A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.
Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.
During the study, participants will visit their study clinic several times.

开始日期2025-08-14

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06963827

/ Recruiting临床3期

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy

Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.
Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time.
In the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.
During the study, participants will visit their study clinic several times.

开始日期2025-07-15

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06722235

/ Recruiting临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.
The participants will be treated with mezagitamab for up to 6 months.
During the study, participants will visit their study clinic several times.
Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).

开始日期2025-02-27

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

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100 项与迈泽妥单抗相关的专利（医药）

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项与迈泽妥单抗相关的文献（医药）

2026-04-01·Current Opinion in Organ Transplantation

Managing the highly sensitized kidney transplant patient

Review

作者: Jackson, Kyle R. ; Parsons, Ronald F.

Purpose of review:

Highly sensitized kidney transplant candidates, particularly those with calculated panel reactive antibody (CPRA) ≥99.9%, face significant immunologic barriers to transplantation. This review highlights recent clinical strategies that have improved transplant access and outcomes in this population, with a focus on allocation policy, kidney-paired donation, and desensitization.

Recent findings:

Updates from national allocation systems and kidney-paired donation programs have demonstrated substantial gains in transplant access for many highly sensitized candidates. However, those with CPRA at least 99.9% remain difficult to match. Novel desensitization approaches, such as imlifidase, proteasome inhibitors, anti-CD38 mAbs, and early-phase CAR T-cell therapies have shown promise in selected patients. Increasingly, immunologic phenotyping or gene expression profiling may help tailor desensitization strategies to individual recipients.

Summary:

Most highly sensitized candidates now achieve transplant through allocation policy or paired donation. For those with CPRA at least 99.9%, desensitization will likely remain an important tool to facilitate transplantation. Emerging therapies and immunologic profiling may help individualize treatment and expand transplant access for this challenging group.

2026-01-06·CLINICAL AND EXPERIMENTAL IMMUNOLOGY

Evolving understandings for the roles of CD38 protein in autoimmunity and autoimmune disease

Review

作者: Ares, Irma ; Zhang, Jieying ; Maximiliano, Jorge-Enrique ; Lopez-Torres, Bernardo ; Wang, Ping ; Ye, Xiaochun ; Anadón, Arturo ; Wang, Xu ; Martínez-Larrañaga, María-Rosa ; Song, Mengping ; Martínez, Marta ; Martínez, María-Aránzazu

Abstract:

Autoimmune diseases are chronic idiopathic disorders characterized by inflammatory responses. Cluster of differentiation 38 (CD38), a surface molecule with enzymatic and signalling capabilities, contributes to the regulation of NAD+ metabolism and mediates various intracellular pathways. Recent research has revealed the influence of the CD38 protein in the pathogenesis of autoimmune diseases. During inflammation, CD38 is involved in regulating biological processes such as cell recruitment, cell activation, cytokine and chemokine release, antigen presentation, and phagocytosis. Dysfunctional CD38 induces autoimmune diseases. CD38 is expressed at low levels in various haematopoietic systems and tissues but exhibits elevated expression in multiple myeloma and plasma cells. CD38-targeted monoclonal antibodies with favourable therapeutic effects have been discovered, such as isatuximab, daratumumab, and mezagitamab. Although CD38-targeted antibodies were originally developed to eliminate malignant immune cells and inhibit their strong activation, these monoclonal antibodies can also inhibit autoantibodies production in autoimmune diseases. CD38 protein is a promising biomarker of autoimmune disease diagnosis and a potential therapeutic target for the treatment of autoimmune diseases. In this review article, we will focus on the latest findings on the involvement of CD38 in autoimmunity and autoimmune disease and assess the value of research and therapeutic application of CD38 in disease control.

2026-01-01·Current Research in Translational Medicine

The efficacy and safety of anti-CD38 monoclonal antibodies in transplant-ineligible newly diagnosed multiple myeloma: A systematic review and meta-analysis of randomized controlled trials

Article

作者: Alamy, Haroon ; Huynh, Huu Than ; Shelar, Vrushali ; El Amri, Imane ; Shah, Hafiz ; Ibrahim Ahmad, Feras Ahmad ; Aliyeva, Turkan ; Natche, Julia

BACKGROUND:

Treatment of transplant-ineligible newly diagnosed multiple myeloma (TIE-NDMM) remains challenging due to age, frailty, and comorbidities. Anti-CD38 monoclonal antibodies, particularly daratumumab, have emerged as promising additions to frontline regimens. However, the long-term outcomes of these therapies are still uncertain. This systematic review and meta-analysis aimed to compare the survival outcome of anti-CD38 antibodies in TIE-NDMM patients.

