A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus

This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

开始日期2024-09-17

申办/合作机构

Zenas BioPharma LLC.

NCT06564311

/ Active, not recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis

This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis

开始日期2024-08-26

申办/合作机构

Zenas BioPharma LLC.

NCT05786573

/ Active, not recruiting临床3期

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With An Open Label Safety and Dose Confirmation Run-In Period, To Evaluate the Efficacy and Safety of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

开始日期2023-09-25

申办/合作机构

Zenas BioPharma LLC.

100 项与奥贝利单抗相关的临床结果

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100 项与奥贝利单抗相关的转化医学

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100 项与奥贝利单抗相关的专利（医药）

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项与奥贝利单抗相关的文献（医药）

2026-10-01·NEW ENGLAND JOURNAL OF MEDICINE

Obexelimab and the Promise of Nondepleting B-Cell Therapy in IgG4-Related Disease

作者: Dörner, Thomas

2026-10-01·NEW ENGLAND JOURNAL OF MEDICINE

Obexelimab for the Treatment of IgG4-Related Disease

Article

作者: Alexander, Tobias ; Chen, Luke Y.C. ; Khosroshahi, Arezou ; Baker, Matthew C. ; Schulze-Koops, Hendrik ; Saeki, Takako ; Quinn, Shauna M. ; Della-Torre, Emanuel ; Kleger, Alexander ; Martinez-Valle, Fernando ; Karadag, Omer ; Stone, John H. ; Culver, Emma L. ; Nakayamada, Shingo ; Dong, Lingli ; Wells, Audrey ; Kawano, Mitsuhiro ; Liu, Yanying ; Okazaki, Kazuichi ; Frulloni, Luca ; Perugino, Cory A. ; Maślińska, Maria ; Rebours, Vinciane ; Meysami, Alireza ; Ebbo, Mikael ; Tanaka, Yoshiya ; Katz, Guy ; Poma, Allen ; González García, Andrés ; Carruthers, Mollie ; Zhang, Wen ; Takahashi, Hiroki ; Schleinitz, Nicolas ; Greene, Thomas J.

BACKGROUND:

IgG4-related disease is a chronic fibroinflammatory condition that can affect virtually any organ system. Glucocorticoid agents are a cornerstone of therapy but are limited by toxic effects, and relapse is common after discontinuation. Obexelimab is a bifunctional monoclonal antibody that inhibits B-cell activity through coengagement of CD19 and FcγRIIb without inducing B-cell depletion.

METHODS:

In this phase 3, double-blind, randomized, placebo-controlled trial, patients with active IgG4-related disease received subcutaneous obexelimab at a dose of 250 mg or placebo once weekly for 52 weeks. For patients in both groups, glucocorticoids were tapered in a standardized schedule to discontinuation at week 8. The primary end point was the time to the first flare of IgG4-related disease for which rescue therapy was required, as determined by both the investigator and the independent adjudication committee. Key secondary end points included complete remission at week 52 and the cumulative dose of glucocorticoid rescue therapy through week 52.

RESULTS:

From January 2023 through November 2024, a total of 194 patients underwent randomization (with 97 assigned to each group). The time to the first disease flare that required rescue therapy was significantly longer with obexelimab than with placebo (hazard ratio, 0.44; 95% confidence interval, 0.28 to 0.71; P<0.001); flares were reported in 26 patients (26.8%) in the obexelimab group and in 53 patients (54.6%) in the placebo group. Obexelimab showed a significant benefit over placebo with respect to all the key secondary end points, including complete remission (37.1% vs. 19.6%, P = 0.005) and the cumulative dose of glucocorticoid rescue therapy (329.5 mg vs. 929.8 mg, P = 0.004). Adverse events included arthralgias (in 19.6% of the patients in the obexelimab group vs. 11.3% of those in the placebo group), hypersensitivity (in 16.5% vs. 11.3%), and diarrhea (in 11.3% vs. 6.2%). Serious adverse events occurred in 10.3% of the patients in the obexelimab group and in 18.6% of those in the placebo group.

CONCLUSIONS:

Among patients with active IgG4-related disease, weekly obexelimab treatment led to a significantly lower risk of disease flare and significantly less glucocorticoid exposure than placebo. (Funded by Zenas BioPharma; INDIGO ClinicalTrials.gov number, NCT05662241.).

