文章核心观点 - 美国FDA已受理Sarclisa(isatuximab)的补充生物制品许可申请(sBLA),用于联合标准治疗方案VRd治疗不适合接受移植的新诊断多发性骨髓瘤患者 [1] - 如获批准,Sarclisa将成为首个获批用于新诊断不适合接受移植的多发性骨髓瘤患者的抗CD38疗法 [1] - 该申请基于IMROZ III期临床试验的积极结果,该试验显示Sarclisa联合VRd较VRd单药在无进展生存期(PFS)方面取得了统计学显著改善 [3] - IMROZ试验是第4个证明Sarclisa联合方案在新诊断多发性骨髓瘤患者中优于标准VRd和KRd治疗的III期试验,进一步证实了Sarclisa的最佳在类地位 [4] 关于IMROZ III期临床试验 - 该全球性、随机、多中心、开放标签的III期临床试验共入组446例新诊断、不适合接受移植的多发性骨髓瘤患者 [7] - 主要终点为无进展生存期,次要终点包括完全缓解率、微小残留病(MRD)阴性率、很好的部分缓解或更好的反应率、总生存期等 [8] - 该试验结果将在2024年ASCO年会和2024年EHA年会上进行口头报告 [4] 关于Sarclisa - Sarclisa是一种单克隆抗体,通过多种机制作用于CD38受体诱导肿瘤细胞凋亡和免疫调节活性 [8] - 基于ICARIA-MM III期试验结果,Sarclisa已在美国和欧盟获批联合泊马度胺和地塞米松治疗复发/难治性多发性骨髓瘤 [9] - 基于IKEMA III期试验结果,Sarclisa在美国和欧盟获批联合卡非佐米布和地塞米松治疗复发/难治性多发性骨髓瘤 [9] - Sarclisa正在多项III期临床试验中评估联合现有标准治疗方案在多发性骨髓瘤治疗全程的应用 [10] 关于多发性骨髓瘤 - 多发性骨髓瘤是第二常见的血液恶性肿瘤,每年全球新诊断病例超过18万例 [11] - 尽管有可用治疗方案,但多发性骨髓瘤仍是一种无法治愈的恶性肿瘤,新诊断患者5年生存率仅为52% [11] - 大多数患者最终会复发,复发性和难治性多发性骨髓瘤预后较差 [11] 关于Sanofi - 赛诺菲是一家创新型全球医疗保健公司,致力于通过科学创新改善人们的生活 [12] - 赛诺菲在多个国家上市,股票代码为EURONEXT: SAN和NASDAQ: SNY [13]

Sanofi (SNY) announced that it has entered into a first-in-class artificial intelligence (AI) collaboration with Formation Bio and OpenAI to build AI-powered software to expedite the development of drugs. Formation Bio is a tech-driven, AI-native pharma company focused on bringing new treatments to patients with more efficient drug development, while OpenAI is an AI research and deployment company. Per the press release, the companies are collaborating to bring together data, software and tuned models aimed ...

Sanofi, Formation Bio and OpenAI announce first-in-class AI collaboration Paris, New York, N.Y., and San Francisco, CA, May 21, 2024. Sanofi, Formation Bio and OpenAI are collaborating to build AI-powered software to accelerate drug development and bring new medicines to patients more efficiently. The three teams will bring together data, software and tuned models to develop custom, purpose-built solutions across the drug development lifecycle. This represents a first collaboration of its kind within the ph ...

Sanofi (NASDAQ:SNY) Q1 2024 Earnings Conference Call April 25, 2024 8:30 AM ET Company Participants Paul Hudson - Chief Executive Officer François-Xavier Roger - Chief Financial Officer Houman Ashrafian - Executive Vice President & Head-Research & Development Brian Foard - Executive Vice President & Head-Specialty Care, Sanofi Thomas Triomphe - Executive Vice President-Vaccines, Sanofi Olivier Charmeil - Executive Vice President-General Medicines, Sanofi Conference Call Participants Peter Welford - Jefferie ...

Sanofi (NASDAQ:SNY) Barclays 26th Annual Global Healthcare Conference March 13, 2024 8:00 AM ET Company Participants Naimish Patel - Global Head of Development for Immunology and Inflammation Shaju Backer - Global Head of Immunology Franchise Conference Call Participants Emily Field - Barclays Emily Field Good morning, everybody. Thanks for joining day 2 of Barclays Global Healthcare Conference here in Miami. My name is Emily Field. I lead the European Equity Research Team, covering European Pharmaceuticals ...

Sanofi (NASDAQ:SNY) Leerink Partners Global Biopharma Conference March 12, 2024 10:40 AM ET Company Participants Naimish Patel - Global Head of Development for Immunology and Inflammation Shaju Backer - Global Head of Immunology Franchise Conference Call Participants Dave Risinger - Leerink Partners Dave Risinger All right. Good morning, everyone. So my name is Dave Risinger, I cover Diversified Biopharmaceuticals for Leerink Partners, and itÂ’s very much my pleasure to welcome you to the session with Sanof ...

