A Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab Compared to Placebo in Adult Participants With Graves' Disease

In this study, researchers will learn more about the use of felzartamab in participants with Graves' Disease, also known as GD. GD is an autoimmune disease, which means the body's immune system attacks its own healthy cells. In people with GD, the immune system produces abnormal antibodies, called thyroid-stimulating hormone receptor antibodies (TRAb), that attack the thyroid gland. This causes the thyroid to become too active and produce too much hormone, a condition called hyperthyroidism.
Participants with GD are often treated with anti-thyroid drugs, or ATDs, which are medicines that help bring thyroid hormone levels back to normal. Felzartamab is designed to target certain immune cells that produce the abnormal TRAb antibodies.
The main goal of the study is to learn whether felzartamab can help bring thyroid hormone levels back to normal and allow participants to stop taking ATDs. Participants will receive either felzartamab or placebo during the study. A placebo looks like the study drug but contains no real medicine.
The main question that researchers want to answer is:
• How many participants have normal thyroid levels without receiving any ATD medicine at Week 24?
Researchers will also learn more about the safety of felzartamab and how the body processes the drug.
The study will be done as follows:
* Participants will be screened to check if they can join the study.
* This is a double-blind study, which means neither the participants, study doctor, or site staff will know if participants are receiving felzartamab or a placebo.
* Participants will be placed into 1 of 3 groups. Two groups will receive felzartamab while the other receives placebo.
* Participants will receive felzartamab or placebo as intravenous (IV) infusions, which are slow injections into a vein using a needle. The Treatment Period will last 20 weeks.
* During the Treatment Period, the study doctor may gradually lower the dose of the ATD if a participant's thyroid levels become normal.
* Afterwards, participants will enter a follow-up period which will last 12 weeks.
* In total, participants will have 22 study visits. Participants will stay in the study for about 9 months (up to 36 weeks).

开始日期2026-07-30

申办/合作机构

Biogen, Inc.

NCT07444489

/ Enrolling by invitation临床3期

An Open-Label Long-Term Extension Study of Felzartamab in Participants With Antibody-Mediated Rejection or Microvascular Inflammation Previously Enrolled in TRANSCEND or TRANSPIRE

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI). AMR happens when the body's immune system creates donor-specific antibodies (DSAs) that attack the transplanted kidney. In late AMR, this typically happens more than 6 months after the kidney transplant. MVI is a condition where the small blood vessels in the transplanted kidney become inflamed. MVI can happen with or without DSAs. Both AMR and MVI can cause the transplanted kidney to stop working properly.
Two earlier studies looked at felzartamab in kidney transplant recipients. Study 299AR301 (TRANSCEND) (NCT06685757) included participants with AMR. Study 299AR201 (TRANSPIRE) (NCT07219043) included participants with MVI.
This study, 299AR302-299AR301 LTE, is a long-term extension of both of these "parent" studies. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years after completing their parent study.
The goal of this study is to learn more about the long-term safety and effects of felzartamab in people with kidney transplants. This study is part of a group of studies looking at long-term felzartamab use in people with organ transplants. This study is a substudy of the main study 299AR302.
The main question researchers will answer relate to safety. Namely, how many participants have adverse events during the study and how lab test results change over time. Adverse events are health problems that may or may not be caused by the study drug.
Researchers will perform kidney biopsies to track kidney health. Researchers will also study how felzartamab affects kidney inflammation, kidney function, immune activity, and overall health.
The study will be done as follows:
* Participants who complete the final visit of the treatment period in one of the parent studies can enroll in this study. This includes participants who stopped receiving felzartamab early but still attended their final visits.
* Participants who did not stop receiving felzartamab in their parent study will continue to receive felzartamab for up to 4 more years in this study. Participants may also stop felzartamab during this study at any time.
* Participants who stopped receiving felzartamab in their parent study will only attend study visits for health monitoring- they will not receive felzartamab.
* Felzartamab will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle.
* Participants receiving felzartamab may have up to 27 study visits over 200 weeks with an additional safety follow-up visit after their final dose.
* Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.