2026-08-15·Klinicka onkologie : casopis Ceske a Slovenske onkologicke spolecnosti

IgG4-related disease – treatment with anti-CD20, anti-CD19 antibodies, and other new drugs

Review

作者: Borský, Marek ; Kubeš, Václav ; Adam, Zdeněk ; Pour, Luděk ; Zbořil, Vladimír ; Adamová, Zuzana ; Štork, Martin ; Čermák, Aleš ; König, Jiří ; Doubek, Michael ; Zdeněk, Zdeněk ; Boichuk, Ivanna

BACKGROUND:

IgG4-related disease (IgG4-RD) can affect any tissue. Characteristic symptoms include tumor-like swelling of one or more organs, lymphadenopathy, involvement of the pancreatic and/or bile ducts, aortitis and retroperitoneal fibrosis, inflammatory swelling of the lacrimal or salivary glands, and nephropathy. Laboratory changes include hyperproteinemia, increased IgG4 concentration, eosinophilia, and elevated circulating plasmablasts. Presence of any of these symptoms should prompt a differential diagnosis focused on IgG4-RD.

GOAL:

International recommendations for treatment of IgG4-RD were published in 2015, and since then, numerous studies and meta-analyses of new treatment approaches have been published. These indicate that, in 2026, the treatment of choice is monoclonal anti-CD20 antibodies, rituximab or obinutuzumab, or alternatively, the anti-CD19 antibody inebilizumab. Rituximab achieves a significantly higher number of treatment responses and has fewer side effects than the previously used prednisone, whether in monotherapy or in combination with oral immunosuppressants. However, even after rituximab treatment, the rate of early relapses is around 16-20%. Therefore, maintenance therapy with rituximab is recommended. Another approach to achieving a longer-lasting treatment response is the combination of rituximab with cyclophosphamide. In 2025, the anti-CD19 monoclonal antibody inebilizumab was approved in the United States and Europe for the treatment of IgG4-RD. It targets a broader range of B cells than rituximab and induces a longer-lasting therapeutic response. The efficacy of other drugs (obexelimab, abatacept, daratumumab, dupilumab, and others) is documented through case reports and small patient series or phase II clinical trials, and we are awaiting the results of phase III registration studies.

CONCLUSION:

Anti-CD20 and anti-CD19 antibodies represent the treatment of choice for IgG4-RD. They achieve a high number of complete treatment responses; however, the treatment does not end there, as it is necessary to prevent disease relapses, which are common without maintenance therapy.

