Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma 赛诺菲的Sarclisa皮下注射剂型通过体外注射器给药，获CHMP推荐批准用于治疗多发性骨髓瘤。Recommendation based on positive results demonstrating comparable efficacy, pharmacokinetics, and safety of Sarclisa regimens administered subcutaneously compared to intravenous infusion 基于证明皮下注射Sarclisa方案与静脉输注相比具有相当的疗效、药代动力学和安全性的积极结果的推荐If approved, Sarclisa subcutaneous (SC) would be the first available anticancer treatment to be administered through an on-body injector (OBI), and the first multiple myeloma medicine available by both SC OBI and manual injection in the EU 如果获得批准，Sarclisa皮下注射剂（SC）将成为首个通过体外注射器（OBI）给药的抗癌治疗药物，同时也是欧盟中首个可通过SC OBI和手动注射方式使用的多发性骨髓瘤药物。Paris, March 27, 2026. 巴黎，2026年3月27日。The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa (isatuximab) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved indications for Sarclisa intravenous (IV) formulation in the EU. 欧洲药品管理局人用医药产品委员会（CHMP）已采纳积极意见，推荐批准Sarclisa（isatuximab）皮下注射（SC）与已批准的标准治疗方案联合使用，用于治疗多发性骨髓瘤（MM）患者，涵盖目前欧盟批准的所有Sarclisa静脉注射（IV）制剂的适应症。If approved, Sarclisa would be the first available anticancer treatment to be administered through both an on-body injector (OBI) and manual injection, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both an OBI and manual injection. A final decision is expected in the coming months.. 如果获得批准，Sarclisa 将成为首个可通过体外注射器 (OBI) 和手动注射两种方式给药的抗癌治疗药物，并且是多发性骨髓瘤 (MM) 中唯一提供 OBI 和手动注射灵活性的抗 CD38 单克隆抗体。最终决定预计将在未来几个月内做出。“This positive CHMP opinion is a pivotal milestone in our mission to improve the treatment experience for multiple myeloma patients and providers,” “这一积极的CHMP意见是我们改善多发性骨髓瘤患者和医疗提供者治疗体验使命中的一个关键里程碑。”says 说Olivier Nataf, 奥利维尔·纳塔夫，Global Head of Oncology at Sanofi. 赛诺菲全球肿瘤学负责人。“Our aim is to evolve the treatment experience by combining the clinically proven efficacy of Sarclisa with innovative subcutaneous delivery via an on-body injector. This advancement reflects our unwavering commitment to patients and dedication to transforming care in ways that truly matter to people living with cancer.”. “我们的目标是通过将 Sarclisa 临床验证的疗效与通过体外注射器创新的皮下递送方式相结合，从而改善治疗体验。这一进步体现了我们对患者的坚定承诺，以及以真正对癌症患者重要的方式改变护理的奉献精神。”The positive CHMP opinion is based on the CHMP的积极意见是基于 results 结果from the IRAKLIA phase 3 study in relapsed and/or refractory (R/R) MM (clinical study identifier: 来自复发和/或难治性（R/R）MM的IRAKLIA 3期研究（临床研究标识符： NCT05405166 NCT05405166), which demonstrated non‑inferiority of the SC formulation compared to the IV formulation. Four additional studies supported the decision and include the GMMG-HD8 phase 3 study in transplant-eligible newly diagnosed MM (NDMM, TE) (clinical study identifier: ），该研究表明皮下注射剂型相比静脉注射剂型具有非劣效性。另有四项研究支持这一决定，其中包括针对适合移植的新诊断多发性骨髓瘤（NDMM，TE）的GMMG-HD8三期研究（临床研究标识符：NCT05804032 NCT05804032), the IZALCO phase 2 study in R/R MM (clinical study identifier: )，IZALCO第二阶段研究在R/R MM中（临床研究标识符：NCT05704049 NCT05704049), and theISASOCUTphase 2 study in transplant-ineligibleNDMM(NDMM, TI)(clinical study identifier: )，以及针对不适合移植的新诊断多发性骨髓瘤（NDMM，TI）的ISASOCUT二期研究（临床研究标识符：NCT05889221 NCT05889221) and one phase 1b study in R/R MM patients who received at least two prior lines of therapy (clinical study identifier: ) 和一项针对接受过至少两种前期治疗的 R/R MM 患者的 1b 期研究 (临床研究标识符: NCT04045795 NCT04045795). ）。 