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更新于：2026-02-28

Mezagitamab

更新于：2026-02-28

概要

概要

基本信息

药物类型

单克隆抗体

别名

Anti-CD38 mAb(Takeda)、TAK-079、TAK079

靶点

CD38

作用方式

抑制剂

作用机制

CD38抑制剂(淋巴细胞分化抗原CD38抑制剂)、ADCC(抗体依赖的细胞毒作用)

治疗领域

免疫系统疾病血液及淋巴系统疾病肿瘤+ [1]

在研适应症

免疫球蛋白a肾病免疫性血小板减少症血小板减少症+ [1]

非在研适应症

肌肉无力重症肌无力复发性多发性骨髓瘤+ [1]

原研机构

Takeda Pharmaceutical Co., Ltd.

在研机构

Spera Pharma, Inc.

Takeda Development Center Americas, Inc.

武田（中国）国际贸易有限公司

+ [1]

非在研机构

Millennium Pharmaceuticals, Inc.

权益机构

Takeda Pharmaceutical Co., Ltd.

XOMA Royalty Corp.

BioInvent International AB

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、儿科研究计划 (欧盟)

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结构/序列

Sequence Code 210789L

来源: *****

Sequence Code 1191632864H

来源: *****

关联

项与 Mezagitamab 相关的临床试验

NCT06948318

/ Recruiting临床3期

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.

100 项与 Mezagitamab 相关的临床结果

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100 项与 Mezagitamab 相关的转化医学

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100 项与 Mezagitamab 相关的专利（医药）

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项与 Mezagitamab 相关的文献（医药）

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.

2025-12-05·Hematology-American Society of Hematology Education Program

Choosing the optimal maintenance strategy in multiple myeloma

Review

作者: Puliafito, Benjamin ; Raje, Noopur ; Cirstea, Diana

Abstract:

While lenalidomide has been the established standard of care for maintenance after autologous stem cell transplantation in newly diagnosed multiple myeloma, risk-adapted maintenance strategies with the addition of proteasome inhibitors can provide additional benefit in high-risk disease. The widespread use of anti-CD38 monoclonal antibodies (mAbs) in induction and consolidation has further disrupted this paradigm, offering the use of anti-CD38 mAbs in maintenance. Novel immunotherapeutic approaches and minimal residual disease–guided maintenance strategies are being actively investigated. The evolution of maintenance strategies provides a window to a future where maintenance therapy is not only more effective at sustaining deep and durable responses but also more dynamic with careful de-escalation strategies.

2025-12-05·Hematology-American Society of Hematology Education Program

Endless possibilities and how to exploit them? What is the optimal treatment sequence?

Review

作者: Lentzsch, Suzanne ; Bhutani, Divaya ; Chakraborty, Rajshekhar

Abstract:

The therapeutic landscape of multiple myeloma has undergone a profound transformation with the incorporation of anti-CD38 monoclonal antibody (mAb)-based quadruplet regimens in the frontline setting and T-cell redirecting immunotherapies in the relapsed setting. In this article, we synthesize evidence from pivotal trials to guide treatment decisions and sequencing across the disease trajectory. For transplant-eligible, transplant-deferred, and fit transplant-ineligible patients who are younger than 80 years old, we use anti-CD38 mAb-, lenalidomide-, and bortezomib/carfilzomib-based quadruplets as an induction regimen. For early relapse (1-3 prior lines), chimeric antigen receptor T-cell therapies targeting B-cell maturation antigen (BCMA) have demonstrated superiority over standard regimens, with ciltacabtagene autoleucel (cilta-cel) being the most efficacious product currently, albeit with some unique toxicities such as parkinsomism. Belantamab mafadotin-based triplets have shown impressive efficacy in lenalidomide and anti-CD38 mAb-refractory patients, although ocular toxicity remains a concern. Anti-CD38 mAb and carfilzomib-based triplets remain an essential therapeutic option in patients not refractory to anti-CD38 mAb. In late relapse (≥4 prior lines), bispecific antibodies (BsAbs) targeting BCMA (teclistamab, elranatamab, and linvoseltamab) and GPRC5D (talquetamab) have demonstrated impressive single-agent activity with distinct toxicity profiles. Emerging evidence supports prioritizing chimeric antigen receptor T-cell therapy before BsAbs when clinically feasible, as sequential efficacy appears compromised in the reverse sequence. For patients with BCMA- and GPRC5D-refractory disease, FcRH5-targeting BsAb (cevostamab), BCL2 inhibitors for t(11;14)-positive disease, and novel trispecific antibodies (BCMAXCD38; BCMAXGPRC5D) offer promising options. Strategic sequencing trials represent a critical unmet need, with PFS (progression-free survival)-2 potentially serving as a valuable intermediate end point to guide clinical decision-making while waiting for mature survival data.