202

项与奥贝利单抗相关的新闻（医药）

2026-10-19

·风湿免疫界

免疫球蛋白G4相关性疾病（IgG4-RD）是一种由免疫介导、可累及全身多器官系统的慢性纤维炎症性疾病。该病好发于中老年人群，临床表现高度异质，若未能及时控制活动炎症，可逐渐进展为不可逆的器官纤维化甚至功能衰竭。由于认识时间短、相对罕见，规范化治疗与科学评估是临床痛点[1]。 2026年，由中华医学会风湿病学分会、海峡两岸医药卫生交流学会风湿免疫分会、中国IgG4相关性疾病协作组及国家皮肤与免疫疾病临床医学研究中心联合发布的《IgG4相关性疾病治疗和评估指南（2026版）》（以下简称“新指南”）正式面世。这是国内首部聚焦IgG4-RD系统受累治疗与评估的循证指南，围绕一线临床医师最关注的9个临床问题，形成了18条推荐意见[1]。新指南在治疗策略方面值得关注的两大亮点：一是将生物制剂的使用时机显著前置——从既往主要用于复发/难治患者的“补救性”选择，前移为对“有重要脏器受累或存在复发危险因素”患者推荐的一线诱导方案之一（与短疗程糖皮质激素联合，激素禁忌或不耐受时可单用），且为强推荐；二是进一步明确在维持治疗阶段推荐靶向B细胞生物制剂治疗。其中，作为目前IgG4-RD领域首个且唯一*获批适应症的药物，伊奈利珠单抗（inebilizumab）凭借MITIGATE研究的高等级证据，在诱导缓解与维持治疗两大环节均获指南重点推荐，成为本次更新中颇受瞩目的药物之一[1-2]。时机前置：生物制剂从“后手”走向“先手” 在既往的IgG4-RD治疗格局中，GC长期是唯一一线药物。无论是2015年国际共识、国内此前的专家共识[3-4]，还是自身免疫性胰腺炎诊治指南[5]，生物制剂更多被定位为GC疗效不佳、复发或激素不耐受时的“补救性”选择，使用时机明显偏后。新指南在肯定GC核心地位的同时，将靶向B细胞生物制剂的使用时机显著前置，实现了治疗范式的关键转变。推荐意见2.3（强推荐，高质量证据）明确指出：有重要脏器受累或存在复发危险因素的IgG4-RD患者，推荐靶向B细胞生物制剂（靶向CD20或CD19的单克隆抗体）联合短疗程（＜3月）糖皮质激素作为诱导缓解治疗方案之一；存在激素禁忌或不耐受时，推荐生物制剂单用[1]。这意味着，生物制剂不再只是GC失败后的“备胎”，而是与GC联合、甚至在无激素条件下单用的一线诱导方案选择[1]。生物制剂的“介入窗口”被显著前移，这一前置化调整具有重要的临床意义：对于存在重要脏器受累（如胰胆管、肾脏、中枢神经系统等）和复发危险因素（多器官受累、低补体血症、过敏史等）的患者，早期应用生物制剂有望更迅速控制炎症、阻断不可逆纤维化进展，并显著减少GC的累积用量及其相关不良反应。维持升级：生物制剂正式写入维持治疗方案 IgG4-RD是一种容易复发的疾病，停药后复发十分常见，维持治疗是决定患者长期预后的关键环节。我国多中心随机对照WInS研究已证实，病情稳定后完全停药组的18个月复发率高达52.1%[6]。在此基础上，新指南在推荐意见中进一步将生物制剂推向全程管理的核心：推荐意见3.2（条件推荐，高质量证据）指出：IgG4-RD患者病情缓解后，建议单用靶向B细胞生物制剂作为维持治疗方案之一，治疗期间密切监测不良反应[1]。指南特别引用伊奈利珠单抗的RCT研究证据，证实在诱导缓解半年后再次给予300 mg治疗，能显著降低复发率，并实现无糖皮质激素的持续缓解[2]。这意味着，对具备复发危险因素或严重脏器受累的患者，生物制剂的介入已从“复发/难治时的挽救”迁移至“诱导期即与激素联用”，并顺延至至“维持期”，构成“诱导+维持”的全程靶向管理闭环。从证据强度看，该推荐虽为“条件推荐”，但其循证基础为“高质量证据”[1]，提示在合适人群中临床应积极考虑。伊奈利珠单抗：唯一*获批IgG4-RD适应症的药物在众多靶向药物中，伊奈利珠单抗的“唯一性”值得特别强调。伊奈利珠单抗为靶向CD19的人源化、无岩藻糖基化IgG1κ单克隆抗体，通过增强抗体依赖的细胞毒作用（ADCC）和巨噬细胞介导的吞噬作用，清除CD19+ B细胞[1-2]。与抗CD20单抗相比，CD19靶点覆盖更早阶段的B谱系细胞（包括前体B细胞与浆母细胞和部分浆细胞），可实现更全面的B细胞谱系耗竭，从源头遏制IgG4-RD的免疫炎症驱动[2]。伊奈利珠单抗是全球首个且目前唯一*获批IgG4-RD适应症的药物，分别于2025年4月和9月获得美国食品药品监督管理局（FDA）与中国国家药品监督管理局（NMPA）批准[2]。其关键证据来自全球多中心、随机、双盲、安慰剂对照的III期临床试验MITIGATE研究，具有高等级循证支撑。研究纳入135例活动期IgG4-RD患者（包括初治和复发），使用3-8周激素后1:1随机接受伊奈利珠单抗或安慰剂治疗，两组均联合短疗程GC（联用8周内减停），于第1天、第15天、第26周各给予300 mg静脉输注，随访52周。结果显示： ◈ 52周时，伊奈利珠单抗组仅7例（10%）出现至少一次复发，显著低于安慰剂组40例（60%），复发风险降低87%[HR=0.13，95%CI :0.06–0.28，P＜0.001]； ◈ 52周时，伊奈利珠单抗组达到无复发、无治疗、完全缓解的患者比例显著高于安慰剂组[OR=4.68，95%CI: 2.2–9.91，P＜0.001]； ◈ 52周时，90%的患者完全停用糖皮质激素。