附表99.1
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Dupixent晚期突破性的控制项3期数据，将在ACAAI上发表。
| ● | Dupixent从基准线显著减少瘙痒和荨麻疹活动；41%的患者达到疾病良好控制状态。 |
| ● | 支持美国监管机构年底的重新提交的确认性数据。 年底时； 如果获得批准，Dupixent将成为十多年来，为患有慢性特发性荨麻疹的人提供的第一种新型定向治疗。 |
| ● | 美国有超过30万人患有慢性特发性荨麻疹，而这些人的情况无法得到足够控制，即使使用了抗组织胺剂。 |
十月的巴黎和纽约塔里敦 24, 2024. 积极的数据来自第3期LIBERTY-CUPID研究，该研究评估了Dupixent（dupilumab）在未接受生物制剂治疗的控制不佳的慢性特发性荨麻疹（CSU）患者中，进行背景治疗的抗组织胺剂。这项研究将在美国过敏、哮喘和免疫学学会（ACAAI）2024年在麻萨诸塞州波士顿举行的年度科学会议上，以大会报告的形式呈现。结果显示，使用Dupixent能显著降低自基准线开始的瘙痒和荨麻疹活动（瘙痒和丘疹）分数，较安慰剂组有更高比例的患者达到良好控制的疾病状态。
Thomas B. Casale博士
南佛罗里达大学莫尔萨尼医学院内科学教授，美国
“慢性特发性荨麻疹是一种发炎性皮肤病，会引起病人突然发作的强烈瘙痒和丘疹，往往严重影响他们的日常生活。这些数据证实了之前A研究中所看到的结果，并强调了Dupixent对于显著缓解症状，帮助患者更好控制这种具有挑战性的疾病的潜力。”
C群研究招募了151名随机分配接受Dupixent (n=74) 或安慰剂 (n=77) 并加入 标准护理 过敏原H1 (H1) 组织胺拮抗剂。24周时，Dupixent表现出与安慰剂相比有显著改善：
| ● | 痒痒程度评分 (8.64- ，营业收入为 6.10分 比基线减少；p=0.02) |
| ● | 荨麻疹（痒和荨麻）活动评分 (15.86- 对比 11.21点 比基线减少；p=0.02) |
| ● | 控制良好的疾病状态（荨麻疹活动评分 ≤ 6; 41% vs. 23%; p=0.005） |
| ● | 完整响应（荨麻疹活动评分=0；30% vs. 18%；p=0.02） |
在C研究中的安全结果通常与Dupixent在其核准的皮肤病指示中已知的安全档案一致。Dupixent和安慰剂的治疗相关不良事件（AEs）的总发生率均为53%。与安慰剂相比，更常见的Dupixent（对于参加CARTITUDE-1和4研究并接受CARVYKTI治疗的患者，其中13%（36/285）的患者出现了ICANS，包括2%（6/285）的患者出现了≥3级别的ICANS。 ICANS的中位发生时间为8天（范围：1至28天）。 在36名ICANS患者中，30名（83％）的患者ICANS得到了解决，且中位解决时间为3天（范围：1至143天）。 在所有患有ICANS的患者中，包括那些在死亡或资料切断时仍有持续神经病变的患者，ICANS的中位持续时间为6天（范围：1至1229天）。 97％（35/36）的患者伴随著ICANS还合并了CRS。 ICANS的发生在69％的患者中与CRS同时发生，在14％的患者中在CRS发作之前发生，在另外14％的患者中，在CRS发作之后才发生。5%）相比，注射部位反应（12% vs. 4%）、意外过量（7% vs. 3%）等AEs更常见于Dupixent。 多个国家都采取了隔离、禁止旅行以及关闭办公室、企业、学校、零售店和其他公共场所等类似的预防措施。 感染（8% vs. 5%）。
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Dupixent已获批在日本、阿拉伯联合酋长国（UAE）用于治疗CSU，并且根据早期试验结果正在接受欧盟的监管审查。除了日本和阿拉伯联合酋长国，尚未有任何监管机构对于Dupixent在CSU治疗中的安全性和有效性进行全面评估。
关于CSU
CSU是一种慢性炎症性皮肤疾病，部分原因是因为第2型炎症引起，导致突然的、令人困扰的荨麻疹和持续的痒。CSU通常使用H1抗组织胺药物来治疗，这些药物针对细胞上的H1受体，以控制荨麻疹症状。 然而，尽管许多患者接受抗组织胺治疗，但这种疾病仍然无法控制，其中一些患者缺乏替代治疗的选择。这些人持续出现可能令人困扰并显著影响其生活质量的症状。美国有30万多人患有靠抗组织胺控制不足的CSU。 第2型 炎症，这会导致突然和具有毁灭性的荨麻疹以及持续的发痒。CSU通常使用H1抗组织胺药物来治疗，这些药物针对细胞上的H1受体，以控制荨麻疹症状。 然而，尽管许多患者接受抗组织胺治疗，但这种疾病仍然无法控制，其中一些患者缺乏替代治疗的选择。这些人持续出现可能令人困扰并显著影响其生活质量的症状。美国有30万多人患有靠抗组织胺控制不足的CSU。
关于Dupixent第3期CSU方案（LIBERTY-CUPID）
LIBERTY-CUPID第3期研究方案，评估Dupixent在CSU中的效果，包括 研究A, B研究, 和「第8条」C研究.
