An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys.
Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure.
In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease.
The main question that researchers want to answer is:
* How many participants achieve a complete response after 104 weeks of treatment?
* A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.
Researchers will also learn about:
* How long it takes before the participants' disease gets worse
* How long the participants' urine protein levels stay low
* How many participants develop antibodies against felzartamab in the blood?
* How many participants achieve a complete response after 76 weeks of treatment
* How many participants have medical problems during the study
* How felzartamab is processed by the body
* How felzartamab affects participants' tiredness and overall physical health
The study will be done as follows:
* Participants will be screened to check if they can join the study. This may take up to 42 days.
* Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.
* If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment.
* If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.
* In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

开始日期2025-05-22

申办/合作机构

Biogen, Inc.

NCT06935357

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.
The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:
• How much does the amount of protein in the urine change from the start of the study to Week 36?
Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.
The study will be done as follows:
* Participants will be screened to check if they can join the study.
* Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
* Neither the researchers nor the participants will know what the participants will receive.
* Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.
* Afterwards, participants will enter a follow-up period which will last 80 weeks.
* In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

开始日期2025-05-08

申办/合作机构

Biogen, Inc.

[+1]

NCT06685757

/ Recruiting临床3期

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.

开始日期2024-12-03

申办/合作机构

Biogen, Inc.

100 项与菲泽妥单抗相关的临床结果

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100 项与菲泽妥单抗相关的转化医学

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100 项与菲泽妥单抗相关的专利（医药）

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项与菲泽妥单抗相关的文献（医药）

2025-08-01·NEPHROLOGY DIALYSIS TRANSPLANTATION

Antibody-mediated rejection—treatment standard

Review

作者: Thaunat, Olivier ; Diebold, Matthias ; Naesens, Maarten ; Budde, Klemens ; Böhmig, Georg A ; Viklicky, Ondrej ; Rostaing, Lionel

ABSTRACT:

Antibody-mediated rejection (AMR) remains a major cause of graft failure, with significant health and economic burden. Despite being recognized >25 years ago, AMR treatment remains unstandardized, and no therapy has gained robust regulatory approval. While uncontrolled series have shown promise, few well-designed trials exist, with most yielding negative results. In the absence of strong trial data, a Transplantation Society expert consensus recommended potential treatment options with low levels of evidence, tailored to clinical phenotypes. Here, we re-evaluate the current evidence for AMR treatment decisions. We conclude that steroids, rituximab, bortezomib, and interleukin-6 (IL-6) antagonists lack sufficiently robust evidence to support their use in AMR. For early AMR, antibody depletion using immunoadsorption could be considered as an alternative to plasmapheresis. High-dose intravenous immunoglobulin (IVIG) may be added, though the supporting evidence remains limited. While previous trials primarily targeted the cause of AMR, recent data on the successful reversal of AMR activity by CD38 antibodies—particularly recent phase 2 trial results—suggest that targeting the cellular inflammation resulting from antibody binding to the endothelium could be a rational approach. Along these lines, in severe early AMR, complement inhibition may also be an option. Ongoing phase 2 trials evaluating prolonged courses of high-dose IVIG, the neonatal Fc receptor blocker efgartigimod, the tyrosine kinase inhibitor fostamatinib, and the complement inhibitor BIVV020, along with phase 3 trials of the anti-IL-6 receptor antibody tocilizumab and the CD38 antibody felzartamab, offer hope for effective, approved therapies targeting different aspects of AMR pathobiology.

2025-07-01·AMERICAN JOURNAL OF TRANSPLANTATION

Microvascular inflammation in kidney allografts: New directions for patient management

Review

作者: Loupy, Alexandre ; Sablik, Marta ; Böhmig, Georg A ; Naesens, Maarten

Microvascular inflammation (MVI) is a key histological feature of immune-mediated injury at the capillary interface of renal allografts, characterized by immune cell infiltration into glomerular and peritubular capillaries. Although traditionally associated with antibody-mediated rejection (AMR), many MVI cases lack detectable donor-specific antibodies (DSA), suggesting the involvement of antibody-independent immune mechanisms or alternative triggers, such as viral infections or ischemia-reperfusion injury. The Banff 2022 scheme introduced a subcategory, "MVI, DSA-negative, C4d-negative," within an overarching AMR or MVI category. This subcategory-similar to AMR-was shown to carry a significant risk of graft failure. Its recognition marks a major advancement, offering a robust framework for investigating the pathophysiology of MVI, which may involve a wide array of overlapping triggers. Emerging evidence from transcriptome analyses highlights natural killer cells as possible effectors, regardless of DSA status. Therapies targeting natural killer cells, particularly the anti-CD38 antibody felzartamab, have shown promising reductions in MVI and molecular injury. Notably, the US Food and Drug Administration has approved an MVI-based primary endpoint for a phase 3 trial evaluating this approach, representing a critical step toward the development of new therapeutics. Recognizing MVI as a multifaceted histological phenotype-driven by diverse triggers-may signal a paradigm shift in transplant medicine.

