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.

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.

496

项与菲泽妥单抗相关的新闻（医药）

2026-08-21

·CPHI制药在线

5款创新药密集获批，恒瑞、三生国健、天境生物等迎来新进展

关注并星标CPHI制药在线近日，国内创新药审批再次迎来一轮密集进展。国家药监局近期陆续批准富马酸立康可泮胶囊、安弗利奇塔单抗注射液、注射用菲泽妥单抗、替恩戈替尼片和小儿通便颗粒上市，涉及阵发性睡眠性血红蛋白尿症（PNH）、痛风性关节炎、多发性骨髓瘤、胆管癌以及儿童便秘等多个治疗领域。从罕见病小分子药物，到抗体药物、肿瘤靶向药，再到中药创新药，这批新品的集中落地，也展现出当前国内创新药研发更加多元化的一面。恒瑞再下一城，立康可泮获批PNH 恒瑞医药子公司成都盛迪医药申报的富马酸立康可泮胶囊通过优先审评审批程序获批上市，商品名为恒优达，用于治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者。该产品属于1类创新药。 PNH是一种罕见的获得性血液系统疾病，补体异常激活会导致红细胞破坏，引起溶血、贫血，并增加血栓等严重并发症风险。立康可泮研发代号为HRS-5965，是恒瑞自主研发的一款口服选择性补体因子B抑制剂。与传统从补体末端进行干预的治疗思路不同，HRS-5965靶向补体旁路中的因子B（Factor B）。支持本次获批的 Ⅲ 期临床研究显示，在未接受过补体抑制剂治疗的 PNH 成人患者中，立康可泮可显著提升血红蛋白水平，有效降低溶血相关指标，相比传统 C5 抑制剂展现出差异化治疗价值。对于恒瑞而言，这也意味着其创新药版图进一步延伸至补体相关疾病和罕见病领域。三生国健：IL-1β抗体进入痛风治疗另一款值得关注的产品来自三生国健。国家药监局批准三生国健申报的安弗利奇塔单抗注射液（皮下注射）上市，商品名为益赛那，用于部分常规治疗受限的成人痛风性关节炎急性发作患者。安弗利奇塔单抗研发代号为SSGJ-613，是一款针对IL-1β的人源化单克隆抗体。IL-1β是痛风急性炎症反应中的重要炎症介质，因此，阻断IL-1β提供了一条区别于非甾体抗炎药、秋水仙碱以及糖皮质激素的治疗路径。已经发表的Ⅱ期临床研究显示，在中国急性痛风性关节炎患者中，单次皮下注射SSGJ-613能够产生与糖皮质激素对照相近的疼痛改善，同时在研究观察期内降低再次急性发作的风险。此次获批适应症也明确针对非甾体抗炎药和/或秋水仙碱禁忌、不耐受或缺乏疗效，以及不适合反复使用类固醇激素的成人患者，因此其临床价值更多体现在为现有治疗手段受限的人群增加新的选择。天境生物CD38抗体落地多发性骨髓瘤在血液肿瘤领域，天境生物也迎来一项重要进展。国家药监局批准天境生物药业（杭州）申报的注射用菲泽妥单抗上市，商品名为境斐。该产品联合来那度胺和地塞米松，用于既往至少接受过一线治疗的多发性骨髓瘤成年患者。