. The US Food and Drug Administration (FDA) has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). The fast track designation process aims to facilitate the development and expedite the review of medicines to treat serious conditions and fill unmet medical need.

美国食品药品监督管理局（FDA）已授予SAR446597快速通道资格，这是一种用于治疗因年龄相关性黄斑变性（AMD）引起的地理性萎缩（GA）的一次性玻璃体内基因疗法。快速通道资格的目的是促进用于治疗严重疾病和满足未满足医疗需求的药物开发，并加快其审查进程。

The FDA created this process to help deliver important new drugs to patients earlier and it covers a broad range of serious illnesses..

FDA创建了这一流程，以帮助患者更早获得重要的新药，它涵盖了多种严重疾病。

SAR446597 delivers genetic material encoding two therapeutic antibody fragments that target and inhibit two critical components of the complement pathway: C1s in the classical pathway and factor Bb in the alternative pathway. This dual-targeting approach potentially offers clinical advantages by providing sustained complement suppression within the retinal microenvironment while significantly reducing treatment burden through elimination of frequent intravitreal injections.

SAR446597 递送编码两种治疗性抗体片段的遗传物质，这些片段靶向并抑制补体途径中的两个关键成分：经典途径中的 C1s 和替代途径中的因子 Bb。这种双重靶向方法通过在视网膜微环境中提供持续的补体抑制，同时通过消除频繁的玻璃体内注射显著减轻治疗负担，可能提供了临床优势。

The therapy aims to address the underlying pathophysiology of complement-mediated retinal diseases through long-term expression of therapeutic proteins following a single intervention..

该疗法旨在通过单次干预后长期表达治疗性蛋白，从而解决补体介导的视网膜疾病的潜在病理生理机制。

Sanofi plans to start a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597.

赛诺菲计划启动一项 1/2 期研究，以评估 SAR446597 的安全性、耐受性和有效性。

Sanofi is also currently evaluating SAR402663, a one-time intravitreal gene therapy, in a phase 1/2 study (clinical study identifier:

赛诺菲目前也正在一项 1/2 期研究中评估 SAR402663（一种一次性玻璃体内基因疗法，临床研究标识符：

NCT06660667

NCT06660667

), for the treatment of patients with neovascular wet age-related macular degeneration.

)，用于治疗患有新生血管性湿性年龄相关性黄斑变性的患者。

About age-related macular degeneration and geographic atrophy

关于年龄相关性黄斑变性和地理性萎缩

AMD is an acquired progressive degeneration of the retina that affects approximately 200 million people globally. Geographic atrophy is an advanced form of dry AMD. It is characterized by enlarging irreversible atrophic lesions due to degeneration of retinal cells leading to permanent vision loss in many patients.

年龄相关性黄斑变性（AMD）是一种后天性的视网膜进行性退化疾病，全球约有2亿人受其影响。地图状萎缩是干性AMD的晚期形式，其特征是由于视网膜细胞退化导致不可逆的萎缩性病灶逐渐扩大，许多患者因此出现永久性视力丧失。

GA affects approximately 1 million people in the US, more than 2.5 million in Europe, and over 5 million people worldwide and has a profound impact on quality of life, including ability to read, drive and perform other daily activities..

地理萎缩症影响着美国约100万人，欧洲超过250万人，全球超过500万人，并对生活质量产生深远影响，包括阅读、驾驶和执行其他日常活动的能力。

About Sanofi in neurology

关于赛诺菲在神经学领域

Our goal is to improve the lives of people with serious neuroinflammatory and neurodegenerative diseases. We are testing the bounds of clinical possibility to research therapies that may address multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy (CIDP), Alzheimer’s Disease (AD), Parkinson’s disease (PD), Age-Related Macular Degeneration (AMD) and other neurological diseases for the people who need them most.

我们的目标是改善患有严重神经炎症和神经退行性疾病患者的生活。我们正在测试临床可能性的界限，研究可能针对多发性硬化症 (MS)、慢性炎性脱髓鞘性多发性神经病 (CIDP)、阿尔茨海默病 (AD)、帕金森病 (PD)、年龄相关性黄斑变性 (AMD) 以及其他神经系统疾病的疗法，为最需要这些治疗的患者提供帮助。

Emerging scientific innovations and investments in ophthalmology have the potential to drive a new phase of growth for Sanofi. We are exploring innovative therapies in retinal diseases with unmet need especially where they connect with immune system conditions..

新兴的科学创新和眼科领域的投资有可能推动赛诺菲新一轮的增长。我们正在探索视网膜疾病的创新疗法，特别是在这些疾病与免疫系统状况相关联且需求未得到满足的领域。

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..

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令人瞩目的增长。我们凭借对免疫系统的深刻理解，发明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。

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.

我们的团队秉持一个目标：我们追逐科学的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，为我们服务的人民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；在 NASDAQ（纳斯达克）上市，代码为 SNY。