2025-06-01·KIDNEY INTERNATIONAL

Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy

Article

作者: Lafayette, Richard ; Manser, Paul T ; Faulhaber, Nicola ; Kräft, Tabea ; Barbour, Sean J ; Shah, Millie ; Floege, Jürgen ; Thakur, Anjali ; Kivman, Lisa ; Barratt, Jonathan ; Härtle, Stefan ; Schwartz, Brian ; Patel, Uptal D

INTRODUCTION:

Felzartamab is a fully human anti-CD38 monoclonal antibody under investigation for treatment of IgA nephropathy (IgAN). IGNAZ (NCT05065970) is a randomized, double blind, placebo-controlled Phase 2a study that assessed the efficacy and safety of felzartamab in 54 patients with biopsy-confirmed IgAN despite maximal renin angiotensin system blockade.

METHODS:

In part 1, patients were randomized in the 6-month treatment period to receive intravenous placebo (12 patients) or felzartamab in three arms: two doses in 15 days (2-dose, 12 patients), five doses in 2 months (5-dose, 11 patients), or nine doses in five months (9-dose, 13 patients). In part 2, six Japanese patients received the felzartamab 9-dose schedule open-label. Follow-up in parts 1 and 2 was 24 and 12 months, respectively, after the first dose. The primary endpoint was change in proteinuria (urine protein to creatinine ratio [UPCR]) at nine months.

RESULTS:

Treatment with felzartamab versus placebo led to rapid (within 3-6 months) reduction in least-squares mean UPCR sustained at nine months (placebo, -5.7%; 2-dose, -12.5%; 5-dose, -12.8%; 9-dose, -29.5%; part 2, -44.8%) and at 18 months after ending treatment (24 months), particularly in the 9-dose arm (-44.5%). Mean decreases in estimated glomerular filtration rate were lower with felzartamab than with placebo through 24 months in part 1 and 12 months in part 2. Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2.

CONCLUSIONS:

Treatment with felzartamab results in sustained reduction of proteinuria, suggesting disease improvement. Further evidence is needed to understand the impact of felzartamab on preservation of kidney function in high-risk patients with IgAN.

