2020年，Cytokinetics授予箕星药业在大中华地区的开发和商业化阿夫凯泰的独家许可权益。2024年， 赛诺菲从箕星药业手中收购阿夫凯泰在大中华区的独家开发和商业化权益。 阿夫凯泰是一种小分子心肌肌球蛋白抑制剂，由Cytokinetics自主研发。该药物通过全面的化学优化来 改善药物治疗指数和药代动力学特征，减少每个心动周期中活性肌球蛋白产力横桥的数量，从而抑制与 肥厚型心肌病相关的心肌过度收缩。同时，该疗法药理学特性使其半衰期更短，仅3-4天，可在8周达最 优剂量。 智通财经APP获悉，12月17日，赛诺菲(SNY.US)宣布第二代心肌肌球蛋白抑制剂(CMI)阿夫凯泰 (Aficamten，中文商品名：星舒平)获得国家药监局批准上市，用于治疗纽约心脏病协会(NYHA)心功能 分级II-III级的梗阻性肥厚型心肌病(HCM)成人患者，以改善运动能力和症状。 据悉，阿夫凯泰片是肥厚型心肌病领域潜在"同类最佳"的治疗药物。此次获批标志着阿夫凯泰片是在中 国实现"全球首发"的创新药，中国的批准早于美国与欧盟等全球其他国家与地区。 ...

Approval Triggers Milestone Payment of $7.5 Million from Sanofi; Cytokinetics Eligible to Receive Additional Milestone Payments and Royalties on Net Sales in Greater China SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO® (aficamten) has been approved by the China National Medical Products Administration (NMPA) for the treatment of adults with New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyo ...

来源：市场资讯 （来源：求实药社） 2025年12月15日，赛诺菲在一天之内按下了两次巨额交易的确认键。 这家法国制药巨头先是宣布与韩国ADEL达成10.4亿美元合作，引进一款处于临床早期的阿尔茨海默病 （AD）抗体；随即又以最高17亿美元的金额深化与美国Dren Bio的合作，加码自身免疫平台。 单日27.4亿美元（约合人民币近200亿）的投入，在资本寒冬尚未完全消退的当下显得尤为刺眼。然 而，这并非一场轻松的"庆功宴"，更像是一次不得不为的高风险资产置换。 在刚刚剥离了现金流稳定的消费者健康业务（Opella）之后，赛诺菲正急于向市场证明，其激进的"纯 创新药"战略能够跑通。这27亿美元的押注，折射出的是一家MNC在专利悬崖与研发困境夹击下的破局 渴望与深层焦虑。 一、 神经科学的"补课"：Tolebrutinib阴影下的对冲 在AD这个被称为"研发黑洞"的领域，赛诺菲不仅是一个后来者，更是一个面临巨大压力的追赶者。 目前的AD市场，卫材与礼来的Aβ（β-淀粉样蛋白）抗体已经抢占了第一波商业化高地。赛诺菲避开了 拥挤的Aβ赛道，转而选择靶向乙酰化Tau蛋白（acK280）的差异化路线。从科学机制上看，AD ...

Core Insights - The focus of the call is on the clinical and regulatory aspects of Sanofi's mid- and late-stage pipeline, emphasizing the importance of science and patience over commercial or financial discussions [2] - Key events in 2025 across various therapeutic areas such as immunology, rare diseases, hemato-oncology, neurology, and vaccines will be highlighted, along with news flow items for the first half and second half of next year and into 2027 [3] - There is a noted deflation of expectations for some 2025 news items, leading to a general anticipation of lower news flow for the upcoming year [3] Group 1 - The call is led by Thomas Kudsk Larsen from the Investor Relations team, indicating a structured approach to investor communication [1] - The presentation aims to keep the discussion focused on scientific developments rather than financial performance [2] Group 2 - The company plans to provide a comprehensive overview of its pipeline, which includes significant therapeutic areas and timelines for upcoming news [3] - The emphasis on lower anticipation for next year's news flow suggests a strategic adjustment in expectations for stakeholders [3]

