SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

下面是2026年4月13日至2026年4月19日这一周国际头部药企（top30）的国际审批、合作授权、收并购、临床进展及财务业绩情况 本周主要内容包括： 国际审批方面，罗氏Elecsys神经丝蛋白轻链检测获欧盟CE认证，用于多发性硬化症神经炎症评估；欧盟批准赛诺菲的Dupixent (dupilumab，度普利尤单抗，IL4，IL13抗体)，用于儿童荨麻疹；欧盟多国推出勃林格殷格翰的LENZELTA疫苗，针对奶牛两种乳腺炎病原体；博士康的Biafine皮肤恢复乳液在美国线上发售；欧加隆的VTAMA软膏（tapinarof，本维莫德，芳香烃受体激动剂）获美国儿童特应性皮炎指南推荐，用于儿童特应性皮炎。 合作授权方面，诺和诺德与OpenAI达成合作，筛选药物候选物；勃林格殷格翰和再鼎医药合作开展临床，评估obrixtamig（DLL3/CD3 T细胞接合剂）与zocilurtatug pelitecan（靶向DLL3的抗体偶联药物）联合，用于低分化神经内分泌癌和广泛期小细胞肺癌效果；再生元和Telix Pharmaceuticals Limited合作，开发放射性药物疗法。 收并购方面，GSK以9.5亿美元收购35Pharma Inc.，获得用于肺动脉高压激活素受体通路管线；吉利德以78亿美元收购Arcellx获得监管审批，将获得BCMA CAR-T疗法及D域技术平台；第一三共拟出售非处方药护肤口腔护理子公司DAIICHI SANKYO HEALTHCARE CO., LTD.股权，卖给Suntory Holdings Limited。总对价2465亿日元；优时比拟以6.5亿美元收购Neurona Therapeutics，获得再生多能干细胞管线用于癫痫。 临床进展方面，强生公布VARIPURE脉冲电场消融导管产品，用于房颤数据；赛诺菲公布基于蛋白质的非mRNA型新冠病毒疫苗Nuvaxovid相较于Moderna的最新mRNA型新冠病毒疫苗mNEXSPIKE的数据；拜耳公布asundexian（FXIa抑制剂），预防缺血性卒中数据；礼来公布Jaypirca (pirtobrutinib，布鲁顿酪氨酸激酶抑制剂）用于慢性淋巴细胞白血病或小淋巴细胞淋巴瘤数据；公布Foundayo (orforglipron，GLP-1激动剂)用于2型糖尿病肥胖数据；雅培公布其生物标志物、多癌症早期检测项目数据；安斯泰来首个患者接受setidegrasib（KRAS G12D基因突变的蛋白质降解剂)给药，用于胰腺导管腺癌；第一三共的ifinatamab deruxtecan，靶向B7-H3 ADC，申请用于广泛期小细胞肺癌，获得美国FDA受理。 详细情况如下。 国际审批方面：  罗氏：4月13日，罗氏宣布，其Elecsys神经丝蛋白轻链（NfL）检测已获得欧盟CE认证，可用于检测确诊为复发缓解型多发性硬化症患者的神经炎症情况。通过血液检测来测量NfL（在神经细胞损伤时释放的蛋白质），Elecsys NfL测试可以呈现与多发性硬化症相关的神经炎症情况。  赛诺菲：4月13日，赛诺菲宣布，欧盟委员会已批准Dupixent (dupilumab，度普利尤单抗)，用于治疗2至11岁患有中度至重度慢性自发性荨麻疹的儿童患者，这些患者对组胺-1抗组胺药反应不佳，并且此前未曾接受抗免疫球蛋白E疗法。批准基于LIBERTY-CUPID临床研究。研究A和研究C的结果表明，在第24周时，Dupixent与安慰剂相比，显著降低了荨麻疹活动（瘙痒和荨麻疹的综合指标），以及瘙痒和荨麻疹严重程度的个体指标。还提高了病情得到良好控制和完全缓解的患者比例，与安慰剂相比有显著差异。Dupixent是全人源单抗，能抑制白细胞介素-4（IL4）和白细胞介素-13（IL13）通路的信号传导，且非免疫抑制剂。由赛诺菲和再生元共同开发。  勃林格殷格翰：4月13日，勃林格殷格翰宣布，推出LENZELTA疫苗，将于2026年4月在欧盟的多个国家上市。针对奶牛两种乳腺炎病原体，金黄色葡萄球菌和大肠杆菌。  博士康：4月14日，博士康宣布，旗下皮肤科业务Ortho Dermatologics宣布，Biafine皮肤恢复乳液已可通过在线订购方式在美国发售。Biafine于1971年在法国首次研发问世，为轻质的乳液配方，旨在维护皮肤的天然屏障功能，同时有助于保持皮肤的水分和舒适度。  欧加隆：4月15日，欧加隆宣布，其VTAMA软膏（tapinarof，本维莫德，芳香烃受体激动剂）获得了美国皮肤病学会在2026年管理与治疗儿童特应性皮炎指南中的推荐。该指南于2026年4月7日发布。指南将VTAMA软膏列为美国皮肤病学会认定的，适用于所有严重程度、针对2岁及以上患有特应性皮炎的儿童的非类固醇外用治疗药物。烈推荐主要基于3期关键试验（ADORING 1 和 ADORING 2）的数据支持。 合作授权方面：  诺和诺德：4月14日，诺和诺德宣布，与OpenAI达成战略合作伙伴关系，将运用人工智能技术来分析复杂的数据集，筛选出有潜力的药物候选物，并缩短从研究阶段到临床应用阶段所需的时间。  勃林格殷格翰：4月15日，勃林格殷格翰和再鼎医药宣布达成临床合作项目，开发双重靶向DLL3的组合疗法。评估obrixtamig（勃林格殷格翰的DLL3/CD3 T细胞接合剂）与zocilurtatug pelitecan（ZL-1310，再鼎医药的靶向DLL3的抗体偶联药物）联合使用的初步临床效果。研究将招募患有低分化神经内分泌癌和广泛期小细胞肺癌患者。两家公司各自保留其相关资产的所有权。  再生元：4月13日，再生元和Telix Pharmaceuticals Limited宣布达成合作，共同开发推广下一代放射性药物疗法。合作将结合再生元双抗等技术与Telix的放射性药物开发平台，涵盖多个实体瘤靶点。