182

项与菲泽妥单抗相关的新闻（医药）

2025-09-04

·医药经济报

云顶新耀月销5亿的创新药出圈！诺华、大冢等巨头酣战

国内免疫球蛋白A（IgA）肾病治疗赛道诞生爆款单品，引发制药巨头加速入局。近日，CDE官网显示，大冢制药的斯贝利单抗注射液上市申请获得受理，拟用于原发性IgA肾病成人患者，以维持肾脏功能。此前该适应症已被纳入优先审评。目前，全球只有四款针对IgA肾病的药物获批上市，分别是诺华制药的阿曲生坦、伊普可泮，百时美施贵宝（BMS）/Travere Therapeutics的司帕生坦，云顶新耀/Calliditas的布地奈德肠溶胶囊（商品名：耐赋康®），均为化学药。此外，还有十余款药物正处在临床阶段。全球及国内IgA肾病管线（部分）值得注意的是，作为肾病治疗领域的大单品，云顶新耀引进的布地奈德肠溶胶囊在今年上半年曾一度脱销。嗅到市场机会的制药巨头，正在加快涌入这一赛道。全球IgA肾病治疗格局重塑IgA肾病是全球最常见的原发性肾小球疾病类型，并且是慢性肾脏病（CKD）和肾衰竭的主要原因。《中国IgA肾病患者诊疗现状蓝皮书》显示，目前，我国有400多万IgA肾病患者，主要集中在青壮年。尽管IgA肾病的特征是肾活检组织病理以IgA沉积为主，但其临床及病理特点存在显著异质性。公开资料显示，IgA肾病进展风险高，大多数IgA肾病患者在诊断后10~15年内进展至肾衰竭，亟需创新疗法解决临床治疗困境。据悉，大冢制药此番申报上市的斯贝利单抗原先是由Visterra开发的一款靶向抑制增殖诱导配体（APRIL）的单抗，可选择性结合并抑制APRIL的活性，在四重打击过程中发挥关键作用。 2018年7月，大冢制药以 4.3亿美元的价格收购 Visterra，将斯贝利单抗收入囊中。2025年5月，大冢制药宣布 FDA已接受斯贝利单抗用于治疗IgA肾病的BLA申请，给予优先审查。该项BLA申请主要基于Ⅲ期 VISIONARY研究和Ⅱ期 ENVISION研究数据支持。在VISIONARY研究中，与安慰剂相比，斯贝利单抗在治疗9个月后，24小时尿蛋白/肌酐比值（uPCR）水平显著降低，且具有统计学和临床意义。此外，斯贝利单抗的FDA处方药使用者费用法案（PDUFA）日期为 2025年11月28日。事实上，在大冢制药之前，BMS/Travere 、诺华等制药巨头已经抢占了IgA肾病治疗领域的市场先机。司帕生坦Sparsentan（商品名：Filspari®）最早在2005年由BMS团队初步开发（代号BMS-346567），是一种融合了血管紧张素Ⅱ受体拮抗剂厄贝沙坦（irbesartan）和内皮素受体拮抗剂联苯磺酰胺结构的首创口服双重拮抗剂，后来项目被Retrophin公司（Travere Therapeutics）收购。由于降尿蛋白效果卓著，2023年2月FDA加速批准司帕生坦用于治疗尿蛋白/肌酐>1.5g/g的IgA肾病。2024年9月，基于该药在PROTECT研究中表现出的肾功能保护作用，FDA取消了蛋白尿的限制，全面批准司帕生坦用于治疗有进展风险的IgA肾病，使其成为唯一获得该适应症的非免疫抑制药物。Travere Therapeutics财报显示，2024年Filspari®销售额为2.27亿美元。 2024年5月，诺华公布了其开发的阿曲生坦治疗IgA肾病患者的Ⅲ期ALIGN研究的预定中期分析结果。2025年4月，阿曲生坦首次获FDA加速批准用于IgA肾病。四个月后，阿曲生坦在中国获批上市，用于降低有疾病进展风险的IgAN成人患者的蛋白尿。这是国内首个获批治疗IgA肾病的非免疫性疗法，也是国内首个且目前唯一针对该适应症的高选择性内皮素A（ETA）受体拮抗剂，有望重塑IgA肾病治疗基石。截图来源：诺华官微 Insight数据库显示，在IgA肾病领域，除获批上市的阿曲生坦外，诺华还有3款产品，旨在针对不同的IgA肾病驱动因素，为患者群体提供多样化的治疗选择。 2024年8月，诺华的伊普可泮获FDA加速批准用于IgA肾病，并于同月在国内递交了用于IgA肾病的新适应症上市申请；与斯贝利单抗相似，诺华也布局了一款靶向APRIL的IgA肾病新药泽戈奇拜单抗，目前正处于Ⅲ期临床阶段。诺华的第三款针对IgA肾病治疗领域的菲泽妥单抗是其以29亿美元收购Morphosys获得的CD38单抗，天境生物拥有其大中华区权益。此前，该药主要用于治疗多发性骨髓瘤，2025年1月其上市申请获CDE受理，IgA肾病适应症正处于Ⅲ期临床阶段。业内观点分析认为，随着多款药物的获批，IgA肾病治疗领域迎来重大突破。从机制研究到临床转化，新型靶向药物正逐步改变传统治疗格局。这些进展不仅印证了临床价值，更标志着IgA肾病治疗正从免疫抑制转向精准靶向时代，为延缓疾病进展提供了全新选择。爆款创新药吸引巨头围猎弗若斯特沙利文数据显示，全球IgA肾病治疗药物市场保持快速增长，预计从2020年的5.67亿美元增至2025年的11.96亿美元，2020年至2025年复合年增长率达16.1%。其中，中国的IgA肾病治疗药物市场预计也将从2020年的0.37亿美元增至2025年的1.09亿美元，复合年增长率达24.6%。值得关注的是，在国内市场上，云顶新耀引进的布地奈德肠溶胶囊表现出色。 2019年6月，云顶新耀与Calliditas Therapeutics签订独家授权许可协议，获得在大中华地区和新加坡开发以及商业化布地奈德肠溶胶囊的权利。该协议于2022年3月扩展，将韩国纳入云顶新耀的授权许可范围。而后，布地奈德肠溶胶囊于2023年11月通过优先审评程序正式获得NMPA的批准，用于治疗具有进展风险的原发性IgA肾病成人患者，补上国内从疾病源头治疗IgA肾病的拼图，并在2024年11月被纳入国家医保药品目录，进一步扩大了其可及性。 2025年5月，布地奈德肠溶胶囊获得NMPA完全批准，取消了对蛋白尿水平的限制，适用于绝大部分IgA肾病患者的治疗。目前，布地奈德肠溶胶囊已在云顶新耀所有授权区域获得批准。根据财报，布地奈德肠溶胶囊今年上半年销售收入达3.03亿元，同比增长81%，一度脱销。在扩产补充申请获批后，云顶新耀的供应能力进一步提升，该产品在1-8月销售收入已达8.25亿元。恢复正常供应后，布地奈德肠溶胶囊的8月单月销售收入达5.20亿元。云顶新耀预计，布地奈德肠溶胶囊的全年销售额将达12-14亿元，并将在2026年继续保持高速增长，预计将达24-26亿元。布地奈德肠溶胶囊月销5亿元的消息一出便吸引来行业热切关注，越来越多的本土竞争对手也将接踵而至。 8月27日，荣昌生物宣布其自主研发的全球首创BLyS/APRIL双靶点融合蛋白创新药泰它西普（商品名：泰爱®）用于治疗IgA肾病的国内Ⅲ期临床研究，达到A阶段的主要研究终点。研究结果显示，与安慰剂组相比，泰它西普组患者在治疗39周时24小时尿蛋白肌酐比值（UPCR）降低了55%（P<0.0001）,且表现出良好的耐受性和安全性。荣昌生物表示将尽快向CDE递交该适应症的上市申请，详细数据将在国际重大学术会议上公布。 2024年10月，根据中国药物临床试验与信息公示平台官网，恒瑞医药正在针对HR19042胶囊开展两项临床研究，分别为一项治疗自身免疫性肝炎的有效性和安全性研究的Ⅱ期临床研究，以及一项治疗原发性IgA肾病的Ⅱ/Ⅲ期临床研究。据恒瑞医药公告介绍，HR19042是一款口服胶囊剂，能增强内皮细胞、平滑肌细胞和溶酶体膜的稳定性，抑制免疫反应和降低抗体合成，从而使组胺等过敏活性介质的释放减少和活性降低。不难看出，当前IgA肾病创新药依然十分稀缺，当前该领域正呈现“创新药稀缺-临床需求迫切-资本加速涌入”的良性循环，推动全球药企通过并购与研发多维度竞逐，未来市场空间广阔极具潜力，鹿死谁手，未成定局。编辑：范晓艳版式编辑：余远泽审校：马飞、张松 A股69家中药企半年报：白云山、云南白药、华润三九等6家净利润超10亿恒瑞双靶点减重新药报产！与信达、礼来等巅峰对决在即医保定点村卫生室监管升级！数千亿第三终端市场生变？ 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

