达雷妥尤单抗/重组人透明质酸酶PH20(Daratumumab/Hyaluronidase-fihj) - 药物靶点：CD38 x Hyaluronic acid_在研适应症：免疫球蛋白轻链淀粉样变性，多发性骨髓瘤，阴燃多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体、酶

别名

DARA-SC、daratumumab and hyaluronidase-fihj、Daratumumab Injection (Subcutaneous Injection)

+ [14]

靶点

CD38 x Hyaluronic acid

作用方式

抑制剂、调节剂

作用机制

CD38抑制剂(淋巴细胞分化抗原CD38抑制剂)、透明质酸调节剂、ADCC(抗体依赖的细胞毒作用)

治疗领域

肿瘤免疫系统疾病心血管疾病+ [3]

在研适应症

免疫球蛋白轻链淀粉样变性多发性骨髓瘤阴燃多发性骨髓瘤+ [13]

非在研适应症

复发性多发性骨髓瘤

原研机构

Janssen Global Services LLCGenmab, Inc.

在研机构

Halozyme Therapeutics, Inc.Janssen Research & Development LLCJanssen-Cilag International NV

+ [5]

非在研机构

Janssen Pharmaceuticals, Inc.

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2020-05-01),

多发性骨髓瘤

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)

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结构/序列

Sequence Code 136165

当前序列信息引自: *****

Sequence Code 9075449L

当前序列信息引自: *****

Sequence Code 9946743H

当前序列信息引自: *****

关联

22

项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的临床试验

NCT07075510

/ Not yet recruiting临床1/2期IIT

A Phase I/II Study of Subcutaneous Daratumumab Administration in the Anterior Upper Thigh Vs Abdomen in Patients With Plasma Cell Disorders

The purpose of this study is to look at the safety, tolerability, and serum concentration of daratumumab administered subcutaneously in the thigh versus the abdomen in patients with plasma cell disorders. Daratumumab is a monoclonal antibody that can attach itself to the CD38 protein on the surface of abnormal plasma cells. Daratumumab can kill the abnormal plasma cells and/or help your immune system find and destroy them. Due to the way daratumumab works, normal cells may also be affected. All reference to the words "study drug" in this consent form will mean Daratumumab.
Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both subcutaneous (DARZALEX FASPRO?) and intravenous (DARZALEX?) ways of being delivered. The FDA has also approved the subcutaneous administration of daratumumab combined with other standard of care drugs for patients with light chain (AL) amyloidosis. Subcutaneous means the drug is given by an injection just beneath the skin. Intravenous (IV) means the drug is given as an injection directly into a vein.
Usually when given subcutaneously, the study drug is given by an injection in the abdomen. Having the drug given by subcutaneous injection (underneath the skin of the abdomen) has lessened the IV related side effects and the drug administration by injection is quicker.
However, some patients cannot receive the study drug injections in their abdomen because they find them very painful or have other medical reasons making it difficult to get these injections. The goal of this study is to see if getting the study drug subcutaneously, injected under the skin by a needle, in the patient's upper thigh will have the same results, or better results, as getting the injection in the abdomen. This would therefore, improve patients access to the drug and provide an alternative place to receive the injection of the drug.
This study will take place at University of Maryland Medical Center and there will be about 30 people who will take place in this study here. Dr. Badros is the Sponsor-Investigator of the study. Funding to conduct the study and study drug are being provided by Johnson & Johnson Innovative Medicine (J&J IM).

开始日期2025-10-01

申办/合作机构

University of Maryland Baltimore

[+1]

NCT06046287

/ Recruiting临床2期IIT

Phase IIa Study to Evaluate Daratumumab for Polyneuropathy Associated With MGUS

The goal of this clinical trial is to learn about daratumumab and hyaluronidase-fihj in patients with monoclonal gammopathy of undetermined significant (MGUS) who have been diagnosed with peripheral neuropathy suspected to be cause by paraproteinemia. The main question[s] it aims to answer are:
• how well does this medication help improve MGUS associated peripheral neuropathy
Participants will be asked be asked to get some testing done prior to starting the trial in order for us to assess your nerve damage or peripheral neuropathy. This will include blood tests, a complete neurologic examination, surveys and tests called electromyogram and nerve conduction studies. Participants that qualify for the trial will take DARZALEX FASPRO® once a week for two months, followed by every other week from months 3 to month 6.

开始日期2025-07-01

申办/合作机构

Georgetown University

[+1]

NCT06142396

/ Recruiting早期临床1期IIT

Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure

The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients.
The primary questions this study aims to answer are:
1. To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord.
2. To evaluate the renal response rate (RRR) after 4 cycles of Dara-CyBord.