Telix从再生元获得4000万美元的预付款，用于获取其放射性药物制造平台，以用于四个初始治疗项目。再生元有权选择再增加四个项目，并需支付额外的预付款。Telix和再生元将平分全球商业化成本和潜在利润，Telix保留对某些潜在产品的共同推广权。如果Telix选择放弃某个项目的共同开发，将有权获得5.35亿美元的开发和商业里程碑奖励，以及未来净销售额的低两位数分成。Telix和再生元将共同开发诊断产品，Telix负责产品的商业化，再生元获得一定比例的利润分成。 收并购方面：  葛兰素史克：4月15日，葛兰素史克宣布，已完成对35Pharma Inc.的收购。35Pharma总部位于加拿大，为临床阶段生物制药公司。此次收购包括HS235，治疗肺动脉高压，HS235靶向激活素受体信号通路，HS235的设计具有更高的选择性，减少了与出血和毛细血管扩张（血管破裂）等不良反应相关的BMP9和BMP10的结合，能够降低出血风险、减少心包积液以及防止血红蛋白剂量性增加，HS235的潜在作用机制还具有广泛的代谢益处，包括脂肪选择性减重、保持肌肉质量以及提高胰岛素敏感性。葛兰素史克以9.5亿美元收购了35Pharma100%的股权。  吉利德：4月17日，吉利德宣布，此前宣布的对Arcellx的收购已获得所有必要的监管批准，将收购要约有效期延长。吉利德将以每股115美元的现金价格收购Arcellx，并附带每股5美元的或有价值权（赋予持有人在从产品上市至2029年年底累计全球净销售额达到至少60亿美元时，可额外获得5美元的收益），在交易完成时将支付78亿美元的股权价值。Arcellx专注于为癌症及其他疾病患者提供新型的创新免疫疗法。吉列德旗下的凯特公司与Arcellx已达成合作，共同开发并推广主要在研药物anitocabtagene autoleucel，针对多发性骨髓瘤患者的靶向BCMA的CAR T细胞疗法。此疗法作为复发或难治性多发性骨髓瘤患者第四线治疗方案已向美国FDA提交了生物制品许可申请，申请基于一期临床研究和关键性二期iMMagine1研究的结果支持。Arcellx的D-域 CAR技术平台还开发出了具有更高特异性和更强结合亲和力的专有靶标结合域，有可能用于下一代CAR T细胞和双特异性疗法。在体内细胞治疗方面，D-域BCMA结合剂也有应用潜力。  第一三共：4月15日，第一三共宣布，已同意将其在DAIICHI SANKYO HEALTHCARE CO., LTD.的全部股份转让给Suntory Holdings Limited。股份转让的总对价预计为2465亿日元。第一三共Healthcare经营非处方药、功能性护肤、口腔护理和食品产品等领域。  优时比：4月17日，优时比宣布达成最终协议，将收购 Neurona Therapeutics，包括其NRTX-1001管线，Neurona Therapeutics 是临床阶段的生物制药公司，专注于推进针对癫痫及其他神经系统疾病的人体再生细胞疗法的研究。Neurona Therapeutics 平台采用再生多能干细胞技术，以输送旨在从结构和功能上修复受损神经回路的细胞。NRTX-1001目前正参与I/II期临床试验，评估对药物抵抗型单侧和双侧内侧颞叶癫痫患者（伴或不伴内侧颞叶硬化症）的癫痫发作频率的影响。该疗法以微创的方式直接将细胞注入大脑，这些细胞能够产生抑制性神经递质γ-氨基丁酸（GABA），用于修复和平衡过度活跃的神经网络，并有可能实现持久的癫痫发作减少效果。优时比将预先支付6.5亿美元，在未来可能达成的里程碑事件后支付最高5亿美元。 临床进展方面：  强生：4月13日，强生宣布，VARIPURE脉冲电场消融导管产品，用于房颤，在12个月的中期有效性及安全性评估中表现良好。主要成果包括：84.2%房性心律失常不再复发，治疗效果显著，其中阵发性患者为90.5%，持续性患者为75.3%。主要不良事件发生率为0.8%，未出现中风、冠状动脉痉挛或其他与脉冲电场消融相关的并发症。有29.7%的患者接受了超出肺静脉范围的治疗，体现了平台的多功能性。  赛诺菲：4月18日，赛诺菲宣布，其基于蛋白质的非mRNA型新冠病毒疫苗Nuvaxovid (NVX-CoV2705)在COMPARE研究中，在所有指标上均显示出相较于Moderna的最新mRNA型新冠病毒疫苗mNEXSPIKE（mRNA-1283），具有显著更低的全身反应性。使用Nuvaxovid的副作用严重程度较低，且持续时间也较短。出现严重全身性症状（如疲劳、头痛或发烧等全身性反应，导致患者无法正常进行日常活动），Nuvaxovid相比mNEXSPIKE减少50%以上，Nuvaxovid的此类情况发生率不到十分之一，而mNEXSPIKE的这一比例为五分之一。Nuvaxovid的严重局部症状（注射部位的反应，如疼痛、红肿或肿胀）较为罕见，且比mNEXSPIKE少75%以上。研究达到了其主要终点，在接种疫苗后的七天内出现至少一种全身性反应的概率具有统计学意义。mNEXSPIKE组中有 91.6%受到影响，而Nuvaxovid组中这一比例为83.6%。mNEXSPIKE 接受者的中度至重度（2级或3级）全身症状发生率为 61.3%，而Nuvaxovid接受者的这一比例为43.1%。mNEXSPIKE接受者的中度至重度局部症状发生率为58.7%，而Nuvaxovid接受者的这一比例为38.7%。Nuvaxovid最初由Novavax授权。赛诺菲拥有Nuvaxovid在美国、欧盟和英国的市场授权。赛诺菲将于2025年在美国、TW和摩洛哥上市销售，并从2026年起将Nuvaxovid的供应范围扩大到其他市场，包括英国、德国和加拿大。  拜耳：4月16日，拜耳宣布，III期OCEANIC-STROKE研究的全部结果已发表于《新英格兰医学杂志》。评估了asundexian（50毫克），每日一次口服因子XIa（FXIa）抑制剂，与安慰剂相比，均与抗血小板疗法联合使用，预防非心源性缺血性卒中或高危短暂性脑缺血发作患者，发生缺血性卒中的效果。