优先审批申请上市上市批准并购临床2期

2025-09-02

·casipharma.com.cn

CASI任命Barbara Krebs-Pohl博士为董事会成员

行业资深专家，在生物制剂开发、战略合作及并购领域经验丰富，横跨生物科技公司与大型制药企业丰富运营经验将助力CID-103（抗CD38单抗）研发进程 2025年9月2日， CASI今日宣布，任命Barbara Krebs-Pohl博士为公司董事会独立董事。 Krebs-Pohl博士是生物技术领域备受尊敬的领军人物，拥有超过27年的行业经验，在产品开发、商业战略和并购整合方面成绩斐然。她曾在多家生物技术公司担任要职。在MorphoSys任首席商务官期间，主导了诺华以29亿美元收购MorphoSys的重大交易。此前，她还在MorphoSys收购并整合 Constellation Pharmaceuticals 过程中发挥了关键作用。作为HI-Bio董事，她推动菲泽妥单抗（felzartamab）与izastobart 的许可交易，最终促成 HI-Bio 被渤健以18亿美元收购。目前，Krebs-Pohl博士担任干细胞研究与再生医学基金会常务董事，同时也是Viopas Venture Consulting合伙人兼常务董事，致力于为新兴生物技术公司提供战略发展与合作咨询。 “在CASI发展的关键阶段加入董事会，我倍感振奋。”Krebs-Pohl博士表示，“近期CID-103用于抗体介导的排斥反应的新药临床试验申请（IND）获得FDA批准，这是CASI在器官移植排斥和自身免疫性疾病领域的重要里程碑。我期待为公司下一阶段的发展贡献力量，共同推动公司在自身免疫疾病领域的创新突破。” CASI执行董事长何为无博士表示：“非常欢迎Barbara加入我们。她丰富的实战经验和战略洞察力将为CASI实现长远发展目标提供有力支持。" CASI首席执行官David Cory补充道：“随着 CID-103项目的持续推进，后续临床数据将进一步验证CD38靶点在不同患者群体和疾病领域的潜力。Barbara的加入，将在董事会层面为公司提供宝贵的战略支持，助力CASI加速创新步伐。”