Of the multiple SC studies two studies showed the use of Sarclisa SC + OBI was associated with greater patient satisfaction compared to IV administration, and patient and healthcare provider preference compared to Sarclisa manual injection, based on patient experience and satisfaction questionnaires fielded in the studies.. 在多项皮下（SC）研究中，有两项研究表明，根据研究中进行的患者体验和满意度问卷调查，使用 Sarclisa SC + OBI 与静脉注射相比，患者的满意度更高，并且相较于 Sarclisa 手动注射，患者和医疗保健提供者更倾向于选择该方式。These collective results provide comprehensive evidence supporting the potential use of Sarclisa SC + OBI to advance patient care in NDMM and R/R MM, while maintaining Sarclisa’s strong efficacy and safety profile. 这些集体结果提供了全面的证据，支持使用 Sarclisa SC + OBI 来提升 NDMM 和 R/R MM 患者的治疗，同时保持 Sarclisa 的高效性和安全性。The studies were conducted using Enable Injections’ enFuse 这些研究是使用Enable Injections的enFuse进行的。® ®hands-free OBI, an automated injector designed to deliver subcutaneously high-volume medicines beginning with the push of a button, to administer Sarclisa SC formulation. The enFuse device uses a thinner and retractable needle that is smaller compared to the needles commonly used for large-volume injections, which may help support patient comfort.. 免手持OBI，一种自动注射器，设计用于通过按下按钮开始皮下注射大剂量药物，以施用Sarclisa SC配方。enFuse设备使用比通常用于大剂量注射的针头更细且可伸缩的针头，这可能有助于提高患者的舒适度。Sarclisa IV is currently approved in four indications in the EU for both NDMM, TI and NDMM, TE, and as early as first relapse in R/R MM. In addition to the EU, a regulatory submission is also under review with the US Food and Drug Administration (FDA). Sarclisa IV 目前在欧盟已获批用于四种适应症，包括 NDMM、TI 和 NDMM、TE，以及早在首次复发时的 R/R MM。除欧盟外，美国食品药品监督管理局 (FDA) 也正在审查其监管提交。Sarclisa SC + OBI or manual injection is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. Sarclisa SC + OBI 或手动注射目前正处于临床研究阶段，其安全性和有效性尚未由任何监管机构评估。About the IRAKLIA study 关于 IRAKLIA 研究IRAKLIA (clinical study identifier: 伊拉克利亚（临床研究标识符：NCT05405166 NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC formulation administered at a fixed dose SC via an OBI versus weight-based dosed Sarclisa IV in combination with pomalidomide and dexamethasone (Pd) in adult patients with R/R MM who have received at least one prior line of therapy. ）是一项随机、开放标签、关键的3期临床试验，评估了通过OBI以固定剂量皮下注射（SC）给予Sarclisa SC制剂与基于体重给药的静脉注射（IV）Sarclisa联合泊马度胺和地塞米松（Pd）在既往至少接受过一种治疗方案的复发/难治性多发性骨髓瘤（R/R MM）成年患者中的非劣效性。The co-primary outcomes assessed were objective response rate (ORR), according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC) and observed Sarclisa concentrations before dosing (C trough) at steady state (pre-dose at cycle 6, day 1 [C6D1]).. 共同主要终点是根据2016年国际骨髓瘤工作组（IMWG）标准，由独立审查委员会（IRC）评估的客观缓解率（ORR），以及在稳态下给药前（第6周期第1天 [C6D1]）观察到的Sarclisa谷浓度（C trough）。About the IZALCO study 关于IZALCO研究IZALCO (clinical study identifier: 伊扎尔科（临床研究标识符：NCT05704049 NCT05704049) was a two-part, randomized, open-label phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via the OBI or by manual injection, in combination with carfilzomib and Kd, for the treatment of adult patients with R/R MM who have received one to three prior lines of therapy. The primary objective is ORR, as assessed by IRC. ）是一项分为两部分的随机、开放标签的 2 期研究，评估 Sarclisa SC 通过 OBI 或手动注射给药，与卡非佐米和 Kd 联合使用，治疗接受过一到三种既往治疗的成人 R/R MM 患者的疗效和安全性。主要目标是由 IRC 评估的 ORR。The key secondary endpoint is patient preference for the Sarclisa SC administered via an OBI versus manual administration of Sarclisa SC. Healthcare provider preference of delivery method is also assessed as exploratory endpoint.. 关键的次要终点是患者对通过OBI给予的Sarclisa SC与手动给予Sarclisa SC的偏好。