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）

2025-07-01·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 ; Ha Rtle, Stefan ; Shah, Millie ; Floege, Jürgen ; Thakur, Anjali ; Kivman, Lisa ; Schwartz, Brian ; Patel, Uptal D ; Barratt, Jonathan

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:

Our study shows 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.

2025-05-01·NATURE MEDICINE

Effect of felzartamab on the molecular phenotype of antibody-mediated rejection in kidney transplant biopsies

Article

作者: Jilma, Bernd ; Mackova, Martina ; Hinze, Christian ; Gauthier, Patrick T ; Schütz, Ekkehard ; Mayer, Katharina A ; Diebold, Matthias ; Budde, Klemens ; Halloran, Philip F ; Chang, Jessica ; Schrezenmeier, Eva ; Böhmig, Georg A ; Patel, Uptal D

Abstract:

A recent randomized controlled trial demonstrated that treatment with anti-CD38 monoclonal antibody felzartamab suppressed antibody-mediated rejection (ABMR) in kidney transplant patients but with recurrence after treatment in some patients. Here we examined the molecular effects of 6 months of felzartamab treatment on biopsies from the trial using genome-wide microarray analysis, comparing pretreatment, end-of-treatment (week 24) and posttreatment (week 52) biopsies from ten patients treated with felzartamab and ten patients in the placebo group. Felzartamab reduced molecular ABMR activity scores in all nine patients with baseline ABMR activity, selectively suppressing interferon gamma-inducible and natural killer cell transcripts, with minimal effect on ABMR stage-related endothelial transcripts. Suppression was often incomplete when ABMR activity was intense, and molecular recurrence was nearly universal by week 52. However, we also found that felzartamab had parenchymal benefits at week 52, slowing the trajectories of molecular injury scores beyond the treatment period, suggesting that suppression of ABMR activity could potentially slow future progression to kidney failure. These data provide preliminary molecular insights into the effects of CD38-directed treatment for ABMR, which have the potential to inform future therapeutic strategies.

178

项与菲泽妥单抗相关的新闻（医药）

2025-07-09

·PMLiVE

Biogen initiates phase 3 study of felzartamab in kidney disease patients

Biogen has announced that it has initiated a phase 3 study of investigational felzartamab in adults with primary membranous nephropathy (PMN), a severe antibody-mediated kidney disease. The 104-week PROMINENT trial, expected to readout in 2029, will randomise approximately 180 patients with moderate- to -high-risk PMN to receive either felzartamab or tacrolimus. It will enrol both newly diagnosed and relapsed patients, and will compare the efficacy and safety of the two drugs in achieving complete remission of protein in the urine (proteinuria). Approximately 36,000 people in the US are affected by PMN, which carries a significant risk of kidney failure and currently has no specifically approved treatments. The condition is a leading cause of nephrotic syndrome, which often presents with very severe swelling and fatigue related to high-grade proteinuria. Despite treatments ranging from immunosuppressants to chemotherapy, approximately one third of patients do not achieve remission. Felzartamab has already been shown in clinical studies to selectively deplete CD38-positive plasma cells, which Biogen said “may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies”. Travis Murdoch, head of the Biogen West Coast Hub, said the company is “encouraged by the opportunity to advance a phase 3 study for PMN, a condition that carries a significant risk of kidney failure”. Biogen gained access to felzartamab in July through its $1.8bn acquisition of Human Immunology Biosciences (HI-Bio), which had exclusively licensed the rights to develop and commercialise the asset across all indications in all countries and territories excluding China in 2022. The drug was originally developed by MorphoSys, which Novartis also acquired last year. Beyond PMN, Biogen has recently initiated two phase 3 studies of felzartamab in IgA nephropathy, and kidney transplant recipients who have been diagnosed with late antibody-mediated rejection. Principal investigator for the PROMINENT trial, Mohamed El-Shahawy, said: “Felzartamab’s mechanism of action designed to deplete the cells that produce the pathogenic antibodies is exciting news for patients that are waiting for potential meaningful new treatment options. “I’m grateful that Biogen is advancing research in this rare kidney disease and am eager to see the continued progress in the study’s enrolment.”