Asundexian显著降低了缺血性中风的发生率，降幅达26%，同时并未增加国际血栓与止血学会严重出血的风险。与安慰剂相比，在与抗血小板治疗联合使用的情况下，asundexian能够降低缺血性中风或严重出血的复合发生率、心血管死亡的复合发生率、所有中风的复合发生率、心肌梗死的复合发生率，以及严重出血和所有原因死亡、致残性中风、致命性出血或症状性颅内出血的复合发生率。  礼来：4月13日，礼来公布了BRUIN CLL-322三期临床试验的阳性初步结果。对比了Jaypirca (pirtobrutinib)（非共价可逆布鲁顿酪氨酸激酶抑制剂）联合维奈克拉和利妥昔单抗，相比仅使用维奈克拉和利妥昔单抗，治疗复发或难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤患者的效果。两组患者的治疗均持续至最长两年，之后患者在疾病进展前不再接受任何治疗。试验达到了主要终点，Jaypirca组显著提高了无进展生存期，具有统计学和临床意义。总生存期关键次要指标在分析中尚未成熟，但有更具优势的趋势。  礼来：4月16日，礼来公布了3期临床试验Achieve-4的阳性初步结果，评估Foundayo (orforglipron)，相比甘精胰岛素，在患有2型糖尿病且伴有肥胖或超重、心血管风险增加的成年人中的疗效和安全性。试验达到了主要指标，在主要不良心血管事件（MACE-4）（包括心血管死亡、心脏病发作、中风或因不稳定和突发胸痛而住院）方面，与甘精胰岛素相比，风险非劣于甘精胰岛素。此外，在52周时在A1C和体重改善方面优于甘精胰岛素，这种改善在104周的治疗期间仍持续存在。全因死亡风险显著降低。治疗组发生MACE-4风险降低了16%，达到了证明非劣效性的预设标准。全因死亡风险比甘精胰岛素低57%。还在包括非高密度脂蛋白胆固醇、收缩压、甘油三酯和高敏C反应蛋白等几种心血管风险因素方面，与基线相比显示出具有临床意义的改善。52周时，A1C相比基线（8.22%）变化，治疗组为降低1.6%，对照组为降低1.0%。体重相比基线（平均90.9kg）变化，治疗组降低8.8%，对照组提高1.7%。Foundayo是每日一次的小分子（非肽类）口服胰高血糖素样肽-1受体激动剂，可在一天中的任何时间服用，不受食物和水摄入量的限制。由中外制药发现，并于2018年由礼来获得授权。  雅培：4月17日，雅培将在2026年美国癌症研究协会年会上展示新的数据，这些数据展示了其多生物标志物、多癌症早期检测项目在持续取得进展方面所取得的成果，为其Cancerguard检测提供了支持。将甲基化和蛋白质生物标志物相结合，能够提高癌症在各个阶段的检测率，每种生物标志物都独立地对整体检测效果有所贡献。Cancerguard是采用多生物标志物类检测方法的癌症早期检测测试，结合了甲基化和蛋白质信号以提高检测能力。  安斯泰来：4月15日，安斯泰来宣布，首个患者已成功接受试验药物setidegrasib (ASP3082)给药，旨在评估其与mFOLFIRINOX（氟尿嘧啶+亚叶酸钙+伊立替康+奥沙利铂）或NALIRIFOX（伊立替康脂质体+氟尿嘧啶+亚叶酸钙+奥沙利铂）联合用药方案，作为KRAS G12D突变型转移性胰腺导管腺癌患者的一线治疗效果。Setidegrasib是安斯泰来发现的针对KRAS G12D基因突变的蛋白质降解剂。特异性地与突变型KRAS G12D蛋白质以及E3连接酶结合，触发该致病蛋白质的降解。  第一三共：4月13日，第一三共以及默沙东的ifinatamab deruxtecan生物制剂许可申请，已获得美国FDA受理，并获得了优先审评资格，用于治疗患有广泛期小细胞肺癌，且在铂类化疗后病情出现进展的成年患者。Ifinatamab deruxtecan由第一三共发现、由第一三共与默沙东共同开发的靶向B7-H3的DXd抗体偶联药物。申请是基于IDeate-Lung01二期试验结果，得到了IDeate PanTumor01一期/二期试验的支持。B7-H3是一种跨膜蛋白，属于B7蛋白家族，与包括PD-1在内的CD28家族受体相结合。B7-H3在多种癌症类型中过度表达，其过度表达已被证明与不良预后相关。Ifinatamab deruxtecan由人源化抗B7-H3 IgG1单抗，通过四肽基可裂解连接子与多种拓扑异构酶I抑制剂负载物（exatecan衍生物，DXd）连接组成。 财务业绩及股息发放方面：  强生：4月14日，强生宣布，其2026年第1季度实现营业收入240.62亿美元，相比去年同期增长9.9%。  强生：4月14日，强生宣布，季度股息提高至每股1.34美元，将于2026年6月9日支付给在2026年5月26日的在册股东。  雅培：4月16日，雅培宣布，其2026年第1季度实现营业收入111.64亿美元，相比去年同期增长7.8%。

ESCMID: Sanofi's Nuvaxovid COVID-19 vaccine showed better tolerability than mNEXSPIKE in head-to-head study First head-to-head, double-blind, randomized phase 4 study powered to directly compare the tolerability profiles of these vaccines in adults in a real-world settingResults were presented today at the European Society of Clinical Microbiology and Infectious Diseases Global Congress in Munich, Germany. Paris, April 