来那度胺(Lenalidomide) - 药物靶点：CK1α x CRBN x IKZF1 x IKZF3_在研适应症：大B细胞淋巴瘤，边缘区B细胞淋巴瘤，成人T细胞白血病/淋巴瘤_专利_临床

概要

基本信息

药物类型

降解型分子胶

别名

1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline、3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione、CMIO-LLD

+ [18]

靶点

CK1α x CRBN x IKZF1 x IKZF3

作用方式

抑制剂、调节剂、降解剂

作用机制

CK1α抑制剂(casein kinase 1 alpha 1 inhibitors)、CRBN调节剂(Cereblon蛋白调节剂)、IKZF1 降解剂(DNA结合蛋白IKAROS 降解剂)

治疗领域

肿瘤免疫系统疾病遗传病与畸形+ [7]

在研适应症

大B细胞淋巴瘤边缘区B细胞淋巴瘤成人T细胞白血病/淋巴瘤+ [62]

非在研适应症

Aase Smith综合征II型急性肾损伤急性淋巴细胞白血病+ [129]

原研机构

Celgene Corp.

在研机构

KRKA dd

Incyte Corp.Incyte Biosciences Japan GK

+ [30]

非在研机构

依格斯（北京）医疗科技有限公司

Penn Pharmaceuticals Group Ltd.

Novartis Pharmaceuticals Corp.

+ [11]

权益机构

Starton Therapeutics, Inc.

Xencor, Inc.

Bend Bioscience LLC

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2005-12-27),

骨髓增生异常综合征

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本)、特殊审批 (中国)

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结构/序列

分子式C13H13N3O3

InChIKeyGOTYRUGSSMKFNF-UHFFFAOYSA-N

CAS号191732-72-6

关联

1,310

项与来那度胺相关的临床试验

NCT07600151

/ Not yet recruiting临床1/2期IIT

A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients

This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.

开始日期2026-12-01

申办/合作机构

Universitätsklinikum Hamburg-Eppendorf

[+2]

NCT07285239

/ Not yet recruiting临床3期IIT

Randomized Phase 3 Trial of Belantamab Mafodotin or Daratumumab in Combination With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma

Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled. Participants will be randomized to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
Belantamab mafodotin is a targeted cancer treatment that works against multiple myeloma cells. It combines a homing device (an antibody) with a powerful cell-killing drug (a toxin), delivering the toxin directly to cancer cells while largely sparing healthy cells.
Minimal residual disease (MRD) testing will be done on bone marrow samples obtained standardly during your treatment. MRD shows whether a very small number of cancer cells can still be detected after treatment, even if standard lab tests shows no signs of cancer.
The purpose of this study is to evaluate if belantamab mafodotin, bortezomib, lenalidomide and dexamethasone (BVRd) improves minimal residual disease (MRD) negative status and/or prolongs progression-free survival (PFS) compared with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) in participants with newly diagnosed multiple myeloma.

开始日期2026-07-01

申办/合作机构

GSK Plc

NCT06348147

/ Suspended临床2期

An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation

This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

开始日期2026-07-01

申办/合作机构

Lineberger Comprehensive Cancer Center

100 项与来那度胺相关的临床结果

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100 项与来那度胺相关的转化医学

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100 项与来那度胺相关的专利（医药）

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5,236

项与来那度胺相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Indirect treatment comparison of DVRd plus DR maintenance (PERSEUS study) versus DVTd or VTd with or without lenalidomide maintenance in transplant-eligible patients with previously untreated multiple myeloma

Article

作者: Nair, Sandhya ; Einsele, Hermann ; Facon, Thierry ; He, Jianming ; Dimopoulos, Meletios A. ; Caillot, Denis ; Sonneveld, Pieter ; Zweegman, Sonja ; Ammann, Eric ; Nobrega, Marjorie ; Broijl, Annemiek ; Spencer, Andrew ; Perrot, Aurore ; Schjesvold, Fredrik ; Gay, Francesca ; Hajek, Roman ; Boccadoro, Mario ; Rodriguez-Otero, Paula ; Hulin, Cyrille ; Sitthi-Amorn, Anna ; Rowe, Melissa ; Leleu, Xavier ; Mina, Roberto

AIMS:

To compare the effectiveness of induction and consolidation with daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) plus maintenance therapy with daratumumab and lenalidomide (DR) with 2 treatment regimens that are widely used for transplant-eligible newly diagnosed multiple myeloma (TE NDMM): bortezomib, thalidomide, and dexamethasone (VTd) or daratumumab-VTd (DVTd) followed by observation (Obs) or lenalidomide maintenance.