开始日期2026-04-16

申办/合作机构

Biogen, Inc.

NCT07219043

/ Recruiting临床2期

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI)

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.
In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI.
The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:
• How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab?
Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.
Adverse events are health problems that may or may not be caused by the study drug.
The study will be done in 2 parts as follows:
* Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
* In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
* Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
* All treatments will be given by intravenous (IV) infusion at the study site.
* Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation.
* Participants will stay in the study for about 1 year.

开始日期2026-01-05

申办/合作机构

Biogen, Inc.

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项与菲泽妥单抗相关的文献（医药）

2026-06-01·Kidney International Reports

Prospective Cohort Study of Felzartamab in Rituximab-Resistant Primary Membranous Nephropathy

Article

作者: Pecoraro, Francesco ; Trillini, Matias ; Podestà, Manuel Alfredo ; Stucchi, Nadia ; Villa, Alessandro ; Diadei, Olimpia ; Portalupi, Valentina ; Todeschini, Marta ; Mister, Marilena ; Marasà, Maddalena ; Nozza, Silvia ; Casiraghi, Federica ; Prandini, Silvia ; Peracchi, Tobia ; Rubis, Nadia ; Ruggenenti, Piero ; Martinetti, Davide ; Fidone, Diego ; Gennarini, Alessia ; Carrara, Fabiola ; Remuzzi, Giuseppe

Introduction:

Approximately 30% of patients with primary membranous nephropathy (MN) and nephrotic syndrome (NS) fail rituximab treatment through mechanisms that could be overcome by the human IgG₁ monoclonal anti-CD38 antibody, felzartamab.

Methods:

In this prospective, single-arm, single-center, open-label trial, 10 consenting Caucasian adult patients with MN, rituximab-resistant NS, and estimated glomerular filtration rate (GFR) > 30 ml/min per 1.73 m² received a 5-month, 9-dose course of 16 mg/kg felzartamab infusions at the Nephrology Unit of Bergamo Hospital, Italy between November 9, 2021 and February 1, 2023 and were followed up with for 24 months. Clinical and laboratory parameters were evaluated at baseline, 1, 2, 5, 6, 9, 18, and 24 months, whereas GFR as well as albumin and IgG fractional clearances were measured at baseline and at 6, 9, 12, 18, and 24 months posttreatment. The primary outcome was 24-hour proteinuria (median of 3 consecutive measurements) at 12 months.

Results:

Twelve-month 24-hour proteinuria was similar to baseline. Linear-mixed model analyses showed no significant time-dependent changes in 24-hour proteinuria and albuminuria; serum total-protein, albumin, creatinine and lipid levels, GFR and albumin fractional clearances. Circulating anti-phospholipase A₂ receptor (PLA₂R) antibodies transiently decreased but were never depleted. All considered Igs transiently decreased up to month 12, and recovered to baseline thereafter. Felzartamab deeply and persistently decreased natural killer (NK), B cells, and antigen-inexperienced transitional B cells; however, it did not affect CD20-expressing memory B cells, plasmablasts, and plasma cells. Treatment was safe and well-tolerated.

Conclusion:

One course of felzartamab was safe and well-tolerated, but ineffective in patients with MN and rituximab-resistant NS, possibly because of the inability to persistently deplete nephritogenic autoantibody-producing CD38-expressing B cells.

