Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

开始日期2024-03-20

申办/合作机构

Bayer AG

[+3]

NCT05688436

/ RecruitingN/A

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

开始日期2021-09-24

申办/合作机构

Biogen, Inc.

NCT04967430

/ Unknown status临床3期IIT

TOGETHER-Toronto: A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter, Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19

Interferon (IFN) lambda is one of the fundamental responses of the innate immune system. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming it safety and tolerability. It is particularly attractive for consideration in the use of acute respiratory illness due to the high expression of the lambda receptor in lung epithelia. We propose to evaluate peginterferon-lambda in ambulatory patients with mild to moderate COVID-19.

开始日期2021-08-27

申办/合作机构

University Health Network

100 项与聚乙二醇干扰素β-1a 相关的临床结果

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100 项与聚乙二醇干扰素β-1a 相关的转化医学

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100 项与聚乙二醇干扰素β-1a 相关的专利（医药）

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104

项与聚乙二醇干扰素β-1a 相关的文献（医药）

2025-02-01·Multiple Sclerosis and Related Disorders

Efficacy and safety of disease-modifying therapies in pediatric-onset multiple sclerosis: A systematic review of clinical trials and observational studies

Review

作者: Moćko, Paweł ; Brzostek, Tomasz ; Śladowska, Katarzyna ; Kawalec, Paweł

OBJECTIVE:

This study aimed to review the efficacy and safety profile of disease-modifying therapies (DMTs) in patients with relapsing pediatric-onset multiple sclerosis (POMS).

METHODS:

A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Published randomized controlled trials (RCTs), nonrandomized studies with a control group, large single-arm studies, and ongoing (unpublished) studies investigating the use of approved and unapproved DMTs in POMS were included. Eligible published studies were identified in MEDLINE (via PubMed), EMBASE, and the Cochrane Library, and unpublished studies were identified in a clinical trials registry (www.

CLINICALTRIALS:

gov).

RESULTS:

A total of 13 published studies were included in the systematic review: 4 RCTs, 3 observational studies with a control group, and 6 large single-arm studies. The following DMTs for the treatment of POMS were evaluated in the included studies: interferon beta-1a, interferon beta-1b, teriflunomide, dimethyl fumarate, fingolimod, natalizumab, glatiramer acetate, and ocrelizumab. All DMTs were shown to be effective in reducing relapse rates, preventing disability progression, and reducing disease activity in MRI in patients with POMS. DMTs that are considered highly effective in adults with multiple sclerosis (natalizumab, fingolimod) were also shown to be more effective than interferon beta-1a in POMS. A total of 9 ongoing (unpublished) studies were identified, including 5 RCTs. The following drugs were evaluated: ozanimod, fingolimod, peginterferon beta-1a, ocrelizumab, ofatumumab, siponimod, alemtuzumab, and natalizumab.

CONCLUSION:

The number of DMTs approved for the treatment of POMS is limited, and some of the available DMTs are used off-label. The available evidence from published studies of varying reliability supports the efficacy of DMTs in POMS. However, well-designed, long-term RCTs in the pediatric population are needed. The results of ongoing studies may fill the existing gap in clinical evidence, possibly leading to the approval of more highly effective DMTs for patients with POMS.

2024-10-01·Multiple Sclerosis and Related Disorders

Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients: A phase 3, randomized, non-inferiority clinical trial (PEGINTEGRITY)

Article

作者: Saeidi, Morteza ; Ghiasian, Masoud ; Baghbanian, Seyed Mohammad ; Abolfazli, Roya ; Ayromlou, Hormoz ; Ghalyanchi Langroodi, Hamidreza ; Asadollahzadeh, Elnaz ; Shaygannejad, Vahid ; Beladi Moghadam, Nahid ; Ashtari, Fereshteh ; Sabzvari, Araz ; Kafi, Hamidreza ; Azimi Saeen, Amirreza

BACKGROUND:

Multiple sclerosis (MS) is a prevalent, disabling, inflammatory, neurodegenerative disease that typically manifests during a highly productive stage of life. Interferon beta-1a was among the first approved disease-modifying therapies for MS and remains among the first-line treatment options. Pegylation of the interferon beta-1a molecule prolongs its half-life while maintaining its efficacy and safety profile. In PEGINTEGRITY study, we aimed to compare peginterferon beta-1a with interferon beta-1a in terms of efficacy and safety in relapsing-remitting multiple sclerosis (RRMS) patients.

