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.

NCT06962800

/ Recruiting临床3期

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.

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专利（医药）

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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.

364

项与菲泽妥单抗相关的新闻（医药）

2026-06-26

·制药网

该药企56亿美元并购后开始砍管线、裁员

点击蓝字关注我们~ 今年5月，Biogen斥资56亿美元！完成对Apellis Pharmaceuticals的收购。然而，在斥资56亿美元收购Apellis后月余，Biogen便开始对Apellis进行大规模砍管线。有分析表示，这看似“高价收购、快速精简”的矛盾操作，实则是Biogen精准布局免疫学赛道、优化资源配置的战略抉择。　　有媒体报道，Biogen已暂停或取消了Apellis的大多数研临床前及临床研发项目，裁撤“少数”研发人员。　　据悉，今年5月，交易完成后，Biogen便开始全面评估Apellis的研发管线，近日相关人士表示，作为Apellis整合的一部分，公司正在对前Apellis临床和临床前产品组合进行全面审查，以进一步评估战略契合度。　　而今年1月，在收购交易宣布之前，Apellis相关人士曾表示，公司“具备依靠商业化收入自我造血的能力，希望推动长期可持续创新。然而，并购完成后，这一战略几乎宣告终止，且多个核心高管也陆续离职。　　资料显示，Apellis是专注于严重补体驱动疾病治疗的企业，拥有两款已获FDA批准的商业化药物EMPAVELI、SYFOVRE。其中，SYFOVRE获批用于治疗继发于年龄相关性黄斑变性的地图样萎缩(GA)；EMPAVELI获批用于治疗C3肾小球病(C3G)与阵发性夜间血红蛋白尿症(PNH)。数据显示，2025年，这两款产品合计实现净销售额6.89亿美元。　　除了上述2款产品外，Apellis管线还包括基因编辑补体疗法、口服补体抑制剂、与Beam Therapeutics合作开发的基因编辑FcRn项目APL-9099，该药物按公司原计划于今年下半年进行IND申请，以及多个处于临床前阶段的候选产品。　　分析指出，当初Biogen收购Apellis的意义不止于两款已上市产品。Biogen正在推进felzartamab(一款抗CD38单抗)在多种罕见肾病中的III期临床，预计2027年上半年头次数据读出。Felzartamab已进入三项III期研究，分别针对肾移植后的晚期抗体介导排斥反应、IgA肾病和原发性膜性肾病。从机制上看，Felzartamab靶向产生致病抗体的浆细胞，而EMPAVELI则作用于补体系统的下游效应，二者形成“源头抑制+效应阻断”的组合，覆盖了免疫介导肾病从发病机制到临床表现的完整链条。　　尽管收购Apellis后，Biogen砍管线、裁员。但是不可否认的是，Biogen正在以“扫货”式的节奏构建起从早期发现到商业化产品的完整免疫学版图。　　除了收购Apellis获得两款已上市免疫药物EMPAVELI和SYFOVRE，今年4月Biogen与天境生物达成8.5亿美元协议获得菲泽妥单抗大中华区权益。6月17日，渤健(Biogen)又宣布与总部位于加州圣地亚哥的私营生物技术公司RayThera达成最终收购协议，交易总价值最高可达10亿美元，此次RayThera的核心管线涵盖多个抗炎小分子候选药物，旨在治疗免疫介导性疾病，其候选药物预计将在2026年第三季度初进入I期临床开发阶段。　　纵观Biogen的系列操作，高价收购后精简管线并非资源浪费，而是成熟药企专业化整合的逻辑。通过剥离契合度低、研发周期长的项目，集中资金、人力、技术资源深耕高价值核心产品，更大化释放并购资产的商业价值。在全球生物医药行业精细化竞争的当下，Biogen通过精准并购、高效整合、战略聚焦的组合拳，持续巩固自己的地位。　　免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。文章来源：制药网 >更多精彩： · 中药行业再释放红利！ · “医药一哥”急刹车 · 近日，医药出海大单集中爆发！ · “国药系”接连卖4家公司 · 华润系再出手！戳“阅读原文”一起进步

