The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).

开始日期2026-08-01

申办/合作机构

TG Therapeutics, Inc.

NCT06864936

/ RecruitingN/AIIT

Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study.
Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS.
We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.

开始日期2026-05-01

申办/合作机构

University of Maryland Baltimore

[+1]

NCT07503873

/ Not yet recruiting临床2期

A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis

The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC with an AI device versus syringe.

开始日期2026-03-21

申办/合作机构

TG Therapeutics, Inc.

100 项与 Ublituximab 相关的临床结果

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100 项与 Ublituximab 相关的转化医学

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100 项与 Ublituximab 相关的专利（医药）

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项与 Ublituximab 相关的文献（医药）

2026-07-01·Multiple Sclerosis and Related Disorders

Updated systematic literature review and network meta-analysis of cladribine tablets versus currently approved disease-modifying treatments for active relapsing-remitting multiple sclerosis

Review

作者: Maheshwari, Vikalp ; Saipriya, J ; Harty, Gerard T ; Jones, Michelle

BACKGROUND:

To update previous work assessing the relative efficacy and safety of cladribine tablets compared to currently approved disease-modifying treatments (DMTs) in patients with active relapsing-remitting multiple sclerosis (RRMS), using systematic literature review (SLR) and network meta-analysis (NMA).

METHODS:

Systematic literature searches were conducted in MEDLINE, Embase, MEDLINE In-Process and CENTRAL databases to identify English-language publications of relevant studies of approved DMTs for RRMS. Searches were conducted from database inception to January 2017, and then further updated from January 2017 to September 2022. Conference websites and trial registries were also searched. NMA considered the effects of DMTs on annualized relapse rate (ARR), confirmed disease progression (CDP), proportion relapse-free (RF), and safety.

RESULTS:

Of 21,181 unique articles retrieved and screened, 66 studies met the inclusion criteria and had their data extracted, including 17 new studies since the previous review; of these, 57 studies assessing 20 DMTs contributed to the NMA. In patients with active RRMS, cladribine tablets were associated with a significant 58% reduction in ARR versus placebo; cladribine tablets were similar or significantly better than other DMT regimens. For 6-month CDP, improvements with cladribine tablets were significantly greater than those of placebo, with no comparator DMT demonstrating significantly better results. For both efficacy endpoints, cladribine tablets ranked sixth among DMTs, behind ofatumumab, ublituximab, alemtuzumab, natalizumab, and ocrelizumab. The overall adverse event risk for cladribine tablets was statistically comparable to all other oral DMTs and both interferon beta-1a regimens.

CONCLUSIONS:

In this updated SLR and NMA, cladribine tablets remain a comparatively effective and safe alternative to other currently approved DMTs in populations of patients with active RRMS.

2026-06-01·JOURNAL OF BIOLOGICAL CHEMISTRY

Impact of heme on the therapeutic efficacy of anti-CD20 antibodies

Article

作者: Cruz-Aguirre, Alan S ; Dimitrov, Jordan D ; Siberil, Sophie ; Kaveri, Srinivas V ; Gilardin, Laurent ; Tavares, Alexia ; Lacombe, Robin V ; Delcourt, Hélène ; Lecerf, Maxime ; Lassouani, Tin Hinan ; Tareste, David ; Teillaud, Jean-Luc ; Marey-Jarossay, Annaelle ; Lacroix-Desmazes, Sébastien

Polyreactivity, the capacity of antibodies to recognize unrelated antigens, is often an undesirable trait in therapeutic antibodies, as it can impair pharmacokinetics and elevate the risk of adverse effects. A growing body of evidence indicates that antibodies can acquire polyreactivity and autoreactivity after transient contact with heme, a byproduct of hemolysis. In our earlier work, we found that nearly 14% of the clinical-stage antibodies are sensitive to heme exposure. Here, we investigated how heme-induced polyreactivity influences the function of anti-CD20 antibodies, focusing on rituximab and CAT 13 (the parental antibody of ublituximab). Using a broad array of approaches, including ELISA, protein microarrays, spectroscopy, surface plasmon resonance, flow cytometry, molecular modeling, cytotoxicity assays, and murine lymphoma models, we demonstrate that rituximab readily acquires polyreactivity upon heme binding. This modification enabled promiscuous interactions with diverse human proteins while leaving recognition of the intended target, CD20, intact. In vitro, complement-dependent cytotoxicity remained unaffected by heme treatment. Mechanistic analyses revealed that heme associates with rituximab at a moderate-affinity site distinct from its CD20 binding interface. Strikingly, however, in vivo experiments showed that systemic heme exposure reduces the therapeutic efficacy of anti-CD20 antibodies. Our findings uncover a context-dependent vulnerability of rituximab and related CD20-targeting antibodies to heme, suggesting that hemolysis and extracellular heme levels may represent overlooked determinants of clinical response in lymphoma treatment.

