Ublituximab

PDF Version PDF 版本During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient treatment 在使用BRIUMVI治疗的第5年，年复发率为0.020，相当于每治疗50年出现一次复发。Overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment BRIUMVI 在持续治疗 5 年期间总体安全性保持一致，长期治疗未出现新的安全信号。NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the publication of long term/five-year data from the ongoing open-label extension (OLE) of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). 纽约，2026年2月17日（GLOBE NEWSWIRE）——TG Therapeutics, Inc.（纳斯达克股票代码：TGTX）今天宣布了来自正在进行的第三阶段ULTIMATE I和II期研究的开放标签扩展（OLE）的长期/五年数据，该研究评估了BRIUMVI（乌比图昔单抗-xiiy）在成人复发型多发性硬化症（RMS）中的应用。The manuscript, authored by Bruce A. C. Cree, MD, PhD, MAS, of the University of California, San Francisco, and colleagues, was published in. 该手稿由加州大学旧金山分校的布鲁斯·A·C·克里（Bruce A. C. Cree）博士、哲学博士、硕士及同事撰写，发表于 。JAMA Neurology JAMA神经病学. The publication presents a comprehensive long-term evaluation of BRIUMVI and demonstrates durable clinical efficacy, low relapse rates, and a consistent safety profile with up to five years of continuous treatment. Additional details from the publication are included below. 该出版物对BRIUMVI进行了全面的长期评估，证明了其持久的临床疗效、较低的复发率，并在长达五年的连续治疗中保持了一致的安全性。出版物中的更多详细信息如下。Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “Acceptance of these five-year ULTIMATE I & II results in JAMA Neurology represents a major milestone for TG Therapeutics and the MS field. These data underscore not only the durable clinical efficacy and consistent safety of BRIUMVI through extended treatment, but also our commitment to advancing long-term evidence that helps clinicians and patients make informed treatment decisions. 迈克尔·S. 韦斯，公司执行主席兼首席执行官表示：“《JAMA神经病学》接受这五年的ULTIMATE I & II研究结果，对TG Therapeutics和多发性硬化症领域来说是一个重要的里程碑。这些数据不仅强调了BRIUMVI在长期治疗中的持久临床疗效和一致的安全性，也表明我们致力于推进有助于临床医生和患者做出明智治疗决策的长期证据。”We believe these findings support BRIUMVI’s continued role as a valuable option for people living with relapsing MS.”. 我们相信，这些发现支持了BRIUMVI作为复发性多发性硬化症患者的一种有价值的选择的持续作用。Bruce Cree, MD, PhD, MAS, Zimmermann Endowed Professor in Multiple Sclerosis, and Professor of Neurology at UCSF Weill Institute for Neurosciences, University of California, San Francisco and lead author of this publications noted, “The long-term results from the ULTIMATE I & II open-label extension demonstrate that continued treatment over five years provided sustained clinical benefits, with relapse rates declining further over time and disability progression remaining low. Bruce Cree，医学博士，哲学博士，MAS，加州大学旧金山分校威尔神经科学研究所多发性硬化症Zimmermann讲席教授，神经学教授，也是本研究的主要作者指出：“ULTIMATE I & II 开放标签延长期试验的长期结果表明，持续五年的治疗提供了持久的临床益处，随着时间推移，复发率进一步下降，而残疾进展保持在较低水平。”Importantly, the overall safety experience remained consistent over extended follow-up. Together, these findings confirm the long-term benefits of ublituximab and support the early initiation of high-efficacy therapy in relapsing multiple sclerosis to help optimize long-term outcomes for patients.”