安全性方面，伊奈利珠单抗总体不良事件发生率未高于安慰剂，临床需充分权衡获益与风险，加强对感染、低丙种球蛋白血症等不良反应的监测与管理[2]。值得注意的是，MITIGATE研究的开放标签扩展期（随访1年）数据显示，伊奈利珠单抗并未增加感染发生风险，长期应用的安全性可控[9]。正是基于上述高质量证据，新指南在诱导与维持两大环节均对伊奈利珠单抗给予明确推荐[1]，使其成为IgG4-RD靶向治疗时代的重要标杆。临床启示与展望新指南的发布，标志着我国IgG4-RD治疗进入“生物制剂介入前移、激素依赖逐步降低”的精准靶向治疗时代。对临床而言，这一理念转变意味着：面对重要脏器受累或有复发危险因素者，不必拘泥于“先激素、后生物制剂”的旧路径，可在诱导期即联合或单用靶向B细胞药物，争取更早、更彻底的炎症控制，减少GC累积毒性与不可逆纤维化[1]。缓解后善用生物制剂维持，尤其是伊奈利珠单抗这类拥有高质量RCT证据的获批药物，可帮助患者实现无GC持续缓解，改善长期预后[1-2]。而无论诱导还是维持，药物的具体选择都须结合患者年龄、合并症、感染风险、经济条件与药物可及性综合决策，并在治疗中密切监测Ig水平与感染征象[1]。生物制剂在真实世界中的长期安全性、不同药物头对头比较、以及在中国人群中的卫生经济学价值，仍有待更多研究填补证据。但毋庸置疑，2026版指南以循证之力推动治疗理念革新，而伊奈利珠单抗作为唯一*获批适应症的靶向药物，正以其高质量证据，引领IgG4-RD迈入精准靶向治疗的新时代[1-2]。扫描二维码获取最新指南原文 *：截至2026年10月声明：本文仅供医疗卫生专业人士参阅参考文献 [1]中华医学会风湿病学分会, 海峡两岸医药卫生交流学会风湿免疫分会IgG4相关性疾病学组. IgG4相关性疾病治疗和评估指南（2026版）[J].中华医学杂志, 2026,106(37):3939-3955. [2] Stone JH, Khosroshahi A, Zhang W, et al. Inebilizumab for Treatment of IgG4-Related Disease[J]. N Engl J Med, 2025, 392(12): 1168-1177. [3]Khosroshahi A, Wallace ZS, Crowe JL, et al. International Consensus Guidance Statement on the Management and Treatment of IgG4-Related Disease[J]. Arthritis Rheumatol, 2015, 67(7): 1688-1699. [4]张文, 董凌莉, 朱剑, 等. IgG4相关性疾病诊治中国专家共识[J]. 中华内科杂志, 2021, 60(3): 192-206. [5]国家消化系统疾病临床医学研究中心（上海）, 等. 中国自身免疫性胰腺炎诊治指南（上海，2023）[J]. 中华胰腺病杂志, 2024, 24(2): 81-93. [6]Peng L, Nie Y, Zhou J, et al. Withdrawal of immunosuppressants and low-dose steroids in patients with stable IgG4-RD (WInS): an investigator-initiated, multicentre, open-label, randomised controlled trial[J]. Ann Rheum Dis, 2024, 83(5): 651-660. [7]Liu Y, Jin K, Yang Y, et al. Efficacy and safety of rituximab induction therapy and effect of rituximab maintenance for IgG4-related disease: a systematic review and meta-analysis[J]. Eur J Intern Med, 2024, 127: 63-73. [8]Wallace ZS, et al. Obexelimab for the Treatment of IgG4-Related Disease[J]. N Engl J Med, 2026 Jun 2; NEJMoa2601337. [9]Stone JH, Culver EL, Khosroshahi A, et al. Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open Label Period of the Phase 3 MITIGATE Trial. Presented at: EULAR 2026 Annual Meeting; June 3-6, 2026; Amsterdam, Netherlands. Abstract POS0440.

