0.25 vs. 0.59 [acalabrutinib plus obinutuzumab and acalabrutinib vs. chlorambucil + obinutuzumab], ASCEND: 0.28 vs. 0.44 and 0.54 [acalabrutinib vs. idelalisib plus rituximab and bendamustine plus rituximab]).

CONCLUSIONS:

The EAIRs of cardiac disorder events was relatively low overall with acalabrutinib versus comparators, regardless of the presence of baseline cardiovascular disorders.

676

项与奥妥珠单抗相关的新闻（医药）

2025-11-14

·医药速览

J. Med. Chem.综述：提升抗体选择性的九大策略！

治疗性抗体已成为现代疾病治疗，尤其是肿瘤和自身免疫疾病治疗的重要组成部分。相较于小分子药物，抗体药物具有更高的靶标特异性、更长的半衰期和更广泛的靶标可及性。随着人工智能和生成模型的快速发展，抗体的从头设计与优化进入了一个新阶段。 11月13日，Mariam Fouad在J. Med. Chem.上发表综述，系统总结了近年来在治疗性抗体设计中提升选择性的关键策略，涵盖结构工程、微环境响应设计、抗体-药物偶联物以及多种临床抗体的作用机制，旨在为抗体药物的研发提供理论支持与实践指导。靶点识别与结构工程策略抗体选择性的核心在于精准识别疾病特异性靶点。这包括识别突变蛋白、过度表达的亚型或仅在病变细胞中出现的构象表位。例如，p53-R175H突变体和EGFRvIII缺失突变体在肿瘤细胞中特异性表达，成为抗体设计的理想靶点。此外，隐蔽表位或构象依赖性表位，如在错误折叠或翻译后修饰蛋白中出现的结构，也为抗体选择性提供了独特机会。糖基化作为抗体和受体蛋白关键的翻译后修饰，对其功能具有深远影响。EGFR具有多个天然糖基化位点，维持其膜外结构域的正确构象。研究人员通过糖基化特异性抗体，如靶向肿瘤相关糖型的抗体，实现了对肿瘤细胞表面蛋白的高选择性识别。以西妥昔单抗为例，其Fab区含有唾液酸化N-糖链，通过糖工程技术改造其N-糖链结构，可增强其与FcγRIIIa的亲和力，提升抗体依赖性细胞毒性（ADCC）能力。通过糖工程技术改造西妥昔单抗Fab区N-糖链结构以增强靶点亲和力（图源：Proc. Natl. Acad. Sci. U.S.A. 2018, 115 (47), 12023– 12027.）针对特定受体异构体或构象状态的抗体设计，是提高选择性的另一重要策略。EGFRvIII是EGFR的肿瘤特异性缺失突变体，在胶质母细胞瘤中常与EGFR扩增共表达。抗体-药物偶联物玛汀-迪妥昔珠单抗 (depatuxizumab mafodotin) 通过其单抗806识别EGFRvIII特有的半胱氨酸富集区，实现对突变型EGFR的高选择性杀伤。此外，抗体还可通过选择性识别受体的非活性或活性构象实现功能调控，如西妥昔单抗和帕尼单抗偏好结合EGFR的非活性构象，阻断其二聚化与信号传导。计算设计与微环境响应策略近年来，人工智能与机器学习在抗体设计中发挥了重要作用。基于图神经网络、Transformer架构的深度学习模型能够准确建模抗原-抗体相互作用的复杂结构特征。 RESP框架通过自编码器与贝叶斯神经网络预测抗体序列与亲和力之间的关系，并结合模拟退火算法进行虚拟突变筛选，显著提升了阿特珠单抗对PD-L1的结合亲和力。 RFdiffusion和ProteinMPNN等工具实现了抗体可变区的从头设计，其生成的结构经冷冻电镜验证具有接近原子级别的精度，展现出在受体拮抗、信号调控和病毒表位靶向等方面的应用前景。 