METHODS:

This study was a randomized, active-controlled, parallel-group, multi-center Phase 3 trial conducted in Iran in participants with RRMS. Participants received 125 µg of subcutaneous peginterferon beta-1a every two weeks or 30 µg of intramuscular interferon beta-1a once a week for up to 96 weeks. The primary outcome was the non-inferiority of peginterferon beta-1a to interferon beta-1a in reducing annualized relapse rate (ARR). Other outcomes included the number of patients with 12-week confirmed disability progression, the number of new or newly-enlarging T2 hyperintense lesions, the number of gadolinium-enhancing lesions, the number of new T1 hypointense lesions, the volume of new or newly-enlarging T2 hyperintense lesions, changes in brain volume, immunogenicity, and safety assessments.

RESULTS:

A total of 168 patients who met the eligibility criteria were enrolled and assigned to two arms of the study, each consisting of 84 participants. Totally, 41 participants (24 patients in the peginterferon beta-1a group and 17 patients in the interferon beta-1a group) were withdrawn from the study. The withdrawn patients were included in the per-protocol analysis for the period of time they were in the study. In 96 weeks, in the per-protocol population, the ARR was 0.05 in the peginterferon beta-1a group versus 0.11 in the interferon beta-1a group, which does not reflect a statistically significant difference (p=0.09; 95 % CI, 0.18-1.14). Considering the upper limit of the one-sided 95 % CI of the rate ratio of peginterferon beta-1a compared to interferon beta-1a, as well as the non-inferiority margin, it can be concluded that the primary outcome was met. The results were also comparable for other efficacy and safety outcomes.

CONCLUSION:

The results demonstrate the non-inferiority of peginterferon beta-1a to interferon beta-1a with similar efficacy in 96-week ARR in RRMS patients. Both arms were also comparable in other efficacy outcomes and safety profiles with no statistically significant differences. These findings support considering peginterferon beta-1a as a safe and efficient option in patients with RRMS. This study was registered on Iranian Registry of Clinical Trials (IRCT201612306135N8) and clinicaltrials.gov (NCT05242133).

2024-04-01·Multiple Sclerosis Journal-Experimental Translational and Clinical

Safety and clinical effectiveness of peginterferon beta-1a for relapsing multiple sclerosis in a real-world setting: Final results from the Plegridy Observational Program

Article

作者: Kumar, Achint ; Belviso, Nicholas ; Nelles, Gereon ; Koster, Thijs ; Salvetti, Marco ; Castro-Borrero, Wanda ; Wray, Sibyl ; Vignos, Megan

Background:

Interferon beta-1a remains an important treatment option for multiple sclerosis, particularly when safety or tolerability concerns may outweigh the benefits of higher-efficacy disease-modifying therapies. The five-year phase 4 Plegridy Observational Program (POP) study (NCT02230969) collected data on real-world safety and effectiveness of Plegridy® (peginterferon beta-1a) treatment in patients with relapsing multiple sclerosis.

Objective:

To explore the real-world safety and effectiveness of peginterferon beta-1a in patients with relapsing multiple sclerosis, including factors influencing treatment discontinuation.

Methods:

Data were collected prospectively from patients ≥ 18 years old with relapsing multiple sclerosis for overall population analysis and for subpopulations including newly/previously diagnosed patients, age, and experience with peginterferon beta-1a. Outcome measures included annualized relapse rates, adverse events, and predictors of time to treatment discontinuation.