临床研究

2026-10-18

·糖研所 Carbo-Lab

一周药闻 | 大分子与生物药行业动态

2026.10.08 – 2026.10.15 本周，NMPA密集放行多款生物制品，ADC赛道BD与监管双热，GLP-1与mRNA平台再添里程碑。精选10条如下。国内动态监管 · GLP-1先为达/辉瑞埃诺格鲁肽获批2型糖尿病适应症，国产GLP-1再扩版图 10月9日，NMPA药品批准证明文件送达信息显示，杭州先为达生物的埃诺格鲁肽注射液（商品名：先维盈）新适应症获批。10月12日，辉瑞宣布该药新增适应症为成人2型糖尿病血糖控制。埃诺格鲁肽为新一代cAMP偏向型GLP-1受体激动剂，今年3月已获批减重适应症。EECOH-1 III期研究显示，1.2mg组治疗24周后HbA1c较基线下降2.43%，达标率80.3%。影响：在司美格鲁肽、替尔泊肽的强势竞争下，埃诺格鲁肽以“降糖+减重”双适应症切入，国产GLP-1的差异化竞争进入兑现期。来源：NMPA官网、澎湃新闻（2026-10-12）监管 · 双抗强生特立妥单抗在华获批，BCMA×CD3双抗进入骨髓瘤市场 10月9日，NMPA批准强生制药特立妥单抗注射液（Teclistamab）上市。该药为BCMA×CD3双特异性抗体，用于复发或难治性多发性骨髓瘤成人患者，通过重定向T细胞杀伤骨髓瘤细胞发挥作用。影响：随着骨髓瘤治疗进入“CAR-T、双抗、ADC”三足鼎立时代，特立妥单抗的入局将加速中国血液瘤双抗市场的临床教育与格局重塑。来源：NMPA官网（2026-10-10）监管 · ADC百利天恒三款ADC集中纳入CDE突破性治疗品种 10月10日，百利天恒宣布，其伦康依隆妥单抗（BL-B01D1）、T-Bren（BL-M07D1，HER2 ADC）及BL-M05D1（Claudin18.2 ADC）三款ADC的相关治疗方案被CDE纳入突破性治疗品种名单，分别用于胆道癌、HER2表达胆道癌及CLDN18.2阳性晚期胃癌。截至目前，BL-B01D1已有9项适应症获CDE突破性治疗认定。影响：单周三款ADC进入突破性治疗，反映出国内ADC赛道正从“单一品种竞争”进入“平台化、适应症矩阵化”的深水区。来源：成都科技/今日头条（2026-10-10） BD · ADC盟科药业近10亿美元出海，HER2 ADC及平台授权瑞士ClearideBio 10月9日，盟科药业与瑞士ClearideBio达成两项协议：全球独家许可MRX-23（HER2 ADC，临床前），里程碑最高2.23亿美元；以及基于自研STOPIN ADC平台的多项目选择权合作，最多6个项目，累计里程碑上限7.5亿美元。盟科此前长期聚焦抗感染小分子，此次正式切入肿瘤ADC赛道。影响：平台技术（尤其是linker-payload优化）的价值正在被全球买家认可，也提示国内传统药企向大分子转型的可行性路径。来源：VCBeat Health（2026-10-09）监管 · mRNA沃森生物首个自主原研mRNA疫苗获批，从“紧急使用”迈向“正式上市” 10月9日，云南沃森生物宣布，其新型冠状病毒mRNA疫苗获国家药监局《药品注册证书》。这是我国第一款基于自主mRNA平台技术正式获批上市的疫苗，标志着中国mRNA疫苗实现从“紧急使用”到“正式注册上市”的关键跨越。目前，其RSV mRNA疫苗、带状疱疹mRNA疫苗已获临床批件。影响：mRNA技术正式获得NMPA“上市牌照”，为后续呼吸道合胞病毒、带状疱疹等mRNA疫苗的临床与商业化铺平道路，国内核酸药物产业链的 regulatory pathway 已完全跑通。来源：都市时报/云南日报（2026-10-09）临床 · 双抗诺诚健华TL1A/IL-23p19双抗获批IND，剑指炎症性肠病 10月12日，诺诚健华宣布，其自主研发的ICP-B161（靶向TL1A和IL-23p19的新型双特异性抗体）获CDE批准开展临床试验，拟用于治疗炎症性肠病（IBD）。该分子可实现超长半衰期和皮下注射给药，临床前数据显示其体内药效优于对应单抗及同类双抗。