METHODS:

We systematically searched PubMed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) published up to April 2025 comparing anti-CD38 mAbs based regimens versus standard therapy in transplant-ineligible NDMM patients. A random-effects model was used to calculate pooled hazard ratios (HRs) with 95 % confidence intervals (CIs).

RESULTS:

A total of six RCTs with 2,625 patients were included in the analysis. Of these, 1,390 (52.9 %) patients received anti-CD38-based regimens. The follow-up duration varied from 41.2 to 86.7 months across the studies. Compared to standard therapy, anti-CD38-based regimens significantly improved both overall survival (OS) (HR 0.70; 95 % CI 0.58-0.84; p=0.0002; I² = 46 %) and progression-free survival (PFS) (HR 0.57; 95 % CI 0.51-0.65; p < 0.00001; I² = 15 %). The pooled results demonstrated that non-frail patients had a longer PFS than frail patients (HR = 0.46; 95 % CI, 0.34-0.63 and HR = 0.55; 95 % CI, 0.45-0.67, respectively), although the difference between the subgroups was not statistically significant (p = 0.36).

CONCLUSION:

In transplant-ineligible NDMM patients, the addition of anti-CD38 monoclonal antibodies to standard regimens significantly improves clinical outcomes. These findings support the integration of anti-CD38 therapy into first-line treatment for this vulnerable patient population.