开始日期2024-11-01

申办/合作机构

Augusta University Research Institute

[+1]

100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的临床结果

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100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的转化医学

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100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的专利（医药）

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13

项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的文献（医药）

2024-10-01·ANNALS OF HEMATOLOGY

The clinical efficacy of a daratumumab-based regimen in relapsed/refractory acute leukemia: a single-center experience

Article

作者: Li, Jing ; Luo, Lin ; Dai, Yi ; Luo, Jun ; Cheng, Peng ; Wei, Zhenbin

Abstract:

Relapsed/refractory acute leukemia (R/R-AL) is associated with a low remission rate, short survival rate, and poor prognosis. Treating R/R-AL remains challenging as there is no standardized effective regimen; hence, there is a need for efficient therapies. CD38 expression has been observed in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Daratumumab is a humanized anti-CD38 monoclonal antibody used to treat multiple myeloma and has been reported to treat R/R-AL safely and effectively. The clinical data of 10 adult patients with R/R-AL who were treated with a daratumumab-based salvage regimen between July 2018 and May 2023 at our center were analyzed retrospectively. Seven AML and three ALL cases were included in the analysis. Seven (70%) patients showed responses to the treatments (complete response [CR], 60%; partial response [PR], 10%). Of the seven responders, three underwent allogenic stem cell transplantation (ASCT), including one who underwent a second ASCT. Among the five patients with R/R AML who had prior exposure to venetoclax, three achieved a therapeutic response (two CR and one PR) when re-treated with venetoclax in combination with daratumumab. The median follow-up time was 6.15 months (0.9–21 months). Overall survival and event-free survival rates at 12 months were 68.6% and 40.0%, respectively. The main adverse events included grade 3 febrile neutropenia (20%) and grade 3 hematological toxicities (60%). The daratumumab-based salvage regimen offers patients with R/R-AL the opportunity of remission with acceptable tolerability, creating the possibility of bridging ASCT.

2023-06-01·Clinical pharmacokinetics

Clinical Pharmacokinetics and Pharmacodynamics of Daratumumab.

Review

作者: Kim, Kyeongmin ; Phelps, Mitch A

Daratumumab is a fully human, monoclonal immunoglobulin G1 and a first-in-class CD38-targeting drug approved by the US Food and Drug Administration for the treatment of patients with relapsed/refractory and newly diagnosed multiple myeloma or newly diagnosed light-chain amyloidosis. CD38 is heavily expressed on malignant myeloma cells, and daratumumab exerts anti-myeloma activity via immune-mediated mechanisms, direct induction of apoptosis, and immunomodulation. Daratumumab is used as monotherapy or in combination with standard-of-care myeloma therapies, including proteasome inhibitors, immunomodulatory agents, DNA-alkylating agents, and corticosteroids. Following an intravenous infusion, daratumumab exhibits nonlinear pharmacokinetics (PK), as clearance decreases with higher doses and over time because of target-mediated effects. Dosing schedules vary depending on indications and co-administered drugs, but generally daratumumab is administered weekly for 6-9 weeks followed by a less frequent dosing regimen, once every 2-4 weeks. Daratumumab exposure is strongly correlated with efficacy, and the exposure-efficacy relationship follows a maximal effect model, whereas exposure is not correlated with safety endpoints. The approved dose of 16 mg/kg of daratumumab results in the saturation of 99% of the target at the end of weekly dosing in most patients, and high target saturation is maintained over time during the less frequent dosing schedule. Infusion-related reactions are frequently observed in patients given daratumumab, particularly with the first infusion, thus prompting long durations of infusion (~ 7 h) and splitting of the first dose across 2 days. This led to the development of a subcutaneous delivery formulation for daratumumab (Dara-SC). Dara-SC provides a similar efficacy and safety profile to intravenous daratumumab (Dara-IV) but has a much lower rate of infusion-related reactions and a shorter infusion time. Exposure-response relationships for efficacy and safety endpoints were similar between Dara-SC and Dara-IV, and co-administered drugs with either Dara-IV or Dara-SC do not significantly affect daratumumab PK. Except for baseline myeloma type and albumin level, none of the other investigated disease and patient characteristics (renal/hepatic function, age, sex, race, weight, Eastern Cooperative Oncology Group performance status) was identified to have clinically relevant effects on exposure to daratumumab monotherapy or combination therapy regimens. Dara-IV exposure was significantly lower in patients with immunoglobulin G myeloma compared with patients with non-immunoglobulin G myeloma (p < 0.0001) and in patients with a lower albumin level, whereas the overall response rate was similar regardless of the myeloma type and albumin level. Daratumumab dose adjustment is not currently recommended based on disease and patient characteristics.

