Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma

赛诺菲 Sarclisa 皮下注射制剂在日本获批，用于多发性骨髓瘤患者

Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV

基于多项研究的批准，包括关键的IRAKLIA 3期研究，该研究证明了与静脉注射Sarclisa相比具有非劣效的疗效和药代动力学特性

Second global approval for Sarclisa SC following the EU

继欧盟之后，Sarclisa SC 获得全球第二个批准

Paris, June 19, 2026.

巴黎，2026年6月19日。

The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).

日本厚生劳动省已批准萨克利莎（sarclisa，伊沙妥昔单抗）皮下注射制剂与获批的标准治疗方案联合使用，用于治疗多发性骨髓瘤（MM）。在日本，萨克利莎皮下注射制剂的获批适应症包括：与泊马度胺和地塞米松（Pd）联用，或与卡非佐米联用，用于治疗复发或难治性多发性骨髓瘤（R/R MM）；以及与硼替佐米、来那度胺和地塞米松（VRd）联用，用于治疗新诊断的多发性骨髓瘤（NDMM）成年患者。

.

。

A regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is under review in Japan. If approved, Sarclisa SC could become the first anticancer treatment to be administered via an OBI, and the first MM medicine in Japan to offer both manual SC injection and OBI administration..

Enable Injections 提交的基于 enFuse 平台的 CirCLIQ 贴身注射器（OBI）监管申请正在日本接受审评。若获批准，Sarclisa SC 将成为首款通过 OBI 给药的抗癌治疗药物，并成为日本首款同时提供手动皮下注射和 OBI 给药方式的多发性骨髓瘤药物。

In recent years, new MM diagnoses have increased steadily in Japan, creating a need for new treatment approaches particularly in the front-line setting. MM is the third most common hematologic malignancy in Japan.

近年来，日本新诊断的多发性骨髓瘤（MM）病例稳步增加，尤其是在一线治疗领域，对新治疗方法的需求日益迫切。多发性骨髓瘤是日本第三常见的血液系统恶性肿瘤。

“Today’s approval of Sarclisa subcutaneous represents an important evolution in how we deliver care for multiple myeloma patients in Japan,”

“今日对Sarclisa皮下注射制剂的批准，代表了我们在日本为多发性骨髓瘤患者提供护理方式的重要演进。”

said

说

Olivier Nataf

奥利维耶·纳塔夫

, Global Head of Oncology at Sanofi.

赛诺菲全球肿瘤学负责人

“This new formulation significantly eases treatment burden and enhances convenience for patients compared to intravenous administration – with the potential to become Japan's first anticancer therapy to be administered via an on-body injector.”

“与静脉给药相比，这种新配方显著减轻了治疗负担并提高了患者的便利性——有望成为日本首个通过贴敷式注射器给药的抗癌疗法。”

The approval is based on results from the IRAKLIA phase 3 study in R/R MM (clinical study identifier:

该批准基于IRAKLIA期3研究在复发/难治性多发性骨髓瘤（R/R MM）中的结果（临床研究标识符：

NCT05405166

NCT05405166

), which demonstrated non-inferiority of the SC formulation compared to IV, as well as

），这表明皮下注射制剂与静脉注射相比具有非劣效性，以及

supportive studies

支持性研究

. In addition to manual SC injection, these studies evaluated Sarclisa SC administered through an OBI, and were conducted using Enable Injections’ enFuse hands-free OBI, an automated injector for subcutaneous delivery of Sarclisa.

除了手动皮下注射外，这些研究还评估了通过一次性身体整合装置（OBI）给药的Sarclisa皮下制剂，并使用了Enable Injections公司的enFuse免手持式OBI（一种用于皮下递送Sarclisa的自动注射器）进行研究。

In the IRAKLIA study, Sarclisa SC administered via an OBI in combination with pomalidomide and dexamethasone (Pd) resulted in a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority (risk ratio: 1.008; 95% confidence interval: 0.903-1.126; p=0.0006), in adult patients with R/R MM who had received at least one prior line of treatment. The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd.