. 重要的是，整体安全体验在延长的随访期间保持一致。这些发现共同证实了乌布利珠单抗的长期益处，并支持在复发缓解型多发性硬化症患者中尽早启动高效治疗，以帮助优化患者的长期预后。"The manuscript can be accessed at the 手稿可以在以下位置访问：JAMA Neurology website JAMA神经病学网站or at our TG Therapeutics 或在我们的TG治疗学publication page 发表页面. 。Title: 标题：Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study 多发性硬化症中Ublituximab五年的研究：ULTIMATE I和II开放标签扩展研究The research article reports clinical outcomes from more than 3,600 participant-years of ublituximab exposure. Following completion of the original 96-week double-blind period, more than 85% of eligible participants elected to enroll in the long-term OLE, where they either continued ublituximab or switched from teriflunomide to ublituximab. 该研究文章报告了超过3600个参与者年的ublituximab暴露的临床结果。在完成最初的96周双盲期后，超过85%的符合条件的参与者选择加入长期OLE，他们要么继续使用ublituximab，要么从特立氟胺转换为ublituximab。More than 70% remained on treatment at Year 5, underscoring strong long-term tolerability and treatment adherence.. 五年时仍有超过70%的患者继续接受治疗，这凸显了其良好的长期耐受性和治疗依从性。Key Efficacy Results 关键疗效结果Patients who continued BRIUMVI treatment exhibited low and decreasing annualized relapse rate (ARR) throughout the observation period, ARR: 0.053, 0.032, and 0.020 for Years 3, 4, and 5, respectively. 持续接受BRIUMVI治疗的患者在整个观察期间表现出较低且逐年下降的年化复发率（ARR），第3、4和5年的ARR分别为：0.053、0.032和0.020。During Year 1 of the open label extension (OLE), patients who switched from teriflunomide to BRIUMVI experienced a significant reduction (-58.4%) in ARR (0.182 vs 0.076). 在开放标签扩展（OLE）的第1年，从特立氟胺转换为BRIUMVI的患者，其年复发率（ARR）显著降低了58.4%（0.182 vs 0.076）。At Year 5, 97.7% of continuous-treatment participants and 95.0% of switch participants remained relapse-free. 在第5年，97.7%的持续治疗参与者和95.0%的转换组参与者仍然没有复发。After 5 years of continuous BRIUMVI treatment, 8% of patients had Confirmed Disability Progression (CDP) lasting 24 weeks compared to 14.3% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 0.612 (0.414, 0.904); p=0.0126], and 92% remained progression free with continuous BRIUMVI treatment.. 持续使用BRIUMVI治疗5年后，8%的患者出现持续24周的确证残疾进展（CDP），相比之下，从特立氟胺转为使用BRIUMVI的患者中有14.3%出现该情况 [HR (95% CI): 0.612 (0.414, 0.904); p=0.0126]，而持续使用BRIUMVI治疗的患者中92%未出现疾病进展。17% of patients treated with BRIUMVI continuously for 5 years achieved Confirmed Disability Improvement (CDI) lasting at least 24 weeks compared to 12.2% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 1.472 (1.048, 2.067); p=0.0249], resulting in one in six patients experiencing improvement in disability after 5 years of continuous BRIUMVI treatment.. 持续使用BRIUMVI治疗5年的患者中有17%实现了持续至少24周的确证残疾改善（CDI），而从特立氟胺转为使用BRIUMVI的患者中这一比例为12.2% [HR (95% CI): 1.472 (1.048, 2.067); p=0.0249]，这意味着在持续使用BRIUMVI治疗5年后，每六名患者中就有一名患者的残疾状况得到改善。The overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment in an exposure-adjusted analysis of adverse events (AEs), with no new safety signals emerging with prolonged treatment. 在对不良事件（AEs）进行暴露调整分析后发现，BRIUMVI 在连续治疗五年的过程中，总体安全性保持一致，长期治疗未出现新的安全信号。Immunoglobulin levels remained stable with prolonged BRIUMVI treatment, and the mean IgM and IgG levels remained above the lower limit of normal. There was no association between decreased immunoglobulin levels and risk of serious infections. 免疫球蛋白水平在长期使用BRIUMVI治疗后保持稳定，平均IgM和IgG水平仍高于正常下限。免疫球蛋白水平降低与严重感染风险之间没有关联。ABOUT THE ULTIMATE I & II PHASE 3 TRIALS 关于ULTIMATE I & II 第三阶段试验ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. ULTIMATE I 和 II 是两项随机、双盲、双模拟、平行分组、活性对照的临床试验，设计相同，针对 RMS 患者进行为期 96 周的治疗。患者被随机分配接受以下两种治疗之一：BRIUMVI，通过静脉输注给药，首次输注 150 mg，持续四小时，两周后第二次输注 450 mg，持续一小时，之后每 24 周输注一次 450 mg，持续一小时，并每日口服安慰剂；或活性对照药物特立氟胺（teriflunomide），每日口服 14 mg，同时按照与 BRIUMVI 相同的时间表给予静脉注射安慰剂。Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. 两项研究均纳入了在前一年中至少复发一次、在前两年中复发两次或前一年中存在T1钆（Gd）增强病灶的患者。患者基线时还需要具备0到5.5分的扩展残疾状态量表（EDSS）评分。The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at. ULTIMATE I 和 II 试验共招募了来自 10 个国家的 1,094 名 RMS 患者。这些试验由斯坦福大学神经病学与神经科学以及儿科的齐默尔曼教授劳伦斯·斯坦曼（Lawrence Steinman）博士领导。有关这些临床试验的更多信息可以在以下网址找到：。www.clinicaltrials.gov www.clinicaltrials.gov(NCT03277261; NCT03277248). (NCT03277261; NCT03277248)。ABOUT TG THERAPEUTICS 关于TG治疗学TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. TG Therapeutics是一家完全整合的、处于商业化阶段的生物制药公司，专注于收购、开发和商业化用于治疗B细胞疾病的新型疗法。除了包括多种研究性药物的研发管线外，TG Therapeutics还获得了美国的批准。Food and Drug Administration (FDA) for BRIUMVI. 食品药品监督管理局 (FDA) 对于 BRIUMVI。® ®(ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. （ublituximab-xiiy）用于治疗成人复发型多发性硬化症患者，包括临床孤立综合征、复发缓解型疾病和活动性继发进展型疾病，同时美国以外的多家监管机构也批准BRIUMVI用于治疗通过临床或影像学特征定义为活动性疾病的RMS成人患者。For more information, visit. 欲了解更多信息，请访问。www.tgtherapeutics.com www.tgtherapeutics.com,and follow us on X (formerly Twitter) ，关注我们在X（原推特）上的账号@TGTherapeutics @TGTherapeuticsand on 并且继续LinkedIn 领英. 。BRIUMVI 布里乌米® ®is a registered trademark of TG Therapeutics, Inc. 是TG Therapeutics, Inc.的注册商标。ABOUT BRIUMVI 关于BRIUMVI® ®(ublituximab-xiiy) 150 mg/6 mL Injection for IV (乌布利珠单抗-xiiy) 150 mg/6 mL 注射液 用于静脉注射BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. BRIUMVI是一种新型单克隆抗体，靶向表达CD20的B细胞上的独特表位。利用单克隆抗体靶向CD20已被证明是管理自身免疫疾病（如RMS）的重要治疗方法。BRIUMVI的独特设计使其缺乏通常在抗体上表达的某些糖分子。Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.. 去除这些糖分子的过程称为糖工程改造，它允许在低剂量下有效清除B细胞。BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.. BRIUMVI在美国适用于治疗患有RMS的成人，包括临床孤立综合征、复发缓解型疾病和活动性继发进展型疾病，并在多个美国以外的国家适用于治疗具有由临床或影像学特征定义的活动性疾病的RMS成年患者。A list of authorized specialty distributors can be found at 授权的特殊分销商列表可以在以下位置找到www.briumvi.com www.briumvi.com. 。