.The National Medical Products Administration (NMPA) in China has approved Sarclisa, an anti-CD38 medicine, in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor..

中国国家医药产品管理局（NMPA）已批准抗CD38药物Sarclisa与pomalidomide和地塞米松（Pd）联合用于治疗至少接受过一种治疗方案（包括来那度胺和蛋白酶体抑制剂）的多发性骨髓瘤（MM）成年患者。。

This approval is based on results from the pivotal ICARIA-MM phase 3 study, using the China-based IsaFiRsT real-world study as bridging data. The ICARIA-MM study demonstrated Sarclisa in combination with Pd significantly reduced the risk of disease progression or death by 40% (HR 0.596, 95% CI 0.44-0.81, p=0.001), and resulted in a clinically meaningful, 6.9-month improvement in overall survival (OS) (HR=0.78; log-rank 1-sided P=0.0319), compared to Pd alone.

这项批准是基于关键的ICARIA-MM第三阶段研究的结果，使用基于中国的IsaFiRsT现实世界研究作为桥接数据。ICARIA-MM研究表明，Sarclisa联合Pd可显着降低疾病进展或死亡风险40%（HR 0.596,95%CI 0.44-0.81，p=0.001），与单独Pd相比，总生存期（OS）有6.9个月的临床意义（HR=0.78；log-rank单侧p=0.0319）。

Additionally, the IsaFiRsT study, which is the first real-world study for the registration of an anti-CD38 therapy in combination with Pd in China, showed an overall response rate (ORR) of 82.6% among relapsed or refractory multiple myeloma (R/R MM) adult patients..

此外，IsaFiRsT研究是中国第一项登记抗CD38治疗联合Pd的现实世界研究，显示复发或难治性多发性骨髓瘤（R/R MM）成人患者的总有效率（ORR）为82.6%。。

Olivier Nataf

奥利维尔·纳塔夫

Global Head, Oncology

肿瘤学全球负责人

“This approval marks an important milestone for Sanofi in China. The results of the ICARIA-MM phase 3 study, coupled with the real-world IsaFiRsT study, highlight the benefit of Sarclisa for patients living with multiple myeloma and the importance of innovative regulatory pathways for timely access to different treatments.

“这一批准标志着赛诺菲在中国的一个重要里程碑。ICARIA-MM 3期研究的结果，加上现实世界的IsaFiRsT研究，突显了Sarclisa对多发性骨髓瘤患者的益处，以及创新监管途径对于及时获得不同治疗的重要性。

We look forward to continuing to build strong partnerships with the medical community, local companies, and authorities in China as we work to bring more innovative treatments to patients.” .

我们期待着在为患者带来更多创新治疗的同时，继续与中国的医疗界、当地公司和当局建立强有力的合作伙伴关系。”。

Through the Lecheng Pilot for real-world data application, the NMPA has increasingly used real-world evidence (RWE) to help accelerate the review and approval of innovative therapies and medical devices in China. Sarclisa was one of the first three treatments authorized for real-world studies as part of the pilot program and is the first blood cancer treatment approved based on RWE, in addition to clinical data..

通过乐成真实世界数据应用试点，NMPA越来越多地使用真实世界证据（RWE）来帮助加速中国创新疗法和医疗器械的审查和批准。Sarclisa是作为试点项目的一部分批准用于现实世界研究的前三种治疗方法之一，也是除临床数据外，第一种基于RWE批准的血癌治疗方法。。

In addition to the NMPA approval, the Chinese Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer Association (CACA) guidelines include Sarclisa-Pd as a 'Category I Recommendation' and the 'Preferred Option' for the treatment of patients with first-relapsed MM. Beyond R/R MM, a regulatory submission for Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) in adult patients not eligible for autologous stem cell transplant, is also under review in China with a final decision expected in the coming months..

除NMPA批准外，中国临床肿瘤学会（CSCO）和中国抗癌协会（CACA）指南还将Sarclisa Pd作为“I类推荐”和治疗首次复发MM患者的“首选选择”。除R/R MM外，Sarclisa联合硼替佐米、来那度胺和地塞米松（VRd）治疗不符合自体干细胞移植条件的成年患者的新诊断多发性骨髓瘤（NDMM）的监管提案也正在中国进行审查，预计将在未来几个月做出最终决定。。

As one of the first multinational companies to enter China in 1982, Sanofi is committed to accelerating the introduction of innovative medicines and vaccines into China, aiming to transform the practice of medicine for the benefit of more Chinese people.

作为1982年首批进入中国的跨国公司之一，赛诺菲致力于加速将创新药物和疫苗引入中国，旨在改变医学实践，造福更多中国人。

About the ICARIA-MM study

关于ICARIA-MM研究

ICARIA-MM was a pivotal phase 3 randomized, open-label, multi-center trial evaluating Sarclisa in combination with Pd versus Pd alone in patients with R/R MM. The study enrolled 307 patients with R/R MM across 96 centers spanning 24 countries. Overall, patients had received a median of three prior lines of anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination..

