An Open Label Study to Investigate the Long-term Safety and Efficacy of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

This is an open label extension (OLE) study of an ongoing randomized controlled clinical study 218224 (Parent Study). The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.

开始日期2024-12-12

申办/合作机构

GSK Plc

[+1]

NCT06381453

/ Recruiting临床2期IIT

Belimumab in the Management of Autoimmune Hepatitis: a Multi-centre, Open-label Trial of Add-on Belimumab Therapy to Standard of Care

Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic & environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability & safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT<2x ULN & corticosteroids at a dose of

开始日期2024-12-11

申办/合作机构

University Health Network

[+1]

NCT06572384

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease (ILD) Associated With Connective Tissue Disease (CTD)

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

开始日期2024-09-11

申办/合作机构

GSK Plc

100 项与贝利尤单抗相关的临床结果

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100 项与贝利尤单抗相关的转化医学

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100 项与贝利尤单抗相关的专利（医药）

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1,320

项与贝利尤单抗相关的文献（医药）

2025-08-01·SEMINARS IN ARTHRITIS AND RHEUMATISM

Infectious complications of Belimumab with standard care in systemic lupus erythematosus: a systematic review and meta-analysis

Review

作者: Wei, James Cheng-Chung ; Fan, Yongsheng ; Chi, Gerald ; Ma, Chenhang ; Wang, Xinchang ; Xia, Shujun ; Wang, Weijie ; Zhao, Yu

OBJECTIVES:

We aimed to evaluate the risk of infectious complications of Belimumab with standard care in systemic lupus erythematosus (SLE).

METHODS:

We searched PubMed, Web of Science, EMBASE, and Cochrane databases for studies on SLE and Belimumab and evaluated the study quality using the Cochrane Collaboration tool (ROB 2). A random-effect model was employed to analyze the results. To evaluate publication bias, Egger's tests were used. We also performed subgroup analysis based on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group(BILAG). The study protocol has been registered in PROSPERO (CRD42023421255).

RESULTS:

Eight studies involving 8545 patients were included, of which four studies had a high attrition bias. The present study suggested that the risks of infectious complications including infection (RR=1.02, 95 %CI=(0.97,1.08), I²=7.7 %) or serious infections (RR=0.94, 95 %CI=(0.77,1.15), I²=0 %), nasopharyngitis(RR=1.02, 95 %CI=(0.79,1.33), I²=36 %), upper respiratory tract infection(RR=0.97, 95 %CI=(0.83,1.14), I²=20.6 %), urinary tract infection(RR=1.09, 95 %CI=(0.91,1.32), I²=0 %), herpes zoster (RR=0.75, 95 %CI=(0.54,1.05), I²=0 %)and influenza(RR=0.98, 95 %CI=(0.69,1.39), I²=0 %) were not significantly increased in patients who received Belimumab with standard care, except for bronchitis (RR=1.51, 95 %CI=(0.98,2.33), I²=23.7 %). Additionally, the subgroup analysis of SLEDAI and the proportion of patients with BILAG 1A/2B did not show any significant impact on infectious complications.

CONCLUSION:

Meta-analysis results demonstrated that intravenous (IV) Belimumab(≤10 mg/kg), along with standard care, did not significantly increase the risk of infectious complications in SLE patients having mild-to-moderate disease activity, except for bronchitis. Baseline disease activity and organ damage did not impact the risk of infectious complications.

2025-07-01·JOINT BONE SPINE

Comparative efficacy and safety of anifrolumab for belimumab-experienced and biologic-naïve patients with systemic lupus erythematosus: Results from the Kyushu Collagen Disease Network for Systemic Lupus Erythematosus (KCDN-SLE) registry

Letter

作者: Maekawa, Makiko ; Ueda, Naoyasu ; Tanaka, Atsushi ; Ayano, Masahiro ; Kushimoto, Kazuo ; Mishima, Koji ; Tsuru, Tomomi ; Doi, Goro ; Akashi, Koichi ; Akahoshi, Mitsuteru ; Ota, Shun-Ichiro ; Nakayama, Tsuyoshi ; Niiro, Hiroaki ; Horiuchi, Takahiko