MATERIALS AND METHODS:

Individual patient-level data from the PERSEUS (NCT03710603) and CASSIOPEIA (NCT02541383) trials were used to compare DVRd + DR with VTd + Obs and with DVTd + Obs. Inverse probability of treatment weighting was used to adjust for differences in baseline patient characteristics between the two trials; inverse probability of censoring weighting was used to adjust for the second randomization of CASSIOPEIA. Data from the CASSIOPEIA and Myeloma XI (EudraCT 2009-010956-93) trials were combined to model outcomes associated with lenalidomide (R) maintenance following induction with DVTd or VTd.

RESULTS:

DVRd + DR showed superior progression-free survival compared with DVTd + Obs (hazard ratio, 0.39 [95% CI = 0.26-0.59]), VTd + Obs (0.17 [95% CI = 0.12-0.25]), DVTd + R (0.62 [95% CI = 0.41-0.92]), and VTd + R (0.29 [95% CI = 0.18-0.43]). Sensitivity analyses showed results were consistent with the base case.

LIMITATIONS:

The indirect treatment comparison was unanchored due to a lack of common comparators and relied on external data from the Myeloma XI trial to model outcomes associated with DVTd or VTd followed by R maintenance. Despite best efforts to identify and adjust for important treatment effect modifiers, there is a potential for residual confounding.

CONCLUSIONS:

Findings from this study suggest that DVRd followed by DR maintenance offers superior survival outcomes compared with current standards of care in TE patients with NDMM.

2026-12-31·Hematology

Neutrophil extracellular trap-related genes in PTCL: identification, prognosis and drug interaction prediction via bioinformatics-machine learning

Article

作者: Chen, Jing ; Cheng, Fanjun ; Fang, Jun

OBJECTIVE:

This study aimed to identify neutrophil extracellular trap-related genes (NET-RGs), explore their prognostic significance, and predict drug interactions in peripheral T-cell lymphoma (PTCL).

METHODS:

Differentially expressed NET-RGs (DE-NRGs) between PTCL and normal tissues were screened. Functional enrichment analysis was conducted. Bioinformatics and machine learning were used to identify hub genes and assess their diagnostic value. Univariate and multivariate analyses were used to evaluate prognostic roles. Correlation and immune infiltration analyses were performed to explore relationships with the tumor microenvironment (TME). Clinical data were collected from PTCL patients who received potential agents (lenalidomide) as first-line treatment.

RESULTS:

A total of 31 DE-NRGs were identified (18 upregulated and 13 downregulated), enriched in inflammatory response, extracellular matrix organization, and infection involvement. Four hub genes (AKT2, MAPK14, IRF1, and TNF) were identified as effective PTCL diagnostic markers. Higher AKT2/MAPK14 expression correlated with poorer overall survival (OS), while elevated TNF expression associated with better OS; AKT2 and TNF independently predicted OS. These genes were implicated in modulating TME remodeling. Potential therapeutic agents (e.g. capivasertib, lenalidomide) were predicted, and lenalidomide may represent a feasible initial treatment option for PTCL, with an objective response rate (ORR) of 40.0% and a maximum survival duration exceeding 50 months.

CONCLUSION:

NET-RGs play crucial roles in diagnosis, prognosis, and TME regulation, and lenalidomide, a putative TNF-targeting agent, may represent a feasible initial treatment option in PTCL.

