ECTRIMS: Sanofi showcases patient focus across multiple sclerosis

欧洲多发性硬化症治疗与研究委员会：赛诺菲展示多发性硬化症患者的关注

14 abstracts across new potential medicines to be presented, including three oral presentations

将展示14篇关于新潜在药物的摘要，其中包括三篇口头报告。

Data support potential for brain-penetrant tolebrutinib to address significant unmet need of disability accumulation by targeting smoldering neuroinflammation in MS

数据支持脑渗透性托布替尼有望通过靶向多发性硬化症（MS）中的隐匿性神经炎症，解决残疾积累的重大未满足需求。

Paris, September 10, 2025

巴黎，2025年9月10日

. New data from 14 abstracts, including three oral presentations, will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 congress in Barcelona, Spain from September 24 to 26, 2025, reinforcing Sanofi’s leadership in multiple sclerosis (MS). The breadth of data, including biomarker innovation, symptom tracking, and additional efficacy and safety data from tolebrutinib and frexalimab, emphasize Sanofi’s commitment to testing the bounds of clinical possibility and defying disability across the spectrum of disease..

来自14份摘要的新数据，包括三份口头报告，将于2025年9月24日至26日在西班牙巴塞罗那举行的欧洲多发性硬化症治疗和研究委员会（ECTRIMS）2025年大会上展示，进一步巩固赛诺菲在多发性硬化症（MS）领域的领导地位。这些广泛的数据涵盖了生物标志物创新、症状追踪以及托莱布鲁替尼和弗雷萨利单抗的更多疗效和安全性数据，彰显了赛诺菲致力于探索临床可能性的边界，并在疾病全谱范围内挑战残疾的决心。

“Our comprehensive approach to multiple sclerosis research demonstrates how we are advancing science across the entire disease spectrum, from novel biomarkers to symptom management and treatment outcomes,” said

“我们对多发性硬化症研究的全面方法展示了我们如何在整个疾病领域推动科学发展，从新型生物标志物到症状管理和治疗结果，”

Erik Wallström

埃里克·瓦尔斯特伦

, MD, PhD, Global Head, Neurology and Ophthalmology Development at Sanofi. “By applying our deep understanding of the immune system, our innovative portfolio focuses on addressing the complex challenges of neuroinflammation and targeting the underlying causes of disease progression in multiple sclerosis to help people live for the moment, not the disease.'.

医学博士，旧金山赛诺菲神经病学和眼科开发全球主管。“通过应用我们对免疫系统的深刻理解，我们的创新产品组合专注于解决神经炎症的复杂挑战，并针对多发性硬化症疾病进展的根本原因，帮助人们活在当下，而不是疾病中。”

Focusing on areas of high unmet need, including in tolebrutinib subgroup analyses

专注于高度未满足需求的领域，包括托莱布替尼亚组分析

New subgroup analyses from the HERCULES phase 3 study (clinical study identifier:

HERCULES 3期研究的新亚组分析（临床研究标识符：

NCT04411641

NCT04411641

) will be presented regarding tolebrutinib’s impact on disability accumulation in people living with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Additional data from the GEMINI 1 and 2 phase 3 studies (clinical study identifier:

）将展示有关托莱布替尼对非复发性继发进展型多发性硬化症（nrSPMS）患者残疾累积的影响。来自GEMINI 1和2期3研究的更多数据（临床研究标识符：

NCT04410978

NCT04410978

and

和

NCT04410991

NCT04410991

, respectively) will detail the effect of tolebrutinib on progression independent of relapse activity in relapsing multiple sclerosis (RMS).

分别详细说明了托莱布替尼对复发性多发性硬化症（RMS）中与复发活动无关的进展的影响。

New data from the phase 2 open-label extension (clinical study identifier:

来自2期开放标签扩展的新数据（临床研究标识符：

NCT04879628

NCT04879628

) evaluating frexalimab in RMS reaffirm its potential to be a novel high-efficacy, non-depleting medicine to impact acute and chronic neuroinflammation by promoting immune regulation via its novel mechanism of action. Frexalimab is currently being evaluated in the FREXALT (clinical study identifier: .

）在RMS中评估frexalimab再次证实了其作为一种新型高效、非耗竭性药物的潜力，可通过其新颖的作用机制促进免疫调节，从而影响急性和慢性神经炎症。Frexalimab目前正在FREXALT（临床研究标识符： 中进行评估。

NCT06141473

NCT06141473

) and FREVIVA (clinical study identifier:

`) 以及 FREVIVA（临床研究标识符：`

NCT06141486

NCT06141486

) phase 3 studies to assess the efficacy and safety in participants with RMS and nrSPMS, respectively.