2026-04-01·TRANSPLANTATION

Updates on Kidney Transplantation From the World Transplant Congress 2025

Review

作者: Cravedi, Paolo ; Noble, Johan

The World Transplant Congress 2025 showcased pivotal advances shaping the future of transplantation. Global efforts to expand access to transplantation accelerated on multiple fronts. Machine perfusion has progressed from an experimental approach to an emerging clinical standard: the Central Preservation and Assessment Service to Optimize Donor Kidney Allocation trial confirmed its value in rescuing discarded kidneys and explored its potential for ex vivo organ repair. For highly sensitized patients, novel desensitization regimens incorporating new proteasome inhibitors and anti-CD38 antibodies (daratumumab, felzartamab) effectively reduced donor-specific antibodies, enabling transplantation in previously ineligible candidates. Improving long-term graft survival remains a central goal, with new immunosuppressive strategies beginning to redefine the therapeutic landscape. Anti-CD38 antibodies also show promise in treating antibody-mediated rejection, while early trials of costimulatory blockade, including anti-CD28, suggest a pathway toward safe tacrolimus minimization or withdrawal. Finally, growing emphasis on novel endpoints and biomarkers reflects a shift toward precision medicine. Artificial intelligence tools that integrate multiomics data are emerging as powerful predictors of graft outcomes. Collectively, these innovations address critical challenges of organ shortage, rejection, and individualized care, charting the next era in transplantation.

2026-01-01·Journal of Immunology Research

Resolving the Interference of Anti‐CD38 Antibodies on Blood Compatibility Assays Using CD38 “Baitbodies” Approach

Article

作者: Hust, Michael ; Steinke, Stephan ; Garritsen, Hendrikus S P ; Gnann, Dianne Celine

Blood transfusion safety depends on swift blood compatibility testing. Alloantibodies recognizing these blood group antigens determine blood compatibility, and the transfusion of incompatible blood can lead to life‐threatening hemolytic transfusion reactions. Recently, the landscape of blood compatibility testing has been complicated due to the interference caused by therapeutic antibodies targeting CD38, a key target in cancer immunotherapy that is also expressed on red blood cells. The presence of anti‐CD38 antibodies in blood samples has been found to bind to test or donor red blood cells, resulting in false positive tests. This interference poses a serious risk as it can potentially mask immunogenic alloantibodies and cause delays in supplying safe blood products. We present the development and application of fragment crystallizable (Fc)‐fusion constructs, referred to as “baitbodies”, designed to neutralize anti‐CD38 antibodies and mitigate false positive test outcomes. The extracellular domain of CD38 was fused to the Fc domain of a murine immunoglobulin G. These baitbody constructs were thoroughly characterized and applied in both serological microcolumn agglutination and automated solid‐phase red cell adherence assays. The CD38‐mFc baitbody successfully prevented agglutination reactions induced by three clinically relevant anti‐CD38 monoclonal antibodies—daratumumab, felzartamab and isatuximab—in spiked samples. This allowed the detection of alloantibodies of the Rhesus, Kell and Duffy blood groups without interference. The CD38‐mFc construct also demonstrated potential in a head‐to‐head comparison with commercial mitigation reagents, DaraEx and Grifols sCD38. Finally, the CD38‐mFc baitbody effectively neutralized daratumumab in patient samples, preventing false positive test outcomes.