Results:

Mean (SD) treatment duration in the overall population ( N = 1172) was 896.0 (733.15) days. Incidence of adverse events was higher in new than experienced users (79.4% vs. 57.0%). New users were more likely than experienced users to discontinue (hazard ratio = 1.60; P < 0.0001). The adjusted annualized relapse rate was 0.09, and at the end of 5 years, 77.1% of patients were relapse-free.

Conclusions:

Peginterferon beta-1a is an effective therapy for managing relapsing multiple sclerosis. The identification of predictors of discontinuation can help inform strategies to enhance treatment persistence.

项与聚乙二醇干扰素β-1a 相关的新闻（医药）

2025-05-05

·梅斯医学

双手越来越无力，肌肉慢慢萎缩，真正的“元凶”藏得太深了！

26岁的王先生（化名）是一位程序员，平时性格温和、思维敏捷。两年前，他开始出现一些“莫名其妙”的症状：先是右手食指无力，敲键盘时经常敲不准，后来连水杯也握不稳。起初他以为是工作太累、颈椎出了问题。休息、按摩、贴膏药，怎么也不见好，反而逐渐加重。第一次就诊是在他出现右手腕明显下垂后，检查提示右桡神经功能受损，但并无外伤史或压迫因素。当时被当作单纯的“周围神经病”处理。但半年后，他左手也出现了类似无力，接着右上臂也开始变得“提不起来”，同时手部肌肉逐渐萎缩。奇怪的是，整个过程中他从未出现麻木或感觉障碍。多次求医，MRI、颈椎CT、血液检查结果都未能明确诊断，肌电图提示多发性运动神经传导阻滞，医生怀疑是某种罕见的神经疾病。直到一次神经科会诊中，有经验的专家敏锐察觉到其肌无力分布“跳跃性”和“不对称性”的特点，并进一步完善电生理检查，发现其非嵌压部位存在典型的运动传导阻滞，而感觉神经传导正常，结合症状进展缓慢、无感觉障碍，最终高度怀疑多灶性运动神经病（MMN），随后完善抗GM1抗体检测，结果阳性。什么是多灶性运动神经病多灶性运动神经病（multifocal motor neuropathy, MMN），是一种自身免疫相关的多发单神经病变。该病起病隐匿、进展缓慢，早期上肢神经受累多见，表现为不对称性肢体远端为主的无力、萎缩，无客观感觉障碍，随病情进展最终可导致肌肉无力萎缩而致残。临床表现多灶性运动神经病（MMN）可发生于任何年龄。起病通常隐匿，病程呈缓慢进展或阶段性加重，可出现较长时间的稳定期。临床表现以多发性单神经病为特征。早期多见于单侧上肢一根或多根神经受累，表现为相应神经支配区域的肌肉无力，主要累及远端肌群，可伴有痉挛或束颤。肌无力的分布通常不对称，可见同一肢体内不同神经受累程度不同，或双侧肢体、上下肢之间存在差异，甚至同一神经支配区域内不同肌肉的无力程度亦可不同。随着病情进展，患者可出现肌肉萎缩。病程较长者可累及多个肢体多根神经，不对称性可能减弱，呈类似多发性周围神经病的分布。部分患者可主诉轻微感觉异常，但通常无明显客观感觉障碍，病程后期个别患者可出现轻度感觉神经受累。脑神经一般不受累。部分无明显无力的肢体腱反射可正常甚至活跃，临床检查无上运动神经元受累体征。诊断诊断依靠临床表现、神经系统查体、实验室检查、神经电生理和神经影像学检测。隐袭起病，缓慢或阶段性进展的双侧肢体远端不对称无力萎缩患者，结合神经系统查体发现至少有2根神经受累，早期上肢受累多见，表现为不对称性肢体无力，随病情发展可出现肌肉萎缩，无客观的感觉异常体征。运动神经传导测定，在非嵌压部位，至少2根神经或1根神经的两个节段出现运动神经部分传导阻滞，相应部位的感觉神经传导正常。血清或脑脊液GM1抗体阳性，IVIG治疗有效等均可支持诊断。治疗静脉注射免疫球蛋白（IVIG）是MMN的一线治疗。多项研究表明，IVIG可改善肌无力和生活质量，可能延缓轴索变性。初始推荐剂量为0.4 g/kg/d，连续5天，部分患者1周内可见疗效，但维持时间一般为1个月左右。有效者可根据个体情况进行间断维持治疗。皮下注射免疫球蛋白在国外已有应用，疗效与静脉注射相当。免疫抑制剂的疗效尚不明确。对于IVIG无效或无法使用者，可尝试环磷酰胺（2–3 mg/kg/d），部分患者有效，亦可用于减少IVIG用量，需密切监测不良反应。其他药物如干扰素β-1a、硫唑嘌呤、环孢素仅见于小样本或个案报道，疗效有限。糖皮质激素可能加重病情，不推荐常规使用。血浆置换在个别患者中可能有效，但亦可能导致症状恶化，不建议常规采用。参考资料：[1]郝嫣霞,陈海,笪宇威,等.多灶性运动神经病临床特点分析[J].北京医学,2018,40(05):410-412+416+492.DOI:10.15932/j.0253-9713.2018.05.009.[2]Corbo M, Quattrini A, Latov N, et al.Localization of GM1 and Gal (beta1-3) Gal NAc antigenic determinants in peripheral nerve[J].Neurology, 1993, 43:809-814.[3]王银霞，吴荷花,张国华,等.急性运动轴索性神经病与急性炎性脱髓鞘性多神经病的比较研究[J].北京医学，2017,39:1142-1145.来源 | 梅斯医学编辑 | wanny神经系统罕见病交流群↓点击下方“阅读原文”，下载梅斯医学APP吧！