2023-03-01·Transplantation

Anti-CD38 Monoclonal Antibodies Interfere With Isoagglutinin Detection

Article

作者: Kamar, Nassim ; Del Bello, Arnaud ; Gauthier, Katia ; Cointault, Olivier ; Vieu, Guillaume

A review.ABO-incompatible considered a safe (ABOi) procedure, kidney respecting transplantation preformed is donor-specific isoagglutinin elimination before the surgery.Hemagglutination remains the most frequently used method to detect isoagglutinin.We assessed isoagglutinin titers in a candidate for ABOi-Iiving donor kidney transplantation (A to O) who was treated by a humanized anti-CD38 IgG monoclonal antibody (daratumumab) a week before for multiple myeloma.Although IgM isoagglutinin titer was low before and after desensitization, IgG isoagglutinin titer, detected with the microcolumn agglutination method (Biorad Liss/Coombs IgG/C3d), was and remained very high (>2048) before and after desensitization using highvolume specihc immunoadsorption.The binding of daratumumab on CD38 that is highly expressed on the surface of red blood cells and myeloma cells induces their agglutination, leading to a false-pos. isoagglutination test until 2 to 6 mo postadministration.Dithiothreitol disrupts the bridging of the disulhde bonds between amino acid residues necessary for structural conformation of some proteins, such as the CD38 antigen (which presents 5 bridges).Hence, dithiothreitol prevents anti-CD38 binding on red blood cells treated and overcomes the interference of the daratumumab and agglutination tests.Other monoclonal antibodies given to treat kidney diseases could also interfere with isoagglutinin. This has to be examined carefully.