2026-12-01·JOURNAL OF MOLECULAR MEDICINE-JMM

Anti-myeloma activity of the CXCR4 antagonist WZ811

Article

作者: Suroviakova, Katarina ; Sedlak, Jan ; Jakubikova, Jana ; Valuskova, Zuzana ; Strizova, Anna ; Marinkovicova, Maria Elisabeth ; Csicsatkova, Nikoleta ; Cholujova, Danka

Abstract:

The CXCR4-CXCL12 axis is crucial for the interaction between malignant plasma cells (PC) and their microenvironment in multiple myeloma (MM). Here, we show that CXCR4 expression is upregulated in MM cell lines and PCs during both premalignant and active stages of MM, compared to normal PCs from healthy donors. The CXCR4 antagonist WZ811 reduced the viability of MM PCs and cell lines, while tumor microenvironment cells from both MM patients and healthy donors exhibited significant resistance. In vivo, WZ811 significantly reduced tumor burden and improved survival. WZ811-mediated MM cell death involved disruption of mitochondrial transmembrane potential, externalization of transmembrane phosphatidylserine, activation of caspases, increased levels of autophagic proteins, and an increase in G 0 /G 1 phase of the cell cycle. WZ811 also eliminated the MM stem cell-like side population, though slight resistance was observed with stromal cells. Additionally, WZ811 increased levels of CXCL12 and extracellular matrix molecules collagen IV and laminin in MM cells. Combining WZ811 with anti-MM agents showed synergism with doxorubicin, dexamethasone, bortezomib, lenalidomide, and pomalidomide, while antagonism was observed with carfilzomib, supporting the clinical assessment of WZ811 in MM.

Key messages:

WZ811 reduced the viability of myeloma primary cells and cell lines.WZ811 reduced tumor burden and improved survival in vivo xenograft model.WZ811 mechanisms involved apoptotic and autophagic cell death.WZ811 eliminated the MM stem cell-like side population.WZ811 synergized with DOX, DEX, BTZ, LEN, and POM.

3,161

项与来那度胺相关的新闻（医药）

2026-05-20

·米内网

【市场】37款新药进院，独家品种太猛了

精彩内容近日，江西中医药大学附属医院·江西省中医院发布公告，将38个品规（37个品种）纳入该院基本用药目录，化学药、中成药、生物药均有涉及，既有贝伐珠单抗注射液、西妥昔单抗注射液等临床大爆款，亦有依沃西单抗注射液、布比卡因脂质体注射液等2025年销售额增速达三位数及以上的潜力品种。从治疗领域看，此次进院品种以抗肿瘤和免疫调节剂、神经系统药物为主，占比分别超过29%、27%；剂型上以注射剂、口服片剂为主，各有13个品种在列。全国医保品种占比接近90%，包括注射用罗特西普、西妥昔单抗注射液、特瑞普利单抗注射液、盐酸氢吗啡酮缓释片、依沃西单抗注射液、注射用瑞康曲妥珠单抗、磷酸钠盐散等多个国谈药；以及马来酸阿伐曲泊帕片、来那度胺胶囊、贝前列素钠片、阿戈美拉汀片、富马酸喹硫平片等多个国采药。从企业看，正大制药有3个品种在列，恒瑞医药（均为国谈药）、人福医药（均为麻醉止痛药）、石家庄四药（均为集采药）各有2个品种在列。药事会通过品种目录注：标*为独家品种来源：江西省中医院、米内网数据库在2025年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端，贝伐珠单抗注射液销售额超过110亿元，西妥昔单抗注射液（默克独家）超过20亿元，特瑞普利单抗注射液（君实生物独家）超过10亿元。贝伐珠单抗注射液是罗氏开发的一款重组人源化抗血管内皮生长因子单克隆抗体，目前已有齐鲁、信达、恒瑞、正大天晴等10余家企业的生物类似药获批。米内网数据显示，近年来中国公立医疗机构终端贝伐珠单抗注射液销售额持续增长，2024年突破100亿元，2025年突破110亿元。从厂家格局看，齐鲁独占超四成市场。近年来中国公立医疗机构终端贝伐珠单抗注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局此外，依沃西单抗注射液（康方生物独家）同比暴涨超8000%；米诺地尔泡沫剂（三生蔓迪独家）、布比卡因脂质体注射液同比涨逾300%，磷酸钠盐散（四川健能制药独家）同比涨逾100%等。依沃西单抗注射液是康方生物开发的一款PD-1/VEGF-A双抗，为全球获批的首个“肿瘤免疫+抗血管生成”机制双抗。该药最早于2024年获批上市，至今已斩获2个适应症，2025年在中国公立医疗机构终端的销售额超过3亿元。 2025年中国公立医疗机构终端依沃西单抗注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至5月20日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com 稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