2025-07-01·AUTOIMMUNITY REVIEWS

Dual B-cell targeting in systemic lupus erythematosus: The role of combined and sequential therapy with rituximab and belimumab

Review

作者: Frade-Sosa, Beatriz ; Gómez-Puerta, José A ; Arnaud, Laurent ; Sarmiento-Monroy, Juan C ; Bruce, Ian N

Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterized by immune dysregulation and autoantibody production. Despite advances in treatment, achieving sustained disease control remains challenging. Rituximab (RTX) and belimumab (BELI) are two B-cell-targeting biologics with complementary mechanisms of action, leading to increasing interest in their combination as a therapeutic strategy for refractory SLE. RTX depletes CD20+ B cells, whereas BELI inhibits B-lymphocyte stimulator (BLyS), reducing the survival of autoreactive B cells. Sequential therapy with these agents may mitigate B-cell repopulation and improve disease control. Recent studies, including SynBioSe and BEAT-LUPUS, suggest that RTX-BELI therapy can reduce autoantibody levels, neutrophil extracellular trap formation, and disease activity, with many patients achieving a lupus low disease activity state (LLDAS). However, the BLISS-BELIEVE and CALIBRATE trials did not demonstrate superiority over monotherapy, highlighting the need to refine patient selection. Combination therapy may be particularly beneficial in lupus nephritis, where BELI delays autoreactive B-cell reconstitution following RTX, potentially prolonging remission. While RTX-BELI therapy is generally well-tolerated, some studies report increased infections, necessitating careful patient monitoring. Lessons from other immune-mediated diseases, including inflammatory bowel disease and rheumatoid arthritis, underscore the potential benefits and risks of dual biologic therapy. Further research, including the ongoing SynBioSe-2 trial, is needed to clarify the optimal use, sequencing, and safety profile of RTX-BELI in SLE. Identifying biomarkers predictive of response may enable personalized treatment approaches, ultimately improving long-term outcomes for patients with refractory SLE.