2026-06-26

·制药网

56亿美元并购后，这家头部药企便开始砍管线、裁员

【制药网行业动态】今年5月，Biogen斥资56亿美元！完成对Apellis Pharmaceuticals的收购。然而，在斥资56亿美元收购Apellis后月余，Biogen便开始对Apellis进行大规模砍管线。有分析表示，这看似“高价收购、快速精简”的矛盾操作，实则是Biogen精准布局免疫学赛道、优化资源配置的战略抉择。　　有媒体报道，Biogen已暂停或取消了Apellis的大多数研临床前及临床研发项目，裁撤“少数”研发人员。　　据悉，今年5月，交易完成后，Biogen便开始全面评估Apellis的研发管线，近日相关人士表示，作为Apellis整合的一部分，公司正在对前Apellis临床和临床前产品组合进行全面审查，以进一步评估战略契合度。　　而今年1月，在收购交易宣布之前，Apellis相关人士曾表示，公司“具备依靠商业化收入自我造血的能力，希望推动长期可持续创新。然而，并购完成后，这一战略几乎宣告终止，且多个核心高管也陆续离职。　　资料显示，Apellis是专注于严重补体驱动疾病治疗的企业，拥有两款已获FDA批准的商业化药物EMPAVELI、SYFOVRE。其中，SYFOVRE获批用于治疗继发于年龄相关性黄斑变性的地图样萎缩(GA)；EMPAVELI获批用于治疗C3肾小球病(C3G)与阵发性夜间血红蛋白尿症(PNH)。数据显示，2025年，这两款产品合计实现净销售额6.89亿美元。　　除了上述2款产品外，Apellis管线还包括基因编辑补体疗法、口服补体抑制剂、与Beam Therapeutics合作开发的基因编辑FcRn项目APL-9099，该药物按公司原计划于今年下半年进行IND申请，以及多个处于临床前阶段的候选产品。　　分析指出，当初Biogen收购Apellis的意义不止于两款已上市产品。Biogen正在推进felzartamab(一款抗CD38单抗)在多种罕见肾病中的III期临床，预计2027年上半年头次数据读出。Felzartamab已进入三项III期研究，分别针对肾移植后的晚期抗体介导排斥反应、IgA肾病和原发性膜性肾病。从机制上看，Felzartamab靶向产生致病抗体的浆细胞，而EMPAVELI则作用于补体系统的下游效应，二者形成“源头抑制+效应阻断”的组合，覆盖了免疫介导肾病从发病机制到临床表现的完整链条。　　尽管收购Apellis后，Biogen砍管线、裁员。但是不可否认的是，Biogen正在以“扫货”式的节奏构建起从早期发现到商业化产品的完整免疫学版图。　　除了收购Apellis获得两款已上市免疫药物EMPAVELI和SYFOVRE，今年4月Biogen与天境生物达成8.5亿美元协议获得菲泽妥单抗大中华区权益。6月17日，渤健(Biogen)又宣布与总部位于加州圣地亚哥的私营生物技术公司RayThera达成最终收购协议，交易总价值最高可达10亿美元，此次RayThera的核心管线涵盖多个抗炎小分子候选药物，旨在治疗免疫介导性疾病，其候选药物预计将在2026年第三季度初进入I期临床开发阶段。　　纵观Biogen的系列操作，高价收购后精简管线并非资源浪费，而是成熟药企专业化整合的逻辑。通过剥离契合度低、研发周期长的项目，集中资金、人力、技术资源深耕高价值核心产品，更大化释放并购资产的商业价值。在全球生物医药行业精细化竞争的当下，Biogen通过精准并购、高效整合、战略聚焦的组合拳，持续巩固自己的地位。　　免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。