项与 Mezagitamab 相关的新闻（医药）

2026-02-26

·bioinvent.com

BioInvent International AB: Year-end report January 1 – December 31, 2025

“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 programs to maximize the probability of success and near-term value creation.”- Martin Welschof, CEO BioInvent. EVENTS IN THE FOURTH QUARTER (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) Phase 1 data of the company’s second anti-TNFR2 antibody BI-1910 (currently paused) presented at SITC 2025 validates TNFR2 as a novel immunotherapy approach in advanced solid tumors Transgene and BioInvent presented translational data and updated clinical results on armed oncolytic virus BT-001 at ESMO 2025 BioInvent announced publication of preclinical and early clinical data for BI-1607 in HER2-positive advanced solid tumors EVENTS AFTER THE END OF THE PERIOD (R) Promising data in ongoing Phase 2a study for BI-1808 with KEYTRUDA® (pembrolizumab) for the treatment of recurrent ovarian cancer Updated clinical data sets solidify potential for both BI-1808 and pembrolizumab combination in ovarian cancer and BI-1206 triplet for the treatment of NHL, see pages 6 and 7 in the year-end report Nomination of two new board members ahead of 2026 Annual General Meeting; Kate Hermans and Scott Zinober EARLIER DURING 2025, IN BRIEF (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximab and 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 Composition of matter patents for BI-1808 granted in US and Japan. They also cover the use of the antibody in the treatment of cancer 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 Strategic changes in portfolio to accelerate lead clinical programs and enhance value creation (R)= Regulatory event FINANCIAL INFORMATION Fourth quarter 2025• Net sales SEK 3.0 (21.4) million• Profit/loss after tax SEK -125.8 (-116.9) million• Profit/loss after tax per share before and after dilution SEK –1.91 (-1.78)• Cash flow from operating activities SEK-90.6 (-98.3) million January – December 2025• Net sales SEK 226.5 (44.7) million• Profit/loss after tax SEK -332.9 (-429.4) million• Profit/loss after tax per share before and after dilution SEK -5.06 (-6.53)• Cash flow from operating activities SEK -247.8 (-380.5) million• Liquid funds, current and long-term investments as of December 31, 2025: SEK 592.7 (867.2) million The complete interim report is available for download below and on the company’s website under Financial reports. INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2025BioInvent’s CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English.When: Thursday February 26, 2026, at 2:00 pm CET The webcast can be reached at https://bioinvent.events.inderes.com/q4-report-2025. If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the conference.https://events.inderes.com/bioinvent/q4-report-2025/dial-in. The conference call will be made available on the company website after the call. 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

临床结果孤儿药免疫疗法临床2期临床1期

2026-02-26

·BioSpace

BioInvent International AB: Year-End Report January 1 - December 31, 2025

LUND, SE / ACCESS Newswire / February 26, 2026 / BioInvent International (STO:BINV) - "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 programs to maximize the probability of success and near-term value creation."- Martin Welschof, CEO BioInvent. EVENTS IN THE FOURTH QUARTER (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) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 (currently paused) presented at SITC 2025 validates TNFR2 as a novel immunotherapy approach in advanced solid tumors Transgene and BioInvent presented translational data and updated clinical results on armed oncolytic virus BT-001 at ESMO 2025 BioInvent announced publication of preclinical and early clinical data for BI-1607 in HER2-positive advanced solid tumors EVENTS AFTER THE END OF THE PERIOD (R) Promising data in ongoing Phase 2a study for BI-1808 with KEYTRUDA® (pembrolizumab) for the treatment of recurrent ovarian cancer Updated clinical data sets solidify potential for both BI-1808 and pembrolizumab combination in ovarian cancer and BI-1206 triplet for the treatment of NHL, see pages 6 and 7 in the year-end report Nomination of two new board members ahead of 2026 Annual General Meeting; Kate Hermans and Scott Zinober EARLIER DURING 2025, IN BRIEF (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximab and 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 Composition of matter patents for BI-1808 granted in US and Japan. They also cover the use of the antibody in the treatment of cancer 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 Strategic changes in portfolio to accelerate lead clinical programs and enhance value creation (R)= Regulatory event FINANCIAL INFORMATION Fourth quarter 2025 • Net sales SEK 3.0 (21.4) million • Profit/loss after tax SEK -125.8 (-116.9) million • Profit/loss after tax per share before and after dilution SEK -1.91 (-1.78) • Cash flow from operating activities SEK-90.6 (-98.3) million January - December 2025 • Net sales SEK 226.5 (44.7) million • Profit/loss after tax SEK -332.9 (-429.4) million • Profit/loss after tax per share before and after dilution SEK -5.06 (-6.53) • Cash flow from operating activities SEK -247.8 (-380.5) million • Liquid funds, current and long-term investments as of December 31, 2025: SEK 592.7 (867.2) million The complete interim report is available for download below and on the company's website under Financial reports . INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2025 BioInvent's CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English. When: Thursday February 26, 2026, at 2:00 pm CET The webcast can be reached at . If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the conference. . The conference call will be made available on the company website after the call. About BioInvent BioInvent 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 . For further information, please contact: Cecilia Hofvander, VP Investor Relations Phone: +46 (0)46 286 85 50 Email: cecilia.hofvander@bioinvent.com BioInvent International AB (publ) Co. Reg. No.: 556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 Attachments BioInvent Q4, 2025 EN Final SOURCE: BioInvent International View the original press release on ACCESS Newswire