Nature重磅！David Baker开发原子级精度抗体从头设计新方法为提高肿瘤选择性并降低系统性毒性，条件活性抗体应运而生。这类抗体在肿瘤微环境的特定生理条件下被激活，如低pH、高蛋白酶活性等。Probody是一类典型的前体型抗体，其活性被掩蔽肽段抑制，直至被肿瘤相关蛋白酶切割才恢复结合能力。抗体设计中的选择性提升策略另一类策略是设计pH依赖性抗体，如靶向VISTA的SNS-101，其在酸性环境中结合增强，而在中性pH下结合减弱，从而避免对循环中髓系细胞的非特异性激活。这些策略共同构成了图中所展示的九大选择性提升途径的核心内容。临床抗体的结构机制与多样性抗CD20抗体是治疗B细胞相关疾病的重要药物。利妥昔单抗（Rituximab）、奥法木单抗（Ofatumumab）和奥滨尤妥珠单抗（Obinutuzumab）虽然靶向同一抗原，但其结合表位、结构与机制存在显著差异。利妥昔单抗结合CD20大胞外环中的构象表位，促进CD20簇集并激活补体系统；奥法木单抗则结合更靠近膜的表位，增强补体依赖性细胞毒性；奥滨尤妥珠单抗则以倾斜角度结合，不诱导脂筏聚集，主要依靠ADCC和直接细胞死亡发挥作用。三种抗CD20单抗的结合表位、结构与机制存在显著差异免疫检查点抑制剂如PD-1/PD-L1抗体则展示了另一种选择性机制。纳武利尤单抗（Nivolumab）和帕博利珠单抗（Pembrolizumab）虽然均靶向PD-1，但其结合表位与机制不同。纳武利尤单抗主要结合PD-1的N端环区，通过空间位阻阻断PD-L1结合；帕博利珠单抗则靶向C'D环区，通过竞争性结合实现抑制。这些结构差异直接影响其生物学效应和治疗特征。纳武利尤单抗和帕博利珠单抗的结合表位双特异性抗体通过同时识别两个不同抗原，增强治疗的精准性与效力。例如，贝林妥欧单抗通过连接CD3与CD19，引导T细胞杀伤白血病细胞；埃普科利单抗（CD3×CD20）用于弥漫大B细胞淋巴瘤；阿米万他单抗则同时靶向EGFR与MET，用于非小细胞肺癌治疗。抗体-药物偶联物（ADC）通过将抗体与细胞毒性药物通过可裂解连接子结合，实现肿瘤特异性药物递送。根据其载荷与连接子化学特性的不同，ADC可分为八类。表. 不同种类的ADC的结构及链接链组成吉妥珠单抗奥佐米星靶向CD33，用于急性髓系白血病；曲妥珠单抗德鲁替康靶向HER2，用于乳腺癌治疗；萨托珠单抗戈维替康靶向TROP-2，用于三阴性乳腺癌和尿路上皮癌。这些ADC在设计上注重连接子在肿瘤微环境中的稳定性与可控释放，以实现最佳的治疗指数。结论与展望治疗性抗体的选择性设计已成为提高其疗效与安全性的核心策略。从表位选择、糖基化工程、构象特异性识别，到AI辅助设计、微环境响应机制及多种抗体形式（如双特异性抗体、ADC等）的不断创新，均展现出抗体药物在精准医疗中的巨大潜力。未来，随着结构生物学、计算设计与实验验证的进一步融合，治疗性抗体将在更广泛的疾病领域实现更高水平的个性化治疗。封面图片: https://doi.org/10.1021/acs.jmedchem.5c01830volume 11, Article number: 88 (2020) 我们已经建立了医药交流群，群里有各大著名企业和重点高校的研究人员。大家可以一起讨论医药热点，分享经验，共同进步。想加入的话，扫码或添加小编微信（VX：YYSL1101），拉您进群！推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群请扫描上方二维码，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送 ①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