2026-06-01·Neurology and Therapy

Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis

Article

作者: Xu, Yihuan ; Steinman, Lawrence ; Gocke, Anne ; Fox, Edward ; Cree, Bruce A C ; Wray, Sibyl ; Mok, Koby ; Arnold, Douglas L ; Hartung, Hans-Peter ; Robertson, Derrick ; Garner, Christopher A ; Alvarez, Enrique ; Qian, Peiqing

INTRODUCTION:

People with highly active multiple sclerosis benefit from early treatment with highly efficacious disease-modifying therapies. Here we present data on the efficacy of ublituximab versus teriflunomide in a subgroup of participants with highly active disease at baseline.

METHODS:

Pooled post hoc analyses of the phase 3 ULTIMATE I (N = 549) and II (N = 545) studies evaluated efficacy measures at weeks 12 and 96 in participants with highly active disease, defined as ≥ 2 relapses in the year prior and ≥ 1 gadolinium-enhancing (Gd+) T1 lesion at baseline.

RESULTS:

In the highly active disease population, the unadjusted annualized relapse rates (ARR) at week 96 were 0.145 and 0.496 for the ublituximab (n = 88) and teriflunomide (n = 80) groups, respectively (70.8% relative reduction, P < 0.001). The number (least squares means) of gadolinium-enhancing T1 lesions per scan for ublituximab versus teriflunomide was 0.114 versus 0.683 at week 12 (83.3% relative reduction) and 0.038 versus 0.875 at week 96 (95.6% relative reduction; both P < 0.001). Corresponding values for new/enlarging T2 lesions (ublituximab versus teriflunomide) were 1.754 versus 4.127 at week 12 (57.5% relative reduction) and 0.568 versus 6.367 at week 96 (91.1% relative reduction, both P < 0.001). No evidence of disease activity-3 (NEDA-3) rates with ublituximab versus teriflunomide were 29.5% versus 10.1% (P = 0.001) at week 12 and 77.9% versus 16.4% (P < 0.001) at week 96 (weeks 24-96, re-baselined).

CONCLUSION:

Ublituximab was associated with significant treatment benefits across multiple efficacy measures versus teriflunomide in participants with highly active disease at baseline.

TRIAL REGISTRATION:

Clinical trial registry: ULTIMATE I and II ClinicalTrials.gov numbers, NCT03277261 (registration date September 7, 2017) and NCT03277248 (registration date September 7, 2017).