临床结果孤儿药临床2期免疫疗法临床1期

2026-02-09

·前途汇医药国际

【JPM 深度观察】武田：从“管理衰退”到“创新驱动增长”的飞跃战略

关注前途汇，获取海内外医药行业最新资讯对接医药并购、新药研发和技术转让合作商机~ 对于拥有 240 年历史的武田而言， 2021-2025年是一个典型的防御期。期间消化夏尔（Shire）并购、应对 Vyvanse 等产品的仿制药冲击。而在今年的JPM大会上，CEO Christophe Weber 定义2026 年为转折点，这源于对财务模型的理性预判。这家营收规模达 4.6 万亿日元（约 300 亿美元）的巨头，正试图通过 8 款核心创新资产，在 2030 年Entyvio 专利到期之前，构建一条主要由创新药驱动的高斜率增长曲线。一、重新定义神经科的临床终点在武田的后期管线中，Oveporexton (TAK861) 是毫无疑问的皇冠明珠。作为全球首个提交 NDA的口服食欲素受体 2（OX2R）激动剂，武田在发作性睡病1 型（NT1）赛道上抢占了先发优势。传统的神经科药物往往只能做到症状缓解，但 Oveporexton 的数据展现了功能性治愈的潜力：清醒维持测试 (MWT)： 63% 的患者达到正常人范围。爱泼沃斯嗜睡量表 (ESS)： 85%的患者回归正常水平。猝倒控制：中位数据显示，患者每周无猝倒天数高达 4.7 天。【行业启示】一旦 Oveporexton获批，它将建立极高的临床门槛，迫使后续的竞争者（如 Alkermes, Jazz 等）必须在头对头研究中证明更优的效力或安全性。武田赌对了靶点，更赌赢了成药性。二、18个月内的发射窗口武田正处于产品密集上市的前夜。未来 18 个月内的三连发，是检验其全球商业化团队执行力的关键战役： 1. Oveporexton (NT1,预计 2026 H2)：这一资产的上市将直接验证武田在神经科学领域的统治力。 2. Rusfertide (真性红细胞增多症 PV, 预计2026 H2)：铁调素（Hepcidin）模拟物。直击 PV 患者频繁放血的痛点，提供持久的红细胞压积控制。这是针对未满足需求的精准打击。 3. Zasocitinib (银屑病, 预计 2027 H1)：高选择性 TYK2 抑制剂。通过优效的安全性（避免 JAK 类药物的脱靶毒性）和每日一次的便利性，重塑口服银屑病市场，并挑战百时美施贵宝（BMS）Sotyktu 的市场地位。【行业启示】这种密集的上市节奏，旨在快速拉升新产品营收占比，以对冲存量资产的自然衰减。对于投资者而言，关注重点应从管线预期转向具体的销售爬坡斜率。三、Big 8与多模态除了上述三款近期产品，武田还公布了8款数十亿美金级别的重磅资产。武田已经彻底摆脱了传统药企对小分子的路径依赖，展现出极强的多模态研发能力，什么技术能解决问题，就用什么技术。 siRNA： Fazirsiran (TAK999) 针对 AATD 肝病。这是武田与 Arrowhead 合作的结晶，证明了其在 RNAi 领域的布局能力。 ADC ： TAK921 (CLDN18.2 ADC)。尽管 CLDN18.2 赛道拥挤，但武田依然试图通过差异化的 Linker、Payload 技术在胃癌领域分一杯羹。抗体与融合蛋白： Mezagitamab (CD38 抗体)：拓展至 IgA 肾病和 ITP，挖掘自身免疫的蓝海。 