并购高管变更临床申请

2025-08-20

·丁香园 Insight 数据库

刚刚！诺华 IgA 肾病新药首次在国内获批上市

8 月 20 日，诺华宣布，诺华的阿曲生坦在中国获批上市，用于降低有疾病进展风险的原发性免疫球蛋白 A 肾病（IgAN）成人患者的蛋白尿（受理号：JXHS2400103）。该适应症此前已被 CDE 纳入优先审评。新闻稿指出，这是国内首个获批治疗 IgA 肾病的非免疫性疗法，是国内首个且目前唯一针对该适应症的高选择性内皮素 A（ETA）受体拮抗剂，有望重塑 IgA 肾病治疗基石。截图来源：NMPA 官网阿曲生坦是一种在研的强效选择性口服 ETA 受体拮抗剂，ETA 受体的激活会导致蛋白尿升高，这与 IgAN 中的肾脏损伤、纤维化和肾功能丧失有关。阿曲生坦有可能添加到目前的支持疗法中，以减少持续性蛋白尿并保护广大患者群体的肾功能。临床前模型也表明阿曲生坦可以减少 IgAN 中的炎症和纤维化。 2025 年 4 月，该药首次获 FDA 加速批准用于 IgA 肾病，成为首个也是唯一一个用于该适应症的强效选择性口服 ETA 受体拮抗剂。 2024 年 5 月，诺华公布了阿曲生坦治疗 IgA 肾病患者的 III 期 ALIGN 研究的预定中期分析结果。这是一项 III 期、随机、双盲、安慰剂对照研究，旨在比较阿曲生坦和安慰剂在存在进行性肾功能丧失风险的 IgA 肾病中的疗效和安全性。结果显示，与接受支持治疗（最大耐受剂量和稳定剂量的肾素-血管紧张素系统 [RAS] 抑制剂）的患者相比，接受阿曲生坦治疗的患者在 36 周时蛋白尿（以 24 小时尿蛋白与肌酐比率 [UPCR] 衡量）减少了 36.1% (p<0.0001)。研究还显示，阿曲生坦具有良好的安全性，与前期报道的数据一致。 Insight 数据库显示，在 IgA 肾病领域，除了本次获批上市的阿曲生坦以外，诺华还有 3 款产品，旨在针对不同的 IgA 肾病驱动因素，为患者群体提供多样化的治疗选择。截图来源：企业官微伊普可泮于 24 年 8 月获 FDA 加速批准用于 IgA 肾病，并于同月在国内递交了用于 IgA 肾病的新适应症上市申请（JXHS2400053），该药是全球首款获批用于降低有快速进展风险的原发性 IgA 肾病蛋白尿的补体旁路途径抑制剂，并有望在中国已获批的阵发性睡眠性血红蛋白（PNH）适应症基础上，加速拓展 IgA 肾病及其他肾脏领域适应症。此外，诺华还有一款靶向增殖诱导配体（APRIL）的 IgA 肾病新药泽戈奇拜单抗，目前正处于 III 期临床阶段。菲泽妥单抗是诺华以 29 亿美元收购 Morphosys 而获得的一款 CD38 单抗，目前 IgA 肾病适应症也处于 III 期临床阶段。 Insight 数据库整理了 2025 年全球新药获批上市清单，扫描下方二维码，回复关键词新药获批即可免费获取（每月初更新一次，目前更新至 7 月）。封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：ccai PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