294

项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的新闻（医药）

2025-07-17

·医药经济报

诺华诺欣妥热卖46亿美元，强生CAR-T销量翻倍，MNC中报放榜！

跨国药企正进入中报季，集中展现其在全球市场的布局与战略调整。7月17日，诺华发布2025年半年报：创造净销售额为272.87亿美元，按固定汇率计算同比增长13%（下同）；实现净利润为76.33亿美元，同比增长31%。其中，诺华中国区销售额为22亿美元，同比增长8%。无独有偶，强生也在前一天发布2025年半年报：其创新制药和医疗科技两大核心业务板块共同创造了高达456.36亿美元的营收，同比增长4.1%。其中，创新制药板块为强生带来290.75亿美元的收入，同比增长3.6%。在日益复杂的国际医药环境中，跨国药企凭借强大的研发实力和多元化的产品线，持续推动创新药物的研发和市场拓展。同时，面对全球医药市场的变化，这些制药巨头也在不断优化业务结构，提升运营效率，以期在激烈的市场竞争中保持领先地位。MNC半年报的密集公布，为业界提供了一个宝贵的观察视角。诺华：肿瘤药创收超80亿美元作为一家纯粹的创新药物公司，诺华明确专注于心血管-肾脏-代谢、免疫学、神经科学和肿瘤学四大核心治疗领域。具体来看，在上半年，肿瘤学管线为诺华贡献了最多收入，高达81.99亿美元，同比增长22%。其中，凭借将适应症范围扩展至早期乳腺癌患者，诺华的明星抗癌药CDK4/6抑制剂Kisqali（瑞波西利）在上半年实现了强劲增长，创造了21.33亿美元，同比增长高达60%。Kisqali上半年居于诺华Top20畅销药榜单的第三位，增速仅次于心血管-肾脏-代谢管线的长效PCSK9产品Leqvio（英克司兰），全年销售额或将突破40亿美元。诺华两款核药Pluvicto（镥[177Lu]特昔维匹肽）和Lutathera（镥[177lu]氧奥曲肽）同样表现不俗，共同创造了12.25亿美元营收。其中，Pluvicto在2024年销售额首次突破10亿美元大关，成为诺华旗下又一款“重磅炸弹”药物，其针对前列腺癌的两项适应症已在国内提交上市申请。心血管-肾脏-代谢管线的贡献仅次于肿瘤学，上半年为诺华创造了51.73亿美元收入，同比增长26%。其中，兼具降压和抗心力衰竭作用的重磅药物Entresto（沙库巴曲缬沙坦）仍是诺华的支柱产品，46.18亿美元销售额和同比22%的强劲增长令其继续霸榜诺华全球最畅销产品。值得一提的是，Entresto尽管在第十一批国采中因存在专利侵权高风险而被豁免纳入，但已有南京一心和、科伦药业两家国内企业的同品种药物突破专利壁垒上市。不仅如此，Entresto在美国市场的独占期也正在受到来自MSN制药、瑞迪博士等公司的多款仿制药挑战。与此同时，该药在美国的Medicare谈判将在明年执行，为其市场表现再添变数。销售增速最高的Leqvio同样值得期待，其在上半年实现收入5.55亿美元，同比增加66%，加速向“重磅炸弹”药物行列迈进。未来若治疗青少年高胆固醇血症等适应症获批，Leqvio有望接棒Entresto，成为诺华的新支柱产品。在免疫学领域，诺华实现收入49.58亿美元，同比增长13%。其中，明星产品Cosentyx（司库奇尤单抗）增速有所放缓，上半年实现收入31.63亿美元，同比增长11%。在中国，Cosentyx的核心专利即将到期，百奥泰已在今年2月提交司库奇尤单抗生物类似药上市申请，市场竞争一触即发。在神经领域，诺华创造收入27.59亿美元，同比增长23%。Kesimpta（奥法妥木单抗）凭借居家注射的便利性，销售额同比增速已提至38%，迅速打开多发性硬化症市场，为诺华在报告期内创收19.76亿美元。基于目前的业绩表现，诺华展望，如果未发生不可预见事件，其全年净销售额将实现高个位数增长。强生：传奇CAR-T实现翻倍增长强生与诺华深耕的疾病领域部分重合，强生聚焦肿瘤、自身免疫、神经科学、感染、肺动脉高压、心血管及代谢等关键领域。其中，肿瘤板块仍是强生创新制药业务的重中之重。上半年，肿瘤板块为强生取得了119.90亿美元的营收，同比增长21.1%。具体来看，该板块主要增长依然来源于Darzalex（达雷妥尤单抗）、Carvykti（西达基奥仑赛）、Erleada（阿帕他胺）和Rybrevant/Lazcluze（埃万妥单抗/兰泽替尼）等拳头产品。作为全球首个获批上市的CD38单抗，Darzalex已成为全球多发性骨髓瘤临床治疗的核心产品，上半年创收67.76亿美元，同比增长21.7%，独自撑起了强生肿瘤板块销售额的“半壁江山”，再度超出业界预期。为了巩固自身在多发性骨髓瘤的霸主地位，强生推出更丰富的产品矩阵，其和传奇生物共同开发的CAR-T细胞疗法Carvykti尤为亮眼。上半年，Carvykti的销售额高达8.08亿美元，同比增长136%，朝着全球年销售额20亿美元的目标狂飙。但英雄迟暮，强生昔日的血液瘤重磅产品Imbruvica（伊布替尼）因同类药物竞争，销售额同比下降7.0%，仅剩14.44亿美元。不过，强生的双抗药物管线正加快显现在多发性骨髓瘤治疗领域的价值。全球首款CD3/BCMA双抗Tecvayli（特立妥单抗）上半年实现销售额3.17亿美元，同比增长18.2%；GPRC5D/CD3双抗Talvey（塔奎妥单抗）也加快放量，实现销售额1.92亿美元，同比增长52%。今年2月，Talvey已在中国获批，用于治疗复发或难治性多发性骨髓瘤。除了血液肿瘤，强生在实体瘤领域也逐步站稳脚跟。其中，雄激素受体抑制剂Erleada（阿帕他胺）是强生在前列腺癌领域的核心产品，上半年创收16.79亿美元，同比增长17.8%。不仅如此，非小细胞肺癌产品组合EGFR/c-Met双抗Rybrevant（埃万妥单抗）和EGFR T790M抑制剂Lazcluze（兰泽替尼）已成功进击一线治疗场景，上半年合计带来3.20亿美元的收入。在过去引以为傲的自免领域，强生正面临前所未有的挑战，该板块在报告期内实现77.00亿美元收入，同比下滑14.1%。具体来看，强生的核心自免产品IL-12p40单抗Stelara（乌司奴单抗）受到生物类似药的强烈冲击，收入仅为32.78亿美元，同比下降38.6%。在克罗恩病新适应症的加持下，强生的IL-23p19单抗Tremfya（古塞奇尤单抗）继续保持25%的高增长，上半年销售额为21.42亿美元。但独木难支，Tremfya的市场增量也难以抵消Stelara、Remicade（英夫利西单抗）和Simponi（戈利木单抗）等专利过期药的销售额下滑。为挽颓势，强生加快培育自免领域的“新接班人”。今年4月，强生65亿美元收购押注的FcRn阻断剂Imaavy（nipocalimab）获得FDA批准上市，用于治疗重症肌无力。此外，口服IL-23R拮抗剂icotrokinra的两项斑块状银屑病Ⅲ期研究已经取得成功，距离上市只差临门一脚。强生判断，当前的产品组合和研发管线使其有望在今年下半年实现高速增长，预计将在肺癌和膀胱癌、重度抑郁症、牛皮癣和心血管等领域获得突破性的批准和提交申请，将以变革性方式改善患者获益。编辑：范晓艳版式编辑：于成林审校：马飞、张松医保飞检来袭！医院、药店这些领域将被重点核查五年3次100亿美元大并购！默沙东将在何处培育“新药王”？第十一批国采正式启动！55个品种入围，涉及默沙东、AZ、诺华、正大天晴、齐鲁、石药www.yyjjb.com.cn洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