206

项与贝利尤单抗相关的新闻（医药）

2025-06-30

·抗体圈

303亿，国内自免甩出「王炸」

近日，荣昌生物甩出“王炸”，泰它西普以42.3亿美元（约303亿人民币）转让海外权益，刷新国内自免领域单品出海交易峰值。 01 “王炸”亮相自身免疫性疾病作为仅次于心血管疾病和癌症的第三大慢性病，其治疗市场正迎来爆发式增长。全球自免治疗市场规模预计从2020年的1206亿美元增至2030年的1752亿美元，其中生物药占比将突破80%。中国市场增速更为迅猛，预计从2020年的25亿美元跃升至2030年的246亿美元（图1），年均复合增长率高达28.3%。这一巨大市场催生了多款“百亿级”生物药，而荣昌生物自主研发的泰它西普，正凭借其卓越的临床价值和商业潜力，成为自免领域的新一代“王炸”产品。图1.中国自免药物的市场规模泰它西普（RC18）是全球首创 BlyS/APRIL 双靶点融合蛋白。能够同时高效抑制B淋巴细胞刺激因子（BLyS）和增殖诱导配体（APRIL）两个对 B 淋巴细胞发育至关重要的细胞信号分子。BLyS和APRIL是调控B细胞成熟、分化和存活的核心因子，在系统性红斑狼疮（SLE）、类风湿关节炎（RA）等自身免疫性疾病中异常高表达。图2.泰它西普的分子结构结构上，泰它西普是 TACI-Fc 融合蛋白，由 TACI 的胞外特定的可溶性部分与人血清中免疫球蛋白 G1（IgG1）的可结晶片段（Fc）构成（图2）。TACI 是一种跨膜蛋白受体，属于肿瘤坏死因子受体超家族成员，配体为 APRIL 和 BlyS。采用接近全人源化的 TACI 片段和全部人源化的 IgG Fc 片段，有效降低了潜在的免疫原性，提高了安全性，并且具备更佳血清稳定性及较长半衰期。图3.泰它西普的作用机制作用机制上，泰它西普可基于 TACI 受体对 BLyS 和 APRIL 两种配体的高亲和力，阻止BLyS 和 APRIL 与它们的细胞膜受体TACI，BCMA，BAFF-R之间的相互作用，全面抑制异常B细胞活化及自身抗体产生，从源头上遏制自身免疫反应（图3）。这种人源化设计大幅降低了免疫原性，同时延长药物半衰期，为长期治疗提供便利。 02 开疆拓土泰它西普凭借其独特的双靶点机制优势，正以前所未有的速度拓展其在自免领域的治疗疆界。2021年3月，泰它西普治疗系统性红斑狼疮（SLE）在中国获附条件批准上市，并于同年底进入国家医保药品目录，成为全球首款治疗SLE的双靶生物新药；2023年11月，其由附条件批准转为完全批准，标志着临床价值的充分验证。目前治疗系统性红斑狼疮仅有3款药物在全球获批上市，分别是贝利尤单抗、泰它西普和阿尼鲁单抗，巨大的临床需求尚未得到满足。泰它西普作为一种双靶点融合蛋白，相比单一靶点的同类产品表现出更优的治疗效果。据临床试验数据显示，泰它西普对 IgM、IgG 及 IgA 的降低效果整体优于贝利尤单抗的降低效果（图4），且有效剂量相对更低（非头对头试验）。图4.泰它西普与贝利尤单抗 IgM、IgG、IgA 较基线降低百分比中位值对比随着SLE适应症的获批，泰它西普后续的拓展步伐坚定而迅速。2024年7月，其类风湿关节炎（RA）适应症在国内获批。此次获批基于一项III期临床研究，荣昌生物在2023年美国风湿病学会（ACR）年会上公布了这一临床试验结果。数据显示，治疗24周时，泰它西普组ACR20应答率远超安慰剂组（60.0% vs 26.9%）（图5），ACR50应答率也显著更高（21.4% vs 5.9%）。