18, 2026. Sanofi's protein-based non-mRNA COVID-19 vaccine Nuvaxovid (NVX-CoV2705) demonstrated statistically significant lower systemic reactogenicity (the expected side effects that might occur following vaccination) compared to mNEXSPIKE (mRNA-1283), Moderna's latest mRNA COVID-19 vaccine, across all pre-specified endpoints in the COMPARE study. The randomized, double-blind study, which enrolled 1,000 adults in the US, was presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Munich, Germany. These results address a persistent challenge: despite the end of the pandemic, COVID-19 continues to cause significant hospitalizations and deaths globally, while placing considerable strain on health systems during seasonal peaks. Yet vaccination uptake remains low, with concerns about vaccine side effects ranking among the top reasons cited by adults for not getting vaccinated against COVID-19. In the COMPARE study, when side effects did occur with Nuvaxovid, they were less severe and shorter in duration compared to mNEXSPIKE. Severe systemic symptoms (body-wide reactions such as fatigue, headache, or fever) that prevent people from carrying out their normal daily activities were more than 50% less frequent with Nuvaxovid, affecting fewer than one in ten Nuvaxovid recipients compared to one in five mNEXSPIKE recipients, an analysis of the data showed. Severe local symptoms (reactions at the injection site such as pain, redness, or swelling) with Nuvaxovid were rare, and more than 75% less frequent compared to mNEXSPIKE. This was reflected in the study participants' own experience: those who received Nuvaxovid were nearly twice as likely as mNEXSPIKE recipients to say they would definitely choose the same vaccine type again the following year. The study met its primary endpoint – the probability of experiencing at least one systemic reaction within seven days of vaccination - with statistical significance, with 91.6% of mNEXSPIKE recipients affected compared to 83.6% of Nuvaxovid recipients (risk difference: 8.0%; 95% CI: 4.0%–12%; p<0.001). The study also showed that 61.3% of mNEXSPIKE recipients experienced moderate-to-severe (Grade 2 or 3) systemic symptoms versus 43.1% of Nuvaxovid recipients (risk difference: 18%; 95% CI: 12%–24%; p<0.001), and 58.7% of mNEXSPIKE recipients experienced moderate-to-severe local symptoms versus 38.7% of Nuvaxovid recipients (risk difference: 20%; 95% CI: 14%–26%; p<0.001). “This study was designed to answer a question