2025-11-14

·有驾

CD20：自免治疗新纪元开启，Gazyva连下三城引领跨界浪潮

近期，CD20靶向疗法在自身免疫疾病领域取得显著突破。罗氏第三代CD20单抗Gazyva（奥妥珠单抗）火力全开：10月获FDA批准用于狼疮性肾炎（LN），成为该领域首款CD20靶向疗法；随后在特发性肾病综合征的INShore试验中展现优势，并于11月宣布系统性红斑狼疮（SLE）的3期研究达到主要终点。Gazyva通过高效清除B细胞、半年一次的给药频率以及良好安全性，正从肿瘤治疗向自免领域快速拓展，验证了成熟靶点在跨疾病应用中的持续潜力。 1. 什么是CD20? CD20是位于B细胞上的一种非糖基化磷蛋白，主要在前B细胞到成熟B细胞阶段表达。CD20分子属疏水、4次跨膜蛋白，由297个氨基酸残基组成，相对分子质量（Mr）约为33×103。CD20的表达在不同的B细胞恶性肿瘤之间是高度可变的 [2-3]。CD20的分子功能与B细胞受体（BCR）的信号传导倾向有关。CD20被证明与B细胞上的其他多种表面蛋白（如CD40、CD53、CD81和CD82）相互作用。有研究表明，一些表观遗传因子（EZH2、HDAC1/2、HDAC6、Sin3A-HDAC1复合物）和转录因子（USF、OCT1/2、PU.1、PiP、ELK1、ETS1、SP1、NFκB、FOXO1、SMAD2/3）也可调节CD20的表达 [4-6]。大量研究已证实CD20是人类B淋巴细胞表面特异性分子标记物，对B淋巴细胞的增殖和分化具有调节作用。绝大部分的B淋巴细胞瘤都有CD20的表达，CD20分子易与抗体结合，且结合后不易脱落、不内化，成为治疗B细胞淋巴瘤的理想靶抗原。目前，抗CD20单克隆抗体是治疗B细胞淋巴瘤（B-cell non-Hodgkin’s lymphoma）的重要靶向药（图1） [4]！图1. 抗CD20单克隆抗体是治疗BCL的重要靶向药 [4] 2. CD20相关的调节机制 01 CD20与B细胞抗原受体 CD20在B淋巴细胞表面以寡聚体形式存在，现有实验证明CD20在B细胞表面形成的是四聚体。CD20与B细胞抗原受体（B cell antigen receptor，BCR）的膜型IgM（sIgM）存在相互作用已被被证实，B细胞活化后，BCR-CD20复合物会解离，磷蛋白、钙调素结合蛋白会暂时被招募到CD20，从而参与胞内信号的传导 [2-4]。 02 CD20与钙离子信号传导钙离子流动对细胞的生物学功能有重要影响。钙池可调控钙离子进人（store-operated calcium entry，SOCE），主要是通过钙离子释放激活钙离子（calcium-release-activatedcalcium，CRAC）通道来提高细胞内的钙离子浓度，是淋巴细胞提高胞内钙离子浓度的主要方式。越来越多的证据表明CD20参与了SOCE，CD20对于胞内钙离子浓度有重要的调节作用，而SOCE所引起钙离子流的强度和持续时间，将影响受体与抗原结合后细胞的功能 [6-8]。 03 抗CD20单抗与B细胞淋巴瘤抗CD20单克隆抗体可以杀死B细胞来源的肿瘤，大量证据表明，抗CD20单克隆抗体与三种作用机制有关，即抗体依赖性细胞毒性（ADCC）、补体依赖性细胞毒性（CDC）和抗体与CD20分子结合引起的直接效应，包括抑制细胞生长、改变细胞周期和细胞凋亡。ADCC是指涂有抗CD20的B细胞通过一种基于细胞的机制被杀死。CDC是指补体膜攻击复合物在细胞表面组装起来。除在正常B细胞中表达外，CD20还在B细胞来源的淋巴瘤、白血病等的肿瘤细胞表达，以及涉及免疫疾病和炎症疾病的B细胞中表达，所以，CD20抗原成为淋巴癌、白血病和某些自体免疫等疾病治疗的目标靶点（图2）[3, 9-12]。图2. 抗CD20单抗抗肿瘤调节作用 [3] 3. 靶向CD20的治疗方式有哪些？靶向CD20的治疗的药物，主要有三种形式，抗CD20单克隆抗体、CAR-T和双特异性抗体。众多已上市和在研的生物制剂集中在CD20单克隆抗体。根据人源化程度以及Fc片段修饰，抗CD20单抗可分为三代，其中第一代是以利妥昔单抗为代表的嵌合或者鼠源单抗，第二代是以奥法木单抗为代表的人源化单抗，第三代的抗CD20单抗以奥妥珠单抗为代表，其抗体的Fc片段经过了糖基化修饰 [13-15]。第一代抗CD20治疗性单克隆抗体药利妥昔单抗，临床多用于联合治疗，特别是难治愈和复发性的淋巴瘤，常用的联合用药方式是R-CHOP，即利妥昔单抗、环磷酰胺、阿霉素、长春新碱、和泼尼松联合使用；第二代抗CD20单抗包括Ofatumumab、Veltuzumab和Ocrelizumab等，降低了第一代抗体的免疫原性，如Ofatumumab能有效诱导利妥昔单抗抵抗的细胞和CD20低表达的恶性B细胞的补体依赖性细胞毒性；第三代单抗奥滨尤妥珠Obinutuzumab，通过糖基化修饰抗体Fc片段，增强靶点结合力，使得ADCC效应增强 [13-15]。 4. 未来展望 CD20靶点的进化远未止步。