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项与菲泽妥单抗相关的新闻（医药）

8 小时之前

·丁香园 Insight 数据库

超 26 亿美元收购！又一款 CD38 单抗在中国获批上市

8 月 12 日，NMPA 官网显示，「菲泽妥单抗」在国内获批上市，治疗多发性骨髓瘤（受理号：CXSS2500003）。截图来源：NMPA 官网菲泽妥单抗（felzartamab，TJ202）是一款靶向 CD38 的在研人源单克隆抗体，在肿瘤及自身免疫性疾病中具有治疗潜力。在多种免疫介导疾病中，菲泽妥单抗有望成为具有首创机制（first-in-class）的创新疗法，并展现出单一产品多适应症开发（pipeline-in-a-product）的潜力。临床研究表明，该药物能够选择性清除 CD38 阳性浆细胞，从而有望改善由致病抗体驱动的多种疾病的临床结局。该药最初由 MorphoSys AG 开发。在海外，2022 年 6 月 HI-Bio 自 MorphoSys 获得了菲泽妥单抗在大中华区以外的全球其它地区的开发和商业化权益；2024 年 7 月，渤健以总额 18 亿美元收购了 HI-Bio，囊获这款重磅管线。而在国内，早在 2017 年 11 月，天境生物就与 MorphoSys 达成合作，获得了菲泽妥单抗在大中华区所有适应症的独家开发和商业化权益。2026 年 4 月 20 日，渤健与天境生物达成合作，获得菲泽妥单抗的大中华区权益，至此将全球权益收归手心。天境生物由此获得 1 亿美元首付款、最高 7.5 亿美元里程碑款以及中个位数至低两位数比例的销售分成。菲泽妥单抗权益流转历史截图来自：Insight 数据库网页版 2019 年，天境生物曾在国内启动一项随机、开放标签、平行对照、多中心 III 期临床研究（试验登记号：NCT03952091/CTR20192600），在至少接受过 1 线治疗的复发或难治性多发性骨髓瘤受试者中比较菲泽妥单抗、来那度胺、地塞米松联合方案与来那度胺、地塞米松联合方案的疗效和安全性。试验在全球共纳入 291 例患者，主要终点为无进展生存期（PFS）。目前该试验已经完成，详细临床数据暂未披露。天境生物新闻稿表示，菲泽妥单抗在 III 期注册性研究中展现出显著优势：与现有疗法相比，在显著降低和减轻输注相关反应、大幅缩短输注时间 (3-5 倍) 的同时，展现出很好的疗效，这些差异化优势有望为广大患者，尤其是对治疗耐受性较为敏感的老年患者群体带来更多获益。关键临床试验时光轴截图来自：Insight 数据库网页版结语 CD38 抗体在多发性骨髓瘤领域的治疗地位已经毋庸置疑。全球范围内此前已有 2 款 CD38 单抗获批治疗多发性骨髓瘤，即强生的达雷妥尤单抗（Darzalex）和赛诺菲的艾沙妥昔单抗（Sarclisa），分别获批于 2015 年和 2020 年。到 2025 年度，两款药物的年度全球销售额合计超过了 150 亿美元，且同比涨幅均超过 20%，表现出强劲的增长态势。而菲泽妥单抗在多发性骨髓瘤的基础之上，还布局了自身免疫领域多个适应症。 Insight 数据库显示，该药用于治疗 IgA 肾病、原发性膜性肾病、肾移植排斥反应 3 个适应症的临床试验均已推动到 III 期，同时还在 II 期阶段布局红斑狼疮适应症。菲泽妥单抗各适应症布局截图来自：Insight 数据库网页版而渤健之所以如此青睐菲泽妥单抗，豪掷超 26 亿美元以囊获此款新药，显然一部分也是基于其在自免领域的优势地位。从临床进展来说，其自免适应症全球 III 期临床已经全面铺开，核心数据有望在 2027 年前后陆续读出。从竞争格局来看，据 Insight 数据库统计，菲泽妥单抗也在第一梯队：全球目前仅有 2 款 CD38 单抗自免适应症推进到了临床 III 期，除菲泽妥单抗外仅有武田的 Mezagitamab。自免适应症开发进度 III 期及以上的 CD38 单抗截图来自：Insight 数据库网页版编辑：ccai 封面来源：站酷海洛免责声明：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。