专利侵权财报免疫疗法细胞疗法

2025-07-17

·凯莱英药闻

强生2025H1：营收增长4.1%，肿瘤业务持续冲锋，双抗药物发力

欢迎关注凯莱英要闻7月16日，强生公布2025H1业绩，上半年营收456.36亿美元，同比增长4.1%。Q2销售额达237.43亿美元，同比增长5.8%，美国市场持续增长。上半年创新药和医疗技术板块收入分别达290.75亿美元（+3.6%）和165.61亿美元（+5.0%）。1核心表现创新药业绩劲增，肿瘤明星产品持续领跑创新药板块，依然是肿瘤业务冲锋。依靠十分丰富的多发性骨髓瘤管线，上半年强生创新药销售额达到119.9亿美元，同比增长21.1%。主要增长依然来源于Darzalex（达雷妥尤单抗）、Carvykti（西达基奥仑赛）、Erleada（阿帕他胺）和埃万妥单抗/拉泽替尼（Rybrevant/Lazcluze）。Darzalex（达雷妥尤单抗）：作为多发性骨髓瘤治疗的核心产品，达雷妥尤单抗受益于市场份额持续提升和适应症拓展，销售额保持稳健增长，堪称强生肿瘤业务的 “压舱石”。达雷妥尤单抗是全球首款获批上市的CD38单抗，用于治疗多发性骨髓瘤。上半年销售额达到67.76亿美元（+21.7%），再度超出预期。Carvykti（西达基奥仑赛）：上半年销售额达8.08亿美元，增长迅猛，全年销售额预期再度拉高。西达基奥仑赛是一种靶向B细胞成熟抗原（BCMA）的CAR-T疗法，使用嵌合抗原受体（CAR）的转基因对患者自身的T细胞进行修饰，以识别和消除表达BCMA的细胞。西达基奥仑赛由强生和传奇生物合作开发，2022年2月，西达基奥仑赛获美国FDA批准上市。免疫学领域，受IL-23p19单抗Stelara（乌司奴单抗）生物类似药冲击等影响，同比下滑严重，销售额为77亿美元（-14.1%）。好在新产品实现某种程度的接力，Tremfya（古塞奇尤单抗）成绩依旧亮眼，上半年销售额达到21.42亿美元（+25%），抵消了一部分Stelara销售下滑的影响。神经学领域，抑郁症药物成年患者的Spravato（艾司氯胺酮鼻喷雾剂）上半年销售额达7.34亿美元（+48.1%），表现出色。今年1月，Spravato新增难治性抑郁症的新适应症，市场前景较好。但Invega系列产品受政策影响销售额略有下滑。交易方面，在MNC大额交易频发的2025年，强生也没有闲着，开年即宣布以146亿美元的价格收购Intra-Cellular Therapies，获得了双相情感障碍I型和II型抑郁产品Caplyta（lumateperone）。该药物在上半年销售额达2.11亿美元，并且即将申报新的预防精神分裂症复发适应症。强生预测其未来峰值年销售额有望超越50亿美元。2双抗药物多点发力值得重点关注的，还有强生的双抗管线。强生已上市药物中，双抗药物销售均表现不俗且仍有较大潜力。Tecvayli（teclistamab，特立妥单抗）是全球首款CD3/BCMA双抗，也是强生多发性骨髓瘤管线中重要的组成部分，上半年Tecvayli实现销售额3.17亿美元（+18.2%）。Talvey（talquetamab，塔奎妥单抗）是一款GPRC5D/CD3 双抗，2023年获批上市用于治疗复发或难治性多发性骨髓瘤成人患者。今年2月在中国获批上市。上半年Talvey快速放量，实现销售额1.92亿美元（+52%）。Rybrevant（amivantamab，埃万妥单抗）是全球首款EGFR/c-MET双抗，2021年就获FDA加速批准上市，用于治疗铂类化疗进展后的携带EGFR外显子20插入突变的晚期或转移性NSCLC患者。今年2月在中国获批上市。上半年Rybrevant和EGFR T790M抑制剂Lazcluze共同实现销售额3.2亿美元。3展望2025 H2展望 2025 年下半年，强生创新药业务有望延续增长态势。全年预计销售额中点上调20亿美元，至934亿美元至增长5.4%。公司管线中，多个潜在重磅产品的研发和审批进展值得关注：Tremfya：在溃疡性结肠炎、克罗恩病等适应症的皮下制剂提交上市申请，有望进一步扩大患者覆盖。Rybrevant：在非小细胞肺癌和头颈癌的新适应症数据即将公布，若获批准将打开更大市场空间。Caplyta：针对辅助治疗重度抑郁症的适应症正在推进，有望成为神经科学领域的下一个增长点。此外，肿瘤领域的双特异性抗体、细胞疗法等前沿疗法研发持续推进，长期增长动力充足。总体来看，随着下半年新品放量和管线推进，强生创新药业务有望继续领跑MNC业绩，为长期增长奠定基础。感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“queenachuen”。“在看”点一下