ICARIA-MM是一项关键的3期随机，开放标签，多中心试验，评估了Sarclisa联合Pd与单独Pd治疗R/R MM患者的疗效。该研究招募了来自24个国家96个中心的307名R/R MM患者。总体而言，患者接受了三种先前抗骨髓瘤疗法的中位数，包括至少连续两个周期的来那度胺和蛋白酶体抑制剂单独或联合给药。。

During the trial, Sarclisa was administered by intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of Pd for the duration of treatment. The primary endpoint of ICARIA-MM was progression-free survival (PFS). Key secondary endpoints included ORR and OS..

在试验期间，Sarclisa以10mg/kg的剂量静脉输注，每周一次，持续四周，然后每隔一周进行28天的周期，并在治疗期间与标准剂量的Pd联合使用。ICARIA-MM的主要终点是无进展生存期（PFS）。关键的次要终点包括ORR和OS。。

About the IsaFiRsT study

关于IsaFiRsT研究

The IsaFiRsT study was a single-arm, observational, prospective, real-world study evaluating Sarclisa in combination with Pd in patients with R/R MM. The study enrolled 24 patients with R/R MM at one site in China. Overall, patients received a median of three prior lines of therapy, including lenalidomide and a proteasome inhibitor, and had measurable serum or urine M-protein..

IsaFiRsT研究是一项单臂，观察性，前瞻性，现实世界的研究，评估了Sarclisa联合Pd治疗R/R MM患者。该研究在中国的一个地点招募了24名R/R MM患者。总体而言，患者接受了三种先前治疗方案的中位数，包括来那度胺和蛋白酶体抑制剂，并且具有可测量的血清或尿液M蛋白。。

During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of Pd for the duration of treatment. Treatment continued until disease progression or unacceptable toxicity.

在试验期间，Sarclisa通过静脉输注以10mg/kg的剂量给药，每周一次，持续四周，然后每隔一周进行28天的周期，并在治疗期间结合标准剂量的Pd。治疗持续到疾病进展或不可接受的毒性。

The primary endpoint of IsaFiRsT was ORR. Key secondary endpoints included PFS, OS, duration of response (DOR) and safety..

IsaFiRsT的主要终点是ORR。关键的次要终点包括PFS，OS，反应持续时间（DOR）和安全性。。

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，可与MM细胞CD38受体上的特定表位结合，诱导独特的抗肿瘤活性。它旨在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细胞表面高度均匀表达，使其成为基于抗体的治疗剂（如Sarclisa）的靶标。

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 FDA..

。。

Currently, Sarclisa is approved in more than 50 countries, including the US and EU, across two indications; Sarclisa is approved under an additional indication in the US. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in combination with Pd for the treatment of patients with R/R MM who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on last therapy.

目前，Sarclisa在包括美国和欧盟在内的50多个国家获得了两种适应症的批准；根据ICARIA-MM 3期研究，Sarclisa被批准与Pd联合用于治疗先前接受过≥2次治疗的R/R MM患者，包括来那度胺和蛋白酶体抑制剂，并且在最后一次治疗中取得进展。

Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received 1–3 prior lines of therapy and in the EU for patients with MM who have received at least 1 prior therapy.

根据IKEMA 3期研究，Sarclisa还被50个国家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先前接受过1-3次治疗的R/R MM患者，在欧盟用于治疗至少接受过1次治疗的MM患者。

In the US, Sarclisa is approved in combination with VRd as a front-line treatment option for adult patients with NDMM not eligible for transplant based on the IMROZ phase 3 study. On November 14, 2024, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Sarclisa-VRd in this patient population.

在美国，根据IMROZ 3期研究，Sarclisa被批准与VRd联合作为成人NDMM患者不符合移植条件的一线治疗选择。2024年11月14日，欧洲药品管理局（EMA）的人类使用药品委员会（CHMP）通过了一项积极的意见，建议在该患者人群中批准Sarclisa VRd。

A final decision is expected in the coming months..

预计未来几个月将做出最终决定。。

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 administration method for Sarclisa in clinical studies.

赛诺菲继续推进Sarclisa作为以患者为中心的临床开发计划的一部分，该计划包括跨越六个潜在适应症的MM治疗连续体的几项2期和3期研究。此外，该公司正在临床研究中评估Sarclisa的皮下给药方法。

The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery..

除了批准的适应症和分娩方法外，任何监管机构都没有对Sarclisa的安全性和有效性进行评估。。

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 gastrointestinal and lung cancers..

在努力成为全球第一大免疫科学公司的过程中，赛诺菲仍然致力于推进肿瘤学创新。通过有针对性的战略决策，该公司重塑并优先考虑了其渠道，利用其在免疫科学方面的专业知识来推动进步。努力的重点是难以治疗的罕见癌症，如选择性血液恶性肿瘤和严重未满足需求的实体瘤，包括多发性骨髓瘤，急性髓细胞白血病，某些类型的淋巴瘤，以及胃肠道和肺癌。。

For more information on Sarclisa clinical studies, please visit

有关Sarclisa临床研究的更多信息，请访问

www.clinicaltrials.gov

www.clinicaltrials.gov

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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，其宗旨是：追求科学奇迹，改善人们的生活。我们在世界各地的团队致力于通过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潜在的改变生命的治疗方案和挽救生命的疫苗保护，同时将可持续性和社会责任作为我们雄心壮志的核心。。