罗氏通过三代单抗（利妥昔、奥瑞利珠、奥妥珠）及双抗技术（如CD20/CD3、CD20/TfR），持续挖掘其价值：在自免领域，Gazyva针对SLE、LN及膜性肾病的临床研究逐步推进；双抗平台更将应用延伸至阿尔茨海默症等神经系统疾病。结合罗氏近期引进长效自免双抗等动向，其免疫管线已覆盖COPD、哮喘、纤维化等多领域。未来，CD20靶点有望通过机制优化与适应症拓展，成为连接肿瘤、自免及神经疾病的核心桥梁，凸显“深度耕耘成熟靶点”的创新价值。为鼎力协助各药企针对CD20在淋巴癌、白血病和某些自体免疫等疾病治疗领域上的研发，CUSABIO现有CD20活性蛋白产品（Code：CSB-MP015007HU），助力您在CD20机制方面的研究或其潜在临床价值的探索（点击查看CD20全系列产品）。 ● CD20 (MS4A1) 重组蛋白 Recombinant Human B-lymphocyte antigen CD20 (MS4A1)-VLPs (Active); CSB-MP015007HU Recombinant Dog B-lymphocyte antigen CD20 (MS4A1)-VLPs (Active); CSB-MP661636DO Recombinant Macaca fascicularis Membrane spanning 4-domains A1 (MS4A1)-VLPs (Active); CSB-MP4516MOV CD20 (MS4A1) 抗体参考文献：[1] Huang X, Qin F, Meng Q, et al. Protein tyrosine phosphatase receptor type D (PTPRD)-mediated signaling pathways for the potential treatment of hepatocellular carcinoma: a narrative review[J]. Ann Transl Med, 2020, 8(18): 1192.[2] Bae WJ, Ahn JM, Byeon HE, et al. PTPRD-inactivation-induced CXCL8 promotes angiogenesis and metastasis in gastric cancer and is inhibited by metformin[J]. J Exp Clin Cancer Res, 2019, 38(1): 484.[3] Kim M, Morales LD, Jang IS, et al. Protein Tyrosine Phosphatases as Potential Regulators of STAT3 Signaling[J]. Int J Mol Sci, 2018, 19(9): 2708.[4] Jones AK, Brown LD, Rozance PJ, et al Differential effects of intrauterine growth restriction and a hyperinsulinemic-isoglycemic clamp on metabolic pathways and insulin action in the fetal liver[J]. Am J Physiol Regul Integr Comp Physiol, 2019, 316(5): R427-R440.[5] Chen YT, Lin WD, Liao WL, et al. PTPRD silencing by DNA hypermethylation decreases insulin receptor signaling and leads to type 2 diabetes[J]. Oncotarget, 2015, 6(15): 12997-13005.[6] Gray GK, McFarland BC, Nozell SE, et al. NF-κB and STAT3 in Glioblastoma: Therapeutic Targets Coming of Age[J]. Expert Rev Neurother, 2014, 14(11): 1293-1306.[7] Jiang Y, Han Q, Zhao H, et al. The Mechanisms of HBV-Induced Hepatocellular Carcinoma[J]. J Hepatocellular Carcinoma, 2021, 8: 435-450.[8] Wesolowski SR, Hay WW Jr. Role of placental insufficiency and intrauterine growth restriction on the activation of fetal hepatic glucose production[J]. Mol Cell Endocrinol, 2016, 435: 61-68.