并购免疫疗法上市批准细胞疗法生物类似药

2025-07-17

·生物制药小编

ADC美国复活战，质疑点仍是眼毒性

退市的ADC药物Blenrep重返美国市场之路可能不会太顺利。近日，FDA的审查人员再次对Blenrep曾报道过的眼毒性副作用产生了担忧。根据其发布的简报文件披露，Blenrep在与其他药物进行联用时（DREAMM-7和DREAMM-8），会引起高眼毒性，包括角膜病变以及视力改变。FDA审查人员指出，这种毒性在目前可用多发性骨髓瘤疗法中未见。除了眼毒性外，FDA在简报中还对Blenrep的两个Ⅲ期临床DREAMM-7和DREAMM-8数据对于美国患者的适用性、对照组的选择等也提出了质疑。今日（7月17日），FDA将召开adcomm，对是否通过Blenrep二次提交的上市申请进行投票表决。现在，FDA在简报文件指出的这些问题，令Blenrep最终能否获得FDA专家组通过颇具悬念。目前，FDA将Blenrep的PDUFA日期定为2025年7月23日。被重提的老问题FDA对于Blenrep眼毒性副作用的担忧，在2020年，对首次对其进行上市审查时便提出了。当时，FDA工作人员在对Blenrep进行审查过程中发现，一项名为DREAM-2的Ⅱ期临床中，有40%接受Blenrep治疗的患者中出现3级以上的眼毒性副作用。当时，葛兰素史克（GSK)解释说，没有患者因此永久丧失视力，公司会尽力确保对该副作用进行管理，包括进行眼科检查，根据情况调整剂量等。不过，FDA的工作人员仍然表示质疑，认为该公司当时没有能够减轻该副作用明确的治疗措施。不过，这个药当时能获批主要是得到了FDA专家组的全力支持，在肿瘤药物咨询委员会（ODAC）上，Blenrep获得了压倒性投票12：0（赞成：反对）结果，支持其作为r/r MM的四线治疗方案（单药）。后来发生的事情就是，Blenrep因验证性Ⅲ期临床DREAMM-3试验失败而火速从美国撤市，以及之后凭借两个Ⅲ期临床DREAMM-7和DREAMM-8的成功，再次重返市场。重返市场面临的挑战2025年4月18日，基于DREAMM-7和DREAMM-8临床数据，Blenrep成功获得了英国药监局（MHRA）的批准，作为r/r MM患者的二线疗法，与硼替佐米/泊马度胺+地塞米松联用。这是自2022年，Blenrep从美国撤市以来首次获得监管批准。现在，Blenrep在欧洲、中国、日本、加拿大和瑞士的上市申请也获得了受理。另一方面，DREAMM-7和DREAMM-8的成功，也令GSK对其未来的销售预期信心大增。在去年的投资者会议上，GSK提出Blenrep的销售峰值可能超过30亿英镑，并且，在MM二线治疗这个位置上，公司的目标是取代强生的Darzalex（CD38单抗）。虽然GSK对于Blenrep再次推出信心十足，但是Blenrep重返市场之后，面临的市场竞争将十分严峻。在Blenrep撤出市场的两年多时间中，r/rMM的用药环境的剧变，两款BCMA CAR-T也成功从4线一跃至2线。另外，三款BCMA/CD3双抗在此期间相继获批。可以说，目前MM二线治疗不缺治疗方案。对于有多种选择的FDA而言，Blenrep身上所存在的任何一个高风险安全性问题都将可能导致其被拒之门外。参考出处：https://www.fda.gov/media/187578/downloadhttps://www.biospace.com/fda/fda-action-alert-roche-gsk-regeneron-morehttps://endpoints.news/fda-questions-the-return-of-gsks-blenrep-in-multiple-myeloma-ahead-of-adcomm/

临床3期抗体药物偶联物临床2期临床失败临床成功

100 项与达雷妥尤单抗/重组人透明质酸酶PH20 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	-

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
免疫球蛋白轻链淀粉样变性	美国	Janssen Biotech, Inc.	2021-01-15
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2020-05-01