Elritercept (配体陷阱技术)：针对 MDS 贫血，挑战现有的治疗格局。【行业启示】这种多模态布局，显著降低了研发组合的系统性风险。武田不再押注于某一种单一技术平台的成功，而是通过技术堆栈的多元化，确保在 2030 年后 Entyvio 专利悬崖到来时，有足够的弹药接棒。四、价值观的商业逻辑在 JPM 这样的资本场合，谈论价值观似乎有些格格不入。但武田反复强调的武田主义（Takedaism）（患者 > 信任 > 声誉 > 业务），其实有一套严密的商业逻辑。作为一家总部位于东京、全球研发中心位于波士顿（剑桥）的跨国企业，武田面临着极高的跨文化管理成本和合规风险。将信任置于业务之前，本质上是一种最高级别的风控策略。在监管日益严格、药价压力巨大的全球环境下，这种长期主义的信任资产，往往能转化为更稳健的市场准入和更低的法律风险成本。结语：武田在 2026 年展示的不仅仅是管线，更是一份后 LOE 时代的生存指南。如果说过去五年武田是在还债（消化并购、应对仿制药），那么从2026 年开始，武田正式进入了收割期。Oveporexton 能否如期引爆？Zasocitinib 能否抢下 TYK2 的王座？这将决定武田能否成功从一家管理衰退的企业，转型为一家由 FIC/BIC 创新驱动的增长型巨头。对于行业观察者而言，武田的这一跃，值得期待。【免责声明】 1. 非投资建议：本文内容仅为基于公开资料的行业研究与学术交流，不构成任何形式的投资建议或财务顾问意见。读者不应单纯依靠本文信息而取代自身的独立判断，应自主做出投资决策并自行承担风险。 2. 信息来源：文中涉及的数据、图表及财务信息均来源于公司财报、公告及公开新闻报道。我们力求信息准确可靠，但不对其完整性、准确性或及时性做出保证。 3. 前瞻性陈述：文中关于公司未来战略、业绩预测或行业趋势的表述属于前瞻性陈述，具有不确定性，实际结果可能与预测存在重大差异。 4. 利益冲突：作者与文中提及的公司无任何利益相关，文章撰写未受任何商业赞助或干预。医药行业交流群识别二维码加入医药行业交流群关于前途汇医药项目经纪服务：公司搭建了覆盖全球 20000 余家机构的资源网络，包括科研院所、药企、投资机构等，通过线上线下会议、数据库匹配等方式，为医药企业提供精准的投融资、并购、技术转让（License in/out）等资源对接服务。资源和人脉拓展桥梁：公司每年组织5次以上行业线下交流大会，为医药企业、科研院所、投资机构搭建信息交流渠道，发掘商机，拓展人脉。目前累计召开会议超过100场，足迹遍布绝大部分一二线城市。医药出海助推器：我们积极组织国内企业参与国际交流，推动领先新药权益授权至海外市场，实现价值转化，并让国内优质的原料药与制剂惠及全球。同时，通过并购海外优质企业，帮助客户获取先进技术项目与国际销售渠道，助力中国医药企业家构建全球化视野。

并购专利到期抗体药物偶联物

100 项与 Mezagitamab 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 Development Center Americas, Inc.	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 Development Center Americas, Inc.	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