）第3阶段研究，以分别评估RMS和nrSPMS参与者的疗效和安全性。

Understanding the larger burden of disease

理解更广泛的疾病负担

Data to assess the clinical and economic burden in patients with SPMS in the US will be presented, in addition to thorough qualitative patient assessment data underpinning the smoldering-associated worsening (SAW) index aimed at identifying subtle disability early. Additionally, findings from the MS-DETECT study (clinical study identifier: .

将展示评估美国SPMS患者临床和经济负担的数据，此外还有支持隐匿性恶化（SAW）指数的深入定性患者评估数据，该指数旨在早期识别细微的残疾。此外，还将展示MS-DETECT研究（临床研究标识符：）的发现。

NCT05816122

NCT05816122

) will be presented, focused on the performance of MSCopilot

将进行展示，聚焦于 MSCopilot 的性能。

®

®

digital biomarkers obtained during the study in a real-world setting to capture clinically meaningful functional dimensions.

在真实世界环境中进行研究期间获得的数字生物标志物，以捕捉具有临床意义的功能维度。

Complete list of ECTRIMS 2025 presentations:

ECTRIMS 2025 演讲完整列表：

Presenting author

报告作者

Abstract title

摘要标题

Presentation details

演示详情

Tolebrutinib

托莱布替尼

Oh

哦

Effects of tolebrutinib on progression independent of relapse activity in the phase 3 GEMINI relapsing MS trials

托莱布替尼在3期GEMINI复发性MS试验中对独立于复发活动的进展的影响

Poster #P794

海报 #P794

Poster Presentation

海报展示

25 September 2025

2025年9月25日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 欧洲中部夏令时间

Fox

狐狸

Subgroup analyses of the phase 3 tolebrutinib in nrSPMS HERCULES trial

HERCULES 试验中 nrSPMS 第三阶段 tolebrutinib 的亚组分析

Poster #P796

海报 #P796

Poster Presentation

海报展示

25 September 2025

2025年9月25日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 欧洲中部夏令时间

Wiendl

维恩德尔

Blood immunoglobulin levels and immune cell populations in the phase 3 GEMINI trials of tolebrutinib in relapsing multiple sclerosis

在复发性多发性硬化症的III期GEMINI试验中，tolebrutinib对血液免疫球蛋白水平和免疫细胞群体的影响

Poster #P800

海报 #P800

Poster Presentation

海报展示

25 September 2025

2025年9月25日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 CEST

Bar-Or

巴尔-奥尔

Blood immunoglobulin levels and immune cell populations in the phase 3 HERCULES trial of tolebrutinib in non-relapsing secondary progressive multiple sclerosis

在非复发性继发进展型多发性硬化症的tolebrutinib III期HERCULES试验中，血液免疫球蛋白水平和免疫细胞群体的变化

Poster #P297

海报 #P297

Poster Presentation

海报展示

25 September 2025

2025年9月25日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 欧洲中部夏令时间

Nicholas

尼古拉斯

tolebrutinib plasma exposure and efficacy response in the phase 3 HERCULES trial in nrSPMS

Tolebrutinib在nrSPMS的3期HERCULES试验中的血浆暴露量与疗效反应

Poster #P292

海报 #P292

Poster Presentation

海报展示

24 September 2025

2025年9月24日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 欧洲中部夏令时间

Vermersch

维尔梅尔施

Effects of tolebrutinib on MSQoL-54 in the HERCULES phase 3 trial in nrSPMS

在HERCULES第三阶段试验中，tolebrutinib对nrSPMS患者MSQoL-54的影响

Poster #P810

海报 #P810

Poster Presentation

海报展示

25 September 2025

2025年9月25日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 中欧夏令时间

Schulte-Mecklenbeck

舒尔特-梅克伦贝克

Tolebrutinib treatment induces complex alterations of the peripheral immune-regulatory network in the blood of patients with non-relapsing secondary progressive MS – results from the TOLEDYNAMIC study

Tolebrutinib治疗在非复发性继发进展型MS患者的血液中诱导外周免疫调节网络的复杂变化——TOLEDYNAMIC研究结果

Poster #P315

海报 #P315

Poster Presentation

海报展示

24 September 2025

2025年9月24日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 欧洲中部夏令时间

Frexalimab

弗雷西单抗

Giovannoni

乔瓦尼وني

Safety and efficacy of frexalimab in participants with relapsing multiple sclerosis: 2.5-year results from the phase 2 open-label extension