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
阴燃多发性骨髓瘤	申请上市	美国	Johnson & Johnson	2024-11-08
难治性多发性骨髓瘤	临床3期	美国	Janssen Research & Development LLC	2017-10-27
难治性多发性骨髓瘤	临床3期	日本	Janssen Research & Development LLC	2017-10-27
难治性多发性骨髓瘤	临床3期	澳大利亚	Janssen Research & Development LLC	2017-10-27
难治性多发性骨髓瘤	临床3期	巴西	Janssen Research & Development LLC	2017-10-27
难治性多发性骨髓瘤	临床3期	加拿大	Janssen Research & Development LLC	2017-10-27
难治性多发性骨髓瘤	临床3期	捷克	Janssen Research & Development LLC	2017-10-27
难治性多发性骨髓瘤	临床3期	法国	Janssen Research & Development LLC	2017-10-27
难治性多发性骨髓瘤	临床3期	希腊	Janssen Research & Development LLC	2017-10-27
难治性多发性骨髓瘤	临床3期	以色列	Janssen Research & Development LLC	2017-10-27

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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


NCT03710603 (PERSEUS, ASCO2025 \| PRNewswire) 人工标引	临床3期	多发性骨髓瘤一线	709	daratumumab+bortezomib+lenalidomide+dexamethasone (Achieved sustained (≥12 mo) MRD neg (10^-5))	淵憲齋網醖製獵鏇範廠(廠鏇鹽簾鹹鏇選鑰積夢) = 網壓獵簾壓選鑰鹹淵壓衊淵餘糧鬱齋願觸餘蓋 (製築廠選壓艱遞壓顧衊, NE ~ NE) 更多	积极	2025-05-30
				bortezomib+lenalidomide+dexamethasone (Achieved sustained (≥12 mo) MRD neg (10^5))	淵憲齋網醖製獵鏇範廠(廠鏇鹽簾鹹鏇選鑰積夢) = 夢網築淵積餘繭範鏇構衊淵餘糧鬱齋願觸餘蓋 (製築廠選壓艱遞壓顧衊, NE ~ NE) 更多
NCT03652064 (CEPHEUS, ASCO2025) 人工标引	临床3期	多发性骨髓瘤一线 HRCA del(17p) \| HRCA t(4;14) \| HRCA t(14;16) ... 更多	395	Daratumumab + bortezomib + lenalidomide + dexamethasone (HiR)	選範鑰鬱簾鏇網築窪餘(糧淵選繭齋艱餘鹹鹹網) = 鹽簾餘顧醖艱窪廠蓋簾積夢膚構鏇壓憲壓鬱鬱 (膚獵範鹽鬱觸鹽鏇鹹糧 ) 更多	积极	2025-05-30
				Bortezomib + lenalidomide + dexamethasone (HiR)	選範鑰鬱簾鏇網築窪餘(糧淵選繭齋艱餘鹹鹹網) = 鬱糧鬱鑰獵鑰製鑰膚觸積夢膚構鏇壓憲壓鬱鬱 (膚獵範鹽鬱觸鹽鏇鹹糧 ) 更多
NCT03710603 (PERSEUS, CTgov)	临床3期	多发性骨髓瘤	709	Lenalidomide+VELCADE+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	構廠構繭築糧鹹窪艱鏇 = 製蓋糧遞夢鬱夢顧廠醖製鹹艱獵製鹽鏇窪窪糧 (製範夢鑰醖齋鑰積廠鏇, 廠網簾顧願糧願蓋繭構 ~ 繭鹹遞鬱築醖廠構夢鹹) 更多	-	2024-12-24
				Lenalidomide+Daratumumab+VELCADE+dexamethasone (Daratumumab + VRd (D-VRd))	構廠構繭築糧鹹窪艱鏇 = 鹹艱蓋鹹鹹製鬱憲廠鏇製鹹艱獵製鹽鏇窪窪糧 (製範夢鑰醖齋鑰積廠鏇, 鬱範窪觸簾壓壓構觸網 ~ 壓範鏇鑰顧顧範觸壓鏇) 更多
