Core Insights - Sanofi's high-dose influenza vaccine, Efluelda (Fluzone High-Dose in North America), shows significantly reduced hospitalization risk for adults aged 65 and older compared to standard-dose vaccines, as evidenced by the FLUNITY-HD study [1][4][3] Study Overview - The FLUNITY-HD study is the largest of its kind, involving nearly half a million participants across multiple seasons and geographic areas, demonstrating the effectiveness of the high-dose vaccine [4][6][5] - The study utilized individual randomization in real-world settings, providing robust evidence for the vaccine's efficacy [2][6] Key Findings - Efluelda/Fluzone High-Dose demonstrated a 31.9% additional reduction in laboratory-confirmed influenza hospitalizations compared to standard-dose vaccines [4][7] - The vaccine also provided 8.8% additional protection against pneumonia/influenza hospitalizations and 6.3% additional reduction in hospitalizations for cardio-respiratory events [4][7] - For every 515 older adults vaccinated with the high-dose vaccine, one all-cause hospitalization is prevented, highlighting its potential to improve quality of life for vulnerable seniors [3][4] Implications for Public Health - The findings suggest that the high-dose vaccine could reshape public health strategies and clinical guidelines, particularly for older adults who are at higher risk for severe influenza-related complications [2][3] - Preventing influenza hospitalizations may lead to societal benefits, including lower healthcare costs and reduced pressure on medical systems [3][4] Product Information - Efluelda is specifically designed for adults aged 60 and older in Europe and for those aged 65 and older in North America, containing four times the antigen of a standard-dose vaccine to enhance immune response [8][9]

Core Insights - Sanofi's high-dose influenza vaccine, Efluelda (Fluzone High-Dose in North America), shows significantly reduced hospitalization risk for adults aged 65 and older compared to standard-dose vaccines, as evidenced by the FLUNITY-HD study [1][4][3] Study Design and Results - The FLUNITY-HD study is the largest of its kind, involving nearly half a million participants across multiple seasons and geographic areas, demonstrating the effectiveness of the high-dose vaccine [4][6] - The study found a 31.9% additional reduction in laboratory-confirmed influenza hospitalizations for older adults receiving the high-dose vaccine compared to standard-dose [4][7] - Additional findings include an 8.8% reduction in pneumonia/influenza hospitalizations and a 6.3% reduction in hospitalizations due to cardio-respiratory events [4][7] Public Health Implications - The high-dose vaccine could prevent one all-cause hospitalization for every 515 older adults vaccinated, highlighting its potential to improve quality of life for vulnerable seniors and reduce healthcare costs [3][4] - The results may influence public health strategies and clinical guidelines, reinforcing the importance of high-dose vaccines for older adults [2][3] Product Information - Efluelda is specifically designed for adults aged 60 and older in Europe and for those aged 65 and older in North America, providing four times the antigen compared to standard-dose vaccines [8][9] - The vaccine aims to enhance immune response in older adults, who are at a higher risk for severe influenza-related illnesses [9]

Core Insights - Sanofi's investment in a new insulin raw material production base in Beijing highlights China's strategic importance to the company and reflects confidence in the long-term economic outlook of China [1][3] Investment Details - The total investment for the insulin raw material production base project is €1 billion, marking it as the largest investment in the pharmaceutical industry in Beijing since the start of the 14th Five-Year Plan [3] - This facility will be the first insulin raw material production base established by a multinational company in China, with a total construction area of nearly 60,000 square meters [3] - The production base is expected to be fully completed and operational by 2032 [3] Industry Context - The Beijing Economic-Technological Development Area has attracted over 5,000 various biopharmaceutical companies, creating a comprehensive industry chain that encompasses research and development, production, services, and sales [1]

Core Viewpoint - Sanofi has officially launched its insulin active pharmaceutical ingredient (API) project in Beijing Economic-Technological Development Area, marking a significant investment in China's pharmaceutical industry and contributing to the country's healthcare goals [1] Group 1: Investment and Infrastructure - The total investment for the new production base is €1 billion, making it the largest investment in Beijing's pharmaceutical sector since the 14th Five-Year Plan [1] - The new facility will cover an area of nearly 60,000 square meters and is expected to be fully operational by 2032 [1] Group 2: Strategic Importance - This project is a key component of Sanofi's "China strategy," aimed at creating a high-quality production network that integrates raw materials and formulations to meet the evolving healthcare needs of Chinese patients [1] - The facility will collaborate with existing production bases in Beijing, Shenzhen, and Hangzhou to enhance operational efficiency [1] Group 3: Technological and Environmental Commitment - The new base will adopt international top-tier production processes and quality systems, incorporating digitalization, automation, and artificial intelligence (AI) to optimize production efficiency and quality control [1] - Sanofi will implement sustainable development strategies at the new facility, including advanced energy management, carbon reduction processes, wastewater treatment, and emissions control [1]