此外，泰它西普组在第24周无放射性学进展的患者比例显著高于安慰剂组（90.2% vs 66.4%），且整体安全性与安慰剂相当。此次获批为占RA用药主流的TNF-ɑ抑制剂提供了有力替代，满足了大量对现有生物制剂反应不佳患者的迫切需求。图5.泰它西普组和安慰剂组的 ACR20 应答率比较当然，泰它西普的征程并未止步。2025年4月，其在美国神经病学学会（AAN）年会公布的治疗全身型重症肌无力（gMG）III期研究数据再次震动业界。该研究证实泰它西普起效迅速，4周即显著改善，24周达到疗效高峰。更值得注意的是，泰它西普在已完成III期研究的gMG药物中创造了最高的MG-ADL应答率数据，且安全性优异。基于此，其gMG适应症于2025年5月在国内获批上市。图6.泰它西普在自免领域在研管线除系统性红斑狼疮、类风湿性关节炎、重症肌无力以外，目前，其针对视神经脊髓炎谱系疾病、IgA肾病等8种自免适应症的临床研究正在积极推进（图6）。 03 重磅出海6月26日，泰它西普迎来了国际化征途的关键里程碑。公司宣布与Vor Biopharma达成一项总金额高达42.3亿美元的重磅合作协议，Vor Bio将获得泰它西普在除大中华区以外全球市场的独家开发、生产与商业化权益。荣昌生物则获得4500万美元首付款、价值8000万美元的股权（可认购Vor Bio公司3.2亿股，占比约23%），以及后续最高可达41.05亿美元的里程碑付款和基于销售额的高个位数至双位数比例提成（图7）。这一交易结构，特别是荣昌生物成为Vor Bio重要股东并深度绑定长期利益的安排，为创新药“出海”提供了值得关注的型模式，显著提升了其在合作中的话语权和议价能力。图7.泰它西普授权出海泰它西普此次扬帆出海绝非偶然。自2021年国内获批上市以来，其市场表现持续亮眼。2024年销售额飙升至9.7亿元人民币，同比激增88%，单年销量突破150万支。截至2024年底，产品已成功进入全国超1000家医院及250多家DTP药房，覆盖31个省级行政区，本土商业化根基已然筑牢。与此同时，其国际化布局同步加速推进，针对重症肌无力（MG）的全球多中心III期临床试验正在积极开展，该适应症更已获得美国FDA授予的快速通道资格以及美欧监管机构认可的孤儿药资格，为其全球拓展奠定了坚实的临床与法规基础。荣昌生物自创立伊始，便锚定ADC、抗体融合蛋白等尖端技术方向。厚积薄发之下，2021年迎来泰它西普和维迪西妥单抗双星闪耀。其中，维迪西妥单抗以26亿美元的交易总额授权给美国Seagen公司，彼时创下中国单药出海金额之最，为公司积累了宝贵的国际授权经验并极大提升了市场信心。如今，荣昌生物依托泰它西普与维迪西妥单抗两大核心产品持续发力，2024年总销售额达到17.17亿元人民币，同比增长高达58.54%。结语泰它西普的成功出海，是荣昌生物在创新中寻求价值最大化的生动缩影。此次远航，不过是序幕初启。参考资料[1]https://www.remegen.cn/uploadfile/2025/06/26/202506260707126183.pdf[2]https://www.remegen.cn/index.php?v=show&cid=68&id=113[3]https://mp.weixin.qq.com/s/6kQd7b0BamUIUqPwC3ePhQ[4]https://mp.weixin.qq.com/s/7k0o4b5y4seempkhZ8uoXQ[5]东海证券研报、各种公开资料等识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