2025-03-31

·Pharma CMC

创新药 “爆发” 获批！今日85个上市申请获NMPA批准

刚刚，NMPA发布2025年03月31日药品批准证明文件送达信息，本批次共有85个受理号获批，均为上市申请，其中多款创新药获批：此前，NMPA公告过的：宜昌东阳光长江药业的艾考磷布韦片获批上市，用于与磷酸萘坦司韦胶囊联用，治疗初治或干扰素经治的基因1、2、3、6型成人慢性丙型肝炎病毒（HCV）感染，可合并或不合并代偿性肝硬化。江西科睿药业申报的玛舒拉沙韦片获批上市，用于既往健康的12岁及以上青少年和成人单纯性甲型和乙型流感患者的治疗，不包括存在流感相关并发症高风险的患者。恒瑞医药的硫酸艾玛昔替尼片获批上市，用于治疗对一种或多种TNF抑制剂疗效不佳或不耐受的活动性强直性脊柱炎成人患者。此外，参天制药的他氟噻吗滴眼液获批上市，推测适应症为：用于降低开角型青光眼或高眼压症成年患者的眼压（IOP），用于对局部单独使用β-受体阻滞剂或前列腺素衍生物疗效不佳而需要联合治疗的患者。他氟噻吗滴眼液是不含防腐剂的0.0015%他氟前列素和0.5%马来酸噻吗洛尔固定剂量复方滴眼液，含有两种对房水动力学有不同作用机制的有效成分，每日滴眼1次即可达到与联合用药相同的有效性和安全性。罗氏的奥瑞利珠单抗注射液（罗可适®）获批上市，每六个月静脉输注一次给药，用于治疗成人复发型多发性硬化症（RMS，包括临床孤立综合征、复发缓解型多发性硬化和活动性继发进展型多发性硬化）和成人原发进展型多发性硬化症（PPMS）。奥瑞利珠单抗是罗氏开发的靶向CD20阳性B细胞的单抗药物。针对复发型多发性硬化症（RMS）的两项随机、双盲、双模拟、阳性药物对照III期临床试验OPERA I和OPERA II结果显示，与干扰素β-1a治疗相比，奥瑞利珠单抗可以显著降低患者的年复发率（ARR）及致残比例（12周确认残疾进展CDP的患者比例）。优时比的罗泽利昔珠单抗注射液获批上市，用于治疗重症肌无力（gMG）。公开资料显示，罗泽利昔珠单抗是一款靶向人类胎儿Fc受体（FcRn）的单克隆抗体，此前已在美国、欧盟、日本等地区获批用于治疗全身性重症肌无力成人患者。百时美施贵宝旗下两款肿瘤免疫治疗药物——欧狄沃（纳武利尤单抗注射液）与逸沃(伊匹木单抗注射液）的联合疗法获批新适应症，用于不可切除或晚期肝细胞（HCC）成人患者的一线治疗，这是中国首个且目前唯一获批的肝细胞癌一线双免疫联合疗法。此次获批基于I期CheckMate-9DW研究，该研究在全球范围内首次证实免疫治疗方案用于肝细胞癌一线治疗，疗效可显著优于两种既往标准治疗药物(仑伐替尼或索拉非尼）。有关研究数据证实：双免方案不仅缓解率高，而且一旦起效，缓解持续时间（DOR）和总生存期（OS）都显著延长。完整批件信息如下：