临床3期并购免疫疗法

2025-07-01

·医药速览

渤健启动CD38单抗的III期临床试验，治疗原发性膜性肾病

6月30日，渤健Biogen宣布，其全球性三期临床研究PROMINENT已正式启动患者给药，旨在评估创新药物Felzartamab对成人原发性膜性肾病PMN患者的疗效与安全性。这项里程碑式的研究，对比的是当前标准疗法中的他克莫司（tacrolimus），预示着在这一尚无特异性获批疗法的罕见免疫介导性疾病领域，未来或将迎来重大突破。原发性膜性肾病是一种严重的抗体介导性肾脏疾病，是肾病综合征的主要原因之一，并伴随着显著的肾功能衰竭风险。患者常常因严重的蛋白尿而出现全身水肿和疲劳，感染风险也随之增加。尽管目前有从免疫抑制剂到化疗等多种治疗方案作为标准护理，但仍有约三分之一的患者无法实现缓解。Felzartamab是一种研究性抗CD38单克隆抗体，被认为是极具潜力的差异化治疗候选药物，有望应用于广泛的免疫介导性疾病。临床研究已证实，Felzartamab能选择性地清除CD38阳性细胞，包括浆细胞，而浆细胞正是产生自身抗体（这些抗体错误地攻击身体自身组织）的源头。对于PMN患者而言，这一点尤为重要，因为据估计，高达80%的PMN患者体内存在由表达CD38的浆细胞产生的抗PLA2R（aPLA2R）自身抗体。通过靶向并清除这些致病性抗体产生的源头，Felzartamab有望从根本上解决PMN的病理机制。这项名为PROMINENT的三期临床试验（NCT06962800）是一项为期104周、随机、开放标签、全球多中心研究。它计划招募约180名中高风险的PMN成人患者，包括新诊断和复发患者。试验的主要终点是评估患者在第104周达到蛋白尿完全缓解的百分比。这项研究将同时评估抗PLA2R自身抗体阳性及阴性患者，并根据PLA2R水平进行分层。血清抗磷脂酶A2受体（PLA2R）抗体水平的变化以及患者报告的结局将作为关键的次要终点进行评估。这是渤健今年启动的第三项Felzartamab三期临床试验，除了PMN，渤健今年还启动了Felzartamab针对肾移植受者晚期抗体介导性排斥反应（TRANSCEND研究，NCT06685757）和IgA肾病（PREVAIL研究，NCT06935357）的两项三期研究。在此之前，Felzartamab已在两项二期研究（M-PLACE和NewPLACE）中进行了评估，这些研究均招募了aPLA2R阳性PMN患者。M-PLACE研究的最终分析显示，大多数患者的aPLA2R滴度在短短一周内就观察到下降（中位下降45%），并且在治疗结束的六个月时，大多数患者的反应率（下降幅度超过50%）显著。此外，Felzartamab的使用还观察到蛋白尿和血清白蛋白水平的改善。在这两项研究中，大多数治疗期不良事件（TEAEs）为轻度至中度，并与Felzartamab在PMN人群中的已知作用机制一致。此次启动Felzartamab治疗PMN的三期研究，再次彰显了CD38单抗在罕见肾脏病领域潜力。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。有问题可发邮件至yong_wang@pku.edu.cn获取更多信息。©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）。进群加作者微信（yiyaoxueshu666）或者扫描公众号二维码添加作者，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