在IRAKLIA研究中，对于至少接受过一线既往治疗的复发/难治性多发性骨髓瘤（R/R MM）成人患者，通过一次性输注装置（OBI）皮下注射Sarclisa联合泊马度胺和地塞米松（Pd）的客观缓解率（ORR）为71.1%，而静脉注射Sarclisa联合Pd的ORR为70.5%，确立了非劣效性（风险比：1.008；95%置信区间：0.903-1.126；p=0.0006）。本研究中观察到的Sarclisa皮下注射联合Pd的总体安全性特征与已确立的Sarclisa静脉注射联合Pd的安全性特征一致。

While 25% of patients treated with Sarclisa IV-Pd experienced infusion reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) that occurred in 0.4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2..

在接受Sarclisa IV-Pd治疗的患者中，25%出现了输液反应，而在接受Sarclisa SC-Pd治疗的患者中，这一比例为1.5%。除低级别局部注射部位反应（ISRs）外，未观察到新的安全性问题；在0.4%的OBI注射中发生了此类反应（19/5,145次注射）。几乎所有ISRs均为1级，仅有一例为2级。

The most common grade ≥3 non hematologic adverse events were pneumonia (14.8% OBI, 15.5% IV), COVID-19 (2.7%, 1.9%), and upper respiratory tract infection (1.5% both arms). The most common grade ≥3 hematologic laboratory abnormalities were neutropenia (84.7% OBI, 74.3% IV), thrombocytopenia (26.1%, 23%), and anemia (17.6%, 19.5%)..

最常见的≥3级非血液学不良事件为肺炎（OBI组14.8%，IV组15.5%）、COVID-19（2.7%，1.9%）和上呼吸道感染（两组均为1.5%）。最常见的≥3级血液学实验室异常为中性粒细胞减少症（OBI组84.7%，IV组74.3%）、血小板减少症（26.1%，23%）和贫血（17.6%，19.5%）。

In Japan, Sarclisa IV is currently approved across five indications, including in combination with VRd in NDMM, as well as four different treatment regimens in R/R MM (in combination with Pd, in combination with carfilzomib and dexamethasone (Kd), in combination with dexamethasone alone, or as a monotherapy).

在日本，Sarclisa IV 目前已获批用于五个适应症，包括与 VRd 方案联合用于治疗新诊断的多发性骨髓瘤（NDMM），以及用于复发/难治性多发性骨髓瘤（R/R MM）的四种不同治疗方案（与 Pd 方案联合、与卡非佐米和地塞米松（Kd）联合、与单用地塞米松联合，或作为单药治疗）。

Sarclisa SC administered via both the CirCLIQ OBI and manual injection was approved in the EU for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in June 2026. An application for Sarclisa SC administered via both OBI and manual injection is currently under review in the US..

2026年6月，欧盟批准了通过CirCLIQ一次性注射器（OBI）和手动注射给药的Sarclisa皮下制剂，用于治疗所有当前已批准的Sarclisa静脉制剂适应症及联合用药方案中的多发性骨髓瘤（MM）患者。目前，美国正在审查通过OBI和手动注射给药的Sarclisa皮下制剂的申请。

About the IRAKLIA study

关于IRAKLIA研究

IRAKLIA (clinical study identifier:

IRAKLIA（临床研究标识符：

NCT05405166

NCT05405166

) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa administered at a fixed dose SC via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee, and observed Sarclisa mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa plasma concentrations..

) 是一项随机、开放标签、关键性 III 期研究，旨在评估在至少接受过一线既往治疗的复发/难治性多发性骨髓瘤（R/R MM）成人患者中，通过 OBI 以固定剂量皮下（SC）给予 Sarclisa 与按体重给药静脉输注（IV）Sarclisa 联合 Pd 方案相比的非劣效性。共同主要终点评估指标包括：由独立审查委员会根据 2016 年国际骨髓瘤工作组标准评估的客观缓解率（ORR），定义为达到严格完全缓解（CR）、完全缓解（CR）、非常好部分缓解和部分缓解的患者比例；以及稳态时（第 6 周期第 1 次给药前 [C6D1]）给药前观察到的 Sarclisa 平均浓度（Ctrough），定义为观察到的 Sarclisa 血浆浓度。

About Enable Injections

关于 Enable Injections

Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse

总部位于辛辛那提的Enable Injections是一家全球医疗健康创新公司，致力于通过开发和制造enFuse来改善患者的治疗体验。

®

®

On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.

体表给药系统。enFuse 系统是一种创新的可穿戴技术，旨在通过皮下注射方式递送大容量的药物和生物制剂治疗产品，以提高便利性、支持更优的治疗效果，并推动医疗体系的经济效益。

For more information, visit .

欲了解更多信息，请访问。

www.enableinjections.com

www.enableinjections.com

.