项与迈泽妥单抗相关的新闻（医药）

2026-04-13

·国际糖尿病idiabetes

精准靶向，迭代前行——KDIGO指南专家组解读IgA肾病补体抑制剂与B细胞调节剂的治疗定位

点击“蓝字”关注我们 2025年，改善全球肾脏病预后组织（KDIGO）再次更新IgA肾病管理指南，此后，美国食品药品监督管理局（FDA）又加速批准了3种IgA肾病治疗药物，其中2种药物的作用机制与既往获批药物存在本质差异。为此，KDIGO IgA肾病工作组特撰写本评论，明确新型药物在IgA肾病整体治疗策略中的定位，为临床实践提供过渡性指导，同时为后续指南的全面更新奠定基础。本文将围绕该评论核心内容，系统解读补体抑制剂与B细胞调节剂等新型药物的临床价值、作用机制及治疗定位，助力临床医师精准应用新型疗法，改善IgA肾病患者预后。一 IgA肾病治疗领域的快速发展与指南更新背景 KDIGO于2021年更新的《肾小球疾病临床实践指南》，是自首版肾小球疾病指南发布十余年后的首次重大更新，其发布背景是长期以来肾小球疾病药物研发进展缓慢，临床治疗手段相对匮乏。但自2021年起，这一局面得到显著改善，多种肾小球疾病的新型治疗药物经临床试验验证有效并获得监管机构批准，其中IgA肾病的治疗进展最为突出，成为该领域的研究热点。为紧跟新型治疗药物的发展步伐，KDIGO于2025年再次更新了IgA肾病临床实践指南，进一步优化了治疗策略。值得关注的是，在该版指南发布后，FDA又加速批准了3种额外的IgA肾病治疗药物。由于其中2种药物的推定作用机制与既往获批药物存在明显差异，KDIGO IgA肾病工作组认为，在获得这些药物及其他潜在疗法的更多证据之前，无需进行指南的全面更新，而是通过撰写简短评论，明确新型药物在IgA肾病整体治疗策略中的定位，为临床实践提供及时、有效的指导。除本文重点讨论的已获批药物外，目前还有多种药物处于Ⅲ期临床试验阶段，涵盖多个治疗靶点，包括B细胞调节剂（povetacicept[泊维他西普]、泰它西普、zigakibart[泽戈奇拜单抗]）、浆细胞清除剂（felzartamab[菲泽妥单抗]、mezagitamab[迈泽妥单抗]）、补体抑制剂（瑞利珠单抗、sefaxersen）、内皮素受体拮抗剂（zibotentan[齐泊腾坦]）、非甾体类盐皮质激素受体拮抗剂（非奈利酮）及醛固酮合酶抑制剂（vicadrostat），未来有望进一步丰富IgA肾病的治疗选择。二 IgA肾病新型获批药物的临床研究与治疗定位 2.1 内皮素A型受体拮抗剂：阿曲生坦 2025年IgA肾病指南更新后不久，阿曲生坦获得FDA加速批准，用于治疗存在快速疾病进展风险的成人原发性IgA肾病患者，这类患者通常被定义为尿蛋白/肌酐比值（uPCR）≥1.5 g/g。该批准基于Ⅲ期ALIGN试验（阿曲生坦治疗IgA肾病患者，NCT04573478）的研究结果。与司帕生坦类似，阿曲生坦属于内皮素A型受体拮抗剂，但与司帕生坦不同的是，阿曲生坦不阻断血管紧张素受体，因此在ALIGN试验中，其给药方式为在肾素-血管紧张素系统抑制剂（RASi）治疗的基础上联合使用。治疗36周后，接受阿曲生坦治疗的受试者uPCR较基线下降38.1%，而安慰剂组仅下降3.1%，两组治疗差异达36.1%（P<0.001），显著优于安慰剂。安全性方面，除阿曲生坦组患者出现轻度液体潴留外，两组不良事件发生率无显著差异。目前ALIGN试验仍在持续进行中，旨在进一步明确与单独使用RASi相比，阿曲生坦是否能延缓IgA肾病患者估算肾小球滤过率（eGFR）的下降。在IgA肾病治疗框架（图1）中，阿曲生坦将作为司帕生坦的替代选择，为临床提供更多治疗方案。图1. IgA肾病（IgAN）中的治疗靶点及治疗定位 2.2 补体抑制剂：伊普可泮大量证据表明，补体系统（尤其是旁路途径）在IgA肾病的肾小球炎症损伤中发挥重要作用，同时补体还可能通过肾小管间质区的促纤维化作用，参与肾功能的慢性进行性损伤。为验证补体抑制剂在IgA肾病中的治疗效果，研究人员开展了Ⅲ期APPLAUSE-IgAN试验（LNP023治疗原发性IgA肾病患者的疗效与安全性研究，NCT04578834），采用口服补体B因子抑制剂伊普可泮，其作用机制为阻断补体旁路途径。