上市批准临床3期临床2期

2024-11-09

·药事纵横

6家专注于多发性硬化症治疗的biotech

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。多发性硬化症是中枢神经系统（CNS）的一种慢性疾病。作为一种不可预测的疾病，对人的影响不同，一些多发性硬化症患者可能只有轻微的症状，而另一些患者可能会在大脑与身体其他部位之间的交流中断时失去清晰地看、写、说或走路的能力。以下是六家专注于多发性硬化症的生物技术公司，几家公司和研究人员试图通过不同的方法来治疗多发性硬化症，比如BTK抑制剂、CAR-T疗法、双特异性抗体，甚至干细胞疗法。 Biogen 主要多发性硬化候选药物：BIIB091 Biogen以其在神经科学领域的开创性工作而闻名。40多年来，它一直在发现和开发中枢神经系统疾病的治疗方法，包括多发性硬化、肌萎缩侧索硬化（ALS）、阿尔茨海默病、抑郁症、狼疮和脊髓性肌萎缩（SMA）的治疗方法。至于多发性硬化症，该公司已经有几种已获批准的治疗方法，包括Avonex、Plegridy和Vumerity，这些药物都用于治疗多发性硬化症的复发。此外，在其现有的研发过程中，百健正致力于开发下一代伯顿酪氨酸激酶（BTK）抑制剂，称为BIIB091，用于复发性多发性硬化成人患者。目前正处于开发的第二阶段。 BTK是一种非受体酪氨酸激酶，可调节被认为与多发性硬化发病机制有关的B细胞和髓样细胞的发育和信号传导。BIIB091除对B细胞产生作用外，还对髓系细胞中的BTK产生可逆性抑制作用，因此预计BIIB091与仅B细胞疗法相比具有更多的临床益处，并且可以解决共价BTK抑制剂中观察到的耐药性。 Immunic Therapeutics 主要多发性硬化候选药物：Vidofludimus calcium immunictherapeutics正致力于慢性炎症性和自身免疫性疾病的小分子疗法的开发。其主要候选药物是vidofludimus calcium（IMU-838），目前正在开发用于治疗多发性硬化。 IMU-838通过有效激活称为核受体相关1 （Nurr1）的神经保护转录因子发挥作用，Nurr1与直接的神经保护特性相关，并可能增强患者的潜在获益。IMU-838还抑制二氢乳清酸脱氢酶（DHODH），后者是过度活跃的免疫细胞和病毒感染细胞代谢的关键酶。这一双重作用不仅针对炎症和抗病毒过程，而且还解决了多发性硬化潜在的神经退行性方面，使其从现有疗法中脱颖而出，现有疗法虽然能够控制多发性硬化的复发，但不能阻止患者的残疾随着时间的推移而恶化。数项正在进行的多发性硬化试验正在对IMU-838进行测试，包括复发性多发性硬化的两项3期试验和进展性多发性硬化的支持性2期试验。2023年10月，Immunic报告了2期试验的阳性中期数据，因为有生物标志物证据表明，IMU-838的活性超出了之前观察到的抗炎作用。最终，这进一步加强了它的神经保护潜力。此外，在2024年1月，Immunic宣布了高达2.4亿美元的私募。 Kyverna Therapeutics 主要多发性硬化候选药物：KVY-101 Kyverna Therapeutics公司正致力于开发针对b细胞驱动的自身免疫性疾病患者的细胞疗法。这家多发性硬化症公司拥有靶向CD19的自体和异体CAR化合物，该分子在B淋巴细胞的发育、激活和分化中起着重要作用，旨在减少细胞因子释放，消耗B细胞，提高临床耐受性。其主要候选药物KYV-101目前正在一项2期试验中评估用于治疗多发性硬化以及重症肌无力。