临床3期临床2期临床失败寡核苷酸

2025-07-01

·氨基观察

两家公司共同押注，自免新王牌即将亮剑？

CD38抗体自免肾病预期升温。6月30日，Biogen发布公告，宣布felzartamab（中文通用名：菲泽妥单抗）治疗原发性膜性肾病（PMN）的全球三期研究PROMINENT（NCT06962800）已完成首例患者给药。这意味着，继AMR的TRANSCEND研究（NCT06685757）和IgAN的PREVAIL研究（NCT06935357）之后，这款CD38抗体在自免肾病领域的三项全球三期临床试验已全面启动。一切都在情理之中。时间倒回到半个月前，Biogen召开了一场专门针对肾病管线的投资者研讨会。CEO Christopher Viehbacher和一众研发高管向分析师详细介绍了公司的重磅产品菲泽妥单抗，以及这款CD38抗体对于“新Biogen”战略转型的重要意义。这场一个多小时的研讨会释放出一个强烈信号：Biogen正在从神经疾病巨头向多元化免疫学公司转型，而菲泽妥单抗就是这一转型的核心驱动力。如今，自免肾病三期临床的全面铺开，预示着Biogen正在全力以赴的推动菲泽妥单抗价值的兑现。这意味着，CD38单抗在自免领域的命运或被改写，同时两家企业的轨迹也可能彻底发生改变。/ 01 /一次聪明的收购故事要从2023年Biogen收购HI-Bio说起。当时很多人看不懂这笔交易，一家专注神经疾病的大药厂，为什么要花重金买一家做肾病的小公司？答案在这次研讨会上变得清晰：Biogen需要在免疫学领域找到新的增长点，而HI-Bio带来的不仅仅是菲泽妥单抗这一个产品，更是一整套精准免疫学平台和经验丰富的团队。收购完成后，Biogen保留了90%以上的HI-Bio团队，并将其打造成西海岸研发中心。这种“biotech式的研发引擎”正是Biogen构建免疫学管线所需要的敏捷性和专业性。/ 02 /不一样的CD38抗体提到CD38抗体，大多数人想到的是强生在血液肿瘤领域大杀四方的明星药物达雷妥尤单抗。但菲泽妥单抗的设计理念完全不同。传统CD38抗体依赖补体介导的细胞毒性来杀伤目标细胞，这种"暴力"方式在血液肿瘤中效果不错，但用在自免疾病上就有问题：输注反应严重，需要缓慢给药，还要担心长期安全性。菲泽妥单抗巧妙地避开了这些问题。它与CD38的结合方式经过精心设计，避免了补体介导的细胞毒性，同时保持对病理性抗体产生细胞的精准清除。这使得菲泽妥单抗能够更精准地清除产生致病性抗体的细胞，而不影响发挥正常免疫功能的B细胞。理论上，CD38策略是清除致病抗体分泌细胞精准度最高的选择，对正常免疫功能的影响最小。最直观的优势就是输注时间从几个小时缩短到30分钟，输注反应也大大减少。更重要的是，菲泽妥单抗具有完整的慢性毒理学和生殖毒理学数据包，这对于需要长期使用的自免疾病治疗至关重要。/ 03 /三张王牌，张张都是同花顺菲泽妥单抗瞄准的三个适应症都已经启动了全球三期临床，每一个都击中了临床痛点。AMR：从绝症到有药可治晚期抗体介导排斥反应，是移植医生最头疼的问题。超过75%的患者最终会失去移植肾，而且目前没有任何获批的治疗药物。这是一个典型的"蓝海"市场。菲泽妥单抗发表在《新英格兰医学杂志》上的二期数据让人眼前一亮：超过80%的患者在6个月时实现了病理学缓解，而安慰剂组仅有20%。这个数字意味着什么？在一个几乎无药可用的领域，菲泽妥单抗可能成为第一个真正有效的治疗方案，而这种疗效差异足以支撑一个孤儿药级别的定价策略。正在进行的TRANSCEND研究计划纳入120名患者，主要终点是6个月时的病理缓解率。考虑到二期的优异表现，这个试验的成功概率相当高。数据预计2027年公布，如果积极，菲泽妥单抗有望成为AMR领域的first-in-class药物。IgAN：告别终生吃药IgA肾病是全球最常见的肾小球疾病，在中国发病率尤其高。现有治疗的最大问题是需要终生用药，一停药就复发。菲泽妥单抗提出了一个颠覆性理念：非慢性治疗。二期数据显示，仅仅5个月的治疗（9次给药），就能在24个月时维持约50%的蛋白尿减少。更有意思的是，病理性IgA抗体被持续抑制，而保护性IgG/IgM抗体快速恢复，这种选择性调节正是精准免疫治疗的理想状态。目前，PREVAIL研究由Biogen和天境生物（TJ Biopharma）推进，主要终点是9个月时的蛋白尿减少。这个适应症的市场最大，但竞争也最激烈。菲泽妥单抗的差异化卖点是“治疗后缓解”，这在患者体验上有明显优势。想象一下，患者只需要五个月内打9针，就能获得两年的“治疗假期”，这对生活质量的改善是巨大的。PMN：填补治疗空白原发性膜性肾病同样面临无药可用的困境。现有治疗要么效果有限，要么副作用严重。菲泽妥单抗在这个领域的独特之处在于它的“B细胞保护”特性——只清除产生病理性抗体的浆细胞，而保留早期B细胞系。Phase 1/2数据显示，无论是新诊断患者还是对CD20抗体和化疗耐药的患者，都能看到持续的PLA2R自身抗体减少和临床改善。PROMINENT研究同样由Biogen和天境生物共同推进。