2026-06-24

·ClinTrials Talk+

2026年6月24日（星期三）医药晨间快报

👋 各位读者朋友，早上好！今天是 2026年6月24日（星期三），为您带来今日份的医药晨间快报。【本期核心动向】· 艾伯维109亿美元收购Apogee 💼 五年多来最大并购，押注IL-13长效抗体，剑指赛诺菲Dupixent百亿市场。· 礼来78亿美元收购Centessa获英国法院批准 💼 今日完成交割，OX2R激动剂项目补强神经科学管线。· 海思科再签14.61亿美元BD大单 💼 半年内第四笔海外授权，两款创新药授权Nuvectis，半年BD总金额超60亿美元。· 第十二批国采正式启动 🛠️ 65个品种入围，8个涉专利争议品种，规则升级强化知识产权管控。· 麦科医药-B今日港交所挂牌上市 📈 西北地区首家18A企业登陆港股。📰 MNC·全球并购与药企动态1. 【艾伯维】109亿美元收购Apogee，五年多来最大并购 6月22日，艾伯维（ABBV.US）宣布以约109亿美元全现金收购临床阶段生物技术公司Apogee Therapeutics（APGE.US）。收购价每股135.11美元，较Apogee上周四收盘价溢价约49%。核心资产zumilokibart（APG777）是一款靶向IL-13的长效单抗，二期数据显示可实现每3至6个月给药一次，有望挑战赛诺菲Dupixent（每年26次注射）。这是艾伯维自2019年以630亿美元收购艾尔建以来的最大一笔交易，交易预计2026年Q3完成。受此消息提振，Apogee盘初股价暴涨近47%，艾伯维亦上涨约4.6%。据行业媒体STAT统计，2026年上半年全球生物医药领域10亿美元以上的收购至少已有34起，总金额突破1300亿美元，已超过2025年全年水平。2. 【礼来】78亿美元收购Centessa获英国法院批准，今日完成交割 6月23日，英国高等法院批准礼来以约78亿美元收购Centessa Pharmaceuticals。Centessa股东将获得每股38美元现金，并有资格获得每股最高9美元的或有价值权（CVR）。该交易预计在6月24日法院命令送达公司注册官后完成。礼来将获得靶向orexin机制的睡眠神经药物项目，orexin机制被认为具备类似GLP-1的广泛代谢疾病延展潜力。3. 【渤健】10亿美元收购RayThera，三个月内第三笔免疫学并购 6月17日，渤健宣布以最高10亿美元收购私营生物技术公司RayThera。RayThera由董青博士和洪基医学博士联合创立（二人此前创立的XinThera于2023年被吉利德收购），专注于免疫学小分子疗法，领先候选药物预计2026年Q3初进入I期临床。这是渤健继56亿美元收购Apellis、8.5亿美元获得天境生物菲泽妥单抗大中华区权益后，三个月内第三笔免疫学重磅交易。🔬 CXO·国内外整合与景气度4. 【东方证券】CXO行业景气高位运行，国内资金端、研发端、订单端多重共振 6月23日，东方证券发布研报称，2026年前五个月国内CXO行业高景气持续，资金端、研发端、订单端多重因素共振向上。BD交易方面，2026年Q1交易总额达614亿美元，单季超过2024年全年590亿美元。临床CRO龙头新签订单和在手订单均有所改善，订单价格开始回升；供给端经历价格战和中小企业出清后，头部企业有望持续提升份额。5. 【保瑞药业】5月营收创历史新高，CDMO稼动率明显回升中国台湾CDMO药厂保瑞药业5月单月合并营收重回20亿元新台币并创历史新高。CDMO业务较Q1月均值提升41.27%、较4月成长16.06%，为历史第三高。公司近期与全球前20大跨国药厂签署“10加2年”长期制造协议。💼 创新药BD·出海与首付款6. 【海思科】与Nuvectis签署14.61亿美元授权协议，半年内第四笔BD 6月23日，海思科（002653.SZ）公告与美国Nuvectis Pharma签订独占许可协议。