免疫疗法临床1期临床2期

2025-11-13

·百度百家

上海国际医药盛会：合作与创新并行

1.1 △ 阿斯利康与青岛合作在第八届中国国际进口博览会上，阿斯利康在进博会上纷纷推出创新药，并与青岛高新区签署协议，提升生产能力。阿斯利康展台吸引了大量关注，展示了其在华的最新生产布局和可持续发展成果，还展出了多款创新药物。与青岛高新技术产业开发区管理委员会达成了合作协议，计划追加投资约1.36亿美元，以扩大青岛生产供应基地的产能，进一步提升阿斯利康吸入气雾剂的产能，以更好地满足哮喘、慢阻肺等呼吸系统疾病患者的治疗需求。 1.2 △ 西门子医疗与瓦里安合作西门子医疗着重展示了其在癌症诊疗方面的前沿技术及与瓦里安的合作。在展会上占据了一千平米的超大展台，以“无惧”为主题，借助前沿科技重构疾病诊疗流程。与瓦里安紧密合作，共同聚焦肝癌、前列腺癌、肺癌、乳腺癌及宫颈癌等高发癌症，展出了包括全新极速能谱血管造影系统ARTIS icono ceiling Xpand、SmART智能自适应放疗方案以及Biograph Vision Quadra极光2.0 PET/CT等在内的众多创新产品。此外，西门子医疗还特别设立了AI专区，并展出了全球首创的DryCool干磁体技术。 1.3 △ 诺华的创新药物诺华展示了其镥[177Lu]特昔维匹肽注射液等创新药物，代表其研发实力。在进博会上，诺华展示了包括多项盖伦奖获奖药物在内的近20款创新产品，覆盖了心血管、肾脏及代谢、肿瘤、免疫及神经科学四大核心治疗领域。特别是放射配体疗法（RLT）药物派威妥（镥[177Lu]特昔维匹肽注射液），其两个适应症在进博会开展前夕同时获得中国批准，彰显了诺华在创新药物研发方面的实力。 1.4 △ 拜耳及其合作拜耳展出创新药物，并与北京人形机器人公司合作，探索智能技术。拜耳在进博会上展示了26款引人注目的展品，包括处方药的创新药物和疗法、健康消费品的自我保健方案，以及作物科学的农业现代化创新。还与北京人形机器人创新中心有限公司共同签署了合作协议，旨在推动人形机器人及具身智能技术在多个场景下的技术开发。 1.5 △ 礼来的进步展示礼来展示了在药物研发的突破，特别在心血管和神经科学领域。在第八届进博会上，礼来展出了多款全球创新药物，如替尔泊肽注射液和多奈单抗注射液，这些药物在各自治疗领域表现突出，尤其是针对阿尔茨海默病等疾病的突破性疗法。 1.6 △ 强生的创新技术强生展出了百余款创新产品，突破性产品特别在中国市场上亮相。以“质愈新”为主题，强生展会上带来了突破性的CEREGLIDE 71远端通路导管和强易达血流导向密网支架等产品，以及多款在亚洲范围内率先获批上市的创新解决方案。 1.7 △ 吉利德的首次展示展会上吉利德展示了创新的抗HIV药物及胆管炎新药。其在HIV治疗领域的突破引起了广泛关注，特别是Lenacapavir（来那帕韦）和Seladelpar原发性胆汁性胆管炎新药，展现了其在医药领域的创新能力。 1.8 △ 赛诺菲的核心药物赛诺菲聚焦心血管领域，展示了几款重要的新药。此次进博会上，赛诺菲特别推出了阿夫凯泰片与普乐司兰钠注射液，这些心血管创新药物在展会期间引起了广泛关注。 