2026-08-10

·赛业生物订阅号

CD38新药研发风向：从单抗拓展到DAC，人源化模型如何助力？

7月10日，赛诺菲宣布其CD38单抗皮下制剂Sarclisa Escena获FDA批准上市。这是继强生Darzalex Faspro之后，第二款实现皮下给药的抗CD38单抗。这一剂型升级标志着CD38赛道的竞争维度已全面向患者用药体验与多元治疗场景延伸。图1 Sarclisa Escena获FDA批准上市[1] CD38单抗“双雄”格局成型从2015年Daratumumab首次获批至今，CD38已跨越至百亿美元级市场，成为血液肿瘤领域最成功的靶点之一。目前市场呈现强生达雷妥尤单抗（Daratumumab）与赛诺菲Isatuximab“双雄”并立的格局。 Daratumumab：2015年11月，强生的Darzalex获FDA批准。后续全面覆盖了多发性骨髓瘤（MM）各治疗线，并推出皮下制剂Faspro，极大提升了患者便利性。2025年，Daratumumab进一步获批用于高危冒烟型MM，以143.5亿美元的全球销售额稳居全球药品销售额前十[2]。 Isatuximab：2020年，FDA批准赛诺菲的Sarclisa联合泊马度胺和地塞米松治疗复发/难治性MM，成为全球第二款CD38单抗，竞争格局形成。2025年全球销售额约6.30亿美元[3]，随着皮下制剂的获批，市场份额将稳步扩大。两款上市药物已在MM一至四线全面布局，全球已获批近60个国家，并被纳入NCCN等指南优先推荐[4]。随着研究深入，CD38的临床潜力正突破单一的MM领域。 CD38作为一种Ⅱ型跨膜糖蛋白，兼具受体信号传导和胞外酶催化两大功能体系，参与细胞黏附、信号转导、NAD⁺代谢以及免疫调控等多种生理过程。CD38在正常组织中表达有限，但在多种疾病状态下呈现异常表达[5]。图2 CD38的功能及其作为抗体靶点的作用机制[6] 目前，靶向药物的探索已向AL淀粉样变性等浆细胞疾病和淋巴系统恶性肿瘤、白血病等血液系统疾病扩展[7-8]。同时，行业开始聚焦自身免疫疾病、炎症相关疾病以及更广泛的免疫调控领域。在肾移植相关抗体介导的排斥反应（AMR）中，Felzartamab（Biogen）的II期试验已显示出高缓解率，并已推进至III期临床；Daratumumab在系统性红斑狼疮（SLE）和视神经脊髓炎谱系疾病（NMOSD）中的探索性研究也获得了积极信号[9-13]。图3 适应症扩展的CD38单抗药物面对抗体药物的日益成熟，行业亟需技术突破以进一步挖掘靶点潜力。 DAC赛道启幕： CD38迎来下一代竞争新变量降解剂-抗体偶联物（DAC）作为一种前沿的创新药物形式，为CD38赛道提供了全新的探索方向。作为ADC技术的延伸，DAC搭载的并非广谱细胞毒素，而是PROTAC或分子胶等靶向蛋白降解剂，将抗体作为高精度的“导航载体”，利用其对抗原的高特异性识别，将蛋白降解剂精准递送至肿瘤细胞内部，特异性降解对肿瘤生存至关重要的关键蛋白（如IKZF1/3），进而引发凋亡级联反应[14]。图4 DAC的结构和靶向降解胞内蛋白功能[15] 因此，DAC靶点不仅要具备高效的内吞与溶酶体逃逸能力，还需确保表达该靶点的肿瘤细胞对降解剂靶向的蛋白高度依赖，且其降解足以驱动肿瘤细胞凋亡。 CD38在一众靶点中杀出重围，成为DAC药物极具潜力的“锚点”。一方面，CD38在多发性骨髓瘤（MM）细胞表面呈现均一且高水平的过表达，同时已有研究证实Daratumumab等CD38抗体介导的内吞效率足以支撑Payload的胞内递送；另一方面，MM细胞的生存高度依赖于IKZF1/3转录因子的活性，而CELMoD类降解剂能高效诱导IKZF1/3的泛素化降解[16-17]。 2025年9月，浙江大学/中科院上海药物研究所团队发表里程碑研究：以daratumumab为抗体部分，一种新型Cereblon E3连接酶调节因子（CELMoD）I034为降解剂payload，通过化学偶联构建DAC，并在体内模型中实现了肿瘤的完全消除。值得注意的是，在降解IKZF1/3后可上调CD38表达，形成正反馈，进一步增强疗效。Dara-VA-I034首次在体内模型中验证了DAC概念在CD38领域的可行性[18]。图5 Dara-VA-I034通过CD38靶向实现肿瘤消除[18] DAC实现了将蛋白质降解技术的催化活性与ADC的组织特异性有机结合，相比于传统ADC分子，DAC规避了小分子毒素易损伤正常组织的问题，具有更强的细胞杀伤效率，同时一个降解剂分子可反复催化降解多个靶蛋白分子。因此，DAC有望成为CD38领域下一代核心竞争方向。 2026年4月，超阳药业在AACR年会上公布其CD38-DAC管线DAC-002的临床前数据，成为大会亮点之一。DAC-002以达雷妥尤单抗为抗体部分，搭载优化可切割接头与强效IKZF1/3分子胶降解剂CY001-80。在H929小鼠异种移植模型中，单次2 mg/kg给药即达到73%的肿瘤生长抑制率，疗效显著优于达雷妥尤单抗（6 mg/kg）与CY001-80口服联用组；单次高剂量可实现肿瘤完全消退。同时，DAC-002在非人灵长类（NHP）中初步展现出良好的安全性特征[19]。此外，恒瑞医药、石药集团等国内头部药企也已相继披露其在CD38-DAC药物管线的布局。图6 CD38-DAC药物管线情况然而，目前CD38 DAC药物开发目前仍处早期，所涉及药物管线均处于临床前研究阶段，安全性与转化数据仍需进一步验证。赛业CD38人源化小鼠模型为衔接创新与转化赋能在CD38-DAC等创新疗法开发中，选择合适的动物模型对评估药效与安全性至关重要。然而，人鼠CD38的氨基酸序列一致性仅约为58%，且CD38在免疫细胞上的表达谱存在物种间差异。而双抗与DAC等创新疗法对“人源靶点+人源免疫效应”的要求更高，传统小鼠模型难以准确评估真实药效，也难以确认药物肝毒性与细胞因子释放综合征（CRS）风险。因此，CM313等CD38抗体药物管线，在临床前阶段引入CD38人源化小鼠模型开展药效与安全性评价，以提高临床转化预测能力[20]。为缩短药物发现到临床验证之间的距离，赛业生物自主研发了CD38人源化小鼠（产品编号：C002047），该模型成功表达人源CD38蛋白，有望真实反映CD38靶向药物在人体内的作用机制与疗效差异。图7 CD38人源化小鼠FACS检测数据扫码咨询订购本文作者：Hazel 编辑：西米审核：西米、🍑momo 参考文献： [1]Sanofi. (2026, July 10). Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector [Press release]. [2]Genmab A/S. (2026, January 21). Genmab Announces Net Sales of DARZALEX® (daratumumab) for 2025 [Press release]. [3]Sanofi. (2026, January 29). Q4 and Full Year 2025 Results [Press release]. [4]NCCN Guidelines®: Multiple Myeloma, Version 5.2026. [5]Horenstein AL, et al. The Circular Life of Human CD38: From Basic Science to Clinics and Back. Molecules. 2020;25(20):4844. [6]Rabelink TJ, de Vries APJ. CD38 - a new target in renal immune disease. Nat Rev Nephrol. 2024;20(10):641-642. [7]Kastritis E, Palladini G, Minnema MC, et al. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis. N Engl J Med. 2021;385(1):46-58. [8]Glisovic-Aplenc T, Diorio C, Chukinas JA, et al. CD38 as a pan-hematologic target for chimeric antigen receptor T cells. Blood Adv. 2023;7(16):4418-4430. [9]Mayer KA, et al. A Randomized Phase 2 Trial of Felzartamab in Antibody-Mediated Rejection. N Engl J Med. 2024;391(2):122-132. [10]ClinicalTrials.gov：NCT06685757. [11]Ostendorf L, et al. Daratumumab in systemic lupus erythematosus: a single-arm phase 2 trial. Nature Communications. 2026;17:1312. [12]Ostendorf L, et al. Targeting CD38 with Daratumumab in Refractory Systemic Lupus Erythematosus. N Engl J Med. 2020;383:1149-1155. [13]ClinicalTrials.gov：NCT05403138. [14]Dragovich PS. Degrader-antibody conjugates. Chem Soc Rev. 2022;51(10):3886-3897. [15]Long R, Zuo H, Tang G, et al. Antibody-drug conjugates in cancer therapy: applications and future advances. Front Immunol. 2025;16:1516419. [16]Yu YH, Tian WT, Grauffel C, et al. An Antibody-Drug Conjugate for Multiple Myeloma Prepared by Multi-Arm Linkers. Adv Sci (Weinh). 2024;11(20):e2307852. [17]Krönke J, Udeshi ND, Narla A, et al. Lenalidomide causes selective degradation of IKZF1 and IKZF3 in multiple myeloma cells. Science. 2014;343(6168):301-305. [18]Li J, et al. Rational engineering of degradation tail-driven CELMoD–antibody conjugates for precision malignancy therapy. Acta Pharmaceutica Sinica B. 2025;15(12):6510-6528. [19]Liu, et al. (2026). DAC-002, a novel IKZF1/3 MGD-CD38 degrader-antibody conjugate for MM treatment [Abstract]. Cancer Research, 86(8_Supplement), LB049. [20]Liu W, Yu J, Sun K, et al. Preclinical characterization of a novel investigational monoclonal antibody CM313 with potent CD38-positive cell killing activity. Front Immunol. 2024;15:1410457. 相关推荐从“快乐假象”到疾病真相：Ube3a KO小鼠揭秘天使综合征的“微笑”之殇诺华31亿重金回购FXI靶向疗法，F11“人源化”小鼠助力终结【抗凝出血】难题小身躯，大使命：挑战人体最大基因DMD的人源化小鼠靶向成纤维细胞的Col1a2-iCre小鼠（附赠工具鼠取材验证重组效率的解决方案）工具鼠系列：MerCreMer与CreERT2的诱导方式有何异同？寻找更好的动脉粥样硬化模型——B6J-Apoe KO小鼠 HFD+CCl4诱导的代谢功能障碍相关性脂肪肝炎MASH（NASH）小鼠结直肠癌（CRC）&家族性腺瘤性息肉病（FAP）研究模型——Apc KO小鼠 SKG小鼠——类风湿性关节炎（RA）和强直性脊柱炎（AS）研究好帮手点击“阅读原文” 立即咨询