菲泽妥单抗（Felzartamab）是一款针对CD38的人源单克隆抗体。CD38在浆细胞等细胞表面表达，也是多发性骨髓瘤领域已经得到验证的重要治疗靶点。值得注意的是，菲泽妥单抗的价值并不局限于多发性骨髓瘤。目前这一分子还被探索用于多种由致病性抗体驱动的免疫相关疾病，其“一个分子、多种疾病”的开发潜力也受到行业关注。随着此次获批，天境生物在国内的核心产品也正式迈入商业化阶段。替恩戈替尼：瞄准FGFR抑制剂耐药患者肿瘤靶向治疗方面，药捷安康的替恩戈替尼片也在近期通过优先审评审批程序获得附条件批准。其商品名为捷恩泰，用于既往接受过系统性治疗和FGFR抑制剂治疗，且具有FGFR2融合或重排的晚期、转移性或不可手术切除胆管癌成人患者。这一适应症最大的特点在于：患者此前已经接受过FGFR抑制剂治疗。 FGFR2融合或重排是部分胆管癌患者的重要驱动因素，FGFR靶向药的出现已经改变了这部分患者的治疗方式。但随着治疗进行，部分患者会出现继发突变并产生耐药，因此，FGFR抑制剂治疗后的下一步怎么走，成为这一领域的重要临床问题。替恩戈替尼是一款多激酶抑制剂，可作用于FGFR1-3、JAK1/2、VEGFR以及Aurora A/B等多个靶点。此前研究也显示，其在经FGFR抑制剂治疗的FGFR2异常胆管癌患者中具有进一步开发潜力。因此，此次获批不仅增加了一款胆管癌新药，更重要的是进一步向FGFR靶向治疗后的耐药场景延伸。中药创新药也迎来一个“首个” 与上述化学药和生物药不同，本轮获批名单中还出现了一款中药创新药。济川药业申报的小儿通便颗粒获批上市，注册分类为中药1.1类创新药，用于小儿便秘中医辨证属食积证患者。值得注意的是，该产品是《中药注册管理专门规定》发布后，首个主治为“证候”的中药创新药。这一产品的意义因此不仅在于增加一种儿童便秘治疗选择，也在一定程度上体现了新中药注册审评体系下，以中医药理论、人用经验和临床证据相结合进行创新药开发的新路径。创新药正在从“单点突破”走向多赛道兑现如果把这5款产品放在一起看，会发现它们之间几乎没有明显的“同质化”。立康可泮进入的是补体和罕见病领域；安弗利奇塔单抗瞄准痛风急性炎症中的IL-1β；菲泽妥单抗继续拓展CD38在血液疾病中的价值；替恩戈替尼解决的是肿瘤靶向治疗后的耐药难题；小儿通便颗粒则探索了中药创新药新的注册和开发路径。这或许比“又有几款创新药获批”本身更值得关注。过去国内创新药研发资源一度高度集中于少数热门靶点和肿瘤赛道，而随着研发能力、临床资源和审评体系逐渐成熟，创新开始向罕见病、自身免疫、炎症、耐药肿瘤以及中药现代化等更加细分的场景扩散。当越来越多产品真正跨过审批门槛，行业竞争的重点也将进一步从“有没有创新管线”转向：产品能否解决真正的临床问题，以及获批之后能否实现商业价值。而对于这一批刚刚拿到上市许可的创新药来说，真正的考验，也才刚刚开始。 END 扫码领取2026年CPHI深圳展门票来源：CPHI制药在线声明：本网站内容仅出于传递更多信息之目的。并不代表制药在线立场。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