256

项与 Ublituximab 相关的新闻（医药）

2026-06-14

·药明康德

针对血液肿瘤，多款蛋白降解疗法进展积极；潜在“best-in-class”小分子激酶抑制剂公布早期临床结果…… | 一周盘点

本期看点： 1. 潜在“best-in-class”布鲁顿酪氨酸激酶（BTK）降解剂bexobrutideg（NX-5948）1期临床试验结果发布，中位随访时间为22.4个月时，慢性淋巴细胞白血病（CLL）患者的中位无进展生存期（PFS）为22.1个月，客观缓解率（ORR）为83.0%。 2. IKZF1/3分子胶降解剂cemsidomide联合地塞米松治疗复发/难治性多发性骨髓瘤（RRMM）的最新分析结果发布，推荐2期剂量/最大耐受剂量下的ORR为53%。 Bexobrutideg：公布1a/b期临床试验的新数据 Nurix Therapeutics公布了其进行的NX-5948-301 1a/b期临床试验的更新临床数据。该试验正在评估其在研BTK降解剂bexobrutideg用于治疗慢性淋巴细胞白血病患者的疗效。Bexobrutideg是一款具有口服生物利用度、具有脑渗透性的在研小分子BTK降解剂，由Nurix和罗氏（Roche）开发。新闻稿指出，它有望成为用于肿瘤、免疫和神经系统疾病领域的潜在“best-in-class”疗法。截至2026年1月1日数据截止时，中位随访时间为22.4个月；患者的中位PFS为22.1个月（95% CI：14.0–NR），ORR为83.0%（95% CI：69.2–92.4）；缓解包括2例完全缓解（CR）、1例淋巴结部分缓解（nPR）和36例PR。在携带BTK抑制剂耐药突变、具有高危分子特征以及存在中枢神经系统（CNS）受累的患者中均观察到缓解。 Nurix还公布了来自两个1b期队列的新数据，这两个队列评估了bexobrutideg在较早线治疗中的表现，包括既往接受过BTK抑制剂治疗但未接受过BCL2抑制剂治疗的患者（队列5），以及未接受过BTK抑制剂治疗的患者，包括初治患者（队列15）。在队列5（n=19）中，可评估患者（n=14）的ORR为92.9%（95% CI：66.1–99.8）。在队列15（n=20）中，可评估患者（n=19）的ORR为84.2%（95% CI：60.4–96.6）。 Cemsidomide：公布1期临床试验数据 C4 Therapeutics公司公布了其已完成入组的cemsidomide 1期临床试验的进一步分析结果。Cemsidomide是一款下一代口服IKZF1/3降解剂，IKZF1/3是多发性骨髓瘤生物学中的关键转录因子。该试验评估其联合地塞米松治疗复发/难治性多发性骨髓瘤（RRMM）的疗效。数据截止日期为2026年2月27日，参与试验的患者此前接受过大量治疗，既往治疗线数中位数为7线。在推荐2期剂量/最大耐受剂量（100 µg）下，cemsidomide达到53%的ORR。在75 µg剂量水平下，cemsidomide达到40%的ORR。在所有评估剂量中，cemsidomide达到36%的ORR。关键新数据显示，在cemsidomide 75 µg和100 µg剂量水平下，患者缓解程度随时间进一步加深。在75 µg剂量水平下，1例此前最佳缓解为PR的患者加深至非常好的部分缓解（VGPR）。在100 µg剂量水平下，多例患者实现更深缓解：1例此前最佳缓解为PR的患者加深至严格完全缓解（sCR）；1例此前最佳缓解为PR的患者加深至VGPR。在100 µg剂量水平下，2例达到sCR和CR的患者实现微小残留病（MRD）阴性。 ELVN-001：公布1期临床试验的新数据 Enliven Therapeutics公司公布其小分子激酶抑制剂ELVN-001的1期ENABLE临床试验的新数据，该研究旨在评估ELVN-001对现有酪氨酸激酶抑制剂（TKI）不耐受、复发或难治的慢性髓系白血病（CML）患者的疗效。ELVN-001是一种强效、高选择性、潜在“best-in-class”的小分子激酶抑制剂，专门针对CML患者的致癌驱动因子BCR-ABL1融合蛋白。ELVN-001还具有针对耐药性最强的BCR-ABL1耐药突变体T315I和其他已知耐药突变体的活性。截至2026年3月10日的数据，在每日一次80 mg剂量组中，总主要分子学缓解率（MMR）达61%，在24周时的MMR率为48%，深度分子缓解（DMR）达成率为30%。对于既往仅接受过1-2种TKI治疗的患者，总MMR为67%，24周时的MMR率为55%。安全性方面，ELVN-001整体耐受性良好，因不良事件停药的比例为6%，多数治疗伴发不良事件为1-2级。 ▲ENABLE试验的研究结果（图片来源：参考资料[13]） Briumvi（ublituximab）：公布1期临床试验数据 TG Therapeutics公司公布了其皮下注射的Briumvi治疗重症肌无力（MG）的积极1期临床试验数据，并启动了一项2期临床试验。Briumvi是一种靶向CD20表达B细胞上独特表位的新型单克隆抗体，通过糖基工程改造去除了抗体上通常表达的某些糖分子，从而能够在低剂量下实现高效的B细胞耗竭。此次公布的结果显示，82%的患者在第24周达到了重症肌无力日常生活活动（MG-ADL）评分的最小临床重要差异（MCID，定义为下降≥2分）。总体而言，第24周观察到MG-ADL评分平均改善4.6分。该疗法耐受性良好，安全性特征与静脉注射的Briumvi在多发性硬化中的已知安全性一致。参考资料： [1] Climb Bio Presents CLYM116 Initial Phase 1 Safety Data and Translational Modeling Results at European Renal Association (ERA) Congress 2026 Supporting Continued Development. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/05/3307292/0/en/climb-bio-presents-clym116-initial-phase-1-safety-data-and-translational-modeling-results-at-european-renal-association-era-congress-2026-supporting-continued-development.html [2] Antag Therapeutics presents positive Phase 1 results at the 2026 Scientific Sessions of the American Diabetes Association for AT7687, a first-in-class GIPR antagonist. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/07/3307739/0/en/antag-therapeutics-presents-positive-phase-1-results-at-the-2026-scientific-sessions-of-the-american-diabetes-association-for-at7687-a-first-in-class-gipr-antagonist.html [3] Amphista Therapeutics announces FDA clearance of IND application for AMX-883, its lead Targeted Glue™ degrader for acute myeloid leukaemia. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/08/3307957/0/en/amphista-therapeutics-announces-fda-clearance-of-ind-application-for-amx-883-its-lead-targeted-glue-degrader-for-acute-myeloid-leukaemia.html [4] Shattuck Labs Announces Phase 1 Results for SL-325. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/08/3307885/0/en/shattuck-labs-announces-phase-1-results-for-sl-325.html [5] Lifordi Immunotherapeutics Presents Phase 1 Clinical Data for LFD-200, a Subcutaneous Glucocorticoid Antibody Drug Conjugate, at EULAR 2026. Retrieved June 12, 2026, from https://www.newsfilecorp.com/release/300497 [6] Atavistik Bio Announces U.S. FDA Clearance of Investigational New Drug Application and Fast Track Designation for ATV-1601 for the Treatment of Hereditary Hemorrhagic Telangiectasia (HHT). Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/09/3308700/0/en/atavistik-bio-announces-u-s-fda-clearance-of-investigational-new-drug-application-and-fast-track-designation-for-atv-1601-for-the-treatment-of-hereditary-hemorrhagic-telangiectasia.html [7] Kymera Therapeutics Announces First Participant Dosed in Phase 1 Trial of Oral IRAK4 Degrader, KT-485, and Milestone Achievement Under Sanofi Collaboration. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/09/3308699/0/en/kymera-therapeutics-announces-first-participant-dosed-in-phase-1-trial-of-oral-irak4-degrader-kt-485-and-milestone-achievement-under-sanofi-collaboration.html [8] TG Therapeutics Announces Positive Topline Phase 1 Data for Subcutaneous BRIUMVI in Patients with Myasthenia Gravis and Initiation of Potential Registration Directed Randomized Phase 2 Trial. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/09/3308725/8790/en/tg-therapeutics-announces-positive-topline-phase-1-data-for-subcutaneous-briumvi-in-patients-with-myasthenia-gravis-and-initiation-of-potential-registration-directed-randomized-pha.html [9] Imviva Biotech Receives FDA Investigational New Drug Approval for CTA313, a Dual-Targeted CD19/BCMA Allogeneic CAR-T Cell Therapy for Autoimmune Diseases. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/09/3308823/0/en/imviva-biotech-receives-fda-investigational-new-drug-approval-for-cta313-a-dual-targeted-cd19-bcma-allogeneic-car-t-cell-therapy-for-autoimmune-diseases.html [10] Lynk Pharmaceuticals' Partner Formation Bio Doses First Participant in Phase 1 Trial of BLKR201 (originally designated as LNK01006), a CNS-Penetrant TYK2 Inhibitor. Retrieved June 12, 2026, from https://www.prnewswire.com/news-releases/lynk-pharmaceuticals-partner-formation-bio-doses-first-participant-in-phase-1-trial-of-blkr201-originally-designated-as-lnk01006-a-cns-penetrant-tyk2-inhibitor-302795362.html [11] Matter Bio Announces FDA Clearance of IND Application for LM-LLO-TT in Pancreatic Ductal Adenocarcinoma. Retrieved June 12, 2026, from https://www.prnewswire.com/news-releases/matter-bio-announces-fda-clearance-of-ind-application-for-lm-llo-tt-in-pancreatic-ductal-adenocarcinoma-302796786.html [12] Cellectis Presents Final Phase 1 Results of Lasme-cel and Preliminary Results on Eti-cel at EHA 2026 Congress. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310207/0/en/cellectis-presents-final-phase-1-results-of-lasme-cel-and-preliminary-results-on-eti-cel-at-eha-2026-congress.html [13] Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components. Retrieved June 12, 2026, from https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-updated-positive-phase-1-clinical-data-and-alignment-with-fda-on-key-phase-3-trial-design-components-302797424.html [14] Theriva™ Biologics Announces Results from VCN-01 Phase 1 Clinical Trial in Head and Neck Cancer Published in Clinical Cancer Research. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310376/0/en/theriva-biologics-announces-results-from-vcn-01-phase-1-clinical-trial-in-head-and-neck-cancer-published-in-clinical-cancer-research.html [15] C4 Therapeutics Presents Phase 1 Data at European Hematology Association (EHA) 2026 Congress Highlighting Cemsidomide as a Potential Best-in-Class IKZF1/3 Degrader for Multiple Myeloma in Heavily Pretreated Relapsed/Refractory Population. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310320/0/en/c4-therapeutics-presents-phase-1-data-at-european-hematology-association-eha-2026-congress-highlighting-cemsidomide-as-a-potential-best-in-class-ikzf1-3-degrader-for-multiple-myelo.html [16] Climb Bio Announces Initial Phase 1b Data Demonstrating On-Target Clinical Activity for Budoprutug in Immune Thrombocytopenia at EHA Congress 2026. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310326/0/en/climb-bio-announces-initial-phase-1b-data-demonstrating-on-target-clinical-activity-for-budoprutug-in-immune-thrombocytopenia-at-eha-congress-2026.html [17] Nurix Therapeutics to Report Updated Phase 1a/b Results for BTK Degrader Bexobrutideg, Highlighting Durable Responses in Relapsed/Refractory CLL/SLL and Promising Activity in Earlier Lines of Therapy. Retrieved June 12, 2026, from https://www.globenewswire.com/news-release/2026/06/11/3310331/0/en/nurix-therapeutics-to-report-updated-phase-1a-b-results-for-btk-degrader-bexobrutideg-highlighting-durable-responses-in-relapsed-refractory-cll-sll-and-promising-activity-in-earlie.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