治疗36周后，接受伊普可泮治疗的受试者uPCR较安慰剂组降低38.3%（P<0.001），基于该研究结果，FDA加速批准伊普可泮用于存在快速疾病进展风险的成人原发性IgA肾病患者。2025年10月16日，APPLAUSE-IgAN试验正式完成，新闻稿指出伊普可泮在eGFR保护方面具有显著疗效，但未公布具体数据。伊普可泮的全面监管批准仍需等待其与单独使用RASi相比，对eGFR下降影响的进一步分析结果。补体抑制治疗的主要顾虑之一是增加包膜细菌感染的风险，因此在使用伊普可泮前，需对患者进行疫苗接种或预防性使用抗生素。在临床试验中，此类感染发生率低于0.5%，且所有感染患者经适当抗生素治疗后均痊愈。总体而言，伊普可泮治疗组与安慰剂组的安全性无明显差异。 2.3 B细胞调节剂：斯贝利单抗斯贝利单抗是最新加入IgA肾病治疗选择的药物，其为人源化单克隆抗体，靶向作用于B细胞存活因子——增殖诱导配体（APRIL）。基于Ⅲ期VISIONARY试验（斯贝利单抗治疗IgA肾病的Ⅲ期试验，NCT05248646）的研究结果，FDA加速批准斯贝利单抗用于存在疾病进展风险的成人原发性IgA肾病患者（无uPCR标准限制）。治疗40周后，斯贝利单抗治疗组受试者uPCR较基线下降50.2%，而安慰剂组则升高2.1%，斯贝利单抗组蛋白尿降幅较安慰剂组达51.2%（P<0.001）。作为直接作用于B细胞的治疗药物，抗APRIL疗法有望减少致病性IgA的产生。VISIONARY试验的药效学研究显示，斯贝利单抗治疗组患者的半乳糖缺乏型IgA1（Gd-IgA1）下降近70%，总IgA下降68.8%，IgM下降74.5%，IgG下降35.0%。安全性方面，斯贝利单抗组与安慰剂组不良事件发生率无显著差异。约8%的斯贝利单抗治疗患者产生具有中和能力的抗药物抗体，此类患者的蛋白尿降幅略低于未产生抗药物抗体的患者（-42% vs. -53%），但这种差异的临床相关性仍需进一步明确。目前VISIONARY试验仍在进行中，以确定斯贝利单抗对eGFR下降的影响。 2.4 B细胞调节剂：阿塞西普另一项采用B细胞治疗药物的Ⅲ期临床试验（atacicept[阿塞西普]）近期已完成，目前正在接受FDA审查。阿塞西普是跨膜激活剂及钙调亲环素配体相互作用因子（TACI）受体与IgG的融合蛋白，TACI是APRIL和B细胞活化因子（BAFF）的共同B细胞表面受体，因此阿塞西普可同时阻断这两种B细胞存活因子的活性。其中，APRIL在浆细胞和浆母细胞分化中发挥重要作用，而BAFF则介导B细胞的存活与成熟。理论上，同时靶向BAFF和APRIL的治疗效果可能优于单独阻断APRIL。为验证这一假设，研究人员开展了ORIGIN 3研究（阿塞西普治疗IgA肾病患者，NCT04716231），结果显示，治疗36周后，阿塞西普组uPCR下降45.7%，安慰剂组下降6.8%，阿塞西普组的治疗优势达41.8%（P<0.001）。阿塞西普组患者治疗36周后Gd-IgA1下降68%，总IgA下降63.5%，IgM下降74.6%，IgG下降35.5%，与药效学机制一致。安全性方面，阿塞西普组与安慰剂组不良事件发生率无显著差异。目前ORIGIN试验仍在进行中，以明确阿塞西普对eGFR下降的影响。但就目前数据而言，尚难以区分选择性APRIL拮抗剂与双重BAFF/APRIL拮抗剂在IgA肾病治疗中的疗效与安全性差异。三 IgA肾病治疗策略的优化与临床实践建议 3.1 治疗药物的选择与定位原则目前IgA肾病的治疗面临两大挑战：一是一线治疗药物的选择，二是最佳治疗持续时间的确定。所有已获批药物在减少蛋白尿和延缓eGFR下降方面均显著优于单独使用RASi（表1），但由于缺乏头对头比较研究，无法根据蛋白尿降幅或eGFR保护效果对这些药物进行排序，因此表1中的不同试验结果不应直接对比。表1. 现有及在研IgA肾病治疗药物Ⅲ期临床试验蛋白尿与eGFR数据注：24小时尿蛋白较基线变化；总斜率；经主要支持性随机系数分析计算。eGFR：估算肾小球滤过率；IgAN：IgA肾病；uPCR：尿蛋白/肌酐比值；NA：本文撰写时尚未公布。目前，阿曲生坦、伊普可泮和斯贝利单抗对eGFR影响的Ⅲ期数据尚待公布，但斯贝利单抗和阿塞西普的Ⅱ期试验数据显示，这两种药物对GFR具有良好的稳定作用。除疗效因素外，药物的可及性和成本也将影响临床治疗选择。