that matters deeply to clinicians and patients alike: how do different COVID-19 vaccines compare in terms of reactogenicity and patient experience? The answer is clear," said Dr. Marcel E. Curlin, Principal Investigator of the COMPARE study and Professor of Medicine at Oregon Health & Science University. "Across every measure we evaluated, we observed that the recombinant protein-based vaccine consistently exhibited lower reactogenicity and less disruption to patient activities than the comparator mRNA vaccine. Individuals cite side effects as a reason they avoid COVID-19 vaccination. These differences could have a significant impact on improving vaccination uptake." "The patient experience with vaccination is essential, because it determines not only whether people get vaccinated, but also whether they come back year after year for routine protection," said Thomas Triomphe, Executive Vice President, Vaccines, Sanofi. "These results show that Nuvaxovid can play a meaningful role in making routine COVID-19 vaccination a reality for more people, which is how we can help address the continued burden of this disease on patients and health systems." Beyond clinical measures, the COMPARE study also captured patient-reported outcomes reinforcing the real-world relevance of Nuvaxovid's tolerability profile. Nuvaxovid recipients reported less disruption to daily activities, including work, school, recreational activities, and caretaking responsibilities, over the seven days following vaccination. Notably, more than half of all participants reported scheduling their vaccination on a specific day of the week in anticipation of potential side effects, highlighting the extent to which tolerability concerns shape vaccination behavior. Together, these findings suggest that a better tolerability experience may favor greater vaccine confidence and willingness to return for routine immunization. About COVID-19Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. However, some will become seriously ill resulting in hospitalization and death. The disease not only causes immediate health impacts but also increases the long-term risk of cardiovascular complications, including heart attacks and strokes, and older adults hospitalized for COVID-19 face substantially higher mortality risk than those hospitalized for influenza. Older adults and those with chronic conditions - including cardiovascular disease, chronic lung disease, diabetes, and obesity - face the highest risk of severe