2026-08-07

·动脉网

渤健2026年并购密集，加速构建第二增长曲线

渤健2026年并购密集，加速构建第二增长曲线。近日，其完成对RayThera的收购，后者专注免疫学小分子疗法，此次收购将巩固渤健免疫学产品组合。实际上，2026年渤健已完成一系列关键交易：3月31日，斥资56亿美元收购Apellis，获两款获批药物；3月25日，与Alteogen达成协议，获两款生物制剂皮下注射制剂独家开发与商业化权；4月，与天境生物达成协议，以8.5亿美元获菲泽妥单抗大中华区权益，此前已获其全球（除大中华区外）权益，并启动多项全球三期临床试验。这一系列交易显示渤健正从神经科学向高增长免疫学等领域拓展。

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

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
多发性骨髓瘤	中国	天境生物药业（杭州）股份有限公司	2026-08-11

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
微血管疾病	临床3期	美国	Biogen, Inc.	2026-04-16
特发性膜性肾病	临床3期	美国	天境生物药业（杭州）股份有限公司	2025-05-22
特发性膜性肾病	临床3期	美国	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	中国	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	日本	天境生物药业（杭州）股份有限公司	2025-05-22
特发性膜性肾病	临床3期	日本	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	阿根廷	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	阿根廷	天境生物药业（杭州）股份有限公司	2025-05-22
特发性膜性肾病	临床3期	澳大利亚	Biogen, Inc.	2025-05-22
特发性膜性肾病	临床3期	澳大利亚	天境生物药业（杭州）股份有限公司	2025-05-22