临床3期上市批准优先审批加速审批免疫疗法

100 项与菲泽妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16375

研发状态

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
多发性骨髓瘤	申请上市	中国	天境生物科技（杭州）有限公司	2025-01-08
特发性膜性肾病	临床3期	美国	Biogen, Inc.	2025-05-22
免疫球蛋白a肾病	临床3期	美国	天境生物科技（杭州）有限公司	2025-03-28
免疫球蛋白a肾病	临床3期	中国	天境生物科技（杭州）有限公司	2025-03-28
免疫球蛋白a肾病	临床3期	阿根廷	天境生物科技（杭州）有限公司	2025-03-28
免疫球蛋白a肾病	临床3期	澳大利亚	天境生物科技（杭州）有限公司	2025-03-28
免疫球蛋白a肾病	临床3期	比利时	天境生物科技（杭州）有限公司	2025-03-28
免疫球蛋白a肾病	临床3期	巴西	天境生物科技（杭州）有限公司	2025-03-28
免疫球蛋白a肾病	临床3期	保加利亚	天境生物科技（杭州）有限公司	2025-03-28
免疫球蛋白a肾病	临床3期	加拿大	天境生物科技（杭州）有限公司	2025-03-28

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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


NCT05065970 (IGNAZ, ASN2024) 人工标引	临床2期	免疫球蛋白a肾病	54	Felzartamab (2 doses in 15 days)	膚鑰齋艱鑰積製鹹憲顧(醖繭製觸艱壓鬱憲鑰廠) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. 膚鹽範範艱襯構鏇襯構 (憲憲觸膚觸願範壓鹹網 ) 更多	积极	2024-10-26
				Felzartamab (5 doses in 2 months)
NCT04145440 (M-PLACE, Pubmed) 人工标引	临床1/2期	特发性膜性肾病 anti-Phospholipase A2 receptor autoantibody-positive	31	Felzartamab 16 mg/kg	淵夢鹹窪壓鹽獵廠膚範(鏇鏇淵遞鑰遞鹽窪壓齋) = 築壓選醖廠願願糧蓋鏇獵選築範糧鬱鑰鹹繭壓 (憲窪鑰構淵鹽網餘夢鬱 ) 更多	积极	2024-06-20
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	襯壓衊夢衊鬱選壓簾網(網膚淵鑰鏇選獵構襯製) = 淵網窪積齋鑰製築繭艱衊夢夢憲鹽構構膚遞糧 (夢製淵憲艱窪衊築糧鏇 )
NCT05021484 (NEWS) 人工标引	临床2期	肾移植排斥反应	22	Felzartamab	簾鑰壓夢壓簾鬱襯壓繭(淵襯艱積衊網鹹築艱網) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. 襯選繭醖鹽網夢選願築 (壓簾夢衊選選願選鹽鹹 )	积极	2024-05-27
				Placebo
NCT05065970 (IGNAZ, PRNewswire) 人工标引	临床2期	免疫球蛋白a肾病	54	Felzartamab	顧顧鹽選範廠選鹽襯獵(餘積餘鬱艱製鹽鹽糧繭) = 範壓鑰憲觸遞襯夢壓壓範顧觸淵顧獵鏇艱築觸 (艱構膚醖顧遞觸膚艱廠 )	积极	2024-05-24
				Placebo	-
NCT04145440 (M-PLACE, ASN2023) 人工标引	临床1/2期	特发性膜性肾病一线	31	Felzartamab	醖鏇壓遞構願願艱衊遞(糧範餘鹹憲廠願衊夢築) = 築淵餘繭醖願構餘夢網觸簾鹹艱顧襯繭顧蓋襯 (憲顧願淵網繭鑰餘膚夢 ) 更多	积极	2023-11-02
				Felzartamab (newly diagnosed or relapsed patients)	齋糧簾壓餘廠夢鑰積築(願糧簾繭糧憲糧憲築繭) = 夢襯齋蓋鏇窪廠鹹艱夢憲鬱鑰夢窪壓襯廠築糧 (衊鏇餘衊廠壓鬱夢窪簾 ) 更多
NCT04145440 (M-PLACE, ASN2022)	临床1/2期	膜性肾小球肾炎 anti-PLA2R Abs	31	Felzartamab (MOR202) 16 mg/kg	構鑰餘壓齋糧襯顧淵積(製廠願襯積衊鏇膚襯艱) = 網淵窪願願夢壓艱遞衊鹽積夢鏇襯鹽餘網壓網 (淵獵鏇簾餘網構鹹憲窪 )	积极	2022-11-05
NCT01421186 (ASCO 12017 \| ASCO 22017) 人工标引	临床1/2期	多发性骨髓瘤	44	dexamethasone+MOR202	選膚齋餘製觸膚積構襯(積憲齋襯憲鹹蓋鹽獵鑰) = The MTD of MOR202 was not reached 齋憲簾鬱醖觸鑰窪鑰鹹 (夢窪顧壓製鑰憲憲醖鹹 )	积极	2017-06-05
				dexamethasone+lenalidomide+MOR202