IMPORTANT SAFETY INFORMATION 重要安全信息Contraindications: BRIUMVI is contraindicated in patients with: 禁忌症：BRIUMVI 在以下患者中禁用：Active Hepatitis B Virus infection 活动性乙型肝炎病毒感染A history of life-threatening infusion reaction to BRIUMVI 危及生命的输液反应史：BRIUMVIWARNINGS AND PRECAUTIONS 警告和注意事项Infusion Reactions: 输液反应：BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. BRIUMVI 可能引发输液反应，包括发热、寒战、头痛、流感样症状、心动过速、恶心、喉咙刺激、红斑以及过敏反应。在多发性硬化症（MS）临床试验中，接受每次输液前使用限制输液反应的预处理药物的 BRIUMVI 治疗患者中，输液反应的发生率为 48%，其中大多数发生在首次输液后的 24 小时内。0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.. 0.6%的接受BRIUMVI治疗的患者出现了严重的输液反应，其中一些需要住院治疗。Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. 在输液期间以及前两次输液完成后至少一小时内，观察接受治疗的患者是否出现输液反应，除非在当前或之前的任何输液中已观察到输液反应和/或超敏反应。告知患者输液反应可能在输液后长达24小时内发生。Administer the recommended premedication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.. 给予推荐的预用药以减少输液反应的频率和严重程度。如果出现危及生命的情况，立即停止输液，永久停用BRIUMVI，并给予适当的对症治疗。较轻的输液反应可能需要暂时停止输液、降低输液速度和/或给予对症治疗。Infections: 感染：Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. 据报道，接受BRIUMVI治疗的患者出现了严重、危及生命或致命的细菌和病毒感染。在多发性硬化症（MS）临床试验中，BRIUMVI治疗患者的整体感染率为56%，而特立氟胺治疗患者为54%。严重感染的发生率分别为5%和3%。There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.. 在使用BRIUMVI治疗的患者中有3例与感染相关的死亡。BRIUMVI治疗患者中最常见的感染包括上呼吸道感染（45%）和尿路感染（10%）。对于有活动性感染的患者，应延迟BRIUMVI的给药，直至感染得到解决。Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. 在免疫抑制治疗后开始使用BRIUMVI或在BRIUMVI后开始免疫抑制治疗时，应考虑可能增加的免疫抑制效果。Hepatitis B Virus (HBV) Reactivation: 乙型肝炎病毒（HBV）再激活：HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. 在临床试验中，使用BRIUMVI治疗的MS患者发生了HBV再激活。在接受抗CD20抗体治疗的患者中，已报告因HBV再激活导致的暴发性肝炎、肝衰竭和死亡病例。在开始使用BRIUMVI治疗前，应对所有患者进行HBV筛查。Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.. 对于乙型肝炎表面抗原（HBsAg）和抗-HB检测结果呈阳性，确认有活动性乙型肝炎（HBV）的患者，请勿使用BRIUMVI进行治疗。对于HBsAg阴性且乙型肝炎核心抗体[HBcAb+]阳性或乙型肝炎病毒携带者[HBsAg+]的患者，在开始治疗前及治疗期间请咨询肝脏疾病专家。Progressive Multifocal Leukoencephalopathy (PML): 进行性多灶性白质脑病 (PML):Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. 尽管在使用BRIUMVI治疗的MS患者中未发生PML病例，但在接受其他抗CD20抗体和其他MS疗法治疗的患者中已观察到导致PML的JC病毒感染。If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.. 如果怀疑出现PML，应暂停使用BRIUMVI并进行适当的诊断评估。与PML相关的典型症状多种多样，会在数天至数周内进展，包括身体一侧的进行性无力或肢体笨拙、视力障碍，以及思维、记忆和方向感的变化，导致意识混乱和人格改变。MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.If PML is confirmed, treatment with BRIUMVI should be discontinued.. 磁共振成像结果可能在临床体征或症状出现之前就已显现；监测与PML一致的体征可能会有所帮助。对可疑发现进一步调查，以便在存在PML的情况下实现早期诊断。据报道，在停用另一种与PML相关的多发性硬化症药物后，最初在诊断时无症状的患者的PML相关死亡率和发病率较那些在诊断时已有典型临床症状的患者为低。如果确诊为PML，应停止使用BRIUMVI治疗。Vaccinations: 疫苗接种：Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. 根据免疫指南管理所有免疫接种：对于活疫苗或减毒活疫苗，至少在开始使用BRIUMVI前4周，并尽可能在使用非活疫苗前至少2周进行。BRIUMVI可能会干扰非活疫苗的效果。在BRIUMVI治疗期间或之后接种活疫苗或减毒活疫苗的安全性尚未得到研究。Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.. 活病毒疫苗的接种在治疗期间和B细胞恢复前不被推荐。Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy 孕期接受BRIUMVI治疗的母亲所产下的婴儿的疫苗接种: ：In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19 在孕期接触过BRIUMVI的产妇的婴儿中，应在接种活疫苗或减毒活疫苗之前，通过CD19检测来评估B细胞计数。