Frexalimab在复发性多发性硬化症患者中的安全性和有效性：来自2期开放标签扩展研究的2.5年结果

Oral Presentation

口头报告

Scientific Session 13: Emergent therapies in MS and related conditions

科学会议13：多发性硬化症及其相关疾病的新兴疗法

26 September 2025

2025年9月26日

9:19 am – 9:26 am CEST

上午9点19分 - 上午9点26分（中欧夏令时间）

Bar-Or

巴尔-奥尔

Long-term treatment effect of frexalimab on NfL and plasma biomarkers of adaptive and innate immunity

弗雷萨利单抗对神经丝轻链和适应性及先天性免疫的血浆生物标志物的长期治疗效果

Oral Presentation

口头报告

Free Communication 2: Therapeutic interventions - from trials to real-world evidence

自由交流 2：治疗性干预——从试验到真实世界证据

24 September 2025

2025年9月24日

15:35 pm – 15:45 pm CEST

15:35 - 15:45 欧洲中部夏令时间

Kebir

凯比尔

CD40L-mediated responses drive compartmentalized neuroinflammation and disease development in a progressive model of MS

CD40L介导的反应驱动了MS进展模型中的区室化神经炎症和疾病发展。

Poster #P144

海报 #P144

Poster Presentation

海报展示

24 September 2025

2025年9月24日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 欧洲中部夏令时间

SAR443820

SAR443820

Montalban

蒙塔尔万

Efficacy and safety of SAR443820 (RIPK1 Inhibitor) in adults with MS: results from the K2 trial​

SAR443820（RIPK1抑制剂）在多发性硬化症成人患者中的疗效与安全性：K2试验结果

Oral Presentation

口头报告

Scientific Session 13: Emergent therapies in MS and related conditions

科学会议13：多发性硬化症及其相关疾病的新兴疗法

26 September 2025

2025年9月26日

9:12 am – 9:19 am CEST

上午9:12 - 上午9:19（欧洲中部夏令时间）

MS Disease State

多发性硬化症疾病状态

Greene

格林

A retrospective matched-cohort study to assess the clinical and economic burden in people with secondary progressive multiple sclerosis in the United States

美国继发性进展型多发性硬化患者临床与经济负担的回顾性匹配队列研究

Poster #P606

海报 #P606

Poster Presentation

海报展示

25 September 2025

2025年9月25日

16:30 pm – 18:30 pm CEST

16:30 - 18:30 欧洲中部夏令时间

Hobart

霍巴特

Robust, longitudinal, qualitative patient assessment underpins valid clinical measurement: The Smouldering Associated Worsening (SAW) Index Study

稳健、纵向、定性的患者评估是有效临床测量的基础：隐匿性恶化（SAW）指数研究

Poster #P1273

海报 #P1273

ePoster

电子海报

24 September 2025

2025年9月24日

8:30 am CEST

上午8点30分（中欧夏令时间）

Vermersch

维尔默施

MSCopilot® digital biomarkers obtained in a real-world setting correlated with their clinical counterparts in the MS-DETECT study

在真实世界环境中获得的MSCopilot®数字生物标志物在MS-DETECT研究中与其临床对应物相关联

Poster #P1583

海报 #P1583

ePoster

电子海报

About tolebrutinib

关于tolebrutinib

Tolebrutinib is an oral, brain-penetrant and bioactive Bruton's tyrosine kinase (BTK) inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in multiple sclerosis. Unlike conventional MS medicines that primarily address peripheral inflammation, tolebrutinib crosses the blood-brain barrier to achieve therapeutic cerebrospinal fluid concentrations, allowing it to modulate both B-cells and disease-associated microglia within the central nervous system (CNS).

Tolebrutinib 是一种口服、可穿透大脑且具有生物活性的布鲁顿酪氨酸激酶 (BTK) 抑制剂，专门设计用于靶向隐匿性神经炎症，这是多发性硬化症致残进展的一个关键驱动因素。与主要针对外周炎症的传统多发性硬化症药物不同，Tolebrutinib 能够穿越血脑屏障，达到治疗性脑脊液浓度，从而调节中枢神经系统 (CNS) 内的 B 细胞和与疾病相关的小胶质细胞。

This mechanism is thought to directly address the underlying pathology of disability in MS by targeting the inflammatory processes that contribute to neurodegeneration and disability accumulation..