illness. In the US, an estimated 74% of adults have at least one such risk factor, underscoring the scale of the vulnerable population that stands to benefit from effective and well-tolerated COVID-19 vaccination. About NuvaxovidNuvaxovid (NVX-CoV2705) is a protein-based, adjuvanted vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2. It is developed using the recombinant technology, an established platform with a long track record across multiple vaccine types. Nuvaxovid has been shown to have a tolerable side-effect profile suitable for routine vaccination and has also demonstrated high efficacy against COVID-19 as a primary vaccination in two pivotal phase 3 studies. As the pandemic has now evolved into an endemic phase, having multiple vaccine options becomes increasingly important for sustainable public health strategies. Nuvaxovid offers healthcare systems a protein-based vaccine option with an established safety and tolerability profile to add to their routine vaccination programs. This diversity is particularly valuable for addressing vaccine hesitancy. Nuvaxovid was originally licensed by Novavax. Sanofi is now market authorization holder for Nuvaxovid in the US, the EU and the United Kingdom. Building on its commercial launch in the US, Taiwan, and Morocco in 2025, Sanofi is expanding Nuvaxovid's availability to additional markets - including the United Kingdom, Germany, and Canada - from 2026 onwards. About Sanofi 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. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comLéo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.comVictor Rouault | +1 617 356 4751 | victor.rouault@sanofi.comTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.comLéa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.comEkaterina Pesheva | +1 410 926 6780 | ekaterina.pescheva@sanofi.com Investor RelationsThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.comKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.comNina Goworek | +1 908 569 7086 | nina.goworek@sanofi.comThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.comYun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Sanofi forward-looking statementThis 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. 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. 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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. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. Attachment Press Release