NCT03652064 (CEPHEUS, PRNewswire) 人工标引	临床3期	多发性骨髓瘤一线	396	DARZALEX FASPRO® + bortezomib, lenalidomide and dexamethasone (D-VRd)	壓鹹構餘構選範蓋餘網(構簾淵餘糧淵選鏇齋鑰) = 餘構選選糧齋構壓築鏇鬱簾襯簾夢鏇衊鑰蓋製 (艱範衊蓋襯繭窪鑰窪積 ) 更多	积极	2024-09-30
				bortezomib, lenalidomide and dexamethasone (VRd)	壓鹹構餘構選範蓋餘網(構簾淵餘糧淵選鏇齋鑰) = 網鑰願製遞積顧繭齋齋鬱簾襯簾夢鏇衊鑰蓋製 (艱範衊蓋襯繭窪鑰窪積 ) 更多
NCT03652064 (CEPHEUS, Company_Website) 人工标引	临床3期	多发性骨髓瘤一线	396	DARZALEX FASPRO+bortezomib+ lenalidomide + dexamethasone	餘構構積淵廠淵遞鑰製(顧糧網獵夢淵淵繭網遞) = 範選願製範繭淵製憲廠艱齋淵憲齋淵繭積簾遞 (遞鬱構糧簾鏇淵製鑰壓 ) 更多	积极	2024-09-27
				Bortezomib+ Lenalidomide+ Dexamethasone	餘構構積淵廠淵遞鑰製(顧糧網獵夢淵淵繭網遞) = 觸壓獵製蓋窪蓋廠簾蓋艱齋淵憲齋淵繭積簾遞 (遞鬱構糧簾鏇淵製鑰壓 ) 更多
NCT03710603 (PERSEUS, FDA_CDER) 人工标引	临床3期	多发性骨髓瘤一线	709	DARZALEX FASPRO-VRd (Patients Eligible for Autologous Stem Cell Transplant)	簾遞積積膚積範觸襯廠(夢艱構觸艱蓋膚糧簾遞) = 衊齋鏇構齋齋壓範遞鏇艱餘壓壓襯鬱壓鹹廠艱 (範壓簾遞齋網構鬱遞鹽 ) 更多	积极	2024-07-30
				VRd (Patients Eligible for Autologous Stem Cell Transplant)	簾遞積積膚積範觸襯廠(夢艱構觸艱蓋膚糧簾遞) = 廠鏇積鹽窪鹹醖獵簾糧艱餘壓壓襯鬱壓鹹廠艱 (範壓簾遞齋網構鬱遞鹽 ) 更多
NCT03277105 (COLUMBA, FDA_CDER) 人工标引	临床3期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	522	DARZALEX FASPRO	鹽鏇衊憲餘獵淵鹽衊範(構廠餘獵獵蓋餘簾顧鏇) = 鑰淵憲顧繭襯簾艱築範築醖願觸鏇選淵遞鏇齋 (鹽簾壓鏇蓋餘鏇鹽簾壓, 35 ~ 47) 更多	积极	2024-07-30
				Intravenous Daratumumab	鹽鏇衊憲餘獵淵鹽衊範(構廠餘獵獵蓋餘簾顧鏇) = 範簾鹽糧艱鬱夢醖鬱餘築醖願觸鏇選淵遞鏇齋 (鹽簾壓鏇蓋餘鏇鹽簾壓, 31 ~ 43) 更多
NCT03871829 (CTgov)	临床2期	多发性骨髓瘤	88	Carfilzomib+Dexamethasone 40 mg (Arm A: Carfilzomib+Dexamethasone (Kd))	簾鹽選築網齋願蓋觸範 = 構築艱糧餘鬱鏇選構膚憲蓋鏇夢衊壓艱獵壓積 (壓膚襯廠製艱鹹醖廠願, 壓範觸鹹衊鹽膚鹹廠鏇 ~ 蓋鏇範襯繭齋廠衊築壓) 更多	-	2023-12-19
				Carfilzomib+Dara-SC 1800 mg+Dexamethasone 40 mg (Arm B: Dara-SC in Combination With Kd (DKd))	簾鹽選築網齋願蓋觸範 = 憲壓廠憲艱窪淵顧簾餘憲蓋鏇夢衊壓艱獵壓積 (壓膚襯廠製艱鹹醖廠願, 糧憲衊餘繭顧鬱鹹範範 ~ 憲鹹構獵繭構醖遞遞繭) 更多
NCT04070378 (DARZAD, CTgov)	临床2期	阿尔茨海默症	16	Daratumumab Injection	壓糧淵鹽製獵膚鑰廠壓 = 獵夢觸壓憲築鏇積選構鏇廠觸蓋鬱壓艱醖齋蓋 (廠憲齋襯憲築鹽獵遞夢, 廠製築鹽襯獵窪憲築繭 ~ 膚鹹遞選製艱醖鏇夢糧) 更多	-	2023-11-29
NCT04396496 (CTgov)	临床2期	POEMS综合征	2	Daratumumab Injection	淵蓋鹹獵網觸襯簾顧遞 = 齋鏇築鏇鏇膚顧淵鹽鏇網簾積壓淵鬱願淵製蓋 (壓廠糧範艱獵壓觸壓築, 鹹淵衊憲願簾製顧鑰積 ~ 憲淵製衊鏇襯鹹衊選積) 更多	-	2023-11-13