今年1月，它被美国食品药品监督管理局（FDA）授予快速通道认定，用于治疗难治性进行性多发性硬化患者。此外，Kyverna在2024年2月通过首次公开发行（IPO）获得了.66亿美元的总收益。 Progentos Therapeutics 几个月前，Progentos Therapeutics才成立，获得了6500万美元的A轮融资，用于推进多发性硬化和其他退行性疾病的治疗。在多发性硬化症等疾病中，残疾是由支持轴突功能和生存的脱髓鞘（即髓鞘受损）引起。在这里，免疫系统攻击髓鞘，导致炎症和神经细胞功能受损。正因为如此，Progentos正在开发一种新型小分子，旨在诱导多发性硬化影响的轴突的髓鞘再生。该公司从麻省理工学院（MIT）的子公司Frequency Therapeutics收购了多发性硬化症项目，后者于2023年与RNA编辑公司Korro Bio进行了反向合并。根据Progentos的说法，当涉及到产生和维持髓磷脂的细胞时，它的分子在动物模型中似乎比以前的方法表现更好。从多发性硬化症公司最近的A轮融资中获得的资金将使其能够通过人体概念验证研究来推进其多发性硬化症项目，并扩大其在其他退行性疾病中的研发渠道。 TG Therapeutics 主要多发性硬化候选药物：ublituximab TG Therapeutics专注于利用b细胞生物学的科学进步为患者开发新的治疗方法，特别专注于开发自身免疫性疾病的治疗方法。该公司于2022年12月宣布，FDA已批准其药物BRIUMVI （ublituximab）用于治疗复发型多发性硬化症患者，包括临床孤立综合征，复发缓解性疾病和活动性继发进行性疾病。此外，在2024年9月，TG Therapeutics报告说，经过5年的BRIUMVI治疗，92%的复发性多发性硬化症患者无残疾进展。 Ublituximab是一种单克隆抗体，靶向表达cd20的b细胞上的一个独特表位。当药物与b细胞结合时，会触发一系列免疫反应，包括抗体依赖性细胞毒性[ADCC]和补体依赖性细胞毒性[CDC]，最终导致细胞破坏。此外，阿妥昔单抗被设计为缺乏抗体上正常表达的某些糖分子，因为去除这些糖分子（称为糖工程的过程）已被证明可增强阿妥昔单抗的效力，特别是在ADCC活性方面。作为与Precision BioSciences合作的一部分，TG Therapeutics还在开发一种名为azer-cel的同种异体CAR-T疗法，用于治疗进展型多发性硬化症。Precision BioSciences发现并授权给TG Therapeutics的这一候选药物最近获得了试验性新药（IND）许可，有望于今年晚些时候开始临床试验。 Zenas BioPharma 主要多发性硬化候选药物：Obexelimab Zenas BioPharma专注于基于免疫学的疗法，目前正致力于开发其主要候选药物obexelimab，用于治疗各种免疫学和炎症疾病，包括多发性硬化。 Obexelimab是一种双功能单克隆抗体，旨在通过与广泛存在于B细胞谱系中的蛋白CD19和FcγRIIb结合来耗竭B细胞。根据该公司的说法，这些靶点的共同参与导致了B细胞活性的抑制。 Zenas BioPharma目前正在一项2期试验中纳入患者，以评估obexelimab治疗复发性多发性硬化患者的疗效和安全性。该公司最近也筹集了可观的资金。2024年5月，该公司宣布在C轮融资中获得2亿美元，9月还宣布了2.25亿美元的IPO。这两轮融资的收益将帮助该公司进一步推进obexelimab的研发。参考资料：各公司官网 -END- 2025CMC-CHINA药博会 • 展位火热预定中！