2026-08-21

·开投瀚润

瀚润资本8月月报

资讯摘要天境生物依坦生长激素α地产化上市申请获国家药监局受理|菲泽妥单抗在中国获批上市，为该产品全球首次获批；亚虹医药与复旦大学附属妇产科医院签署战略合作协议|CLDN6/9-ADC用于治疗晚期实体瘤的新药临床试验申请获美国FDA批准；璎黎药业TGFβR1（ALK5）抑制剂YL-13027片获CDE批准启动纤维狭窄性克罗恩病II期临床；易豹集团携手阿里瓴羊启动“北极星智能体集群”战略合作共建国际贸易全链路AI服务新生态；均普智能交付全球头部车企方向盘智能装配线，全球化精密制造能力再获国际验证；度亘核芯荣获维科杯•OFweek 2026最佳激光元器件技术创新奖|测试中心通过CNAS实验室认可；瑞云冷链携手座头鲸与苏州农发集团、昆山花桥经济开发区达成战略合作。特别声明：本公众号的观点、分析仅代表作者个人意见，不构成对阅读者的投资建议。天境生物天境生物与济川药业联合宣布依坦生长激素α地产化上市申请获国家药监局受理天境生物(TJBiopharma)与济川药业集团有限公司(以下简称“济川药业”)近日联合宣布，双方合作推进的依坦重组人生长激素注射液(以下简称通用名“依坦生长激素a”或“依坦”)地产化上市申请已正式获得国家药品监督管理局(NMPA)受理(受理号:CXSS2600122)。天境生物与渤健宣布菲泽妥单抗在中国获批上市，为该产品全球首次获批天境生物(TJBiopharma)与渤健生物(Biogen，纳斯达克代码:BlIB，以下简称“渤健”)今日共同宣布，注射用菲泽妥单抗(felzartamab for injection,商品名:境斐，以下简称“菲泽妥单抗”)已获得中国国家药品监督管理局(NMPA)批准上市，用于与来那度胺和地塞米松联合用药，治疗既往至少接受过一线治疗的多发性骨髓瘤成年患者。 (来源声明：天境生物TJBIO公众号，版权归原作者所有。) 亚虹医药亚虹医药与复旦大学附属妇产科医院签署战略合作协议 2026年7月28日，亚虹医药与复旦大学附属妇产科医院 (又称“上海市红房子妇产科医院”) 正式签署全面合作框架协议。双方将分别依托在创新药研发与临床医疗领域的核心优势，在女性宫颈病变及HPV相关疾病领域开展产、学、研全方位合作，共同探索治疗新模式、推动临床和转化医学研究以及培养专业人才，让科技创新真正造福女性健康。亚虹医药CLDN6/9-ADC用于治疗晚期实体瘤的新药临床试验申请获美国FDA批准中国上海，2026年8月13日——聚焦泌尿生殖系统肿瘤及女性健康的全球化创新药公司亚虹医药（股票代码：688176.SH）近日宣布，其控股子公司自主研发的APL-2501（CLDN6/9-ADC）用于治疗晚期实体瘤的新药临床试验申请（IND）获美国食品药品监督管理局（FDA）批准。 APL-2501是公司自主研发的搭载专有亲水性连接子、基于拓扑异构酶抑制剂的抗CLDN6/9抗体药物偶联物（ADC），预计可以用于治疗包括卵巢癌、非小细胞肺癌、子宫内膜癌、胃癌等多种晚期实体瘤。 (来源声明：亚虹医药公众号，版权归原作者所有。) 