基于IgA肾病发病机制的“四重打击学说”，临床治疗应根据药物的推定作用机制，匹配其靶向的“打击环节”（图1）。其中，第1~3重打击描述了循环致病性IgA的产生、IgA免疫复合物（IgA-IC）的形成以及这些免疫复合物在肾小球系膜区的沉积；目前致病性IgA常被等同于Gd-IgA1，但这一认知可能过于简化，致病性IgA的具体形式仍需进一步明确。尽管如此，能够减少Gd-IgA1或总IgA产生的药物，有望有效针对第1~3重打击。第4重打击描述了致病性IgA沉积对肾脏的影响，以及系膜区免疫复合物蓄积所激活的多种损伤途径；能够减轻肾小球炎症或阻断补体的药物，有望有效针对第4重打击。图1（改编自2025年KDIGO IgA肾病指南更新中的图3）展示了不同药物类别与其预期靶向的致病环节的匹配关系，需注意的是：该匹配关系聚焦于药物的主要作用，所有药物均可能具有潜在的有益次要作用（如内皮素受体拮抗剂[ERA]/双重内皮素血管紧张素受体拮抗剂[DEARA]可能具有抗炎作用）；部分患者可能从新型治疗药物的联合使用中获益，但目前尚无相关联合用药数据，因此图1未强调联合治疗策略；药物的排列顺序不代表其疗效或安全性的推荐等级或使用顺序。 3.2 长期治疗的安全性考量与特殊人群管理大多数IgA肾病治疗药物可能需要长期使用（持续使用或周期性使用）。目前已知，在免疫介导性疾病中，长期BAFF抑制具有良好的耐受性，但关于APRIL抑制或BAFF/APRIL双重抑制的长期安全性数据仍缺乏。长期补体抑制的安全性也需进一步关注，尽管慢性补体抑制（尤其是C5拮抗）在非典型溶血性尿毒症综合征、阵发性睡眠性血红蛋白尿症和C3肾小球病中已显示出良好的安全性。图1还提示，对于第1~3重打击与慢性肾脏病（CKD）应同步干预。IgA肾病患者确诊时，许多已处于中度晚期CKD阶段，因此早期干预CKD具有重要意义，但具体治疗方案需个体化。由于进展性CKD的部分损伤机制与第4重打击启动的损伤机制相似，因此将第4重打击与CKD分开考量可能存在一定局限性，但这种分类方式有助于梳理治疗策略。值得注意的是，多项IgA肾病Ⅲ期临床试验的显著发现是，在临床试验范围内，所有IgA肾病亚组患者（不同种族、GFR水平、蛋白尿水平、系膜细胞增生[M]、内皮细胞增生[E]、节段性硬化[S]、间质纤维化/肾小管萎缩[T]及新月体[C]评分[MEST-C评分]），无论接受内皮素-1拮抗、补体抑制还是B细胞生长因子拮抗治疗，均能获得同等获益。这一发现支持KDIGO的推荐意见：肾活检结果仅用于预后评估，不用于指导治疗决策。 3.3 治疗策略的未来展望随着IgA肾病新型治疗药物的不断获批，图1中的治疗框架将不断完善和定期更新，纳入新的药物或药物类别。随着更多临床试验数据、真实世界数据和验证生物标志物数据的积累，未来有望明确推荐特定治疗药物或联合治疗方案作为理想的一线治疗选择。此外，随着致病性IgA具体形式的进一步明确（可能涵盖在Gd-IgA1的范畴内），以及能够追踪致病环节和肾脏对损伤及治疗反应的生物标志物的出现，图1的治疗框架将得到进一步细化。四总结与展望近年来，IgA肾病治疗领域迎来快速发展，新型治疗药物的获批显著丰富了临床治疗选择，推动治疗模式从“支持治疗”向“对因治疗”转变。本评论作为2025年KDIGO IgA肾病指南的过渡性指导，明确了补体抑制剂（伊普可泮）、B细胞调节剂（斯贝利单抗、阿塞西普）及内皮素A型受体拮抗剂（阿曲生坦）等新型药物的治疗定位，为临床医师提供了及时的实践指导。需要强调的是，本评论未涵盖IgA肾病治疗中的诸多重要问题，例如低水平蛋白尿与IgA肾病不良预后的关联、血尿的临床意义、维持治疗、联合治疗、治疗持续时间及治疗转换等。这些问题将在KDIGO IgA肾病指南的下一次正式更新中得到重点探讨。未来，随着更多临床试验和真实世界研究的开展，IgA肾病的治疗策略将进一步优化，实现更精准的个体化治疗，最终改善患者的长期预后。同时，随着对疾病发病机制的深入探索，有望发现更多新的治疗靶点，推动IgA肾病治疗领域的持续突破。来源：Kidney Int. 2026 Mar 31:S0085-2538(26)00213-9. doi: 10.1016/j.kint.2026.03.003. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《肾医线》编辑部）