目前全球尚无同靶点双抗上市。影响：TL1A和IL-23是IBD领域最受关注的两个靶点，诺诚健华以双抗形式同时阻断两条通路，有望实现“1+1>2”的协同效应，是国产自免双抗的重要起点。来源：证券时报e公司（2026-10-12）国际动态临床/监管 · ADC百利天恒T-Bren获FDA许可启动全球III期临床，瞄准尿路上皮癌 10月14日，百利天恒宣布，其HER2 ADCT-Bren（BL-M07D1）用于PD-(L)1治疗进展后的HER2表达转移性尿路上皮癌的全球多中心III期临床试验申请获FDA许可。这是百利天恒第二项独立发起并主导的全球III期临床。该药目前正在中美开展20项临床试验，覆盖乳腺癌、胃癌、胆道癌、肺癌及泌尿系肿瘤等。影响：从CDE突破性治疗到FDA全球III期许可，百利天恒的ADC管线在同一周内收获国内外双重里程碑，“中国研发、全球临床”的出海模式已成为本土创新药企的标杆路径。来源：腾讯新闻/医药魔方（2026-10-14）监管 · ADC艾伯维c-Met ADC获FDA两项突破性疗法认定，覆盖肺癌与肠癌当地时间10月8日，艾伯维宣布，其在研c-Met靶向ADCtelisotuzumab adizutecan（Temab-A）获FDA两项突破性疗法认定：联合贝伐珠单抗用于难治性转移性结直肠癌，单药用于经治c-Met高表达非鳞状非小细胞肺癌。目前其临床项目已包含多项III期及II/III期研究。影响：c-Met是实体瘤中表达广泛但成药难度较高的靶点，Temab-A在结直肠癌和肺癌两大瘤种同时获得BTD，为ADC向“冷肿瘤”和联合治疗拓展提供了新范式。来源：新浪新闻/康迅网（2026-10-10）临床 · 单抗信达生物Sycume III期成功，填补慢性甲状腺眼病70年药物治疗空白 10月8日，信达生物宣布，其抗IGF-1R抗体Sycume（IBI311）在治疗 inactive thyroid eye disease（慢性/非活动性甲状腺眼病）的III期RESTORE-3研究中达到主要终点。24周时，治疗组眼球突出应答率60.4% vs 安慰剂23.5%（p=0.0003）。该药已纳入2026年国家医保，此次数据将支持其向慢性期患者拓展。影响：慢性甲状腺眼病患者约占总体2/3，此前几乎只能依赖手术。Sycume将生物制剂的治疗窗口从急性期扩展至慢性期，意味着巨大的患者人群扩容和长期用药市场。来源：Biopharm International/AllSci（2026-10-08）临床 · 双功能抗体Zenas双功能抗体obexelimab长期数据亮眼，IgG4-RD复发风险降至7% 当地时间10月8日–10日，Zenas BioPharma公布obexelimab（CD19×FcγRIIb双功能抗体）III期INDIGO研究的开放标签扩展数据。结果显示，IgG4-RD患者接受obexelimab治疗12个月的无复发概率达93%，糖皮质激素毒性显著降低（p=0.021）。该药通过抑制B细胞活性而非清除起效，皮下注射，具有差异化机制。影响：IgG4-RD作为一种慢性、易复发的自身免疫病，长期依赖糖皮质激素。obexelimab在维持治疗期展现出极高的无复发率和类固醇减量能力，有望成为自免领域“去激素化”管理的重要选项。来源：CheckOrphan/Zenas BioPharma（2026-10-08）一周小结本周大分子药物领域呈现三大主线： 1. 监管端密集放行：NMPA一周内连续批准GLP-1、双抗、mRNA疫苗等多个重磅品种，国内生物药审评效率持续提升。 2. ADC热度不减：从百利天恒的CDE/FDA双里程碑，到盟科药业的近10亿美元出海，再到艾伯维的FDA突破性认定，ADC继续扮演最活跃赛道。 3. 自免赛道升温：诺诚健华双抗IND获批、信达生物Sycume慢性期数据成功、Zenas obexelimab长期数据优异，自身免疫病正成为继肿瘤之后大分子药物的下一个主战场。建议持续关注年底ASH、ESMO IO及国内创新药谈判动态。