授予Nuvectis在全球范围（大中华区除外）开发HSK42360的独家权利，以及在全球范围（大中华区、东南亚及印度除外）开发HSK39297的独家权利。海思科将获得4000万美元首付款和近期里程碑付款，以及最高14.21亿美元额外里程碑付款，外加销售提成。HSK42360是BRAF paradoxical breaker抑制剂，可克服第一代BRAF抑制剂的耐药问题；HSK39297是补体B因子小分子抑制剂，已在中国递交PNH适应症NDA。这是海思科半年内落地的第四笔BD交易，累计总金额已超60亿美元。7. 【BD出海持续高景气】2026年全年交易总额有望突破1500亿美元据医药魔方预测，2026年全年中国创新药BD交易总额有望突破1500亿美元大关。Q1交易总额已达614亿美元，超过2024年全年总和。BD出海已成为中国创新药企最重要的资金来源之一，覆盖小分子、ADC、双抗、小核酸、基因治疗、AI制药等全赛道。💊 新药审批·全球监管动态8. 【NMPA】迈威生物6MW5311注射液获临床试验批准 6月24日，迈威生物（688062.SH）公告，注射用6MW5311获NMPA临床试验批准，同意单药在复发/难治血液瘤中开展临床试验。此前该药已获FDA临床试验许可，成为全球首款获批开展临床试验的靶向LILRB4/CD3的TCE创新药。9. 【NMPA】新华制药LXH-2103注射液获临床试验批准 6月22日，新华制药公告，公司收到国家药监局核准签发的LXH-2103注射液《药物临床试验批准通知书》。10. 【NMPA】东亚药业依帕司他片获药品注册证书 6月24日，东亚药业公告，依帕司他片获得NMPA药品注册证书。📊 政策宏观与资本市场11. 【第十二批国采】正式启动，65个品种入围，规则升级强化知识产权管控 6月23日，国家组织药品联合采购办公室发布第12批国采公告，正式启动集采工作。本次共纳入65个品种，其中16款单品在公立医疗机构年销超10亿元，高血压大品种沙库巴曲缬沙坦在列。申报资格截止日为2026年6月23日（含）前获得国内有效注册批件的产品。新规重点强化知识产权管控，8个涉专利争议品种，企业若无法出具无侵权承诺将直接撤网。同时优化报价锚点机制严控低价内卷，加码境外仿制药质量审核。药品信息填报时间为6月23日至6月26日，投标报名截至7月13日。12. 【第十二批国采规则解读】参比制剂复活机制落地，原研药可获医院准入资格第12批集采延续“稳临床、保质量、反内卷、防围标”原则。延续第11批按厂牌报量做法，并新增报价未入围的参比制剂不带量复活机制——原研药只要主动下调报价且符合规则也能复活中选，可获得医院准入资格。此外，进口参比制剂转移至境内生产的药品可以参与投标。集采还新增中选药品开展质量回顾分析的要求。13. 【麦科医药-B】今日港交所挂牌上市，西北地区首家18A企业陕西麦科奥特医药科技股份有限公司将于6月24日正式在港交所主板挂牌上市，成为西北地区首家以18A规则上市的未盈利生物科技企业。发行价区间18.2-21港元，基石投资者认购总金额约4.49亿港元。14. 【礼邦医药-B】今日招股截止，6月29日上市礼邦医药-B于6月18日至6月24日招股，全球发售5675.54万股H股，发售价每股22.60港元，预期6月29日上市。15. 【国家医保局】药品比价小程序全国上线，精准破解药价乱象全国31个省份及新疆生产建设兵团已全部完成药品比价小程序上线，基本实现三个“全部”：全部统筹区域医保患者可及、全部医保定点药店价格公开、全部医保目录内药品可查。📖 晨间共勉“创新需要坚持，也需要勇气。”—— 杰夫·贝索斯（亚马逊创始人）【免责声明】本快报基于公开信息整理，旨在传递行业动态，不构成任何投资或医疗建议。具体内容请参考官方公告。关注我，每日清晨，与您共读医药新的一天。