这项研究设计很有意思，包含两个给药疗程，中间有药物假期，进一步验证非慢性治疗的可行性。/ 04 /下一步棋怎么走？Biogen显然不满足于现有的三个适应症。狼疮性肾炎（LN）的一期研究已经在进行中，预计2026年有初步数据。考虑到达雷妥尤单抗在狼疮肾炎中的off-label成功案例，菲泽妥单抗在这个领域的前景值得期待。更大的想象空间在于CD38平台的扩展。Biogen正在开发皮下制剂，这将大大提升给药便利性。同时，下一代CD38抗体也在研发中，目标是在保持选择性的基础上，实现更大的商业灵活性和更广泛的适应症覆盖。/ 05 /商业逻辑：小而美的市场策略菲泽妥单抗的商业化策略很聪明。它没有追求大而全的市场覆盖，而是专注于高度专业化的医生群体。AMR治疗主要集中在全美250个移植中心，其中50-100个处理了大部分患者。IgAN和PMN的治疗则主要由约5000名核心肾病科医生负责。这种高度集中的特点，让Biogen可以用相对较小的销售团队实现精准覆盖。更重要的是，这些医生对新疗法的接受度很高。在缺乏有效治疗手段的情况下，只要有足够的临床证据支持，他们会很快采用新的治疗方案。定价策略也很清晰：AMR瞄准孤儿药定价，IgAN和PMN则采用基于价值的定价模式。考虑到这些疾病的严重性和现有治疗的局限性，支付方接受度应该不成问题。/ 06 /全球布局，中国先行菲泽妥单抗的监管注册策略展现了全球视野和本土化并重的思路。在美国，AMR已经获得突破性疗法认定和孤儿药资格，计划基于6个月数据提交上市申请；IgAN可能走加速审批路径；PMN则待完整2年数据出来后BLA。更有意思的是中国市场的布局。菲泽妥单抗在中国（包括港澳台）的权益属于天境生物，而他们与Biogen的合作模式为全球开发提供了独特优势。根据公告，天境生物不仅与Biogen共同推进IgAN和PMN的全球三期研究，还负责这两个适应症在中国的监管沟通和上市注册工作。这种安排的精妙之处在于：天境可以利用全球临床数据，同时基于对中国监管环境的深度理解，制定更适合的注册策略。天境的先手棋也很巧妙。多发性骨髓瘤适应症的BLA已经递交NMPA，有望率先在中国上市。这不仅为公司建立CD38抗体的商业化基础设施，更为后续自免适应症的监管申报积累了宝贵经验。想象一下，当IgAN和PMN的全球数据公布时，天境已经有了完整的产品注册、生产、合作销售体系，这种执行效率上的优势是巨大的。考虑到中国是IgAN的高发地区，这种权益安排和战略布局的价值可能被严重低估了。/ 07 /一款产品，两家公司的转型密码菲泽妥单抗三项全球三期研究的全面启动，我们可以很清晰的看到：菲泽妥单抗作为一款作用机制独特的CD38抗体，成为了两家公司战略转型的关键驱动力。对Biogen来说，菲泽妥单抗是从单一神经疾病公司向多元化免疫学公司转型的重要支柱。这种转型不是简单的业务扩张，而是对未来增长引擎的重新定义。对天境生物而言，菲泽妥单抗同样意义重大。自身免疫领域一直是天境的战略布局，有多款临床阶段在研创新项目，菲泽妥单抗加强了天境在自免领域的发展实力，标志着公司正在自免领域高歌猛进。通过与Biogen的深度合作，让天境生物在自免疾病这个巨大市场中确立了自己的地位。从投资角度看，这种双重转型提供了独特的机会点：近期催化剂：AMR的三期数据将是一个重要节点。如果数据积极，不仅Biogen的免疫学转型会得到验证，天境的自免布局价值也会重新被市场认知。差异化优势：在竞争激烈的自免疾病领域，菲泽妥单抗的“非慢性治疗”理念和B细胞保护特性为两家公司都提供了清晰的差异化价值。平台潜力：CD38平台的扩展空间巨大，从肾病到其他自免疾病，从静脉制剂到皮下制剂。这种平台价值将同时惠及Biogen的全球布局和天境的中国深耕。当然，风险也是客观存在的。三期试验的样本量更大，能否重复二期的优异表现还需要验证。竞争对手也在加快推进，时间窗口有限。但从两家公司展现的战略决心来看，菲泽妥单抗可能已经超越一款产品，而成为两家公司未来发展的战略基石。对于关注生物医药投资的人来说，这种“双重转型、平台价值、差异化优势”的组合，在当前市场环境下确实不多见。声明：本文仅为行业分析，不构成投资建议。资料来源：1.https://investors.biogen.com/news-releases/news-release-details/biogen-initiates-phase-3-study-felzartamab-treatment-primary2.https://investors.biogen.com/news-releases/news-release-details/biogen-highlights-potential-felzartamab-range-immune-mediated3.https://investors.biogen.com/static-files/b1c16e69-3bc8-42df-b3c8-5de3d6c8c7c94.https://www.tjbio.com/news/12769PS：欢迎扫描下方二维码，添加氨基君微信号交流。