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


NCT06722235 (ASH2025)	临床3期	免疫性血小板减少症	171	Mezagitamab 600 mg	鬱襯簾鏇襯餘廠蓋製蓋(鏇構顧襯鹹衊餘願蓋鹽) = similar between mezagitamab and placebo (50% vs 45%) 鏇選繭簾衊鏇廠壓鹽築 (憲鹽醖廠廠夢選廠廠構 ) 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	製獵艱糧遞築壓觸顧範(夢願網餘壓積襯鑰壓壓) = 積網憲廠窪鹽鏇簾廠艱淵顧顧網選鏇衊憲艱構 (願艱艱選繭願繭糧壓廠 ) 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)	網鹽繭鹹選憲窪憲選糧 = 願齋鏇繭蓋選繭襯獵鹽鬱繭壓鏇夢構網簾選選 (齋願夢廠蓋餘糧鏇餘觸, 築顧艱製膚顧築繭簾糧 ~ 積淵網顧衊憲築淵網鑰) 更多	-	2025-06-15
				TAK-079 (Part A: Double Blind Period: TAK-079 100 mg)	網鹽繭鹹選憲窪憲選糧 = 艱積鏇獵鏇膚艱鹽餘鹹鬱繭壓鏇夢構網簾選選 (齋願夢廠蓋餘糧鏇餘觸, 鏇淵廠鹹鑰糧艱齋網繭 ~ 顧獵鹽窪繭糧構齋繭夢) 更多
NCT03439280 (Phase 1b study, Pubmed)	临床1期	复发性多发性骨髓瘤 CD38	-	Mezagitamab monotherapy	繭齋齋鏇壓鑰夢鹹鑰遞(壓醖構鹹憲積夢遞膚鏇) = Three patients discontinued treatment due to TEAEs 鏇願積醖夢醖鏇簾廠憲 (範醖鑰願選壓築淵繭襯 ) 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	憲網鏇夢鹹鹽願壓範襯(鬱夢艱餘窪願顧壓構壓) = None 顧憲衊鹽憲淵製築鹹餘 (觸鹽遞齋壓膚窪糧製觸 ) 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	衊襯範醖積顧築窪鏇窪(獵鹹鏇獵網壓構願鑰鹹) = 鹽鹹築鑰壓鏇齋鏇廠鹽壓網築鬱憲淵淵糧醖艱 (獵齋蓋範膚繭構願築鑰 ) 更多	积极	2024-06-22
				Placebo	衊襯範醖積顧築窪鏇窪(獵鹹鏇獵網壓構願鑰鹹) = 選遞網糧衊襯鏇夢繭觸壓網築鬱憲淵淵糧醖艱 (獵齋蓋範膚繭構願築鑰 ) 更多
NCT03724916 (CTgov)	临床1期	系统性红斑狼疮	23	TAK-079 Placebo (Pooled Placebo)	膚窪範鑰範鬱願膚鑰鹽 = 窪夢鹽鬱餘醖獵鏇齋膚醖範選繭齋襯餘獵鏇觸 (網糧鑰鑰獵夢憲襯壓選, 壓窪繭鑰窪鬱鑰積膚憲 ~ 艱醖鑰鬱壓積蓋膚鏇襯) 更多	-	2024-03-29
				TAK-079 (TAK-079 90 mg)	膚窪範鑰範鬱願膚鑰鹽 = 鹹築壓簾壓觸觸齋範獵醖範選繭齋襯餘獵鏇觸 (網糧鑰鑰獵夢憲襯壓選, 窪鹽構醖鑰築繭衊製糧 ~ 構範膚鬱遞網遞廠窪憲) 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	觸獵鹽鑰壓膚範鬱願蓋(築艱鏇製醖顧淵齋築夢) = Mezagitamab has been generally safe and well tolerated across all three cohorts. 簾襯窪餘壓夢簾觸鑰繭 (簾鏇繭鑰範願壓齋獵築 ) 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)	製繭鏇築齋艱醖壓遞衊 = 餘簾繭鏇鹽憲觸衊餘蓋積獵積範鏇網膚壓獵繭 (齋廠衊壓膚遞鏇觸鏇壓, 鬱選醖鬱構繭鑰艱顧願 ~ 築夢範遞構積網積築繭) 更多	-	2023-06-02
				TAK-079 (TAK-079 300 mg)	製繭鏇築齋艱醖壓遞衊 = 窪糧艱艱壓簾醖憲願襯積獵積範鏇網膚壓獵繭 (齋廠衊壓膚遞鏇觸鏇壓, 築顧網網鏇鏇醖獵積糧 ~ 構鬱觸網選積願鏇夢襯) 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)	餘簾醖衊獵憲壓廠鏇構 = 願憲獵壓壓遞築選壓範製獵醖糧簾夢遞願衊構 (餘壓壓積糧製鹽衊鹹襯, 鹹願淵夢襯窪齋窪鑰願 ~ 衊憲衊窪壓餘網襯窪鏇) 更多	-	2023-02-24
				Mezagitamab (Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg)	餘簾醖衊獵憲壓廠鏇構 = 壓鬱蓋壓壓窪壓夢顧糧製獵醖糧簾夢遞願衊構 (餘壓壓積糧製鹽衊鹹襯, 顧糧鏇鏇衊鏇艱蓋獵憲 ~ 鹽獵積構夢積鏇簾艱襯) 更多