临床2期细胞疗法免疫疗法临床1期临床3期

100 项与聚乙二醇干扰素β-1a 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10483	聚乙二醇干扰素β-1a	L03AB13	DB09122

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
多发性硬化症	美国	Biogen, Inc.	2014-08-15
复发-缓解型多发性硬化	欧盟	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	冰岛	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	列支敦士登	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	挪威	Biogen Netherlands BV	2014-07-18

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
流感样症状	临床3期	美国	Biogen, Inc.	2013-11-01
复发性多发性硬化	临床3期	美国	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	比利时	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	保加利亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	加拿大	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	智利	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	哥伦比亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	克罗地亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	捷克	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	爱沙尼亚	Biogen, Inc.	2009-06-01

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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


German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2023)	N/A	多发性硬化症	247	Interferon beta-1a	鬱壓鏇淵選鑰願醖衊網(壓願鏇鏇獵窪願衊壓願) = comparable between exposed children and controls during the observation period 繭窪膚餘壓膚餘顧繭繭 (齋顧憲壓蓋繭鑰構憲顧 ) 更多	积极	2023-09-30
NCT03870763 (CTgov)	临床3期	复发-缓解型多发性硬化	11	Dimethyl Fumarate (Dimethyl Fumarate 240 mg)	繭遞鹹壓醖鹽遞艱獵窪(願蓋廠製鏇範繭膚襯窪) = 鹽蓋壓顧蓋願窪齋構選鏇觸鬱願鹽製衊築淵鏇 (餘範範憲衊簾蓋願艱淵, 夢窪鹹願顧衊憲齋蓋壓 ~ 淵築夢選製網網繭鹽齋) 更多	-	2023-05-16
				Peginterferon Beta-1a (Peginterferon Beta-1a 125 µg)	繭遞鹹壓醖鹽遞艱獵窪(願蓋廠製鏇範繭膚襯窪) = 遞製糧範壓鬱鏇艱觸蓋鏇觸鬱願鹽製衊築淵鏇 (餘範範憲衊簾蓋願艱淵, 願壓壓製壓醖範餘構鏇 ~ 衊顧鑰壓選願積製範願) 更多