2026-05-20

·BioSpace

GSK and the pan-Canadian Pharmaceutical Alliance (pCPA) initiate negotiations for Blenrep for the treatment of relapsed or refractory multiple myeloma

This is another key milestone in offering relapsed and refractory multiple myeloma patients a treatment featuring a differentiated mode of action. MISSISSAUGA, ON , May 20, 2026 /CNW/ - GSK is pleased to welcome the start of negotiations with the pCPA for Blenrep (belantamab mafodotin for injection), in combination with bortezomib and dexamethasone, or in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including lenalidomide for the latter combination. GSK's focus is on supporting a process that balances timely access with long-term sustainability for people living with this incurable disease, within the context of a rapidly evolving and resource-intensive treatment landscape. We look forward to collaborating with the pCPA, provinces, clinicians, and the broader myeloma community. This engagement brings hope to Canadians living with myeloma who urgently need new treatment options," said Martine Elias, Chief Executive Officer of Myeloma Canada . "We are encouraged by the start of negotiations for a therapy that not only extends life, but also considers how patients can live better, experience less treatment burden, including the possibility of being treated closer to home" Elias stated. "We are committed to offering meaningful options for multiple myeloma patients, informed by the perspectives of those directly impacted by the disease, said Sridhar Venkatesh, President & General Manager, GSK Canada ." About multiple myeloma Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. 1,2 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. 3 Multiple myeloma is a significant concern in Canada, where in 2025 alone, 4,300 people were diagnosed with the disease. 4 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. 1 About Blenrep Blenrep is an antibody-drug conjugate (ADC) comprised of a humanized anti-BCMA monoclonal antibody conjugated to the cytotoxic agent monomethyl auristatin F. In Canada, Blenrep (belantamab mafodotin for injection) is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Specifically, Blenrep is indicated: in combination with bortezomib and dexamethasone (BVd), in adult patients who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone (BPd), in adult patients who have received at least one prior line of therapy, including lenalidomide. Please consult the Product Monograph at for complete safety information. The Product Monograph is also available by calling 1-800-387-7374. GSK in Oncology Our ambition in oncology is to help increase overall quality of life, maximize survival, and change the course of disease, expanding from our current focus on blood and women's cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at . Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025, and GSK's Q1 Results for 2026. References 1 Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660. 2 Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676–681.doi: 10.1053/j.seminoncol.2016.11.004. 3 Global Cancer Observatory. International Agency for Research on Cancer. World Health Organization. Multiple Myeloma fact sheet. Available at: Accessed 5 March 2025. 4 Multiple myeloma statistics. Canadian Cancer Society. Available at: . Accessed 6 May 2026. SOURCE GlaxoSmithKline Inc.