上市批准

2025-06-25

·GBIHealth

拜耳与清华大学达成第六期科研战略合作

药械追踪No.1 / GE医疗脑部造影剂Vizamyl获美国FDA批准扩大标签，包括AD定量分析2025年6月25日，GE医疗（纳斯达克代码：GEHC）宣布，美国食品药品监督管理局（FDA）已批准其用于β-淀粉样蛋白检测的正电子发射断层扫描（PET）造影剂Vizamyl（氟[18F]美他酚）的标签更新。Vizamyl于2013年首次获批，用于评估有认知障碍的阿尔茨海默病（AD）成人患者β淀粉样蛋白神经炎性斑块密度。此次修订后的标签即刻生效，扩大了Vizamyl在AD检测领域的适应证，新增定量分析功能，临床医生借助相关软件计算淀粉样蛋白密度，从而得出更为客观的评估结果。新标签还取消了之前对使用Vizamyl监测抗淀粉样蛋白疗法疗效的限制，现允许使用Vizamyl评估淀粉样蛋白斑块下降水平，以决定是否可以停止相关治疗。->点击文末阅读原文，解锁完整双语新闻No.2/ 拜耳与清华大学达成第六期科研战略合作2025年6月24日，拜耳与清华大学签署双方第六期科研战略合作协议，进一步助力涵盖肿瘤、心血管及肾脏、神经学和罕见病以及免疫学等多个重点领域内的基础研究成果向新药研发转化，并加速推动药物创新价值链上的前沿科研进展。根据合作协议，拜耳将在未来三年内继续资助双方联合科研项目，并向在生命科学领域以及药物创新方面做出卓越科研贡献的清华大学科学家提供奖励，持续深化双方科研交流与探讨。2009年拜耳就开始与清华大学合作，双方16年间共合作开展75个联合研究项目。->点击文末阅读原文，解锁完整双语新闻No.3 / GSK倍力腾获美FDA批准治疗5岁以上LN患者2025年6月24日，葛兰素史克（LSE/NYSE：GSK）宣布，美国FDA已批准倍力腾（贝利尤单抗，200 mg/mL 自动注射器）用于5岁及以上患有活动性狼疮性肾炎（LN）患者。倍力腾是一种针对B淋巴细胞刺激因子（BlyS）的特异性抑制单克隆抗体，通过结合可溶性BLyS，可抑制B细胞（包括自身反应性B细胞）的存活，并减少B细胞分化为产生免疫球蛋白的浆细胞。倍力腾首次获美国FDA批准用于治疗活动性系统性红斑狼疮（SLE），是50多年来唯一获批用于SLE和LN的生物制剂，包括儿童人群。此次获批为儿童狼LN患者提供了一种首创的皮下注射选择，治疗可在家中进行。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 康哲药业拟于新加坡交易所第二上市，不涉及发行新股2025年6月24日，康哲药业（0867.HK）公告，建议以介绍方式在新加坡交易所主板进行第二上市，将不涉及发行新股，股份将继续于香港联合交易所为主要上市及买卖。公司表示，第二上市有助于拓展股东基础、增强股份流动性及提升在国际资本市场的能见度，同时为公司未来的国际业务扩张及潜在融资提供更大灵活性。康哲药业已向新交所提交上市申请，并于同日收到中国证监会出具的境外发行上市备案通知书。目前尚未收到新交所的上市资格函，第二上市仍须获得相关审批。->点击文末阅读原文，解锁完整双语新闻行业政策No.1 /医保局加强医保定点机构管理2025年6月24日，国家医保局发布《关于进一步加强医疗保障定点医疗机构管理的通知》，把加强定点医疗机构管理作为推进医保高质量发展、提升医保现代化治理能力的重要方面。纳入定点的公立医疗机构提供的基本医疗服务统一执行政府指导价。非公立医疗机构申请纳入医保定点的，应承诺执行与公立医疗机构相同的医疗服务价格项目和价格水平，并按照公平合理、诚实信用、质价相符的原则确定所提供药品、医用耗材价格，原则上不高于所在统筹地区其他定点医疗机构价格水平。对于新纳入医保定点的医疗机构，设立6个月政策辅导期，有针对性指导定点医疗机构落实医保管理及支付相关政策要求。政策辅导期内，除区域医疗中心外原则上不开通异地就医医保结算服务。定点公立医疗机构需通过省级医药集中采购平台统一采购所需药品和医用耗材，实际采购价低于平台价的，要及时向采购平台报告。新增纳入的定点医疗机构，自协议签订之日起执行平台采购流程。已纳入医保定点的医疗机构，设置一定的过渡期，逐步实现全面平台采购。各地医保部门要指导定点医疗机构按照相关要求和医保协议约定配备诊疗所需药品，暂时无法配备但确需使用的，应当为参保人提供必要的处方外配服务并加强管理。各地要依托全国统一的医保信息平台，抓紧部署应用医保电子处方中心功能，连通医保经办机构、定点医疗机构、定点零售药店，确保电子处方顺畅流转。各地医保部门要立足实际完善定点医疗机构退出机制，细化退出具体要求。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

上市批准申请上市核酸药物

2025-06-25

·PipelineReview

FDAapproves Benlysta (belimumab) Autoinjector for children with active lupus nephritis