这种机制被认为通过针对导致神经退行性变和残疾累积的炎症过程，直接解决了多发性硬化症（MS）中残疾的根本病理。

Tolebrutinib was previously granted

托莱布替尼此前已获授予

breakthrough therapy designation

突破性疗法指定

by the FDA, based on positive results from the HERCULES phase 3 study in adults with nrSPMS. Tolebrutinib is also being evaluated in a phase 3 clinical study for the treatment of primary progressive multiple sclerosis.

基于HERCULES第三阶段研究在患有nrSPMS的成人中取得的积极结果，tolebrutinib已获得FDA批准。Tolebrutinib还正在一项第三阶段临床研究中进行评估，用于治疗原发性进展型多发性硬化症。

The regulatory submission for tolebrutinib to treat nrSPMS and to slow disability accumulation independent of relapse activity in adult patients is being evaluated under

针对托莱布替尼治疗nrSPMS以及减缓成年患者与复发活动无关的残疾积累的监管提交正在评估中。

priority review

优先审查

by the US Food and Drug Administration. Additional regulatory applications are also under review around the world, including in the EU.

美国食品和药物管理局批准。其他监管申请也正在世界范围内进行审查，包括欧盟。

For more information on tolebrutinib clinical studies, please visit

有关tolebrutinib临床研究的更多信息，请访问

www.clinicaltrials.gov

www.clinicaltrials.gov

.

。

Tolebrutinib represents Sanofi's commitment to developing innovative treatments that address the underlying causes of neurological diseases and potentially transform the treatment landscape. Standing at the intersection of neurology and immunoscience, Sanofi is focused on improving the lives of those living with serious neuro-inflammatory and neuro-degenerative conditions including MS, chronic inflammatory demyelinating polyneuropathy, Alzheimer’s disease, Parkinson’s disease, age-related macular degeneration, and other neurological diseases.

Tolebrutinib 代表了赛诺菲致力于开发针对神经系统疾病根本原因的创新疗法，并有可能改变治疗格局。站在神经学与免疫科学的交汇点，赛诺菲专注于改善那些患有严重神经炎症和神经退行性疾病（包括多发性硬化症、慢性炎性脱髓鞘性多发性神经病、阿尔茨海默病、帕金森病、年龄相关性黄斑变性及其他神经系统疾病）的患者的生活。

The neurology pipeline currently has several projects in phase 3 studies across multiple indications..

神经学管线目前在多个适应症中已有数个项目处于第三阶段研究。

About frexalimab

关于frexalimab

Frexalimab (SAR441344) is an investigational, novel, high efficacy anti-CD40L, with the potential to impact both acute and chronic neuroinflammation in MS, by promoting immune regulation through peripheral and CNS immune recalibration, without causing lymphocyte depletion.

Frexalimab（SAR441344）是一种研究中的新型高效抗CD40L药物，具有通过外周和中枢神经免疫系统重调来促进免疫调节的潜力，从而影响多发性硬化症（MS）中的急性和慢性神经炎症，且不会导致淋巴细胞耗竭。

Frexalimab is being evaluated in studies across multiple disease states, including two phase 3 studies in RMS and nrSPMS, and phase 2 studies in systemic lupus erythematosus, Type 1 diabetes and focal segmental glomeruloscelerosis. Frexalimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority..

Frexalimab 正在多种疾病状态下进行评估，包括两项针对 RMS 和 nrSPMS 的三期研究，以及针对系统性红斑狼疮、1 型糖尿病和局灶节段性肾小球硬化的二期研究。Frexalimab 目前尚处于临床研究阶段，其安全性和有效性尚未得到任何监管机构的评估。

Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc. For more information on frexalimab clinical studies, please visit

赛诺菲正在根据ImmuNext公司的独家许可开发frexalimab。有关frexalimab临床研究的更多信息，请访问

www.ClinicalTrials.gov

www.ClinicalTrials.gov

.

。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time..

赛诺菲是一家以研发为驱动、以人工智能为助力的生物制药公司，致力于改善人们的生活并实现引人注目的增长。我们凭借对免疫系统的深刻理解，研发能够治疗和保护全球数百万人的药物和疫苗，同时拥有一个创新的研发管线，有望使数百万人进一步受益。我们的团队秉持一个使命：追逐科学奇迹以改善人们的生活；这激励我们通过应对当今最紧迫的医疗、环境和社会挑战，推动进步并为我们服务的人群和社区带来积极影响。