1.9 △ 飞利浦的健康科技飞利浦展示了全面的智能健康产品及解决方案。飞利浦在展会上带来了多个领域的创新产品，其中包括在心血管应用体验上的先进设备和技术，给观众留下了深刻印象。 1.10 △ 罗氏的创新领导地位罗氏在展会上全方位展示了其医药创新能力及生产基地的建设。作为“全勤生”的医药巨头，罗氏展示了40余款全产品矩阵和创新解决方案，包括首次亮相的抗CD20单克隆抗体-佳罗华（奥妥珠单抗）等创新药物。 1.11 △ 诺和诺德的临床合作诺和诺德与上海临床研究机构推进合作，加速创新转化。诺和诺德与上海临床创新转化研究院（ACITS）携手，致力于在临床研究与转化研究领域展开全面合作。 1.12 △ 因美纳的基因技术因美纳重点是本土化生产及NGS解决方案，推动基因技术发展。在博览会上，因美纳展示了与上海相关企业的战略合作，标志着其本地化进程的又一重要里程碑。 1.13 △ 万益特的肾脏治疗万益特展示了自主品牌的肾脏治疗产品及未来规划。作为首次亮相进博会的新公司，万益特带来了多款创新肾脏治疗产品，如PrisMax，彰显其在多脏器治疗领域的实力。 1.14 △ 勃林格的健康合作鼓励在代谢疾病方面的研究合作与创新。勃林格殷格翰与首都医科大学附属北京友谊医院及上海市医学会展开了战略合作，聚焦代谢功能障碍相关脂肪性肝炎等关键疾病领域。 1.15 △ 泰尔茂的神经血管创新泰尔茂的战略产品为神经血管治疗带来新突破。泰尔茂神经介入携WEB自膨式动脉瘤瘤内栓塞器亮相，该产品以其独特的技术为患者提供了优质的治疗体验。 1.16 △ 丸红制药的皮肤创新丸红制药通过新合作与产品线扩展，强化其在皮肤领域的地位。丸红制药展台展示了其在皮肤领域的最新创新药物和突破性疗法，进一步巩固其行业领先地位。 1.17 △ 森世海亚的健康发展森世海亚展示了公司在自然疗愈产品上的丰富性和前瞻性。其在展会上推出了全线健康产品，与产学研医各界携手，推动微循环健康领域的发展。 1.18 △ SGS与ICA的合作合作重点在于利用健康指标提升产品舒适性与质量验证。SGS与ICA国际脊骨神经科学会携手，致力于探索人类工效学与脊骨神经健康的创新解决方案。

上市批准放射疗法

100 项与奥妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09321	奥妥珠单抗	L01XC15	DB08935

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
狼疮性肾炎	美国	Genentech, Inc.	2025-10-17
CD20阳性B细胞慢性淋巴细胞白血病	日本	Chugai Pharmaceutical Co., Ltd.	2022-12-23
CD20阳性滤泡性淋巴瘤	日本	Nippon Shinyaku Co., Ltd.	2018-07-02
CD20阳性滤泡性淋巴瘤	日本	Chugai Pharmaceutical Co., Ltd.	2018-07-02
滤泡性淋巴瘤	澳大利亚	F. Hoffmann-La Roche Ltd.	2014-05-15
慢性淋巴细胞白血病	美国	Genentech, Inc.	2013-11-01