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·E药经理人

B细胞耗竭疗法行业深度调研及发展战略咨询报告

B细胞在人体免疫系统中发挥着重要功能，包括生产抗体、向T细胞呈递抗原、产生炎性细胞因子等，但当B细胞的免疫功能出现异常增强时便会出现自身免疫疾病，例如多发性硬化症(MS)重症肌无力(MG)、系统性红斑狼疮(SLE)原发性免疫血小板减少症(ITP)等。B细胞耗竭疗法(BCDT)是通过一定手段来清除B细胞从而减弱自身免疫来达到治疗目的，目前已经在多种B细胞相关自免疾病的治疗中都展现出了巨大潜力。 CD38 单抗:具备强大的浆细胞耗竭能力，在重症SLE和ITP 中看到积极疗效。2024年6月，武田Mezagitamab宣布针对 ITP 的 Ilb期试验达到主要终点,16 周时完全血小板反应率高达81.8%:2024年6月，康诺亚公布CM313 针对 ITP的|IT研究结果同样积极，24周时总体缓解率达到64%。凭借独特的浆细胞耗竭机制，CD38 在自免疾病中的潜力有望进一步挖掘。而 BTK 抑制剂虽然自免开发几经波折，目前在CSU与阴燃型 MS 中也取得重要进展。另外，近期CD3 双抗重磅交易事件频发，表明CD3 双抗用于治疗B细胞相关自免疾病的大潜力。未来 CD3 双抗用于B细胞相关自免适应症的开发热度会持续攀升，建议持续关注国内具有优质 CD3 双抗平台和产品的公司。那么，在B细胞耗竭疗法当前形势下，我们该如何把握和抓住B细胞耗竭疗法的发展机遇和前景趋势呢? 识别二维码进群▼领取报告《2024-2030年B细胞耗竭疗法行业深度调研及发展战略咨询报告》正是在此背景下撰写的，旨在为行业内外相关者提供一份全面、深入、前瞻性的分析与指导。本报告在大量周密的市场调研基础上，依据国家统计局国家海关总署、相关行业协会、国内外相关报刊杂志的基础信息以及专业研究单位等公布和提供的大量数据，对我国B细胞耗竭疗法行业发展特征、发展现状、行业发展环境等内容进行详细的阐述和深入的分析，并重点分析影响行业未来发展的关键因素，对未来的发展前景与趋势作了审慎的判断并对企业未来发展战略、投资布局等提供可参考的路径与方向。展望未来七年，报告深入剖析了B细胞耗竭疗法行业的发展趋势，包括技术进步、市场潜力、政策环境、竞争格局以及患者需求等多方面因素。特别强调了技术创新对于推动疗法迭代升级、拓宽应用范围的关键作用，同时探讨了国际合作、资本布局、监管政策变化等行业动态对产业发展的影响。相信通过本报告对这些问题的全面深入的研究和梳理下，您对B细胞耗竭疗法行业信息的了解与把控将上升到一个新的台阶，这将为您经营管理、战略部署、成功投资提供有力的决策参考价值，也为您抢占市场先机提供有力的保证。一审| 石宛佳二审| 李芳晨三审| 李静芝