2026-06-13

·百度百家

全球新药/创新药最新进展（2026年6月）

近两个月，全球创新药研发持续取得积极进展，为患者带来更多治疗希望。肿瘤领域，多项免疫治疗和精准靶向药研究获得突破，部分药物有望帮助患者降低复发风险、延长生存时间。肥胖症和糖尿病领域，新一代减重药物显示出更好的减重效果，未来患者或将拥有更方便、更有效的治疗选择。对于重症肌无力、银屑病等慢性疾病患者，多款创新疗法在临床试验中展现出良好的疗效和安全性，有望改善长期生活质量。此外，罕见病和难治性疾病领域也不断传来积极消息，为过去缺乏有效治疗方案的患者带来新的希望。随着人工智能技术加速药物研发，新药上市速度有望进一步提升。总体来看，创新药正朝着疗效更好、副作用更少、治疗更精准的方向发展，患者未来可期待更多个体化治疗选择。本篇我们盘点了近期创新药最新进展，以供大家参考学习： ① 《NEJM》：Atezolizumab辅助治疗Ⅲ期结肠癌Ⅲ期研究 Atezolizumab Plus FOLFOX for Stage III Colon Cancer (ATOMIC Trial) 据《New England Journal of Medicine》2026年报道，ATOMICⅢ期研究评估了PD-L1抑制剂阿替利珠单抗联合FOLFOX方案用于dMMRⅢ期结肠癌辅助治疗。结果显示，联合治疗显著降低复发风险，改善无病生存期。 📊 结果与意义这是免疫治疗首次在局部晚期dMMR结肠癌辅助治疗领域取得明确阳性结果，有望重塑该类患者术后标准治疗策略。原文：NEJM，2026年3月发表（ATOMIC Trial） ② Reuters：罗氏减重药CT-388Ⅱ期结果积极 CT-388 Demonstrates Significant Weight Loss in Phase II Trial 据Reuters 2026年报道，Roche公布双靶点GLP-1/GIP受体激动剂CT-388Ⅱ期研究结果。患者48周平均体重下降22.5%，且减重曲线尚未达到平台期。 📊 结果与意义 CT-388成为礼来替尔泊肽和诺和诺德司美格鲁肽的重要潜在竞争者，进一步推动全球减重药市场竞争升级。原文：Reuters，2026-01-27 ③ The Times：阿斯利康口服减重药取得突破 Elecoglipron Shows Positive Mid-Stage Results 据The Times 2026年报道，AstraZeneca口服GLP-1受体激动剂Elecoglipron在Vista研究中实现36周平均减重11.8%，显著优于安慰剂。 📊 结果与意义· 口服减重药有望提高患者依从性，成为下一代肥胖症治疗的重要方向。原文：The Times，2026-06-09 ④ FDA：首创新型降压药Baxdrostat获批 Baxdrostat Approved for Resistant Hypertension 据美国FDA 2026年公布，Baxdrostat获批用于联合治疗高血压。该药通过选择性抑制醛固酮合成酶发挥作用。 📊 结果与意义这是近年来高血压领域最受关注的新机制药物之一，为难治性高血压患者带来新的治疗选择。原文：FDA Novel Drug Approvals 2026 ⑤ FDA：Vepdegestrant获批乳腺癌精准治疗 Vepdegestrant Approved for ESR1-Mutated Breast Cancer FDA于2026年批准Vepdegestrant用于ESR1突变、HR阳性/HER2阴性晚期乳腺癌患者。该药属于新一代口服SERD。 📊 结果与意义进一步推动乳腺癌精准治疗发展，为内分泌耐药患者提供新的治疗方案。原文：FDA，2026-05-01 ⑥ FDA：Sonrotoclax获批套细胞淋巴瘤 Sonrotoclax Receives FDA Approval in Mantle Cell Lymphoma FDA批准BCL-2抑制剂Sonrotoclax用于复发难治性套细胞淋巴瘤。 📊 结果与意义 BCL-2靶向治疗版图进一步扩大，为BTK抑制剂失败患者提供新的后线治疗选择。原文：FDA，2026-05-13 ⑦ TG Therapeutics：Briumvi拓展重症肌无力适应症 Briumvi Shows Strong Efficacy in Myasthenia Gravis 据Investors Business Daily报道，Briumvi在重症肌无力早期临床研究中，82%患者获得显著症状改善。 📊 结果与意义显示抗CD20治疗在自身免疫疾病中的广阔潜力，有望挑战现有重症肌无力治疗格局。原文：IBD，2026-06-11 ⑧ Tango Therapeutics：胰腺癌联合疗法取得积极数据 Vopimetostat Combination Shows Promise in Pancreatic Cancer 据《华尔街日报》报道，Vopimetostat联合Daraxonrasib治疗胰腺癌研究中，12例患者中11例出现肿瘤缩小。 📊 结果与意义胰腺癌长期缺乏有效治疗方案，该结果为KRAS相关靶向联合疗法带来新希望。原文：Wall Street Journal，2026-06-08 ⑨ Takeda：AI设计银屑病创新药Ⅲ期成功 Takeda Oral Psoriasis Drug Outperforms Sotyktu 据BioSpace 2026年报道，武田研发的AI辅助设计口服银屑病药物在Ⅲ期研究中达到完全皮损清除率超过35%，显著优于Sotyktu。 📊 结果与意义人工智能驱动药物研发开始进入收获期，验证AI发现药物的临床价值。原文：BioSpace，2026-06-11 ⑩ Incyte引进VGA039布局血液病市场 VGA039 Advances as Novel Therapy for von Willebrand Disease 据《Financial Times》报道，Incyte以最高20亿美元交易获得VGA039全球权益。该药正处于Ⅲ期临床阶段，用于治疗冯·维勒布兰德病。 📊 结果与意义罕见病创新药持续受到资本和大型药企追捧，反映血液病领域创新价值不断提升。原文：Financial Times，2026-06-08

2026-06-11

·allsci.com

TG Therapeutics aiming to expand Briumvi to myasthenia gravis after positive early data