。

About Sarclisa

关于Sarclisa

Sarclisa (isatuximab) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM. Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide.

Sarclisa（伊沙妥昔单抗）已在近60个国家获批，用于新诊断多发性骨髓瘤（NDMM）和复发/难治性多发性骨髓瘤（R/R MM）特定患者的四个适应症。基于Sarclisa的治疗方案已在全球范围内用于超过70,000名患者。

Sarclisa SC is approved in the EU and the UK in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration..

Sarclisa SC 在欧盟和英国已获批准，与获批的标准治疗方案联合使用，用于治疗多发性骨髓瘤（MM）患者，适用于这些国家中 Sarclisa IV 当前所有获批的适应症。它是首个通过一次性注射器（OBI）给药的抗癌治疗药物，也是多发性骨髓瘤治疗中唯一可提供皮下注射一次性注射器给药和手动注射两种灵活给药方式的抗 CD38 单克隆抗体。

Sarclisa SC is approved in Japan in combination with VRd, for the treatment of adult patients with NDMM, as well as Pd and Kd for the treatment of patients with R/R MM.

Sarclisa SC在日本获批，联合VRd用于治疗新诊断的多发性骨髓瘤（NDMM）成人患者，以及联合Pd和Kd用于治疗复发/难治性多发性骨髓瘤（R/R MM）患者。

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need..

在赛诺菲，我们秉持对肿瘤学的长期承诺，不断追寻科学奇迹，以改善癌症患者的生活。我们致力于通过开发创新、首创及同类的最佳免疫疗法和靶向疗法，变革癌症治疗格局，专注于满足罕见且难治性癌症领域尚未被满足的重大需求。

For more information on Sarclisa clinical studies, please visit

有关 Sarclisa 临床试验的更多信息，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.

赛诺菲是一家研发驱动、人工智能赋能的生物制药公司，致力于改善人类生活并实现强劲增长。我们凭借对免疫系统的深刻理解，研发用于治疗和保护全球数百万人的药物与疫苗，并通过创新的产品管线惠及更多人群。我们的团队秉持一个宗旨：追寻科学奇迹，改善人类生活；这激励我们应对当今最紧迫的医疗、环境和社会挑战，推动进步，为员工和我们服务的社区带来积极影响。

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

赛诺菲在泛欧交易所（股票代码：SAN）和纳斯达克（股票代码：SNY）上市。

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Sanofi forward-looking statements

赛诺菲前瞻性陈述

This press release contains forward-looking statements within the meaning of applicable securities laws, including 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 regarding the marketing and other potential of the product; regarding potential future events and revenues from the product.

本新闻稿包含适用证券法律（包括经修订的1995年《私人证券诉讼改革法案》）所定义的前瞻性陈述。前瞻性陈述是指非历史事实的陈述。这些陈述包括对产品市场推广及其他潜力的预测和估计，以及与之相关的基础假设；还包括对产品潜在未来事件及收入的预测和估计。

Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” 'attempt,' “target,” “project,” 'strategy,' 'strive,' 'desire,' “predict,” “forecast,” “ambition,” “guideline,” 'seek,' “should,” “will,” 'goal,' or the negative of these and similar expressions are intended to identify forward-looking statements.

“预期”、“预计”、“相信”、“打算”、“估计”、“计划”、“能够”、“考虑”、“可能”、“旨在”、“可以”、“或许”、“潜在”、“目标”、“尝试”、“指标”、“规划”、“战略”、“努力”、“期望”、“预测”、“展望”、“雄心”、“指导方针”、“寻求”、“应当”、“将”、“目的”等词语，以及这些词语的否定形式或类似表述，均用于识别前瞻性陈述。

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.

尽管赛诺菲管理层认为此类前瞻性陈述中所反映的预期是合理的，但提醒投资者注意，前瞻性信息和陈述受多种风险和不确定性的影响，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陈述中明示、暗示或预测的内容存在重大差异。

These risks, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug.

这些风险、不确定性和假设包括但不限于：意外的监管行动或延误，或一般的政府监管，这些因素可能影响产品的可获得性或商业潜力；产品可能无法在商业上取得成功；监管机构关于是否以及何时批准候选产品的决定；美国在强制降低药品价格方面的政治压力。

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

本新闻稿中提及的所有商标均为赛诺菲集团所有，enFuse 和 CirCLIQ 除外。

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