. The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi’s commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available.

美国食品药品监督管理局（FDA）已授予riliprubart用于实体器官移植中抗体介导的排斥反应（AMR）研究性治疗的孤儿药资格。这一认定体现了赛诺菲致力于解决移植医学中一个关键的未满足需求，目前AMR仍然是一个重大挑战，且尚无FDA批准的治疗方法可用。

The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US. .

美国食品药品监督管理局（FDA）授予治疗罕见病或病情的试验性疗法孤儿药资格，这些疾病或病情在美国影响不到20万人。

Alyssa Johnsen

艾莉莎·约翰森

Global Therapeutic Area Development Head, Immunology and Inflammation, Sanofi

全球治疗领域开发负责人，免疫学与炎症，赛诺菲

'Orphan drug designation for riliprubart marks an important milestone in our mission to address critical challenges in transplant medicine leveraging our expertise in immunology. Antibody mediated rejection represents a serious threat to transplanted organs and patient survival. Through riliprubart's innovative mechanism of action, we hope to bring forward a treatment option that could significantly improve outcomes for kidney transplant recipients.'.

“Riliprubart获得孤儿药资格认定标志着我们在利用免疫学专业知识解决移植医学关键挑战的使命中迈出了重要一步。抗体介导的排斥反应对移植器官和患者存活构成了严重威胁。通过Riliprubart的创新作用机制，我们希望能够推出一种治疗选择，显著改善肾移植受者的预后。”

Riliprubart is currently being explored in multiple clinical studies across different indications in transplant and neurology. A phase 2 clinical study is currently ongoing, exploring its potential in kidney transplant recipients (

Riliprubart目前正在进行多个跨适应症的临床研究，涉及移植和神经学领域。一项二期临床研究正在进行中，探索其在肾移植受者中的潜力（

NCT05156710

NCT05156710

). The study includes two patient cohorts: those at risk of developing rejection and those with active forms of antibody-mediated rejection. In addition, Sanofi is conducting two phase 3 studies exploring riliprubart in chronic inflammatory demyelinating polyneuropathy (CIPD), a rare neurological disorder, specifically in patients refractory to standard of care (MOBILIZE, clinical study identifier: .

). 该研究包括两个患者队列：那些有排斥反应风险的患者和那些患有活动性抗体介导排斥反应的患者。此外，赛诺菲正在进行两项三期研究，探索利普鲁巴特在慢性炎性脱髓鞘性多发神经病（CIPD）中的应用，这是一种罕见的神经系统疾病，特别是针对对标准治疗无效的患者（MOBILIZE，临床研究标识符： 。

NCT06290128

NCT06290128

), and in IVIg-treated patients (VITALIZE, clinical study identifier:

），以及在使用IVIg治疗的患者中（VITALIZE，临床研究标识符：

NCT06290141

NCT06290141

). The broad clinical development program for riliprubart emphasizes Sanofi's commitment to exploring riliprubart’s potential across multiple immune-mediated conditions with high unmet medical needs.

）。利立普鲁巴特的广泛临床开发计划强调了赛诺菲致力于探索利立普鲁巴特在多种免疫介导疾病中的潜力，以满足高度未满足的医疗需求。

About Riliprubart

关于Riliprubart

SAR445088 (riliprubart) is a potential first-in-class, IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

SAR445088（利利普鲁巴特）是一种潜在的首创、IgG4人源化单克隆抗体，可选择性抑制先天免疫系统经典补体途径中的活化C1s。利利普鲁巴特目前正处于临床研究阶段，其安全性和有效性尚未得到任何监管机构的评估。

About AMR

关于AMR

Antibody-mediated rejection is a serious complication that may arise after solid organ transplantation, occurring when the recipient’s immune system produces antibodies that attack the transplanted organ. Sensitized recipients, who have pre-existing antibodies that target foreign antigens including those found on transplanted organs, face a high risk of developing antibody-mediated rejection.

抗体介导的排斥反应是实体器官移植后可能出现的严重并发症，发生在受体免疫系统产生攻击移植器官的抗体时。具有预先存在抗体的致敏受体，这些抗体针对包括移植器官上的抗原在内的外来抗原，面临发生抗体介导排斥反应的高风险。

Subsequent immune response can lead to inflammation, organ damage, and organ failure if left untreated. .

如果不及时治疗，随后的免疫反应可能导致炎症、器官损伤和器官衰竭。

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，发明能够治疗和保护全球数百万人的药物和疫苗，并通过创新的研发管线惠及更多人群。我们的团队秉承一个使命：追求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。