2026-03-31

·bioinvent.com

BioInvent International AB publishes Annual Report 2025

Lund, Sweden – March 31, 2026 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immunomodulatory antibodies for cancer immunotherapy, today announced that the Annual Report for 2025 has been published. The Annual Report is attached to this press release in pdf format and is available on the company’s website www.bioinvent.com. BioInvent’s key achievements in 2025 centered on advancing the lead programs BI-1808 and BI-1206 into mid-stage clinical development, presenting encouraging data at major scientific meetings, and strengthening the financial and strategic position. “During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier stage programs to maximize the probability of success and near-term value creation. This portfolio optimization reflects a disciplined approach to development and partnering, aligning investment with the strongest clinical signals and upcoming milestones. In summary, 2025 was a year of clinical validation and strategic consolidation. We advanced our most promising programs into Phase 2a, delivered encouraging data, and controlled our financial position through disciplined portfolio management and royalty monetization.” – Martin Welschof, CEO of BioInvent. KEY EVENTS IN 2025• (R) Promising early Phase 2a monotherapy data for the company’s lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025• (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company’s lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin’s Lymphoma (NHL) presented at ASH 2025• Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma• Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL)• (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximaband Calquence® for the treatment of NHL• BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency• (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025• Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced• (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million• FDA Fast Track Designation received for BI-1808 for the treatment of CTCL• BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL (R)= Regulatory event In line with the information in the Year-end report for 2025 issued end of February 2026, it is the Board of Directors’ and the CEO’s assessment that the company is, based on ongoing projects, financed into the latter part of Q1 2027. The Board of Directors and the CEO continuously evaluate various options to finance the company’s activities, but since no such financing has been secured at the time of signing of the annual report, this indicates an uncertainty. However, the Board of Directors and the CEO assess that there are good possibilities for future financing solutions. See page 35 and 69 of the annual report. EXPECTED KEY CATALYSTS 2026 The priorities for 2026 are clear: complete the ovarian cancer cohort expansion with BI-1808 and report data in H2 2026; continue to optimize BI-1808 development for CTCL; and progress BI-1206 in NHL as datasets mature and partnering opportunities develop. By the second half of this year, we expect to have the first data from the BI-1206 Phase 2a study in first-line NSCLC. Mid-2026:• First combination data for BI-1808 and pembrolizumab for the treatment of cutaneous T-cell lymphoma (CTCL), as well as additional CTCL monotherapy data• Additional data for BI-1206 triplet combination for the treatment of non-Hodgkin’s lymphoma (NHL)H2 2026:• Additional Phase 2a data for BI-1808 in combination with Keytruda (pembrolizumab) for the treatment of solid tumors• First read-out from the Phase 2a study of BI-1206 in combination with pembrolizumab for treatment-naïve NSCLC patients and uveal melanoma patients. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with drug candidates in ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. This information is information that BioInvent International is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-03-31 11:45 CEST.

临床结果孤儿药免疫疗法临床2期快速通道

100 项与迈泽妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16370

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
免疫球蛋白a肾病	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	中国	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	奥地利	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	哥伦比亚	Takeda Development Center Americas, Inc.	2025-07-15
免疫球蛋白a肾病	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	法国	Takeda Pharmaceutical Co., Ltd.	2025-07-15

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临床结果

适应症

分期

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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