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

赛诺菲在 EURONEXT（欧洲证券交易所）上市，代码为 SAN；并在 NASDAQ（纳斯达克）上市，代码为 SNY。

Media Relations

媒体关系

Sandrine Guendoul

桑德琳·根杜尔

| +33 6 25 09 14 25 |

| +33 6 25 09 14 25 |

sandrine.guendoul@sanofi.com

桑德琳·格恩杜尔@赛诺菲.com

Evan Berland

埃文·贝兰德

| +1 215 432 0234 |

| +1 215 432 0234 |

evan.berland@sanofi.com

埃文·伯兰@赛诺菲.com

Léo Le Bourhis

里奥·勒布尔希斯

| +33 6 75 06 43 81 |

| +33 6 75 06 43 81 |

leo.lebourhis@sanofi.com

leo.lebourhis@sanofi.com

Victor Rouault

维克多·鲁奥

| +33 6 70 93 71 40 |

| +33 6 70 93 71 40 |

victor.rouault@sanofi.com

victor.rouault@sanofi.com

Timothy Gilbert

蒂莫西·吉尔伯特

| +1 516 521 2929 |

| +1 516 521 2929 |

timothy.gilbert@sanofi.com

timothy.gilbert@sanofi.com

Léa Ubaldi

莱娅·乌巴尔迪

| +33 6 30 19 66 46 |

| +33 6 30 19 66 46 |

lea.ubaldi@sanofi.com

lea.ubaldi@sanofi.com

Investor Relations

投资者关系

Thomas Kudsk Larsen

托马斯·库兹克·拉森

| +44 7545 513 693 |

| +44 7545 513 693 |

thomas.larsen@sanofi.com

thomas.larsen@sanofi.com

Alizé Kaisserian

阿利泽·凯塞里安

| +33 6 47 04 12 11 |

| +33 6 47 04 12 11 |

alize.kaisserian@sanofi.com

alize.kaisserian@sanofi.com

Felix Lauscher

费利克斯·劳舍尔

| +1 908 612 7239 |

| +1 908 612 7239 |

felix.lauscher@sanofi.com

felix.lauscher@sanofi.com

Keita Browne

凯塔·布朗

| +1 781 249 1766 |

| +1 781 249 1766 |

keita.browne@sanofi.com

keita.browne@sanofi.com

Nathalie Pham

娜塔莉·范

| +33 7 85 93 30 17 |

| +33 7 85 93 30 17 |

nathalie.pham@sanofi.com

娜塔莉·法姆@赛诺菲.com

Tarik Elgoutni

塔里克·埃尔戈特尼

| +1 617 710 3587 |

| +1 617 710 3587 |

tarik.elgoutni@sanofi.com

塔里克·埃尔古蒂@赛诺菲.com

Thibaud Châtelet

蒂博·沙特莱

| +33 6 80 80 89 90 |

| +33 6 80 80 89 90 |

thibaud.chatelet@sanofi.com

thibaud.chatelet@sanofi.com

Yun Li

李云

| +33 6 84 00 90 72 |

| +33 6 84 00 90 72 |

yun.li3@sanofi.com

yun.li3@sanofi.com

Sanofi forward-looking statements

赛诺菲前瞻性声明

This media update contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance.

本媒体更新包含1995年《私人证券诉讼改革法案》（经修订）所定义的前瞻性陈述。前瞻性陈述并非历史事实。这些陈述包括预测、估计及其基本假设，关于未来财务结果、事件、运营、服务、产品开发和潜力的计划、目标、意图和期望的陈述，以及关于未来表现的陈述。

Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

前瞻性声明通常可以通过“预期”、“预计”、“相信”、“打算”、“估计”、“计划”等词语和类似表述加以识别。尽管赛诺菲的管理层认为这些前瞻性声明中反映的预期是合理的，但投资者应注意，前瞻性信息和声明受到各种风险和不确定性的制约，其中许多难以预测且通常超出赛诺菲的控制范围，可能导致实际结果和发展与前瞻性信息和声明中表达或暗示或预测的内容存在重大差异。

These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and comm.

这些风险和不确定性包括但不限于研发、未来临床数据及分析（包括上市后）、监管机构（如FDA或EMA）的决定，涉及是否以及何时批准任何可能为这些候选产品提交的药物、器械或生物制品申请，以及他们关于标签和其他可能影响这些候选产品可用性或商业潜力的事项的决定，候选产品即使获得批准也可能无法取得商业成功，未来批准和商业化进展等因素所带来的不确定性。

All trademarks mentioned in this press release are the property of the Sanofi group except for MSCopilot.

本新闻稿中提到的所有商标均为赛诺菲集团的财产，MSCopilot 除外。

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