抗体药物偶联物

2026-05-19

·摩熵医药

国内81款新药IND获批！51款品种过评，安徽杰玺医药领跑

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 PART 01 周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。本文将深入分析2026年5月11日至2026年5月17日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。 PART 02 国内81款新药IND获批根据摩熵医药数据库统计，2026年5月11日至2026年5月17日期间，共有107个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号88个，进口药品受理号19个。本周共计81款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药39款，生物药41款，1款中药。本周获批临床创新药/改良型新药部分信息速览（不含补充申请）注：完整数据可识别“文末”二维码下载查看 PART 03 本周全球TOP10创新药研发进展 5月13日，百济神州宣布FDA已批准新一代BCL2抑制剂索托克拉的新药上市申请（NDA），用于治疗接受过两种系统治疗（包括BTK抑制剂）治疗的复发或难治性（R/R）套细胞淋巴瘤（MCL）患者。索托克拉是一款新一代且具有同类最优潜力的在研BCL2抑制剂，具有独特的药代动力学和药效学特征。实验室和早期药物开发研究结果表明，索托克拉是一种具有强效性和特异性的BCL2抑制剂，半衰期短且无蓄积。截图来源：全球药物研发数据库（查数据.找摩熵）索托克拉在多种B细胞恶性肿瘤中表现出良好的临床活性，正在进行单药和联合疗法的开发，其中包括和百悦泽的联合治疗。值得关注的是，在早期临床试验中，索托克拉联合百悦泽治疗初治慢性淋巴细胞白血病（CLL）患者在短时间内显示出前所未有的微小残留病不可检出（uMRD）率。 5月15日，NMPA官网显示，艾伯维申报的艾可瑞妥单抗获批上市，联合利妥昔单抗和来那度胺适用于治疗复发或难治性滤泡性淋巴瘤（FL）成人患者。（受理号：JXSS2500127/8）。此前该申请曾被纳入优先审评。艾可瑞妥单抗最初由Genmab公司开发，艾伯维在2020年与Genmab达成一项总额达39亿美元的合作，以共同开发和商业化Genmab的三种下一代双抗产品，其中就包括艾可瑞妥单抗（Epcoritamab）。作为一款IgG1双特异性抗体，艾可瑞妥单抗可同时与T细胞上的CD3和B细胞上的CD20结合，并诱发T细胞介导的淋巴瘤B细胞杀伤。本周全球 TOP10 创新药研发进展截图来源：摩熵医药周报 PART 04 本周全球TOP10积极/失败临床结果本周全球Top 10积极/失败临床进展盘点：5月13日，诺和诺德在土耳其伊斯坦布尔举行的2026年欧洲肥胖大会（ECO2026）上公布了3期OASIS 4临床试验的最新亚组分析结果。数据显示，相较于安慰剂，Wegovy®片剂（司美格鲁肽片剂25 mg）在成人肥胖症患者中展现出良好的治疗效果。截图来源：全球药物研发数据库（查数据.找摩熵）最新研究结果显示，近三分之一（28.8%）服用Wegovy®片剂后在治疗早期即产生应答的成人（即在第16周时体重减轻≥10%）患者，在治疗第16周的平均体重减轻为13.2%。该早期应答人群在试验结束时（第64周）的平均体重降幅进一步提升至21.6%。与此同时，未达到“早期应答”标准的受试者在试验结束时仍实现了11.5%的体重降幅。这表明，截至试验结束，两组人群均达到了具有临床意义的体重降幅。除显著的体重减轻外，在ECO2026上公布的OASIS 4试验另一项分析显示，在服用Wegovy®片剂的人群中，近八成基线身体功能较差的受试者在功能评分方面达成了具有临床意义的改善（77.3%，而安慰剂组为42.9%）。这些功能评分用于评估身体活动能力的多个方面，包括活动范围和耐力。与此同时，这一人群所实现的体重降幅与整体Wegovy®片剂人群相当。本周全球 TOP10 积极/失败临床结果截图来源：摩熵医药周报 PART 05 51款品种过评，安徽杰玺医药领跑根据摩熵医药数据库统计，2026年5月11日至2026年5月17日期间，共有99项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号93项（包括化药3类，4类），新注册分类临床申请受理号2项，一致性评价申请4项。本周4个品种通过一致性评价（按受理号计4项），47个品种视同通过一致性评价（按受理号计63项）。本周无生物类似物注册申报动态。本周过评/视同过评品种主要为消化系统与代谢药物；过评/视同过评产品剂型主要为片剂。截图来源：摩熵医药周报本周乳果糖口服溶液片过评/视同过评受理号最多，有4个，盐酸米诺环素胶囊、卡络磺钠注射液和精氨酸布洛芬颗粒过评/视同过评企业最多，均为2家；本周安徽杰玺医药有限公司过评/视同过评品种最多，有2种，本周过评/视同过评企业包括安徽杰玺医药有限公司、中寰医药有限公司、哈尔滨三联药业股份有限公司等共53家。截图来源：摩熵医药周报本周羧甲司坦颗粒为首次过评/视同过评品种。本周盐酸苯海索片、复方电解质醋酸钠葡萄糖注射液、多索茶碱片3款品种为过评/视同过评达7家企业品种。摩熵咨询本期完整周报识别二维码领取下载 END 本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-202505 2024年医药企业综合实力排行榜-202505 中国带状疱疹疫苗行业分析报告-202505 2023H2-2024H1中国药品分析报告-202504 数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-202503 点击阅读原文，申请摩熵医药企业版免费试用！

临床申请优先审批申请上市一致性评价

100 项与来那度胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04687	来那度胺	L04AX04	DB00480