并购临床3期临床成功临床2期免疫疗法

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
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研发状态

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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	Biogen, Inc.	2025-05-08
免疫球蛋白a肾病	临床3期	日本	Biogen, Inc.	2025-05-08
抗体介导的排斥反应	临床3期	美国	Biogen, Inc.	2024-12-03
抗体介导的排斥反应	临床3期	加拿大	Biogen, Inc.	2024-12-03
难治性多发性骨髓瘤	临床3期	中国	天境生物科技（杭州）有限公司	2019-03-27
难治性多发性骨髓瘤	临床3期	中国台湾	天境生物科技（杭州）有限公司	2019-03-27
复发性多发性骨髓瘤	临床3期	中国	天境生物科技（杭州）有限公司	2019-03-27
复发性多发性骨髓瘤	临床3期	中国台湾	天境生物科技（杭州）有限公司	2019-03-27

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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)	觸網鬱簾壓網鹽遞鑰膚(夢夢淵積簾衊鏇選廠構) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. 鬱壓壓繭願鹽膚醖齋齋 (觸積醖製鹽窪鑰製顧襯 ) 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	窪願鏇餘獵鑰積衊蓋憲(廠蓋積夢餘廠築廠齋顧) = 膚壓鹽憲糧鹽鑰築簾鬱觸網鹹餘製選齋齋淵餘 (觸蓋鏇遞製蓋獵範膚夢 ) 更多	积极	2024-06-20
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	鬱廠憲鬱鬱繭願窪遞齋(繭夢艱繭鏇醖餘襯鹹簾) = 窪積夢遞夢鏇鏇鹹構夢遞窪積齋壓網選壓遞顧 (醖構壓鑰夢憲膚築衊鹽 )
NCT05021484 (NEWS) 人工标引	临床2期	肾移植排斥反应	22	Felzartamab	網窪築遞憲顧範艱願淵(範製選醖餘鏇鹹醖齋夢) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. 襯範夢顧簾餘遞顧壓鬱 (壓餘膚齋鹽壓選鹽壓積 )	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	獵構廠憲窪艱蓋願網糧(夢鹽網網顧選獵襯窪獵) = 簾簾餘糧觸願鹹憲鏇願廠築築願鹹構繭糧衊鑰 (餘鹽鏇襯壓觸蓋獵築憲 )	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	衊艱鬱觸淵廠醖鹹觸衊(餘製網鏇齋製鏇築鹹築) = 顧憲簾廠窪範構淵憲繭鬱衊廠膚選繭齋構鏇鏇 (築選選蓋壓衊網艱鹽構 ) 更多	积极	2023-11-02
				Felzartamab (newly diagnosed or relapsed patients)	鹽壓鹹鑰壓鏇獵壓壓遞(獵鬱顧鏇簾醖餘簾憲簾) = 艱壓鑰蓋窪鏇顧廠鏇廠糧齋遞襯壓鏇範繭鑰鬱 (糧製鹹窪鏇壓壓艱築觸 ) 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	廠選網窪簾醖獵選醖糧(糧鑰衊範醖觸衊淵製觸) = 網艱醖衊築憲夢製夢壓廠夢鹽壓範繭築夢顧鏇 (製壓鏇膚憲網淵蓋餘網 )	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	觸醖築憲網衊鑰構壓蓋(淵窪膚鏇蓋顧窪糧憲淵) = The MTD of MOR202 was not reached 積窪廠蓋鹽膚夢齋糧鹽 (範願鬱鹽簾繭簾鹹餘齋 )	积极	2017-06-05
				dexamethasone+lenalidomide+MOR202