璎黎药业国内率先推进至临床阶段的肠道限制性TGFβR1(ALK5)抑制剂直击全球未满足治疗空白近日，上海璎黎药业有限公司宣布，公司自主研发的1类创新药YL-13027片收到国家药品监督管理局药品审评中心（CDE）核准签发的《药物临床试验批准通知书》，批准开展用于纤维狭窄性克罗恩病（Fibrostenosing Crohn's Disease, FSCD）的II期临床试验。截至目前，全球范围内尚无选择性ALK5小分子抑制剂获批上市，YL-13027 是国内率先进入临床开发阶段、针对肠道纤维化适应症的口服ALK5抑制剂，与全球同机制领先品种处于相近研发梯队，标志着国产抗纤维化创新药在该前沿靶点实现同步突破。 (来源声明：璎黎药业公众号，版权归原作者所有。) 易豹集团 7月27日，易豹集团与阿里瓴羊“北极星智能体集群”战略合作开工会顺利召开。会议就项目整体建设框架、核心业务场景智能体建设内容、智能体生态梯次建设次序、联合交付机制达成全面共识，标志着双方在国际贸易全链路智能体集群的深度合作正式进入落地实施阶段。 (来源声明：易豹集团公众号，版权归原作者所有。) 均普智能 2026年7月，均普智能（SH.688306）成功为某世界500强头部车企打造并交付了新一代方向盘智能装配线，助力其核心转向系统零部件实现高效、高精度、柔性化量产。该产线可兼容40余种配置组合，以30秒行业领先节拍实现单日近千台产出。此次交付再次验证了均普智能在高端汽车智能制造领域的全球化服务能力。 (来源声明：均普智能PIA公众号，版权归原作者所有。) 度亘核芯创新突破 | 度亘核芯荣获维科杯•OFweek 2026最佳激光元器件技术创新奖！近日，由OFweek维科网·激光主办的“OFweek 2026中国激光产业高质量发展峰会暨激光行业年度评选”在深圳圆满收官。度亘核芯“新型非DFB架构高功率976nm低温漂激光芯片与模块”，凭借颠覆性技术创新、显著提升激光泵浦源竞争优势，在近百家参评企业及项目中突围, 荣获年度评选“最佳激光元器件技术创新奖“！权威认证！度亘核芯测试中心通过CNAS实验室认可！近日，度亘核芯测试中心顺利通过中国合格评定国家认可委员会（CNAS）评审，正式取得符合 ISO/IEC 17025:2017《检测和校准实验室能力的通用要求》的认可证书。这一突破代表实验室检测能力达到国际通用规范，也印证公司在质量管理体系建设、产品研发与品质管控方面迈上全新台阶。 (来源声明：度亘核芯公众号，版权归原作者所有。) 瑞云冷链近日，瑞云冷链携手座头鲸与苏州市农业发展集团、昆山花桥经济开发区战略合作签约仪式在花桥经济开发区隆重举行。昆山市委常委、常务副市长王昊，市委常委，区党工委书记、管委会主任王超，区党工委副书记、管委会副主任赵姝，苏州市农业发展集团有限公司党委书记、董事长俞颂家，座头鲸董事长王江川，瑞云冷链董事长、CEO郑瑞祥，以及昆山市区两级相关部门领导共同出席并见证签约。此次签约标志着瑞云冷链在深化区域产业布局、推动现代农业冷链数字化协同上迈出了关键一步，将共同开启农业冷链数字化与产业协同的新篇章。 (来源声明：瑞云冷链公众号，版权归原作者所有。)