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
大B细胞淋巴瘤	美国	Seagen, Inc.	2025-02-11
边缘区B细胞淋巴瘤	美国	Bristol Myers Squibb Co.	2019-05-28
成人T细胞白血病/淋巴瘤	日本	Bristol-Myers Squibb KK	2017-03-02
染色体5q缺失综合征	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
染色体5q缺失综合征	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
滤泡性淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
套细胞淋巴瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	欧盟	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	冰岛	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2007-06-14
输血依赖性贫血	挪威	Bristol-Myers Squibb Pharma EEIG	2007-06-14
多发性骨髓瘤	美国	Bristol Myers Squibb Co.	2006-06-29

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
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	美国	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	日本	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	阿根廷	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	澳大利亚	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	奥地利	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	加拿大	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	哥伦比亚	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	捷克	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	法国	Incyte Corp.	2021-05-11
T细胞/组织细胞丰富的大B细胞淋巴瘤	临床3期	德国	Incyte Corp.	2021-05-11

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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


NCT02659293 (ATLAS, Pubmed \| Lancet Haematol)	临床3期	多发性骨髓瘤一线	180	Carfilzomib+Lenalidomide+Dexamethasone	壓選壓淵憲顧淵鏇簾壓(鬱鏇顧壓窪遞獵鹽廠遞) = 鹽積選選鑰憲鹽鬱獵窪鑰築襯鹹醖選壓遞鑰膚 (遞鬱選襯襯鬱遞願構願 ) 更多	积极	2026-04-01
				Lenalidomide	廠蓋壓齋顧鏇選觸顧艱(築構醖鏇餘鹹鹹鬱範網) = 夢衊壓遞衊齋艱膚積艱衊廠夢蓋憲簾壓衊遞選 (窪鹹壓選壓觸簾艱鏇構, 27.6 ~ 48.2) 更多
NCT03477539 (CTgov)	临床2期	多发性骨髓瘤	49	Lenalidomide+Autologous Hematopoietic Stem Cell Transplantation+Daratumumab	蓋範憲壓觸糧鹹繭鏇鑰 = 淵簾鏇鹹鑰選築壓範遞夢衊鏇構繭鬱蓋餘獵選 (襯壓窪壓築顧繭鏇鹹壓, 餘夢淵範蓋淵選遞繭蓋 ~ 築窪窪壓憲夢夢觸窪窪) 更多	-	2026-03-09
NCT01919086 (CTgov)	临床2期	多发性骨髓瘤	30	Lenalidomide+Bortezomib+Dexamethasone	網築醖蓋窪糧繭淵鏇糧 = 製膚顧遞製構製遞蓋餘醖觸遞製繭窪襯淵鬱範 (糧鏇觸淵憲夢顧膚鬱鬱, 獵壓範醖製廠選鬱願廠 ~ 簾觸製範獵遞獵壓衊艱) 更多	-	2026-03-02