German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2022)	N/A	多发性硬化症	70	Interferon-beta 1a exposure during pregnancy	鑰鏇製鑰鬱顧淵艱遞壓(願襯衊積憲蓋鏇願鹽艱) = 齋鹹鏇憲餘壓選餘廠製製製淵醖艱遞網製鏇醖 (淵衊鬱齋膚衊夢築顧夢 )	积极	2022-10-12
IMSE 6 (ECTRIMS2021)	N/A	-	393	Peginterferon beta-1a	築糧廠淵鬱蓋製壓窪遞(簾選淵鑰壓築醖繭繭襯) = General disorders and administration site were also the most common for non-serious AEs (68%) 鏇顧顧糧淵顧夢繭鹽襯 (艱鏇鬱齋築鬱顧顧網齋 ) 更多	积极	2021-10-12
Plegridy Observational Program (ECTRIMS2021)	N/A	复发性多发性硬化	1,208	Peginterferon beta-1a	製壓夢構醖壓網製壓衊(夢壓膚壓糧遞鑰壓夢築) = 顧醖憲廠鬱積壓衊蓋構膚衊願艱淵構鏇遞願構 (蓋顧顧願衊鏇築艱鹹淵 ) 更多	积极	2021-10-12
				Placebo	製壓夢構醖壓網製壓衊(夢壓膚壓糧遞鑰壓夢築) = 鬱鹽醖衊蓋憲顧淵獵壓膚衊願艱淵構鏇遞願構 (蓋顧顧願衊鏇築艱鹹淵 ) 更多
ECTRIMS2020	N/A	多发性硬化症	2,479	Peginterferon beta-1a	願鹽夢鑰窪醖淵糧壓願(積淵壓製網繭壓廠製窪) = 簾鏇遞醖蓋範簾鬱夢製餘顧鬱鬱襯範衊鏇餘遞 (艱願鑰衊襯範艱壓範蓋 ) 更多	-	2020-12-07
				Intramuscular interferon beta-1a	構觸艱鏇廠淵齋鹹網壓(鏇艱窪憲糧網築齋窪願) = 憲範廠積窪繭淵淵壓遞獵網淵襯窪簾窪鏇築艱 (鏇選糧築鹽顧範觸鹹繭 )
IMSE 6 (ECTRIMS2020)	N/A	-	364	Peginterferon beta-1a	淵壓艱積夢繭憲鏇遞積(鬱網醖構構製簾淵顧齋) = A total number of 18 adverse events (6 serious) were reported to Swedish Medical Product Agency. 選繭淵膚鬱壓鑰鹹範鏇 (鹽糧鹹願艱齋願膚衊簾 )	-	2020-12-07
ECTRIMS2020	N/A	-	-	Peginterferon beta-1a	構築網齋簾齋鹽憲夢觸(憲簾淵觸廠獵繭艱夢構): ARR ratio = 1.18 (95% CI, 0.72 ~ 1.94), P-Value = 0.5047 更多	-	2020-12-07
				Non-pegylated interferons
MS PATHS (ECTRIMS2020)	N/A	-	817	Peginterferon beta-1a	襯醖廠醖鬱積鏇鹹糧願(糧糧鏇糧衊鹹製窪膚構) = 壓糧繭廠鏇獵構膚衊艱膚襯構壓願網鑰鏇鹽衊 (鬱衊夢鬱鹹衊夢鏇顧遞 ) 更多	积极	2020-12-07
				Intramuscular interferon beta-1a	襯醖廠醖鬱積鏇鹹糧願(糧糧鏇糧衊鹹製窪膚構) = 鬱廠獵壓製積鏇醖艱獵膚襯構壓願網鑰鏇鹽衊 (鬱衊夢鬱鹹衊夢鏇顧遞 ) 更多
NARCOMS (ECTRIMS2020)	N/A	复发性多发性硬化	-	Intramuscular interferon beta-1a	願淵窪醖襯製範廠製鹹(繭糧壓齋鬱窪衊選構鹹) = 獵顧築壓蓋艱遞夢範觸繭餘壓鬱顧膚鹹繭衊廠 (製範膚範積顧獵鹽廠夢 ) 更多	积极	2020-12-07
				Peginterferon beta-1a	願淵窪醖襯製範廠製鹹(繭糧壓齋鬱窪衊選構鹹) = 鑰衊窪鹹艱糧餘顧簾膚繭餘壓鬱顧膚鹹繭衊廠 (製範膚範積顧獵鹽廠夢 ) 更多