2026-08-21

·药研苑

恒瑞医药立康可泮获批上市治疗阵发性睡眠性血红蛋白尿症

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年8月20日恒瑞医药宣布，富马酸立康可泮胶囊（恒优达®）的新药上市申请已获得国家药品监督管理局批准，用于治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者。本次获批基于多中心、随机、开放、阳性对照3期临床试验HRS-5965-301的研究结果。HRS-5965-301研究共纳入76名既往未接受补体抑制剂治疗的PNH成人患者。入组患者按1:1比例随机接受立康可泮50mg每日两次，或C5补体抑制剂依库珠单抗（Eculizumab）。研究结果显示，第18~24周，立康可泮组和依库珠单抗组4次测量中至少3次血红蛋白（Hb）≥12g/dL的比例分别为70.0%和11.1%（P<0.0001），4次测量中至少3次Hb水平较基线升高≥2g/dL的比例分别为95%和55.6%（P<0.0001），立康可泮组和依库珠单抗组Hb水平分别平均升高5.47g/dL和2.86g/dL（P<0.0001），慢性疾病治疗功能评估-疲劳（FACIT-Fatigue）评分分别平均提高8.6分和4.4分，立康可泮组网织红细胞计数平均下降118.97x10⁹/L，而依库珠单抗组平均上升42.40x10⁹/L（P<0.0001）；治疗2周后，立康可泮组和依库珠单抗组脱离输血依赖的比例分别为100%和86.1%（P=0.0149）。在安全性方面，研究期间未观察到主要不良血管事件（MAVE），立康可泮组和依库珠单抗组治疗相关不良事件（TRAE）的发生率分别为72.5%和55.6%，立康可泮组发生2例（5%）治疗相关严重不良事件，分别为上呼吸道感染和感染性肺炎，均属中度不良事件（Bing Han., 2026）。阵发性睡眠性血红蛋白尿症（Paroxysmal Nocturnal Hemoglobinuria，PNH）是一种后天获得性溶血性疾病。该病源于造血干细胞PIG-A基因突变引起细胞表面缺失部分膜蛋白。缺失的膜蛋白为一组通过糖肌醇磷脂（Glycosylphosphatidylinositol，GPI）锚连在细胞表面的膜蛋白，其中包括CD55（衰变加速因子，DAF）和CD59（反应性溶解膜抑制物，MIRL）。CD55通过加速补体C3/C5转化酶的降解，阻止补体级联反应的早期活化，避免细胞被补体系统破坏。CD59能够直接与补体C8/C9结合，抑制膜攻击复合物（MAC）的形成，防止细胞膜被穿孔溶解。PNH由于缺乏CD55和CD59，导致补体系统介导的血管内溶血。立康可泮（研发代号：HRS-5965）为小分子口服补体B因子抑制剂，通过与补体B因子结合，阻止补体B因子激活C3蛋白，抑制C3介导的补体级联反应。目前国内获批的体B因子抑制剂，还包括伊普可泮（Iptacopan）、兰诺可泮（Lanoracopan）和思普可泮（Ciprocopan）。伊普可泮获批适应症已涵盖PNH、C3肾小球病和IgA肾病，包括：用于治疗阵发性睡眠性血红蛋白尿症（PNH）成人患者；用于治疗C3肾小球病（C3 G）成人患者，以降低蛋白尿；以及用于降低有疾病快速进展风险的原发性免疫球蛋白A肾病（IgA肾病）成人患者的蛋白尿水平。兰诺可泮和思普可泮获批适应症与立康可泮一致。思普可泮一日只需要给药一次，伊普可泮、兰诺可泮和立康可泮均为一日两次。推荐指数：★★ 推荐原因：目前国内已有4款补体B因子抑制剂获批，伊普可泮的适应症最全，思普可泮使用最方便。兰诺可泮和思普可泮获批的时间也不长。立康可泮需要加快商业化进度，并争取拓展更多的适应症。个人观点，仅限参考。相关阅读：石药申请白蛋白结合型多西他赛联合安尼妥一线治疗晚期乳腺癌晚期HER2突变NSCLC一线治疗三期试验，德曲妥珠击败标准方案转移性NSCLC，PD-1/CTLA-4双抗Volrustomig未能KO帕博利珠艾加莫德α用于成人自身免疫性肌炎3期临床试验取得积极结果美纳里尼非镇静抗组胺药物比拉斯汀口崩片申请上市克服奥希替尼耐药，和黄赛沃替尼联合方案3期试验获阳性结果康希诺生物申请吸附无细胞百（五组分）白破联合疫苗新药上市 FDA批准百时美施贵宝Iberdomide用于多发性骨髓瘤 Zipalertinib一线治疗EGFR exon20ins NSCLC三期试验达到终点拜耳申请阿柏西普8mg新增治疗视网膜静脉阻塞继发黄斑水肿甘李药业申请肾病瘙痒治疗药物醋酸地非法林注射液首仿上市齐鲁制药申请艾地苯醌片新增上市用于Leber遗传性视神经病变赛诺菲申请尼塞韦新增上市用于第二个呼吸道合胞病毒流行季天境生物CD38单抗抗菲泽妥单抗获批用于多发性骨髓瘤远方通达申请硫酸锌注射液首仿上市相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

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,

后查看更多信息

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	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	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

