. The Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Sarclisa, in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ phase 3 study.

日本厚生劳动省（MHLW）基于IMROZ三期研究的数据，批准了Sarclisa联合硼替佐米、来那度胺和地塞米松（VRd）用于治疗新诊断的多发性骨髓瘤（NDMM）成人患者。

“In recent years, new multiple myeloma cases have increased steadily in Japan and other Asian-Pacific nations, creating a need for new treatment approaches, particularly in the front-line setting. While Sarclisa-based combinations have been approved for relapsed or refractory patients in Japan, this approval represents the first indication for certain newly diagnosed patients.

“近年来，日本和其他亚太国家的新发多发性骨髓瘤病例稳步增加，这催生了对新治疗方法的需求，尤其是在前线治疗环境中。虽然基于 Sarclisa 的组合疗法已经在日本获批用于复发或难治性患者，但此次批准代表了针对某些新诊断患者的首个适应症。”

We are pleased to offer physicians an important new option for their patients earlier in the treatment journey, building upon our continued commitment to advancing innovative oncology treatments in difficult-to-treat hematologic malignancies around the world.”.

我们很高兴为医生提供一个重要的新选择，让患者在治疗过程的早期就能受益，这是我们持续致力于在全球范围内推进难以治疗的血液系统恶性肿瘤的创新肿瘤治疗方案的又一体现。"

In Japan, Sarclisa was launched in August 2020 and has been approved for four different treatment regimens (in combination with pomalidomide and dexamethasone, as monotherapy, in combination with carfilzomib and dexamethasone, or in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma).

在日本，Sarclisa于2020年8月上市，已被批准用于四种不同的治疗方案（与泊马度胺和地塞米松联合使用、单药治疗、与卡非佐米和地塞米松联合使用，或与地塞米松联合用于治疗复发性或难治性多发性骨髓瘤患者）。

In addition, Sarclisa has front-line approvals in the EU and the US. In the Asia Pacific region, Sarclisa combination regimens were also .

此外，Sarclisa已在欧盟和美国获得一线批准。在亚太地区，Sarclisa联合疗法也获得了批准。

recently approved

最近批准的

by the National Medical Products Administration in China, specifically Sarclisa-VRd in NDMM patients who are not eligible for autologous stem cell transplant, as well as

由中国国家药品监督管理局批准，特别是用于不适合自体干细胞移植的新诊断多发性骨髓瘤患者使用Sarclisa-VRd方案，以及

Sarclisa in combination with pomalidomide and dexamethasone (Pd)

Sarclisa联合泊马度胺和地塞米松（Pd）

for the treatment of adult patients with relapsed or refractory MM who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

用于治疗接受过至少一种先前疗法（包括来那度胺和蛋白酶体抑制剂）的复发或难治性多发性骨髓瘤成年患者。

About Sarclisa

关于Sarclisa

Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa.

Sarclisa（isatuximab）是一种CD38单克隆抗体，能够结合多发性骨髓瘤（MM）细胞上CD38受体的特定表位，诱导显著的抗肿瘤活性。它通过多种作用机制发挥作用，包括程序性肿瘤细胞死亡（凋亡）和免疫调节活性。CD38在MM细胞表面高度且均匀地表达，使其成为诸如Sarclisa等基于抗体治疗药物的靶点。

In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US Food and Drug Administration..

在美国，Sarclisa 的非专利名称是 isatuximab-irfc，其中 irfc 是根据美国食品药品监督管理局发布的生物制品非专利命名行业指南指定的后缀。

Currently, Sarclisa is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple indications. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

目前，Sarclisa已在包括美国、欧盟、日本和中国在内的50多个国家获得批准，涵盖多种适应症。基于ICARIA-MM三期研究，Sarclisa在美国、欧盟和日本被批准与Pd联合用于治疗接受过至少两种前期疗法（包括来那度胺和蛋白酶体抑制剂）的复发/难治性多发性骨髓瘤（R/R MM）患者；该组合也在中国获批用于接受过至少一线前期治疗（包括来那度胺和蛋白酶体抑制剂）的患者。

Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy.

基于IKEMA的三期研究，Sarclisa已在全球50多个国家获得批准，与卡非佐米和地塞米松联合使用，包括在美国用于治疗接受过一到三线既往治疗的复发/难治性多发性骨髓瘤（R/R MM）患者，以及在欧盟用于至少接受过一种既往治疗的多发性骨髓瘤（MM）患者。

In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. This combination is also approved in Japan for patients with NDMM..

在美国、欧盟、英国和中国，基于IMROZ三期研究，Sarclisa联合VRd被批准作为移植不合格NDMM患者的一线治疗选择。该组合在日本也获批用于NDMM患者。

Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous (SC) administration method for Sarclisa in clinical studies.

赛诺菲继续推进 Sarclisa 的以患者为中心的临床开发计划，该计划包括在多发性骨髓瘤治疗过程中跨越六个潜在适应症的多项 2 期和 3 期研究。此外，该公司正在临床研究中评估 Sarclisa 的皮下（SC）给药方法。

In January 2024, Sanofi reported positive results from the .

2024年1月，赛诺菲报告了来自 。的积极结果。

IRAKLIA phase 3 study

伊拉克利亚三期研究

evaluating Sarclisa SC formulation administered via an on-body delivery system (OBDS) in combination with Pd compared to intravenous (IV) Sarclisa in patients with R/R MM. In December 2024, additional positive results from the program, including the

评估通过身体佩戴递送系统（OBDS）给予的Sarclisa SC制剂与Pd联合使用，对比静脉注射（IV）Sarclisa在R/R MM患者中的效果。2024年12月，该项目的更多积极结果出炉，包括

GMMG-HD7 phase 3 study

GMMG-HD7 第三阶段研究

evaluating Sarclisa-RVd induction therapy in transplant-eligible NDMM patients, were also presented at the 66

评估Sarclisa-RVd诱导疗法在适合移植的新诊断多发性骨髓瘤患者中的应用，也在第66届会议上展示。

American Society of Hematology Annual Meeting and Exposition. The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery.

美国血液学会年会暨博览会。Sarclisa 的安全性和有效性尚未由任何监管机构在其批准的适应症和给药方法之外进行评估。

In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as well as gastroenteropancreatic neuroendocrine tumors and other gastrointestinal and lung cancers..

在努力成为全球排名第一的免疫科学公司过程中，赛诺菲始终致力于推进肿瘤学创新。通过有针对性的战略决策，公司重塑并优先安排了其研发管线，利用其在免疫科学方面的专业知识推动进展。工作重点放在难以治疗、通常为罕见的癌症上，例如某些血液系统恶性肿瘤和具有关键未满足需求的实体瘤，包括多发性骨髓瘤、急性髓系白血病、某些类型的淋巴瘤，以及胃肠胰神经内分泌肿瘤和其他胃肠道及肺癌。

About Sanofi

关于赛诺菲

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions..

我们是一家创新的全球医疗保健公司，以一个目标为动力：我们追求科学的奇迹以改善人们的生活。我们的团队遍布全球，致力于通过努力将不可能变为可能来改变医学实践。我们为全球数百万人提供可能改变生命的治疗选择和拯救生命疫苗保护，同时将可持续发展和社会责任置于我们志向的核心。