+ 加号B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.. B细胞。这些婴儿体内B细胞的耗竭可能会增加接种活疫苗或减毒活疫苗的风险。灭活疫苗或非活疫苗可以在B细胞恢复之前接种。应考虑评估疫苗的免疫反应，包括咨询合格的专家，以确定是否产生了保护性免疫反应。Fetal Risk: 胎儿风险：Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.. 基于动物研究的数据，BRIUMVI 在给孕妇使用时可能会对胎儿造成伤害。据报道，怀孕期间接触其他抗 CD20 B 细胞耗竭抗体的母亲所产下的婴儿出现了短暂的外周 B 细胞耗竭和淋巴细胞减少。建议具有生育潜力的女性在 BRIUMVI 治疗期间以及最后一剂后的 6 个月内使用有效的避孕措施。Reduction in Immunoglobulins: 免疫球蛋白减少：As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. 正如任何B细胞耗竭疗法所预期的那样，观察到免疫球蛋白水平下降。在RMS临床试验中，据报道，0.6%的接受BRIUMVI治疗的患者出现免疫球蛋白M（IgM）下降，而接受特立氟胺治疗的患者中无一例出现下降。在治疗期间，特别是对于有机会性感染或反复感染的患者，以及在治疗停止后直至B细胞恢复前，应监测定量血清免疫球蛋白的水平。Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.. 如果免疫球蛋白低的患者出现严重的机会性感染或反复感染，或者长期的低丙种球蛋白血症需要使用静脉注射免疫球蛋白治疗时，应考虑停止BRIUMVI疗法。Liver Injury: 肝损伤：Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.. 在治疗多发性硬化症（MS）的抗CD20 B细胞耗竭疗法（包括BRIUMVI）的上市后监测中，已报告出现具有临床意义的肝损伤，且未发现病毒性肝炎。肝损伤的迹象，包括显著升高的血清肝酶和总胆红素升高，发生在给药后的数周至数月内。Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury. 接受BRIUMVI治疗的患者，如果发现丙氨酸氨基转移酶（ALT）或天门冬氨酸氨基转移酶（AST）超过正常上限（ULN）的3倍，并且血清总胆红素超过正常上限的2倍，则可能面临严重药物性肝损伤的风险。Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. 在开始使用BRIUMVI治疗前，应获取肝功能测试结果，并在治疗期间监测任何肝损伤的迹象和症状。对于报告可能提示肝损伤的症状的患者，包括新发或恶化的疲劳、食欲不振、恶心、呕吐、右上腹不适、深色尿液或黄疸，应及时测量血清转氨酶、碱性磷酸酶和胆红素水平。If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.. 如果存在肝损伤且未确定其他病因，则停止使用 BRIUMVI。Most Common Adverse Reactions: 最常见的不良反应：The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. 在RMS试验中，最常见的不良反应（发生率至少为10%）是输液反应和上呼吸道感染。Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com. 对BRIUMVI有疑问的医生、药剂师或其他医疗保健专业人员应访问www.briumvi.com。ABOUT BRIUMVI PATIENT SUPPORT in the U.S. 关于BRIUMVI患者支持在美国的情况BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com. BRIUMVI患者支持计划是由TG Therapeutics设计的灵活项目，旨在以最适合美国患者的方式，支持他们完成治疗过程。有关BRIUMVI患者支持计划的更多信息，请访问www.briumvipatientsupport.com。ABOUT MULTIPLE SCLEROSIS 关于多发性硬化症Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. 复发性多发性硬化症（RMS）是一种中枢神经系统（CNS）的慢性脱髓鞘疾病，包括复发缓解型多发性硬化症（RRMS）患者以及继续经历复发的继发进展型多发性硬化症（SPMS）患者。RRMS是最常见的多发性硬化症（MS）形式，其特征是出现新的或恶化的症状（复发），随后进入恢复期。It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.. 据估计，美国约有 100 万人患有 MS，其中大约 85% 最初被诊断为 RRMS。1,2 1,2The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS. 大多数被诊断为复发缓解型多发性硬化症（RRMS）的患者最终会发展为继发进展型多发性硬化症（SPMS），他们的残疾状况会随着时间的推移而逐渐恶化。全球范围内，超过230万人被诊断出患有多发性硬化症（MS）。1 1Cautionary Statement 警告声明This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. 本新闻稿包含涉及若干风险和不确定性的前瞻性陈述。对于这些陈述，我们要求1995年《私人证券诉讼改革法案》中包含的前瞻性陈述的安全港保护。Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. 本新闻稿中的任何前瞻性陈述均基于管理层的当前预期和信念，并受到多种风险、不确定性和重要因素的影响，这些因素可能导致实际事件或结果与本新闻稿中包含的任何前瞻性陈述所表达或暗示的内容存在重大差异。In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.. 除我们在向美国证券交易委员会（SEC）提交的报告中不时确定的风险因素外，可能导致我们实际结果产生重大差异的因素包括以下内容。