医疗提供者对给药方式的偏好也被评估为探索性终点。About the ISASOCUT study 关于ISASOCUT研究ISASOCOUT (clinical study identifier: ISASOCOUT（临床研究标识符：NCT05889221 NCT05889221) is an open-label phase 2 study assessing Sarclisa SC administered via the OBI in combination with bortezomib, lenalidomide and dexamethasone (VRd) in NDMM patients ineligible for autologous stem-cell transplant (ASCT). The primary objective is rate of very good partial response (VGPR) or better, according to the 2016 IMWG criteria assessed by IRC. ）是一项开放标签的 2 期研究，评估 Sarclisa SC 通过 OBI 给药与硼替佐米、来那度胺和地塞米松（VRd）联合用于不符合自体干细胞移植（ASCT）条件的新诊断多发性骨髓瘤（NDMM）患者。主要目标是根据独立审查委员会（IRC）评估的 2016 年 IMWG 标准，达到非常好的部分缓解（VGPR）或更好的比率。The study is ongoing.. 研究正在进行中。About the GMMG-HD8 study 关于GMMG-HD8研究GMMG-HD8 (clinical study identifier: GMMG-HD8（临床研究标识符：NCT05804032 NCT05804032) was a randomized, open-label, multicenter phase 3 study evaluating the non-inferiority of Sarclisa SC administered via an OBI versus Sarclisa IV, both in combination with VRd at induction, for the treatment of patients with NDMM eligible for ASCT. The primary endpoint of the study is non-inferiority of SC to IV administration as measured by VGPR or better after induction therapy. ）是一项随机、开放标签、多中心的3期研究，评估了通过OBI给予Sarclisa皮下注射（SC）与静脉注射（IV）Sarclisa在诱导治疗中与VRd联合使用的非劣效性，用于治疗适合ASCT的新诊断多发性骨髓瘤（NDMM）患者。该研究的主要终点是诱导治疗后通过VGPR或更佳反应测量的SC与IV给药的非劣效性。Results from an interim analysis were submitted to support the conversion of the indication from Sarclisa IV to Sarclisa SC.. 中期分析的结果已提交，以支持将适应症从 Sarclisa IV 转换为 Sarclisa SC。About Enable Injections 关于启用注入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® 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.. 总部位于辛辛那提的Enable Injections是一家全球医疗保健创新公司，致力于通过开发和制造enFuse® 贴身递送系统来改善患者的治疗体验。enFuse系统是一种创新的可穿戴技术，旨在通过皮下注射方式输送大剂量的药物和生物治疗剂，以提高便利性、支持更优的治疗效果并推动医疗系统的经济效益。About Sarclisa 关于SarclisaSarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, 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. Sarclisa（isatuximab）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，用于多发性骨髓瘤（MM）的多线治疗。基于ICARIA-MM三期研究，Sarclisa在美国和日本被批准与Pd联合使用，用于治疗已接受过至少两种前期治疗（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。Additionally, Sarclisa is approved in the EU 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 and have relapsed on the last therapy, and in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. 此外，Sarclisa在欧盟被批准与Pd联合使用，用于治疗接受过≥2种既往治疗（包括来那度胺和蛋白酶体抑制剂）且在最后一次治疗后复发的R/R MM患者；在中国，该药物适用于接受过至少一线既往治疗（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 Kd, 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也已在50多个国家获得批准与Kd联合使用，包括在美国用于治疗接受过一到三种前期治疗的复发/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前期治疗的多发性骨髓瘤（MM）患者。In the US, EU, 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. Sarclisa is also approved in the EU in combination with VRd as an induction treatment for transplant-eligible NDMM patients, based on the GMMG-HD7 phase 3 study. 在美国、欧盟和中国，基于IMROZ三期研究，Sarclisa联合VRd被批准作为不适合移植的新诊断多发性骨髓瘤（NDMM）患者的一线治疗选择。此外，根据GMMG-HD7三期研究，Sarclisa联合VRd在欧盟也被批准用于适合移植的NDMM患者的诱导治疗。In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility.. 在日本，Sarclisa 获批与 VRd 联合使用，作为无论移植资格如何的一线治疗选择。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，我们一直致力于肿瘤学领域，不断追求科学奇迹，以改善癌症患者的生活。我们致力于通过开发创新的、同类首创和最佳的免疫疗法及靶向疗法，来改变癌症治疗现状，特别是针对那些罕见且难以治疗、存在高度未满足需求的癌症。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. 。