抗体药物偶联物突破性疗法临床3期免疫疗法细胞疗法

2026-10-18

·BioSpace

Zenas BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - October 16, 2026

WALTHAM, Mass., Oct. 16, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune and inflammatory diseases, today announced that on October 15, 2026 (the “Grant Date”), the Compensation Committee of the Company’s Board of Directors granted an aggregate of 74,900 restricted stock units of the Company’s common stock (“RSUs”) to newly hired employees of the Company as an inducement material to such employees’ entry into employment with the Company, in accordance with Nasdaq Listing Rule 5635(c)(4) (the “Inducement Grant”). The RSUs will vest in four (4) equal installments over a four-year period, with vesting as to twenty-five percent (25%) of the RSUs subject to the award on each of October 15, 2027, October 15, 2028, October 15, 2029 and October 15, 2030. Inducement Grants are subject to the employees’ continued service with Zenas through the applicable vesting dates. The Inducement Grants were granted pursuant to, and are subject to, the terms and conditions of the Company’s 2026 Inducement Plan and the applicable award agreement. About Zenas BioPharma, Inc. Zenas is a clinical-stage global biopharmaceutical company focused on the development and commercialization of therapies for autoimmune diseases and inflammatory conditions. Zenas combines our experienced leadership team with a disciplined global product candidate acquisition approach to identify, acquire and develop product candidates with the potential to deliver clinically meaningful benefits to patients. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind CD19 and FcγRIIb to inhibit the activity of B cells implicated in many autoimmune diseases without depleting them. Zenas believes that the unique mechanism of action of obexelimab and its self-administered, subcutaneous injection regimen may enable sustained control across multiple chronic autoimmune diseases. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a novel, potentially best-in-class, oral, IL-17AA/AF inhibitor, ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, and ZB014, a preclinical, half-life extended anti-CD19 and FcγRIIb monoclonal antibody. For more information about Zenas BioPharma, please visit and follow us on LinkedIn . The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. All rights reserved. Contacts: Investors: Argot Partners Zenas@argotpartners.com Media: Kristin Ainsworth SVP, U.S. Commercial Strategy & Corporate Affairs 612.839.6748

100 项与奥贝利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11496	-	-	DB15032

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
温热型自身免疫性溶血性贫血	临床3期	意大利	Zenas BioPharma LLC.	2023-09-25
温热型自身免疫性溶血性贫血	临床3期	波兰	Zenas BioPharma LLC.	2023-09-25
温热型自身免疫性溶血性贫血	临床3期	西班牙	Zenas BioPharma LLC.	2023-09-25
温热型自身免疫性溶血性贫血	临床3期	中国台湾	Zenas BioPharma LLC.	2023-09-25
温热型自身免疫性溶血性贫血	临床3期	英国	Zenas BioPharma LLC.	2023-09-25
免疫球蛋白G4相关疾病	临床3期	美国	上海泽纳仕生物科技有限公司	2022-12-15
免疫球蛋白G4相关疾病	临床3期	日本	上海泽纳仕生物科技有限公司	2022-12-15
免疫球蛋白G4相关疾病	临床3期	阿根廷	上海泽纳仕生物科技有限公司	2022-12-15
免疫球蛋白G4相关疾病	临床3期	加拿大	上海泽纳仕生物科技有限公司	2022-12-15
免疫球蛋白G4相关疾病	临床3期	法国	上海泽纳仕生物科技有限公司	2022-12-15

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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