查看全部结果

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)	顧遞製膚構鏇窪鏇築積(餘願觸構鏇餘觸鹹鬱構) = 鏇廠鑰範壓繭鹽餘鏇觸鑰襯觸膚衊窪壓遞壓廠 (簾憲構簾鏇鹹衊範觸範, 19.43) 更多	-	2026-04-28
				Placebo+Felzartamab (Part 1: Felzartamab Dosing Arm M1)	顧遞製膚構鏇窪鏇築積(餘願觸構鏇餘觸鹹鬱構) = 廠糧選餘築構製艱願遞鑰襯觸膚衊窪壓遞壓廠 (簾憲構簾鏇鹹衊範觸範, 19.41) 更多
NCT05065970 (IGNAZ, ASN2025)	临床2期	免疫球蛋白a肾病	54	Felzartamab	憲觸淵憲選範衊製鑰觸(壓窪鏇觸壓窪選鏇淵鏇) = 網顧遞壓選醖鹽鬱構憲糧餘壓選顧襯製觸醖淵 (積觸鏇製膚製膚艱鏇鬱 ) 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	衊製繭窪積繭顧選蓋醖(窪範構築衊顧鹽廠鑰鏇) = Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2. 構淵淵齋網繭糧蓋夢膚 (襯憲選繭憲鏇衊鹹製糧 )	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)	淵鹽積獵網築鏇醖構構(憲鹹製糧顧選簾鬱憲築) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. 窪艱醖顧鑰選範選觸襯 (願憲顧積廠膚鹹壓廠壓 ) 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	淵壓齋繭網繭鹹網糧膚(鏇窪繭築衊蓋範淵鹹鬱) = 窪窪夢鑰憲鹽簾齋膚築餘齋鹽餘範夢積築繭襯 (齋選夢繭遞鬱積顧廠顧 ) 更多	积极	2024-06-20
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	觸餘範簾醖鑰鑰構壓艱(鬱獵憲鏇餘醖鹽簾齋憲) = 齋衊鹹顧廠網鹹繭鏇簾構廠膚網顧選鏇齋選鏇 (憲餘鏇淵構鬱膚壓鏇膚 )
NCT05021484 (NEWS) 人工标引	临床2期	肾移植排斥反应	22	Felzartamab	選夢製廠憲壓積鑰獵選(鬱鏇醖餘網鏇顧範鹹餘) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. 遞蓋廠構網餘糧構鏇窪 (夢鏇簾鬱構鹽選衊夢築 )	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	鹹鹹築範憲醖鹹築衊鹽(鹹壓窪築窪壓淵遞製網) = 鏇衊鑰廠衊鬱製糧積遞憲壓獵遞夢範壓艱襯獵 (網齋淵範餘觸製簾網憲 )	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	淵構網願鹽蓋願齋醖壓(鑰淵鏇齋夢淵鬱憲窪觸) = 鹹夢簾蓋夢簾齋鹽夢鹽襯鬱願鏇製鬱製網餘窪 (淵窪廠願選壓遞繭繭網 ) 更多	积极	2023-11-02
				Felzartamab (newly diagnosed or relapsed patients)	範鬱齋簾簾遞糧鏇獵積(築齋鹹齋夢醖鏇壓膚積) = 觸簾窪衊鬱淵築淵築淵膚獵鏇艱夢簾膚壓範鹹 (鏇鬱艱憲範憲膚齋鹹夢 ) 更多
NCT04145440 (M-PLACE, ASN2023)	临床1/2期	特发性膜性肾病 aPLA2R+	31	Felzartamab (Cohort 1)	齋醖簾獵願壓繭淵鏇壓(壓鏇憲夢選壓蓋膚醖膚) = 獵獵獵觸顧鑰窪構積淵壓鹽憲範顧憲範獵顧觸 (艱築鏇築夢襯繭願夢蓋 ) 更多	积极	2023-11-02
				Felzartamab (Cohort 2)	齋餘廠淵衊淵構壓鏇遞(願願窪夢壓鹽網鑰網顧) = 艱觸鑰顧獵膚遞壓構壓獵餘醖鹹觸壓蓋夢願鏇 (網鹽鑰遞齋醖遞窪膚蓋 ) 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	廠鏇壓鑰膚獵鹹鹹觸願(鬱膚鹽衊繭鏇構鹹齋憲) = 鹹範築鑰廠鹹簾廠構窪繭衊繭糧簾鑰繭簾鬱餘 (鑰鑰積繭衊憲顧蓋窪遞 )	积极	2022-11-05