收购与并购 - 公司完成了对QRIB Intermediate Holdings, LLC (QRIB)的收购,收购价格为14.19亿美元[657] - 公司完成了对Provention Bio, Inc.的收购,收购价格约为28亿美元[658] - 公司在收购时需要对被收购公司的可辨认资产和负债进行公允价值计量,并确认或有对价负债[665] 收入确认与价格优惠 - 公司的收入主要来自于生物制药和消费者保健两个业务分部,其中生物制药业务收入为378.9亿欧元,消费者保健业务收入为51.8亿欧元[684] - 公司采用IFRS 15准则确认收入,主要在产品控制权转移给客户时确认收入[660,661,662] - 公司提供各种价格优惠,如折扣、返利等,这些优惠在计算收入时进行估计并作为销售额的扣减项[663] - 公司的其他收入包括来自许可安排的专利费收入、销售第三方产品收入以及提供生产服务收入[664] 资产减值 - 公司需要对商誉和无形资产进行减值测试,涉及多项关键假设和判断[668,669,670,672] - 无形资产减值损失为896百万欧元,主要反映了放弃某些R&D项目的战略决定[733] 重组费用 - 公司的重组费用包括集体裁员或提前退休福利、合同提前终止补偿以及重组地点的合理化成本[679,680] 业务表现 - 2023年生物制药业务净销售额为37,890百万欧元，同比增长0.2%，按固定汇率计算增长5.1%[687] - DUPIXENT销售额为10,715百万欧元，同比增长29.2%，按固定汇率计算增长34.0%[688] - AUBAGIO销售额下降52.6%，主要由于仿制药进入市场[689] - NEXVIAZYME/NEXVIADYME销售额为425百万欧元，占庞贝病治疗产品总销售额的35.2%[690] - FABRAZYME治疗法布瑞病的销售额为991百万欧元，同比增长11.2%[691] - 高尔氏病治疗产品CEREZYME和CERDELGA的总销售额为985百万欧元，同比增长8.4%[692] - ALTUVIIIO上市后在2023年实现159百万欧元的销售额[693] - SARCLISA销售额为381百万欧元，同比增长37.1%[695] - 疫苗业务销售额为7,474百万欧元，同比增长8.3%，主要得益于BEYFORTUS的推出[707,708] - 消费者保健业务销售额为5,180百万欧元，同比增长6.3%[714] - 2023年Rest of the World地区净销售额下降3.8%,但按CER计算增长6.5%至14,166百万欧元,主要得益于DUPIXENT(+46.1% CER至1,346百万欧元)和CHC(+11.7% CER至2,376百万欧元)的出色表现[722] 其他收入 - 其他收入增加41.1%至3,374百万欧元,主要包括VaxServe销售非Sanofi疫苗(2,167百万欧元,较2022年的1,567百万欧元增加)以及来自制造服务合同和新冠疫苗的收入[723] 费用 - 研发费用为6,728百万欧元,占净销售额的15.6%,与2022年持平[725] - 销售和一般管理费用为10,692百万欧元,占净销售额的24.8%,较2022年增加1.9%,主要由于生物制药分部营销支出和CHC商业支出增加[726] - 其他经营收支净额为-2,224百万欧元,主要反映了与Regeneron的单抗联盟利润份额增加[728,729] - 无形资产摊销费用为2,172百万欧元,主要由于ELOCTATE和TZIELD产品摊销增加[731,732] 财务状况 - 2023年净利润为5,400百万欧元,每股基本收益为4.31欧元[751,752] - 2023年业务经营利润为12,670百万欧元,占净销售额的29.4%,较2022年下降2.8%[753,754] - 2023年公司净现金流入为102.58亿欧元，较2022年的105.26亿欧元有所下降[761] - 2023年投资活动净现金流出为62亿欧元，主要由于收购Provention Bio, Inc.和QRIB Intermediate Holdings, LLC[763] - 2023年融资活动净现金流出为80.52亿欧元，主要包括赎回36.64亿欧元债券和向股东派发44.54亿欧元股息[766] - 2023年自由现金流为84.78亿欧元，与2022年基本持平[767] - 2023年12月31日净债务为77.93亿欧元，较2022年12月31日的64.37亿欧元有所增加[774] - 2023年12月31日权益总额为743.53亿欧元，较2022年12月31日的751.52亿欧元有所下降[773] - 2023年12月31日公司持有现金及现金等价物87.1亿欧元[784] - 2023年12月31日公司未使用的已确认信贷额度为80亿欧元[786] - 公司预计未来经营活动产生的现金流将足以偿还债务[778] - 公司面临客户延迟付款或不付款的风险，正采取积极的收款政策[785] 研发投入 - 公司研发团队利用深厚专业知识推动业务增长，截至2023年12月31日共有11,660名员工从事研发活动[795] - 2021年、2022年和2023年研发支出分别为56.92亿欧元、20.22亿欧元和67.28亿欧元[795] 公司治理 - 董事会负责制定公司业务方向并确保其实施，关注社会和环境问题[810] - 董事会成员的独立性、多样性和专业能力得到重视，目前独立董事占比79%[823,835] - 公司重视包容性和多元化，在高管团队中女性占比25%，非法国

Press Release Specialty Care growth, strong launch uptake of Beyfortus® and ALTUVIIIO® drive solid Q3 results Paris, October 27, 2023 Q3 2023 sales growth of 3.2% at CER and business EPS(1) decrease of 2.1% at CER • Specialty Care grew 13.5% driven by Dupixent® (€2,847 million, +32.8%) and ALTUVIIIO® more than offsetting the impact of Aubagio® generic competition in the U.S. • Stable Vaccines sales (-0.6%) benefited from strong Beyfortus® launch offsetting lower influenza vaccines sales • General Medicines ...

Exhibit 99.1 TABLE OF CONTENTS 1. CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS 2 CONSOLIDATED BALANCE SHEETS – ASSETS 2 CONSOLIDATED BALANCE SHEETS — SHAREHOLDERS’ EQUITY AND LIABILITIES 3 CONSOLIDATED INCOME STATEMENTS 4 CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME 5 CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY 6 CONSOLIDATED STATEMENTS OF CASH FLOWS 8 NOTES TO THE CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2023 10 INTRODUCTION 10 A/ Basis of preparation of the half-ye ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 Or ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Or ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SEC ...