INDIGO (ACR2026)	临床3期	免疫球蛋白G4相关疾病	7	Influenza vaccine	艱艱窪網艱鹹夢憲構艱(糧鬱製廠艱齋選襯襯願) = 憲鬱艱憲範鑰築憲餘簾鬱憲醖遞廠膚獵襯顧觸 (廠構廠壓鏇齋範襯顧鏇 ) 更多	积极	2026-11-06
				Influenza vaccine	膚鹹襯積願觸鹽廠膚積(願範遞繭製膚淵淵艱遞) = 窪夢齋獵窪鏇鑰顧繭範鹹範選鑰衊窪醖顧壓鑰 (壓壓觸夢壓壓夢製觸醖 ) 更多
INDIGO (ACR2026)	临床3期	免疫球蛋白G4相关疾病	251	Obexelimab 250 mg	夢糧願積願積襯簾鹽範(簾醖顧獵餘壓糧艱壓膚) = 製膚簾廠餘觸鹽築鑰夢醖築壓鏇網糧糧獵鏇遞 (願鏇構淵鹹簾廠艱鬱鹹 ) 更多	积极	2026-11-06
				Placebo	夢醖餘衊膚積顧襯壓廠(鏇鹽餘餘壓醖蓋窪觸襯) = 願獵簾憲鹽鬱窪壓夢範遞構遞構願獵艱艱獵製 (膚齋襯築淵壓醖鏇鑰選 ) 更多
NCT05662241 (INDIGO, Pubmed \| N Engl J Med)	临床3期	免疫球蛋白G4相关疾病	194	Obexelimab 250 mg	鬱遞築艱鹽遞遞窪醖繭(鑰鹽構蓋鏇繭遞壓簾鏇) = in 19.6% of the patients in the obexelimab group vs. 11.3% of those in the placebo group 窪廠構簾襯製觸膚顧艱 (醖窪膚構鏇鹽醖鑰繭襯 ) 更多	积极	2026-10-01
				Placebo
NCT05662241 (INDIGO, EULAR2026)	临床3期	免疫球蛋白G4相关疾病	194	Obexelimab 250 mg	鹹積糧糧衊網壓顧觸餘(繭積鹹淵構醖鹹憲範鹹) = 膚餘醖築糧廠夢艱廠夢衊窪艱繭製衊選築積選 (壓製糧簾遞廠醖構襯遞 ) 更多	积极	2026-06-11
				Placebo	鹹積糧糧衊網壓顧觸餘(繭積鹹淵構醖鹹憲範鹹) = 築夢淵鏇築獵鏇網網鹹衊窪艱繭製衊選築積選 (壓製糧簾遞廠醖構襯遞 ) 更多
NCT06564311 (MoonStone, ACTRIMS2026)	临床2期	复发性多发性硬化	116	Obexelimab 250 mg	齋醖齋範觸廠淵鏇獵願(築繭鹹廠糧糧鹽淵膚壓) = 網鏇鬱遞餘窪遞鬱糧範築觸鏇衊艱觸醖築鹽膚 (蓋襯夢鹹鏇鏇範製蓋壓, 0.00 ~ 0.06)	积极	2026-02-05
				Placebo	齋醖齋範觸廠淵鏇獵願(築繭鹹廠糧糧鹽淵膚壓) = 壓醖艱餘鹽顧積糧壓顧築觸鏇衊艱觸醖築鹽膚 (蓋襯夢鹹鏇鏇範製蓋壓, 0.11 ~ 0.51)
NCT05662241 (INDIGO, NEWS) 人工标引	临床3期	免疫球蛋白G4相关疾病	194	Obexelimab	窪鹽衊簾選齋餘鹹糧簾(簾範窪鏇網壓築壓廠壓) = 範鬱簾鬱壓醖蓋網醖積顧鹽構憲蓋醖繭夢餘鑰 (鬱願廠襯構鹹觸淵範夢 ) 达到	积极	2026-01-06
				安慰剂	窪鹽衊簾選齋餘鹹糧簾(簾範窪鏇網壓築壓廠壓) = 觸範淵齋廠鹹憲夢網鹽顧鹽構憲蓋醖繭夢餘鑰 (鬱願廠襯構鹹觸淵範夢 ) 达到
NCT06564311 (MoonStone, GlobeNewswire) 人工标引	临床2期	复发性多发性硬化	116	Obexelimab 250 mg	艱簾艱製願願遞鑰膚鏇(繭夢夢淵衊積鏇淵廠網) = 網鏇製構獵夢膚製鹽網膚壓鹽築淵齋鏇鹽蓋夢 (鑰繭窪網構觸鏇鏇築築, 0.00 ~ 0.06) 达到	积极	2025-10-27
				Placebo	艱簾艱製願願遞鑰膚鏇(繭夢夢淵衊積鏇淵廠網) = 衊鬱淵鬱繭餘鬱積膚鏇膚壓鹽築淵齋鏇鹽蓋夢 (鑰繭窪網構觸鏇鏇築築, 0.11 ~ 0.51) 达到
NCT05786573 (SApHiAre, ASH2024)	临床2期	-	6	Obexelimab	夢膚廠選選遞窪繭範窪(餘鬱繭繭鏇積簾願醖夢) = 夢夢網繭鏇觸醖壓壓艱蓋遞築淵鬱鑰膚憲積艱 (觸廠範範鹽蓋膚窪選積 )	积极	2024-11-05
NCT02725476 (Pubmed \| Lancet Rheumatol)	临床2期	免疫球蛋白G4相关疾病	15	Obexelimab 5 mg/kg	鹹艱蓋鹹膚夢鬱鹽糧淵(夢襯衊鹹窪積衊願簾齋) = 13 (87%) of 15 patients reported adverse events, one of which (an infusion reaction) resulted in treatment discontinuation 鹹積壓選廠遞糧淵憲醖 (衊鏇醖鹹網遞鑰鏇積糧 )	积极	2023-08-01
ACR2020	临床2期	系统性红斑狼疮 CD27+ \| APP	68	Obexelimab	艱鹽衊艱遞鏇餘餘壓襯(積繭鑰選蓋顧鏇積齋簾) = 選衊壓鑰鏇廠範衊齋夢築願壓艱蓋繭獵廠廠淵 (襯鑰網範膚糧糧膚築夢 ) 更多	积极	2020-11-09
				Placebo	艱鹽衊艱遞鏇餘餘壓襯(積繭鑰選蓋顧鏇積齋簾) = 顧衊選願築顧醖築夢選築願壓艱蓋繭獵廠廠淵 (襯鑰網範膚糧糧膚築夢 ) 更多