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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, CTgov)	临床2期	免疫球蛋白a肾病	54	Placebo (Part 1: Placebo)	夢鑰積艱願鏇觸鏇鏇醖(鏇鏇簾選鹹繭觸艱憲積) = 顧夢憲鏇顧夢憲鹹鹽膚廠簾壓願繭襯糧醖壓築 (網繭齋觸繭窪獵構獵艱, 19.43) 更多	-	2026-04-28
				Placebo+Felzartamab (Part 1: Felzartamab Dosing Arm M1)	夢鑰積艱願鏇觸鏇鏇醖(鏇鏇簾選鹹繭觸艱憲積) = 夢願遞夢衊繭糧鑰衊獵廠簾壓願繭襯糧醖壓築 (網繭齋觸繭窪獵構獵艱, 19.41) 更多
NCT05065970 (IGNAZ, ASN2025)	临床2期	免疫球蛋白a肾病	54	Felzartamab	憲築鹹獵膚構遞憲鑰積(膚鏇構積簾觸獵鹽淵齋) = 廠積廠築膚糧窪憲願壓積遞艱鑰網壓簾窪夢餘 (簾廠獵鹹艱餘餘襯構鬱 ) 更多	积极	2025-11-07
NCT05065970 (IGNAZ, Pubmed \| Kidney Int \| ASN2025)	临床2期	免疫球蛋白a肾病	54	Felzartamab 2-dose	鹽憲齋膚鹽糧蓋廠鏇衊(糧艱遞艱淵襯壓蓋鏇繭) = Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2. 選壓糧製齋積構壓鬱鬱 (範鬱繭觸窪齋蓋廠簾繭 )	积极	2025-10-01
				Felzartamab 5-dose
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)	積餘糧襯範衊鬱廠願築(膚構獵網鬱鏇築夢鬱觸) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. 顧觸襯蓋醖鏇鹹鹹艱齋 (觸窪齋鑰醖鬱顧繭廠觸 ) 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	鬱餘築顧衊簾糧衊簾鏇(願鬱衊憲簾範窪襯製壓) = 觸艱壓獵齋網膚鏇範鏇鏇糧製製遞夢鬱淵艱蓋 (觸範築範鏇選構簾鬱觸 ) 更多	积极	2024-06-20
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	憲醖齋製鏇範繭顧蓋簾(製鏇製網鑰願廠蓋廠網) = 網廠壓憲淵網獵繭窪夢夢襯淵製憲範窪壓範壓 (餘觸廠艱願壓獵蓋廠窪 )
NCT05021484 (NEWS) 人工标引	临床2期	肾移植排斥反应	22	Felzartamab	襯鹽憲衊鬱遞鑰憲顧蓋(鑰鏇鑰簾醖廠觸鹽衊醖) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. 窪繭構簾構獵襯觸餘壓 (糧齋範餘遞齋願夢窪製 )	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	齋範繭構繭廠網糧廠淵(鏇選糧憲觸餘遞範憲網) = 範壓構艱築鹹網繭壓餘範餘糧憲繭蓋製窪醖顧 (憲網積願壓顧餘製憲餘 )	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	鑰鹹製製繭夢願遞膚壓(衊衊壓夢願積選憲顧選) = 鹽齋網糧夢蓋獵餘築願鹹簾鏇築艱願製鑰醖蓋 (選糧遞衊鏇積築顧鬱鏇 ) 更多	积极	2023-11-02
				Felzartamab (newly diagnosed or relapsed patients)	獵襯鏇範願鹽壓顧糧鹽(獵鑰構築壓膚齋憲範餘) = 築願遞憲窪襯築範製製鹹鹹獵獵築襯艱齋顧鏇 (願鏇簾夢願蓋夢製襯觸 ) 更多
NCT04145440 (M-PLACE, ASN2023)	临床1/2期	特发性膜性肾病 aPLA2R+	31	Felzartamab (Cohort 1)	網願艱範遞構醖繭築簾(憲積鹽襯選遞選餘襯積) = 艱憲觸齋鑰獵糧簾醖範鏇鹹壓夢膚獵積鹽構壓 (夢艱選鑰艱衊鹹醖齋獵 ) 更多	积极	2023-11-02
				Felzartamab (Cohort 2)	衊積夢膚衊獵鏇齋鹽積(窪糧簾膚鹹網膚窪夢獵) = 廠簾糧憲鏇範遞糧積構遞築齋齋齋鑰窪鑰襯鹹 (範製鏇簾鑰齋觸餘糧鹹 ) 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	觸鑰遞網壓鹽壓衊網繭(夢繭觸齋壓襯網獵淵壓) = 憲繭糧簾願製艱願鹹膚糧選構衊觸醖艱網壓窪 (蓋艱襯構簾構壓膚襯夢 )	积极	2022-11-05