TG Therapeutics (Nasdaq: TGTX) reported Phase I data showing that subcutaneous ublituximab (Briumvi), its glycoengineered anti-CD20 B-cell depleting antibody, produced clinically meaningful improvements in myasthenia gravis (MG) patients. The firm indicated that a Phase II trial will be initiated testing a sequential treatment strategy pairing an FcRn inhibitor for rapid symptom control followed by ublituximab for sustained B-cell depletion. TG is intent on expanding Briumvi beyond its approved multiple sclerosis indication into a generalized MG market that has grown substantially more competitive. The Phase II design — using argenx’s Vyvgart (efgartigimod alfa) as an induction agent before randomizing to ublituximab or placebo — is an unusual attempt to combine two mechanistically distinct drug classes in a sequential regimen. Trial data The Phase I cohort enrolled 11 adults with acetylcholine receptor antibody-positive MG (mean age 74; mean baseline MG-ADL 8.24), receiving subcutaneous ublituximab at exposures demonstrated to be at least equivalent to the approved intravenous regimen. At Week 24, 82% of patients achieved the minimal clinically important difference in MG-ADL (defined as a ≥2-point decrease), with a median time to MCID of 30 days. Mean MG-ADL improvement was 4.6 points. The safety profile was described as generally consistent with the established intravenous Briumvi profile in MS. These are small-sample, uncontrolled data and should be interpreted with caution; the absence of a comparator arm precludes conclusions about relative efficacy. The Phase II trial, now enrolling approximately 120 patients, uses a single induction cycle of efgartigimod (four weekly infusions), then randomizes MG-ADL responders 1:1 to intravenous ublituximab or placebo for 24 weeks. The primary endpoint is time to clinical worsening, defined as a ≥2-point MG-ADL increase or myasthenic crisis requiring hospitalization. A 72-week open-label extension follows. Competitive context The MG treatment landscape is crowded with approved FcRn inhibitors — argenx’s Vyvgart, Johnson & Johnson’s Imaavy (nipocalimab), and UCB’s Rystiggo (rozanolixizumab) — as well as complement inhibitors and, in late-stage development, BCMA-directed CAR-T therapies from Cartesian Therapeutics (Nasdaq: RNAC) and Kyverna Therapeutics (Nasdaq: KYTX). Ublituximab’s proposed differentiation rests on durable B-cell depletion as a maintenance strategy following FcRn-mediated rapid IgG reduction, a hypothesis the Phase II is designed to test. Cross-trial comparisons are limited by differences in patient populations, trial design, and endpoints. The Phase II is described as potentially registration-directed, though TG has cautioned that a successful result would not automatically qualify as a registrational study. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

临床2期临床1期临床结果免疫疗法细胞疗法

100 项与 Ublituximab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11243	Ublituximab	-	DB11850

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
复发性多发性硬化	美国	TG Therapeutics, Inc.	2022-12-28

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
复发-缓解型多发性硬化	申请上市	英国	Neuraxpharm	2024-12-05
弥漫性大B细胞淋巴瘤	临床3期	美国	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	澳大利亚	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	以色列	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	意大利	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	波兰	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	斯洛伐克	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	韩国	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	西班牙	TG Therapeutics, Inc.	2016-05-25
弥漫性大B细胞淋巴瘤	临床3期	英国	TG Therapeutics, Inc.	2016-05-25

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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