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	天境生物药业（杭州）股份有限公司	2025-01-08
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

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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)	觸鑰醖齋獵顧淵鹽淵獵(鹽壓鹹獵夢築窪鬱選願) = 淵憲選願繭觸衊製鏇鹽範艱觸構範製遞廠襯築 (網醖憲遞築淵製範簾簾, 19.43) 更多	-	2026-04-28
				Placebo+Felzartamab (Part 1: Felzartamab Dosing Arm M1)	觸鑰醖齋獵顧淵鹽淵獵(鹽壓鹹獵夢築窪鬱選願) = 願簾齋製醖蓋選蓋壓餘範艱觸構範製遞廠襯築 (網醖憲遞築淵製範簾簾, 19.41) 更多
NCT05065970 (IGNAZ, ASN2025)	临床2期	免疫球蛋白a肾病	54	Felzartamab	鬱膚餘鑰膚鹽餘膚廠齋(鏇膚壓範網顧獵範築廠) = 廠築蓋獵糧範簾鹹鏇鏇艱繭壓壓鏇壓製網艱鬱 (淵襯齋艱鏇繭憲廠壓壓 ) 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	艱齋築衊觸繭鏇鏇齋簾(壓觸夢齋廠鹽構餘艱觸) = Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2. 淵憲觸範顧鏇鹽構淵餘 (夢範衊鹽衊襯遞遞醖構 )	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)	構衊顧鏇鏇簾簾窪艱繭(艱齋獵築鏇願製夢觸鏇) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. 蓋遞鏇鹽餘鏇窪築網廠 (積鏇夢築鏇鬱鑰餘觸鏇 ) 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	膚鏇淵廠艱簾範餘壓獵(窪餘築顧齋窪鬱蓋簾築) = 鹽膚夢願鹹夢鹽衊糧範齋壓網艱襯鹹製鑰觸繭 (艱餘範鏇網觸齋廠築齋 ) 更多	积极	2024-06-20
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	餘壓齋觸網顧鏇憲構鹹(製築壓艱窪壓積構壓簾) = 壓鹹壓構憲蓋鬱鑰鏇夢觸積膚壓齋鬱淵簾選憲 (鑰鑰蓋鹹壓範觸憲願衊 )
NCT05021484 (NEWS) 人工标引	临床2期	肾移植排斥反应	22	Felzartamab	窪壓艱願艱鹹鏇鑰淵窪(選顧鏇顧網遞觸衊壓齋) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. 艱齋壓蓋醖積壓範淵製 (繭遞鑰築糧餘醖網製顧 )	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	築遞淵艱鏇廠鹹願願蓋(築築淵廠選繭鹽積衊觸) = 觸顧醖壓憲網艱淵顧網鏇淵壓選餘衊鬱鹽齋鑰 (繭齋鹹獵鬱糧鹹憲蓋蓋 )	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	簾鹹憲繭鹹襯積鏇淵壓(簾蓋積遞鹽築積簾淵遞) = 製廠糧積觸廠夢淵構鏇齋遞鬱網蓋顧鑰襯觸廠 (構鏇繭齋鬱鹹窪窪觸糧 ) 更多	积极	2023-11-02
				Felzartamab (newly diagnosed or relapsed patients)	壓獵蓋構觸鑰襯鬱窪顧(積製廠廠襯鹽製獵窪簾) = 構願鏇夢夢顧壓餘繭鹹鏇願築遞鹽築鹽獵鬱願 (鏇窪構鏇選願選願襯願 ) 更多
NCT04145440 (M-PLACE, ASN2023)	临床1/2期	特发性膜性肾病 aPLA2R+	31	Felzartamab (Cohort 1)	餘選夢鬱衊夢顧鹹襯鹽(憲艱廠齋鹽糧蓋膚獵鹽) = 鏇觸壓願蓋憲鏇簾衊範憲窪範壓鑰積鑰構獵糧 (廠觸齋網襯憲網繭觸糧 ) 更多	积极	2023-11-02
				Felzartamab (Cohort 2)	築蓋衊餘網網襯積選鬱(廠鬱餘淵築廠構衊糧遞) = 廠齋醖選夢淵構衊積獵襯顧憲願築築範醖淵構 (簾鹹顧餘構夢網遞衊夢 ) 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	廠襯蓋憲鬱遞窪壓網醖(糧齋餘衊範襯觸製餘願) = 顧選壓鑰餘鑰範衊襯構觸顧製積餘鏇醖蓋鹽選 (夢範夢廠壓築顧遞衊鬱 )	积极	2022-11-05