然而，赛诺菲为Rezurock提交的、用于治疗慢性移植物抗宿主病(cGVHD)的上市授权申请，未获得 CHMP的积极意见。慢性移植物抗宿主病是干细胞移植后的一种并发症。 赛诺菲指出，Rezurock已在包括美国在内的十几个国家上市。该公司表示，CHMP的这一决定令人失 望，并将寻求对该决定进行重新审查。 赛诺菲通用药物部门执行副总裁Olivier Charmeil表示："我们将继续与欧洲药品管理局密切合作，致力 于为欧盟等待治疗的患者带来这一疗法。" 智通财经APP获悉，在本周召开的会议上，欧洲药品管理局(EMA)的专家小组对赛诺菲(SNY.US)与 Insmed(INSM.US)的两款新药做出了推荐在该地区上市的积极意见。 EMA下属的欧洲药品管理局人用药品委员会(CHMP)于2025年10月13日至16日召开了10月会议。除了推 荐新药获批外，该委员会还否决了赛诺菲的一款新药，并推荐了8项新的药品适应症扩展申请。 EMA于周五发布的会议简报显示，赛诺菲的布鲁顿酪氨酸激酶抑制剂——Wayrilz(rilzabrutinib)已获得 CHMP的积极意见，该药物被推荐作为免疫性血小板减少症的后线治疗。免疫性血小 ...

Core Insights - Sanofi has officially launched its insulin raw material project in Beijing Economic and Technological Development Zone, marking a significant investment in the pharmaceutical sector [1] Investment Details - The total investment for the new production base is €1 billion, making it the largest investment project in Beijing's pharmaceutical industry since the start of the 14th Five-Year Plan [1] - This facility will be the first insulin raw material production base established by a multinational company in China [1] Project Specifications - The new base will consist of multiple production and supporting buildings, with a total construction area of nearly 60,000 square meters [1] - The facility is expected to be fully completed and operational by 2032 [1]

赛诺菲大中华区总裁施旺表示："这项投资是赛诺菲'中国方案'的重要组成。新基地将与已有的北京、深圳与杭州三地的生 产基地形成协同，打造覆盖从原料药到制剂的高质量生产网络，更高效地满足中国患者日益变化的医疗需求。依托赛诺菲在糖 尿病领域百余年的专业积淀，我们将继续携手政府、产业与学术界伙伴，共同推动糖尿病防控与管理，助力实现'健康中国 2030'愿景。" （编辑 郭之宸） 糖尿病是中国和全球重大慢性疾病，据统计，全球约有8.28亿名成年人患有糖尿病。作为糖尿病治疗的基石疗法，胰岛素 的需求极为庞大，保障其稳定、可持续供应，对于改善患者预后、延缓并发症、降低社会长期医疗支出至关重要。 赛诺菲执行副总裁兼制造与供应事业部负责人欧秉德（Brendan O'Callaghan）表示："这项里程碑式的投资再次突显了中国 作为赛诺菲关键战略市场的基石地位，也体现了我们对中国经济及医疗体系长期前景的信心。依托中国政府持续深化的创新改 革，我们正在北京建设赛诺菲全球最先进、数字化程度最高的生产基地之一，以期为中国广大糖尿病患者带来具有深远意义的 福祉。该项目不仅将强化我们的制造网络和供应链韧性，更彰显了赛诺菲以敏捷高效的行动满足 ...

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Wayrilz (rilzabrutinib) for treating immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, with a final decision expected soon [1][2] Group 1: Product Information - Wayrilz is the first BTK inhibitor for ITP, addressing the root cause of the disease through multi-immune modulation [5][7] - The drug has already received approval in the US and the UAE, and is under regulatory review in China [3] - Wayrilz has received fast track and orphan drug designations in the US, EU, and Japan for ITP and other rare diseases [3] Group 2: Clinical Study - The positive CHMP opinion is based on the LUNA 3 phase 3 study, which demonstrated that Wayrilz met both primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms [2][4] - The LUNA 3 study involved a randomized, multicenter design, comparing Wayrilz to placebo over a treatment period of 12 to 24 weeks [4] Group 3: Disease Context - Immune thrombocytopenia (ITP) is characterized by low platelet counts (<100,000/μL), leading to various bleeding symptoms and risks, including potentially life-threatening episodes [8] - Patients with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment [8]

Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia Recommendation based on LUNA 3 phase 3 study demonstrating rapid and durable platelet response and significant improvements in bleeding, quality of life measures, and other ITP symptoms   If approved, Wayrilz will be the first BTK inhibitor for ITP in the EU, targeting the root cause of the disease through multi-immune modulation Paris, October 17, 2025. The European Medicines Agency’s Committee for Medicinal Products ...

Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease Paris, October 17, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the marketing authorisation application for Rezurock (belumosudil) for the third-line treatment of adults and pediatric patients with chronic graft-versus-host disease (cGVHD). Sanofi will seek a re-examination of the CHMP opinion. cGVHD is a life-threatening co ...