ENHANCE (AAN 12026 \| AAN 22026 \| AAN 32026 \| AAN 42026 \| AAN 52026 \| AAN 62026 \| AAN 72026 \| AAN 82026 \| AAN 92026 \| AAN 102026 \| AAN 112026)	N/A	复发性多发性硬化	221	Ublituximab 600 mg (relapsing multiple sclerosis + Treatment-naive or transitioning from other therapies)	鑰選獵積淵鑰夢鏇獵夢(製網壓鏇鬱鹽壓網鹹廠) = 糧鹹鏇遞廠鑰鹽選憲壓糧艱構製範遞顧鬱鹽鏇 (壓選廠鑰選窪壓構壓鏇 )	积极	2026-04-25
NCT04130997 (ULTIMATE OLE, Pubmed \| JAMA Neurol)	临床3期	多发性硬化症	851	Ublituximab (UBL-UBL)	鹽夢壓廠範築窪鏇選壓(願齋壓膚膚構繭遞糧淵) = serious infections (excluding COVID events) of 2.10 (UBL-UBL) and 2.58 (TER-UBL). 艱繭鹹範選壓觸鑰鹹觸 (獵積網憲壓獵夢艱構築 ) 更多	积极	2026-04-01
				Ublituximab (TER-UBL)
NCT03277248 \| NCT03277261 (ULTIMATE I, Pubmed \| Neurol Ther)	临床3期	复发性多发性硬化	549	Ublituximab	鹽願憲餘繭鬱繭獵築衊(淵淵夢窪積憲淵鹽選構) = 築壓窪構膚製夢網選餘窪壓艱觸簾廠鹽廠遞廠 (糧廠鹹構選膚齋膚襯膚 ) 更多	积极	2026-03-06
				Teriflunomide	鹽願憲餘繭鬱繭獵築衊(淵淵夢窪積憲淵鹽選構) = 憲製醖築夢襯顧積獵鹽窪壓艱觸簾廠鹽廠遞廠 (糧廠鹹構選膚齋膚襯膚 ) 更多
NCT06433752 (ENABLE, ACTRIMS2026)	临床4期	复发性多发性硬化	393	Ublituximab	醖襯鑰鑰艱願廠窪選遞(廠衊構膚簾獵製鏇襯選) = 蓋鹽願網廠餘顧糧範醖糧餘積窪壓鏇鬱淵顧積 (淵願鬱鑰繭簾簾膚艱鏇 ) 更多	积极	2026-02-05
NCT06433752 (ENABLE, Corporate Publications \| Company_Website) 人工标引	临床4期	复发性多发性硬化	393	Ublituximab (received at least one dose)	顧糧壓醖顧壓遞齋鹽壓(淵觸糧餘廠製築鑰艱構) = 艱衊蓋構膚壓襯襯餘願憲夢鏇獵餘選憲製鬱鏇 (壓齋鏇積鑰憲鬱夢艱簾 ) 更多	积极	2025-09-24
NCT03277248 \| NCT03277261 (ULTIMATE II, Company_Website \| Corporate Publications) 人工标引	临床3期	复发性多发性硬化	-	Ublituximab (continuously, 6 yrs)	醖築醖製鹹構衊壓憲糧(築淵範鹽獵製蓋網築鬱) = 鑰獵遞憲製獵廠築構觸糧網製鑰鑰蓋顧鬱襯鹹 (鑰衊範艱顧壓廠廠夢網 ) 更多	积极	2025-09-24
				Teriflunomide (2 yrs in DBP), then switched to Ublituximab (4 yrs in OLE)	鑰簾廠淵艱鏇窪憲觸衊(獵鑰窪簾鬱構餘廠構艱) = 鏇鹽餘鹹構齋願壓醖簾廠憲選範淵觸齋顧鬱選 (壓鬱鹹獵窪衊鑰遞膚壓 ) 更多
NCT05877963 (ENHANCE, Corporate Publications \| Company_Website) 人工标引	临床3期	复发性多发性硬化	221	Ublituximab (single 600 mg infusion on Day 1) (4-hour infusion)	廠衊膚積鹹齋範獵築獵(窪壓鏇獵糧鹽顧簾範憲) = 製憲網觸範淵艱壓製淵憲遞夢襯築獵膚範艱夢 (鬱觸鏇構願獵廠廠鏇製 )	积极	2025-09-24
				Ublituximab (single 600 mg infusion on Day 1) (3-hour infusion)	廠衊膚積鹹齋範獵築獵(窪壓鏇獵糧鹽顧簾範憲) = 顧積簾餘艱夢窪鑰餘窪憲遞夢襯築獵膚範艱夢 (鬱觸鏇構願獵廠廠鏇製 )
P7-1.017 (AAN2025)	N/A	复发性多发性硬化	-	Ublituximab	積廠窪襯鹽獵顧夢鬱鹽(構築顧網鏇築夢簾願簾) = 範齋鹽繭願繭膚夢願製窪膚願鏇製繭壓遞觸艱 (獵鑰簾鏇構鹽窪簾鏇壓, 2.23) 更多	-	2025-04-07
ENAMOR (AAN2025)	临床3期	CD20	401	Ublituximab	鬱網積衊窪鬱選夢構齋(遞顧鏇獵糧憲鏇鏇窪範) = 鬱鹹壓網齋繭淵鬱簾範糧齋艱齋鹽構繭壓鬱廠 (膚壓選網鹽遞糧齋壓淵 ) 更多	积极	2025-04-07
NCT05877963 (ENHANCE Study \| TG1101-RMS401, ACTRIMS2025 \| Corporate Publications) 人工标引	临床3期	复发性多发性硬化	44	Ublituximab 450 mgUblituximab 450 mg	鏇鹽蓋鑰襯襯繭餘構壓(衊製鏇積鹽廠獵艱鬱遞) = 醖膚鏇鹽網膚憲艱網觸醖糧蓋衊構簾襯範壓鏇 (鹹襯顧襯蓋蓋積襯願齋 )	积极	2025-02-27
				Ublituximab 150 mg	鏇鹽蓋鑰襯襯繭餘構壓(衊製鏇積鹽廠獵艱鬱遞) = 艱蓋願夢窪鬱壓簾願遞醖糧蓋衊構簾襯範壓鏇 (鹹襯顧襯蓋蓋積襯願齋 )