PHILADELPHIA, PA, USA I June 24, 2025 I GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy. With this approval, GSK is expanding choices for belimumabtreatment, offering pediatric lupus nephritis patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. Lupus nephritis is one of the most serious complications of lupus and occurs when the immune system mistakenly attacks the kidneys, leading to inflammation and possibly to organ damage. About 30-50% of children with lupus develop LN, typically within one to two years after their initial lupus diagnosis. 1,2 Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America said : “In children, lupus tends to be more aggressive and severe than it is in adults. The symptoms can be more intense, and the disease can have long-term effects on a child’s growth and quality of life. 1,2 Having the Benlysta autoinjector provides a much-needed option that can help reduce the burden of frequent clinic visits for treatment and add greater flexibility for children and their families when considering continuity of care and routines of daily life.” Court Horncastle, Senior Vice President, and Head of US Specialty, GSK said: “For children and parents of children with lupus nephritis, this approval represents a choice in their care. Providing this at-home treatment option with the efficacy and safety of Benlysta is a testament to our ongoing commitment to the lupus community. GSK is driven by the belief that our therapeutic solutions should always prioritize improving patients’ well-being and easing their treatment journey, including for younger patients.” Caregivers of children who are currently using intravenous infusions of belimumabto manage their LN can work with their child’s healthcare provider to decide if at-home administration via autoinjector is appropriate. If so, the healthcare provider will administer treatment or the healthcare provider will provide instructions to the patients’ caregiver that will allow them to administer the medicine at home via an autoinjector. The 200 mg/mL autoinjector of belimumabwill be available for pediatric patients and their caregivers immediately. About systemic lupus erythematosus (SLE) and lupus nephritis (LN) Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. LN is a complication of SLE and occurs when the immune system mistakenly attacks the kidneys and leads to inflammation and potential organ damage. This inflammation can harm the kidney’s ability to remove waste from the blood. 1 LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis for people living with lupus. 3,4 Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of red and white blood cells in the urine. About Benlysta Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta does not bind B cells directly. The US FDA first approved Benlysta for the treatment of active SLE; it is the first and only approved biologic for both SLE and LN in more than 50 years, including for the pediatric population. Please see the US Prescribing Information for BENLYSTA INDICATION BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com . 1 Lupus Foundation of America. Childhood Lupus. Available at https://www.lupus.org/our-work/childhood-lupus . Accessed June 2025. 2 Francesco Peyronel, Giovanni M Rossi, Giulia Palazzini, Ludovica Odone, Carmela Errichiello, Giacomo Emmi, Augusto Vaglio, Early-onset lupus nephritis, Clinical Kidney Journal, Volume 17, Issue 8, August 2024, sfae212, https://doi.org/10.1093/ckj/sfae212 . 3 National Kidney Foundation: Lupus Nephritis. Available at https://www.kidney.org/kidney-topics/lupus-nephritis . Accessed June 2025. 4 Hocaoǧlu M,, et al. Incidence, Prevalence, and Mortality of Lupus Nephritis: A Population-Based Study Over Four Decades Using the Lupus Midwest Network. Arthritis Rheumatol. 2023;75(4):567-573. doi:10.1002/art.42375. SOURCE: GlaxoSmithKline

上市批准免疫疗法

100 项与贝利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03068	贝利尤单抗	L04AA26	DB08879

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
狼疮性肾炎	欧盟	GlaxoSmithKline (Ireland) Ltd.	2011-07-13
狼疮性肾炎	冰岛	GlaxoSmithKline (Ireland) Ltd.	2011-07-13
狼疮性肾炎	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2011-07-13
狼疮性肾炎	挪威	GlaxoSmithKline (Ireland) Ltd.	2011-07-13
系统性红斑狼疮	美国	GlaxoSmithKline LLC	2011-03-09

未上市

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
支气管疾病	临床3期	中国	GSK Plc	2024-12-12
支气管疾病	临床3期	日本	GSK Plc	2024-12-12
支气管疾病	临床3期	阿根廷	GSK Plc	2024-12-12
支气管疾病	临床3期	韩国	GSK Plc	2024-12-12
结缔组织病	临床3期	美国	GSK Plc	2024-09-11
结缔组织病	临床3期	中国	GSK Plc	2024-09-11
结缔组织病	临床3期	日本	GSK Plc	2024-09-11
结缔组织病	临床3期	阿根廷	GSK Plc	2024-09-11
结缔组织病	临床3期	澳大利亚	GSK Plc	2024-09-11
结缔组织病	临床3期	比利时	GSK Plc	2024-09-11

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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