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
边缘区B细胞淋巴瘤	申请上市	中国	F. Hoffmann-La Roche Ltd.	2019-09-28
膜性肾小球肾炎	临床3期	荷兰	-	2025-10-01
肿瘤溶解综合征	临床3期	美国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	澳大利亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	法国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	希腊	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	塞尔维亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	西班牙	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	中国台湾	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	英国	AbbVie, Inc.	2024-08-05

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临床结果

适应症

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


NCT04221477 (REGENCY, CTgov)	临床3期	狼疮性肾炎	271	Acetaminophen+Methylprednisolone+Prednisone+Obinutuzumab+MMF+Diphenhydramine (Obinutuzumab)	顧艱鏇膚衊夢糧廠夢壓 = 廠襯鬱齋觸築選繭築膚鬱鹹壓鏇願顧艱夢鹽醖 (餘鹽選獵壓選淵艱鏇簾, 夢窪憲膚廠壓網襯鏇積 ~ 鏇築壓蓋築範糧醖憲壓) 更多	-	2025-11-06
				Placebo+Acetaminophen+Methylprednisolone+Prednisone+Obinutuzumab+MMF+Diphenhydramine (Placebo)	顧艱鏇膚衊夢糧廠夢壓 = 膚繭繭簾選鏇遞鹽鬱衊鬱鹹壓鏇願顧艱夢鹽醖 (餘鹽選獵壓選淵艱鏇簾, 獵膚觸鑰襯餘網鏇窪憲 ~ 醖遞顧壓鹽膚鏇蓋顧廠) 更多
NCT04963296 (ALLEGORY, GlobeNewswire) 人工标引	临床3期	系统性红斑狼疮	-	Gazyva/Gazyvaro + standard therapy	襯獵廠醖鑰淵憲壓網餘(繭願淵衊範鏇壓窪鹹築) = 觸願遞觸鹹夢艱憲鑰鏇衊餘範繭網餘築膚願製 (顧糧淵齋糧憲遞鹹範艱 ) 达到更多	积极	2025-11-03
				Placebo + standard therapy	觸觸壓構網鏇鹹艱膚醖(窪艱獵築齋廠獵網鹽憲) = 鹹鹽積範遞選憲簾遞鏇顧鹽積獵範艱獵遞觸積 (憲網醖餘衊淵積鑰膚鏇 ) 达到更多
NCT05627557 (INShore, Company_Website) 人工标引	临床3期	先天性肾病	85	Gazyva/Gazyvaro (obinutuzumab)	網糧廠窪選憲鹹鏇積網(製鬱鏇鹹淵積膚構衊築) = more people achieving sustained complete remission with Gazyva/Gazyvaro compared with mycophenolate mofetil (MMF) 觸夢廠鏇遞鹽衊願繭構 (襯製淵遞鏇繭鏇窪獵構 ) 达到更多	积极	2025-10-28
				Mycophenolate mofetil (MMF)