NCT06722235 (ASH2025)	临床3期	免疫性血小板减少症	171	Mezagitamab 600 mg	壓鹽繭憲遞夢積鏇艱觸(築餘顧衊築積鏇積鏇遞) = similar between mezagitamab and placebo (50% vs 45%) 衊壓夢鹹鏇製齋淵觸廠 (構範襯構糧糧淵選壓襯 ) 更多	积极	2025-12-06
NCT05174221 (ASN2025 \| Company_Website)	临床1期	免疫球蛋白a肾病	17	Mezagitamab	願窪蓋餘遞襯憲艱淵憲(選願壓鑰簾構簾鹽齋艱) = 膚襯夢糧膚鑰構衊淵遞網餘構範壓淵糧鹹蓋積 (製淵簾壓醖襯夢繭蓋壓 ) 更多	积极	2025-11-07
NCT04278924 (TAK-079-1004, CTgov)	临床2期	免疫性血小板减少症	41	Placebo (Part A & B: Double Blind Period: Placebo)	顧積蓋夢鬱壓膚衊鑰淵 = 構鹹淵選顧衊鹽鑰獵鬱鹽衊選壓鏇遞鹽餘餘膚 (簾襯獵積淵蓋壓糧齋膚, 選簾網衊醖選選襯廠鹹 ~ 觸鹽獵窪醖願顧齋範糧) 更多	-	2025-06-15
				TAK-079 (Part A: Double Blind Period: TAK-079 100 mg)	顧積蓋夢鬱壓膚衊鑰淵 = 鬱觸觸艱齋築願糧鏇選鹽衊選壓鏇遞鹽餘餘膚 (簾襯獵積淵蓋壓糧齋膚, 觸鬱淵積構鏇製鏇製網 ~ 淵鏇築鹹壓餘艱顧顧鬱) 更多
NCT03439280 (Phase 1b study, Pubmed)	临床1期	复发性多发性骨髓瘤 CD38	-	Mezagitamab monotherapy	鬱憲顧構顧憲鑰襯鹹膚(鏇網網簾餘鹽壓顧憲繭) = Three patients discontinued treatment due to TEAEs 壓壓鏇廠願蓋鹹淵鏇艱 (簾壓鏇簾蓋積夢鑰鬱觸 ) 更多	积极	2024-12-01
NCT05174221 (ASN2024) 人工标引	临床1期	免疫球蛋白a肾病	17	Mezagitamab	蓋蓋鹽齋範壓醖製衊選(膚壓選壓襯醖廠襯窪顧) = None 淵鏇鑰壓範壓築蓋觸鹹 (衊觸膚範積醖簾醖淵襯 ) 更多	积极	2024-10-25
NCT04278924 (TAK-079-1004, PipelineReview) 人工标引	临床2期	免疫性血小板减少症	-	Mezagitamab	鏇範積製顧齋襯網製鏇(觸鏇齋遞網選齋糧簾醖) = 顧齋積淵襯繭積齋廠鏇壓遞繭願夢鹹網願網蓋 (鹽齋積夢醖蓋廠鬱鹹獵 ) 更多	积极	2024-06-22
				Placebo	鏇範積製顧齋襯網製鏇(觸鏇齋遞網選齋糧簾醖) = 構齋鹹壓鹽夢遞範醖糧壓遞繭願夢鹹網願網蓋 (鹽齋積夢醖蓋廠鬱鹹獵 ) 更多
NCT03724916 (CTgov)	临床1期	系统性红斑狼疮	23	TAK-079 Placebo (Pooled Placebo)	製淵糧鬱鑰構壓願襯鑰 = 襯鹹膚鑰鬱夢範襯艱遞襯廠憲襯齋醖襯糧夢醖 (衊鑰獵獵鹽遞構構選積, 齋製襯淵淵糧艱鑰窪遞 ~ 糧構鬱憲鹹廠淵遞構壓) 更多	-	2024-03-29
				TAK-079 (TAK-079 90 mg)	製淵糧鬱鑰構壓願襯鑰 = 蓋繭壓構醖窪觸積蓋淵襯廠憲襯齋醖襯糧夢醖 (衊鑰獵獵鹽遞構構選積, 憲淵觸蓋製積糧簾壓構 ~ 鏇夢鏇簾齋鬱淵廠築鬱) 更多
NCT04278924 (TAK-079-1004, Biospace) 人工标引	临床2期	免疫性血小板减少症	-	Mezagitamab	蓋構範繭餘觸製艱鬱夢(糧選醖構選淵壓鑰衊鏇) = Mezagitamab has been generally safe and well tolerated across all three cohorts. 鹹鑰襯顧餘顧衊醖範獵 (鏇餘鏇醖築蓋鹹憲窪選 ) 更多	积极	2024-03-13
				Placebo
NCT04159805 (CTgov)	临床2期	重症肌无力	36	TAK-079 Placebo (TAK-079 Placebo-matching)	獵願鏇壓鏇觸觸獵艱鑰 = 淵顧壓鹽醖夢襯簾製繭願遞廠積衊選醖積願憲 (鹹鏇選選繭鹽糧鬱構鑰, 製蓋憲遞膚網積夢餘觸 ~ 簾築遞鑰膚鹹壓窪壓齋) 更多	-	2023-06-02
				TAK-079 (TAK-079 300 mg)	獵願鏇壓鏇觸觸獵艱鑰 = 簾遞構夢窪衊顧襯餘繭願遞廠積衊選醖積願憲 (鹹鏇選選繭鹽糧鬱構鑰, 鬱衊鹽憲膚襯鑰願網簾 ~ 遞衊積糧獵廠廠壓製醖) 更多
NCT03439280 (Phase 1b study, CTgov)	临床1/2期	复发性多发性骨髓瘤	50	Mezagitamab (Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg)	範遞鑰構遞夢餘製觸艱 = 願顧遞鹽鏇獵齋繭鹹糧淵選構網壓憲鬱繭憲壓 (鑰積淵鏇鹹糧觸醖蓋繭, 鬱構鹽簾憲選獵襯鑰醖 ~ 壓醖選蓋鬱觸遞窪範鹽) 更多	-	2023-02-24
				Mezagitamab (Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg)	範遞鑰構遞夢餘製觸艱 = 網襯鹽鑰觸鹹蓋鹹襯獵淵選構網壓憲鬱繭憲壓 (鑰積淵鏇鹹糧觸醖蓋繭, 觸夢鑰繭淵獵夢夢艱衊 ~ 醖糧遞衊膚鏇築鏇夢製) 更多