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤	140	Daratumumab+ bortezomib/cafilzomib+ lenalidomide+ dexamethasone (CD34+ cells <5×10^6/kg)	築鏇構夢製鬱壓構衊願(獵鏇餘鹹艱鬱簾醖窪繭) = 淵網襯窪鑰鏇糧鹹糧蓋窪鹹選觸齋製積鬱夢淵 (積願襯網鑰積廠衊壓衊 ) 更多	积极	2026-02-04
				Daratumumab+ bortezomib/cafilzomib+ lenalidomide+ dexamethasone (CD34+ cells ≥5×10^6/kg)	築鏇構夢製鬱壓構衊願(獵鏇餘鹹艱鬱簾醖窪繭) = 觸夢獵壓觸衊製網簾構窪鹹選觸齋製積鬱夢淵 (積願襯網鑰積廠衊壓衊 ) 更多
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤	71	Daratumumab+Bortezomib+Lenalidomide+Dexamethasone	遞襯淵夢艱憲觸衊製獵(齋鑰醖積鑰糧齋蓋窪鬱) = 觸製蓋壓鏇壓憲壓範選餘餘繭蓋鑰襯鹹淵齋範 (鑰窪鑰鹽鹽憲遞顧淵醖 ) 更多	积极	2026-02-04
				Daratumumab+Bortezomib+Lenalidomide+Dexamethasone (2025 IMS/IMWG high-risk criteria)	遞襯淵夢艱憲觸衊製獵(齋鑰醖積鑰糧齋蓋窪鬱) = 淵糧糧繭製襯範餘蓋艱餘餘繭蓋鑰襯鹹淵齋範 (鑰窪鑰鹽鹽憲遞顧淵醖 ) 更多
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤巩固 \| 维持	179	CAR-T consolidation	艱築壓築蓋選鏇顧鹹選(鏇鑰願膚選窪構壓積鹹) = 網餘廠淵網顧網觸鹽構鏇蓋壓鑰蓋艱鑰鏇鹽齋 (鏇積夢鹽製範繭遞繭醖 ) 更多	不佳	2026-02-04
				Lenalidomide maintenance	壓願廠遞積觸膚襯襯鏇(憲襯廠夢鹹積獵衊觸衊) = 顧餘蓋簾鬱築網鹽築餘鑰構顧繭鏇鏇衊糧襯遞 (繭遞簾衊鹽遞蓋繭襯選 ) 更多
NCT02389517 (CTgov)	临床2期	多发性骨髓瘤 \| 残留肿瘤	42	Lenalidomide+Ixazomib Citrate+Dexamethasone (Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone))	齋糧構齋鏇窪觸繭築繭 = 鑰壓蓋網築鹹獵繭蓋獵鹹齋醖製窪鏇淵獵範艱 (淵網餘鏇鹹夢鏇鬱鑰製, 憲艱鹹顧膚鬱廠積範網 ~ 簾壓窪餘鹹淵廠鑰廠願) 更多	-	2026-01-22
				Lenalidomide (Arm II (Lenalidomide))	齋糧構齋鏇窪觸繭築繭 = 鬱襯鏇選鏇築壓憲窪醖鹹齋醖製窪鏇淵獵範艱 (淵網餘鏇鹹夢鏇鬱鑰製, 觸觸觸窪遞衊膚齋窪繭 ~ 製淵醖鑰獵遞窪繭築廠) 更多
NCT05032820 (BMTCTN1902, CTgov)	临床2期	多发性骨髓瘤	40	leukapheresis+Lenalidomide+bb2121+Fludarabine+Cyclophosphamide	衊齋衊製艱憲鹽壓餘醖 = 繭願遞壓衊簾淵窪繭範願網選鏇蓋鹹餘膚醖憲 (獵憲築壓糧願憲齋憲憲, 遞窪築選衊蓋壓遞鹹膚 ~ 壓選艱選鹹糧艱選願衊) 更多	-	2026-01-12
NCT03702725 (CTgov)	临床1期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	14	Lenalidomide+Ibrutinib+Dexamethasone (Dose Level 1 (Starting DL))	製膚齋選製鹽顧鏇窪遞 = 衊獵襯糧淵願憲齋願憲膚襯壓淵齋襯鑰餘願鬱 (鹽繭構觸積鬱築遞鏇窪, 鹹襯願築獵觸網築選鏇 ~ 願獵選憲鹹鏇壓廠醖廠) 更多	-	2026-01-06
				Lenalidomide+Ibrutinib+Dexamethasone (Dose Level 2)	製膚齋選製鹽顧鏇窪遞 = 醖鏇醖衊願觸網艱觸憲膚襯壓淵齋襯鑰餘願鬱 (鹽繭構觸積鬱築遞鏇窪, 積獵壓憲襯夢網網築憲 ~ 鹽簾顧築鏇夢襯鏇積積) 更多
NCT05409066 (EPCORE FL-1, Pubmed \| Lancet)	临床3期	难治性滤泡性淋巴瘤二线	488	Epcoritamab + Lenalidomide + Rituximab	選選窪遞糧窪選鹽窪觸(衊簾餘構製膚構繭糧鬱) = 鹹鬱繭糧艱鑰鑰遞衊憲膚衊醖醖餘製蓋築鹹觸 (鑰壓築齋憲遞鹹壓鏇鹽, 92 ~ 97) 更多	优效	2026-01-01
				Lenalidomide + Rituximab	選選窪遞糧窪選鹽窪觸(衊簾餘構製膚構繭糧鬱) = 選獵壓衊淵鬱鑰遞顧壓膚衊醖醖餘製蓋築鹹觸 (鑰壓築齋憲遞鹹壓鏇鹽, 74 ~ 84) 更多