Such forward-looking statements include but are not limited to statements regarding expectations for the timing and success of the commercialization and availability of BRIUMVI 此类前瞻性声明包括但不限于关于BRIUMVI商业化和可用性的时间和成功预期的声明。® ®(ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; expectations of future revenue for BRIUMVI, or TG expenses or profit estimates or targets; expectations and timing for our clinical trials of subcutaneous ublituximab (the active ingredient in BRIUMVI), and sometimes referred to as subcutaneous BRIUMVI, including feasibility, approvability and commercial acceptance; expectations and timing for our ENHANCE Phase 3 trial combining day 1 and day 15 doses, including, feasibility, approvability and commercial acceptance and impact on BRIUMVI sales; and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG.. (ublituximab-xiiy) 用于美国或其他美国以外司法管辖区的 RMS；预期医疗保健专业人员 (HCP) 和患者对 BRIUMVI 在获批适应症上的接受和使用情况；对 BRIUMVI 未来收入的预期，或 TG 的费用、利润估算或目标；关于皮下注射 ublituximab（BRIUMVI 的活性成分），有时也称为皮下注射 BRIUMVI 的临床试验的预期和时间安排，包括可行性、可批准性和商业接受度；我们 ENHANCE 第三阶段试验结合第 1 天和第 15 天剂量的预期和时间安排，包括可行性、可批准性、商业接受度以及对 BRIUMVI 销售的影响；以及对我们任何管线产品或计划的预期和时间安排，包括 Azer-cel 或 BRIUMVI 在 MG 中的应用。Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the risk that the commercialization of BRIUMVI does not continue to exceed expectations; the risk that our BRIUMVI revenue targets will not be achieved; the uncertainties generally inherent in research and development; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. 可能导致我们实际结果发生重大差异的其他因素包括以下内容：公司继续将BRIUMVI商业化的能 力；处方趋势无法保持或处方未被填写的风险；未能获得和维持支付方覆盖范围；医疗保健专业 人员对BRIUMVI的兴趣无法持续的风险；BRIUMVI的销售势头在年内无法持续的风险；BRIUMVI 的商业化无法继续超出预期的风险；我们的BRIUMVI收入目标无法实现的风险；研究和开发中普遍 存在的不确定性；监管发展、立法行动、行政命令，包括征收关税和美国政策变化。and other jurisdictions; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2024 and in our other filings with theSEC.. 以及其他司法管辖区；以及总体政治、经济和商业状况。关于我们及其他风险和不确定性的进一步讨论，请参阅我们截至2024年12月31日的财政年度的Form 10-K年度报告，以及我们向美国证券交易委员会（SEC）提交的其他文件。Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at. 本新闻稿中包含的任何前瞻性声明仅截至本新闻稿发布之日。我们不承担更新这些前瞻性声明以反映此后发生的事件或情况的义务。本新闻稿及之前的新闻发布可在以下网址查阅：。www.tgtherapeutics.com www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. 我们网站上的信息并未通过引用并入本新闻稿，仅供参考之用。CONTACT: 联系人：Investor Relations: 投资者关系： Email: 电子邮件：ir@tgtxinc.com ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4 电话：1.877.575.TGTX (8489)，选项4Media Relations: 媒体关系：Email: 电子邮件：media@tgtxinc.com 媒体@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 6 电话：1.877.575.TGTX (8489)，选项61. 1.MS Prevalence. National Multiple Sclerosis Society website. MS患病率。国家多发性硬化症协会网站。 https://www.nationalmssociety.org/About-the-Society/MS-Prevalence https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 。访问日期：2020年10月26日。2. 2.Multiple Sclerosis International Federation, 2013 via 国际多发性硬化症联合会，2013年 viaDatamonitor 数据监控器p. 236. 第236页。