C研究是一项随机、双盲、安慰剂对照的临床研究，评估Dupixent相较於单独使用抗组织胺药物在151名CSU患者中的疗效和安全性，这些患者年龄在六岁及以上，尽管使用抗组织胺药物仍有症状，且未曾接受omalizumab治疗（即 附加发行除外) 至 标准照护 抗组织胺药物和omalizumab产生症状的患者） 生物学不敏感者)。 主要终点在24周评估瘙痒自基准的变化（按照每周瘙痒严重程度评分[ISS7]， 0-21 指标在24周，按照每周荨麻疹活动评分（UAS7）测试从基准的瘙痒和荨麻疹的变化（UAS7， 0-42 比例，达到良好控制疾病状态的患者（UAS7 ≤ 6），以及完全响应（UAS7=0)。
关于Dupixent
Dupixent（杜热珠单抗）是一种完全人源单克隆抗体，抑制IL4和IL13途径的信号传递，并非免疫抑制剂。Dupixent开发计划已显示出显著的临床效益和减少 第2型发炎 在第3个研究中，确定IL4和IL13是造成第2型发炎的关键主要驱动因素之一 第2型发炎 疾病中扮演著重要角色的多个相关且常见的共病症 共病疾病。
Dupixent已在60多个国家获得监管批准，用于一个或多个适应症，包括特定患有特应性皮炎、哮喘、慢性鼻窦炎合并鼻息肉、嗜酸性食道炎、肉芽肿性瘙痒、慢性自发性荨麻疹和不同年龄人群的慢性阻塞性肺病患者。全球有超过100万患者正在接受Dupixent治疗。
Dupilumab开发计划
赛诺菲安万特和Regeneron正在根据全球合作协议共同开发Dupilumab。 迄今为止，Dupilumab已在超过60个临床研究中进行研究，涉及超过10,000名患有各种慢性疾病的患者，其中部分由 第二型炎症。
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In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven in part by type-2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
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关于赛诺菲安万特
我们是一家创新的全球医疗保健公司，以一个目的为驱动力：我们追求科学的奇迹，以改善人们的生活。我们遍布全球的团队致力于通过将不可能变为可能，从而改变医学的实践。我们为全球数百万人提供有可能改变生命的治疗选择和挽救生命的生物-疫苗保护，同时将可持续性和社会责任放在我们的抱负核心。
赛诺菲安万特在欧洲证券交易所：SAN及纳斯达克：SNY 上市
赛诺菲安万特媒体关系
Sanrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
伊凡·伯兰德 | + 1 215 432 0234 | evan.berland@sanofi.com
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com
提摩西 吉尔伯特 | + 1 516 521 2929 | timothy.gilbert@sanofi.com
赛诺菲安万特投资者关系
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
艾莉丝 凯瑟利安 | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com
蒂博 沙特莱 | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
赛诺菲安万特媒体关系
伊兰 叶伦 | +1 914-330-9618| ilana.yellen@regeneron.com
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Regeneron Investor Relations
Mark Hudson | + 914-847-3482 | mark.hudson@regeneron.com
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