NCT04221477 (REGENCY, ACR2025)	临床3期	狼疮性肾炎	136	Obinutuzumab+Standard Therapy	壓糧憲遞壓觸願糧鹹醖(選憲廠鏇夢繭糧衊壓鹽) = 糧衊廠遞簾鬱構憲範觸鹹餘製蓋鏇齋製餘顧構 (積構積範顧顧廠壓衊夢 ) 更多	积极	2025-10-24
				Placebo+Standard Therapy	壓糧憲遞壓觸願糧鹹醖(顧膚簾範構壓壓衊範鏇) = 築憲憲積願鑰艱製觸壓襯遞網襯淵蓋選網鹹憲 (鏇遞淵願構襯築淵簾窪 ) 更多
ACR2025	N/A	抗中性粒细胞胞质抗体相关性血管炎 PR3+	5	Obinutuzumab	製積夢鹽選餘觸糧膚範(製構範窪膚蓋廠願構壓) = Obinutuzumab was effective in inducing and maintaining disease remission. Those patients with detectable ANCA titres at time of obinutuzumab treatment seroconverted from positive to negative. 鏇獵襯鑰選夢膚鬱顧鑰 (遞壓選範衊膚範顧餘範 ) 更多	积极	2025-10-24
NCT04221477 (REGENCY, ACR2025)	临床3期	狼疮性肾炎	286	Obinutuzumab plus standard therapy	製製醖蓋遞選網鹽選網(糧積範餘齋壓衊膚範觸) = 構範憲齋襯顧壓醖鏇築鹽淵獵網願夢艱衊憲範 (積構蓋艱顧齋鏇積蓋範, 45.6) 更多	积极	2025-10-24
				Placebo plus standard therapy	製製醖蓋遞選網鹽選網(糧積範餘齋壓衊膚範觸) = 膚鹹廠憲築鹹齋觸艱積鹽淵獵網願夢艱衊憲範 (積構蓋艱顧齋鏇積蓋範, 338.5) 更多
NCT04221477 (REGENCY, ACR2025)	临床3期	狼疮性肾炎	328	Obinutuzumab + Mycophenolate mofetil + Glucocorticoids	餘憲憲艱夢襯獵鹹齋顧(獵鑰夢獵淵製膚鏇蓋鏇) = 製鏇獵膚糧廠獵範廠選鹹鏇艱築獵醖衊鏇鹹襯 (選鑰鬱構憲壓淵鹹範淵 ) 更多	积极	2025-10-24
				Placebo + Mycophenolate mofetil + Glucocorticoids	餘憲憲艱夢襯獵鹹齋顧(獵鑰夢獵淵製膚鏇蓋鏇) = 膚膚積餘衊積積築醖淵鹹鏇艱築獵醖衊鏇鹹襯 (選鑰鬱構憲壓淵鹹範淵 ) 更多
NCT04221477 (REGENCY, ACR2025)	临床3期	狼疮性肾炎	271	Obinutuzumab+Standard Therapy	膚網齋選積選襯鑰繭鏇(襯蓋簾蓋鏇夢鏇簾衊積) = 壓遞憲蓋淵繭鹹鏇艱觸蓋網艱遞觸憲齋鏇蓋齋 (遞顧衊築鑰齋餘願鏇網 ) 更多	积极	2025-10-24
				Placebo+Standard Therapy	膚網齋選積選襯鑰繭鏇(襯蓋簾蓋鏇夢鏇簾衊積) = 觸願鹹齋膚鏇艱齋憲醖蓋網艱遞觸憲齋鏇蓋齋 (遞顧衊築鑰齋餘願鏇網 ) 更多
NCT02550652 (NOBILITY, ACR2025)	临床2期	狼疮性肾炎 IFN-I	126	Obinutuzumab	鹽憲鹽醖餘壓構願鏇遞(簾鏇鑰選衊網窪糧壓選) = 鑰襯鏇積簾鏇顧獵選糧積簾窪鬱獵構窪蓋廠鏇 (簾鹽餘鹽廠鹽鬱鹽鬱鏇 )	积极	2025-10-24
				Placebo	鹽憲鹽醖餘壓構願鏇遞(簾鏇鑰選衊網窪糧壓選) = 淵繭築壓鑰膚餘築網艱積簾窪鬱獵構窪蓋廠鏇 (簾鹽餘鹽廠鹽鬱鹽鬱鏇 )
NCT02315768 (CTgov)	临床1/2期	慢性淋巴细胞白血病	32	Ibrutinib+GA101	獵廠糧艱齋鹽範糧窪醖 = 齋壓網壓齋窪構願鹽艱餘衊衊願糧構蓋顧鬱鏇 (獵膚齋選鏇鏇選鹽觸築, 製醖憲壓鏇築願選衊鏇 ~ 淵築構築鑰憲簾網淵廠) 更多	-	2025-09-15