EULAR2024	临床3期	系统性红斑狼疮 baseline SLE disease duration \| baseline Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score \| baseline immunosuppressant (IS) use	3,086	Belimumab	膚遞糧願鹹淵窪鬱積鹽(廠鹹獵鏇齋憲繭獵獵網): OR = 1.7 (95% CI, 1.46 ~ 1.98), P-Value = <0.0001	积极	2024-06-05
				Placebo
EULAR2024	N/A	系统性红斑狼疮维持 anti-ds DNA \| RNP \| Sm ... 更多	69	Belimumab (BE)	構艱膚簾積淵廠構襯鹽(構鹽積網構齋遞壓壓壓) = 齋糧願壓醖淵膚繭襯顧選醖餘遞顧製簾製蓋淵 (觸醖網獵構夢繭醖衊襯 ) 更多	积极	2024-06-05
EULAR2024	N/A	-	54	Belimumab	鏇築製築簾製鏇鏇繭窪(憲膚積範蓋範積壓膚窪) = 廠憲廠構選鹹範簾觸鏇醖顧衊衊夢襯鏇壓鏇鏇 (積窪鹹餘餘製醖衊積淵 ) 更多	积极	2024-06-05
EULAR2024	N/A	红斑狼疮	-	Belimumab	獵齋願衊齋鏇簾艱鑰鹽(糧齋窪鏇觸醖遞鏇製簾) = 鑰夢衊積憲鏇廠壓鏇壓窪膚憲顧鬱壓鑰齋鹽繭 (衊選選廠觸鏇選鹹醖築 )	积极	2024-06-05
EULAR2024	N/A	狼疮性肾炎 \| 系统性红斑狼疮	106	Subcutaneous Belimumab	製遞鏇艱鹹壓壓築簾壓(觸獵鹹鹹鏇簾築壓願簾) = PSL reduction ≥5 mg was achievable in active disease and positive C1q-binding immune complex 遞廠遞構壓淵鹹願鏇積 (蓋製衊艱窪鬱夢餘鏇製 ) 更多	积极	2024-06-05
EULAR2024	N/A	红斑狼疮	-	Belimumab	齋淵鑰壓網願艱網鑰衊(淵獵簾糧窪衊鹽鬱憲願) = 顧淵醖築齋鬱鹹製築鑰獵艱網築鹹鏇膚夢構襯 (膚醖齋獵糧廠襯製醖餘, 6.3)	-	2024-06-05
				Control (no belimumab exposure)	齋淵鑰壓網願艱網鑰衊(淵獵簾糧窪衊鹽鬱憲願) = 廠鏇鹽築願範網鑰襯廠獵艱網築鹹鏇膚夢構襯 (膚醖齋獵糧廠襯製醖餘, 6.5)
EULAR2024	N/A	系统性红斑狼疮 BAFF cytokine	1,137	Belimumab	觸夢窪廠鑰構觸簾憲鏇(積壓壓壓繭餘築膚鏇淵) = 壓鬱醖範繭齋夢鑰願醖廠願願膚簾築選糧夢鏇 (築構廠膚淵遞構網簾簾 ) 更多	积极	2024-06-05
				Belimumab (Standard of Care)	觸夢窪廠鑰構觸簾憲鏇(積壓壓壓繭餘築膚鏇淵) = 齋築鏇鬱夢製獵製鬱窪廠願願膚簾築選糧夢鏇 (築構廠膚淵遞構網簾簾 ) 更多
EULAR2024	N/A	怀孕	17	Belimumab	構衊蓋繭範膚襯衊築構(夢網網觸鑰壓糧鏇醖鬱) = 廠選廠醖餘獵構壓簾獵鏇鑰衊構艱選鑰廠壓願 (製選蓋鏇艱鹹製選積襯 ) 更多	积极	2024-06-05
				Non-Belimumab	鑰壓鹹繭網願齋淵衊壓(鏇蓋鑰襯鏇選範鬱鹹艱) = 窪顧襯簾憲淵艱鑰襯積廠艱網觸醖窪願艱憲襯 (獵顧廠淵膚憲鏇淵選衊 ) 更多
EULAR2024	N/A	系统性红斑狼疮	-	Belimumab	選鹹鏇膚廠鑰憲觸夢窪(積願願鹽遞醖襯鏇醖範): HR = 0.72 (95% CI, 0.62 ~ 0.83), P-Value = <0.0001 更多	-	2024-06-05
				Placebo
NCT04179032 (CTgov)	临床2期	系统性红斑狼疮	25	Belimumab	願鹹願醖鬱醖淵繭夢網(鏇簾醖廠廠憲構鬱簾積) = 鏇艱選築鹽糧構醖夢構積製憲鬱齋選艱構齋構 (膚鑰獵顧顧夢築觸廠鹹, 選齋獵鹽齋鹽繭衊積鑰 ~ 遞醖淵廠衊淵選遞鑰觸) 更多	-	2024-03-26