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，研发药物和疫苗，为全球数百万人提供治疗和保护，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。我们的团队秉承一个使命：追逐科学奇迹以改善人们的生活；这激励我们推动进步，并通过应对当今最紧迫的医疗、环境和社会挑战，为我们服务的人群和社区带来积极影响。Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 赛诺菲在EURONEXT上市，代码为SAN，在NASDAQ上市，代码为SNY。Media Relations 媒体关系Sandrine Guendoul 桑德琳·根杜尔| +33 6 25 09 14 25 | | +33 6 25 09 14 25 |sandrine.guendoul@sanofi.com 桑德琳·根杜尔@赛诺菲.comEvan Berland 埃文·贝兰德| +1 215 432 0234 | | +1 215 432 0234 |evan.berland@sanofi.com 埃文·伯兰@赛诺菲.comLéo Le Bourhis 里奥·勒布尔希斯| +33 6 75 06 43 81 | | +33 6 75 06 43 81 |leo.lebourhis@sanofi.com leo.lebourhis@sanofi.comVictor Rouault 维克多·鲁奥| +1 617 356 4751 | | +1 617 356 4751 |victor.rouault@sanofi.com victor.rouault@sanofi.comTimothy Gilbert 蒂莫西·吉尔伯特| +1 516 521 2929 | | +1 516 521 2929 |timothy.gilbert@sanofi.com timothy.gilbert@sanofi.comLéa Ubaldi 莱娅·乌巴尔迪| +33 6 30 19 66 46 | | +33 6 30 19 66 46 |lea.ubaldi@sanofi.com lea.ubaldi@sanofi.comEkaterina Pesheva 叶卡捷琳娜·佩舍娃| +1 410 926 6780 | | +1 410 926 6780 |ekaterina.pescheva@sanofi.com ekaterina.pescheva@sanofi.comInvestor Relations 投资者关系Thomas Kudsk Larsen 托马斯·库德斯克·拉森|+ 44 7545 513 693 | |+ 44 7545 513 693 |thomas.larsen@sanofi.com 托马斯.拉森@赛诺菲.comAlizé Kaisserian 阿利泽·凯塞里安| + 33 6 47 04 12 11 | | + 33 6 47 04 12 11 |alize.kaisserian@sanofi.com alize.kaisserian@sanofi.comKeita Browne 凯塔·布朗| + 1 781 249 1766 | | + 1 781 249 1766 |keita.browne@sanofi.com keita.browne@sanofi.comNathalie Pham 娜塔莉·范 | + 33 7 85 93 30 17 | | + 33 7 85 93 30 17 |nathalie.pham@sanofi.com 娜塔莉·冯@赛诺菲.comNina Goworek 尼娜·戈沃雷克| +1 908 569 7086 | | +1 908 569 7086 |nina.goworek@sanofi.com 尼娜·戈沃雷克@赛诺菲.comThibaud Châtelet 蒂博·沙特莱| + 33 6 80 80 89 90 | | + 33 6 80 80 89 90 |thibaud.chatelet@sanofi.com thibaud.chatelet@sanofi.comYun Li 李云| +33 6 84 00 90 72 | | +33 6 84 00 90 72 |yun.li3@sanofi.com yun.li3@sanofi.comSanofi forward-looking statements 赛诺菲前瞻性声明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. 本新闻稿包含适用证券法（包括经修订的 1995 年私人证券诉讼改革法案）所指的前瞻性陈述。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. 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. 前瞻性声明是指并非历史事实的声明。这些声明包括对产品市场和其他潜力的预测、估计及其基本假设；涉及与产品相关的潜在未来事件和收入。诸如“预期”、“预计”、“相信”、“打算”、“估计”、“计划”、“可以”、“考虑”、“可能”、“旨在”、“或许”、“也许”、“潜力”、“目标”、“尝试”、“针对”、“项目”、“策略”、“努力”、“期望”、“预测”、“展望”、“抱负”、“指导方针”、“寻求”、“应该”、“将要”、“目的”，或这些词语的否定形式及类似表述，均旨在识别前瞻性声明。. 。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. 尽管赛诺菲的管理层认为这些前瞻性陈述中反映的预期是合理的，但投资者应注意，前瞻性信息和声明受到各种风险和不确定性的约束，其中许多风险和不确定性难以预测且通常超出赛诺菲的控制范围，这可能导致实际结果和发展与前瞻性信息和声明中表达或暗示或预计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 prices including “most favored nation” pricing for State Medicaid programs; the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues; competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. 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迟，或政府监管总体上可能影响产品的可用性或商业潜力；产品可能无法取得商业成功；监管机构关于是否以及何时批准某一候选产品的决定；美国国内要求强制降低药品价格的政治压力，包括针对各州医疗补助计划的“最惠国”定价；研发固有的不确定性，包括未来临床数据和对现有临床数据（包括上市后数据）的分析，以及意外的安全性、质量或生产问题；普遍的竞争；与知识产权相关的风险及任何正在进行或未来的诉讼及其最终结果；不稳定的经济和市场状况；全球危机对我们、我们的客户、供应商、厂商及其他业务合作伙伴的影响，以及他们中任何一方的财务状况，同时也包括对我们员工和整体全球经济的影响。The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Aut. 风险和不确定性还包括在向美国证券交易委员会和法国金融市场管理局提交的公开文件中讨论或确定的不确定性。All trademarks mentioned in this press release are the property of the Sanofi group with the exception of enFuse. 本新闻稿中提到的所有商标均为赛诺菲集团的财产，enFuse 除外。Attachment 附件Press_Release 新闻稿Share 分享