Sanofi (NasdaqGS:SNY) Update / Briefing December 16, 2025 11:15 AM ET Company ParticipantsLouisa Hector - Head of Global Pharma Equity ResearchThomas Kudsk Larsen - Head of Investor RelationsSachin Jain - VPSarita Kapila - Co-Head European Pharmaceuticals Equity ResearchSimon Baker - Head of Global Biopharma ResearchNone - Company RepresentativeJames Quigley - Executive DirectorGraham Parry - Managing Director and Head of European Pharmaceuticals Biotechnology Equity ResearchJean-François Toussaint - Global ...

Key Takeaways SNY stock fell nearly 2% after two setbacks tied to Sanofi's investigational MS drug tolebrutinib.The FDA pushed its decision on tolebrutinib for nrSPMS to the first quarter of 2026 after new submissions.SNY said tolebrutinib failed the primary endpoint in a phase III PPMS study, ending development in that use.Shares of Sanofi (SNY) fell nearly 2% on Monday after the company reported two setbacks in connection with its investigational multiple sclerosis (MS) drug, tolebrutinib.FDA Delays Decis ...

R&D Leadership and Organization - Sanofi is building a skilled and thoughtful R&D leadership team and organization[5, 6, 7, 106] - The company is strengthening capabilities across research, translational medicines, development, medical, regulatory affairs, and digital[106] Pipeline Highlights and Approvals - Sanofi achieved three new medicine and vaccine approvals in 2025: Qfitlia, Wayrilz, and Nuvaxovid[12, 13, 106] - Dupixent showed benefit across relevant endpoints in Bullous pemphigoid, with 12.2% difference in patients achieving sustained remission compared to placebo + OCS and 27.8% difference in patients with ≥4-point improvement in PP-NRS[20, 21] - Dupixent clinically meaningfully improved radiographic, endoscopic, and symptoms of Allergic fungal rhinosinusitis, with lower proportion of patients receiving SCS treatment and/or surgery[24] - Amlitelimab (OX40L mAb) in AD: first phase 3 study met primary and key secondary endpoints, showing clinically meaningful improvement in skin clearance and disease severity[26] - Brivekimig (TNFaxOX40L Nanobody®) in HS: phase 2a study achieved primary objective, with 54% of participants achieving HiSCR75[28, 29] - Itepekimab (IL33 mAb) in COPD: AERIFY-1 study showed a significant reduction in moderate or severe exacerbations of 27.1% at Week 52 with Q2W dosing across EOS level[38] - Duvakitug (TL1A mAb) in CD/UC: positive and encouraging phase 2b data presented at ECCO 2025, with 48% clinical remission in Crohn's disease high dose group[46, 47] - Fluzone HD demonstrated superior protection vs standard-dose influenza vaccines against hospitalization in older adults, including a -31.9% reduction in laboratory confirmed influenza hospitalization[75] - Monovalent RSV (mRNA) vaccine showed 74.9% efficacy against RSV LRTD in a phase 2 study[80] Pipeline Replenishment and Digital Transformation - Sanofi is progressing on pipeline entries augmented by strategic business development[107] - The R&D digital plan aims at reducing cycle times across the R&D value chain by more than 40%[94, 95, 107] Upcoming News Flow - Sanofi anticipates >15 regulatory decisions, >30 regulatory submissions, and >15 phase 3 data readouts in 2026 and 2027[108]

South Korea-based ADEL said late on Monday that it has entered a $1.04 billion partnership with French drugmaker Sanofi to develop and sell the biotech company's experimental Alzheimer's disease treat... ...

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston B ...

Dren Bio, a privately held, clinical-stage biotechnology company, has a new collaboration with Sanofi SA (NASDAQ:SNY) . The new agreement is built on the existing relationship between the two companies, following Sanofi’s acquisition earlier this year of Dren Bio’s DR-0201 program for deep B-cell depletion. • Sanofi shares are experiencing downward pressure. Why are SNY shares declining?The collaboration covers the discovery and development of a next-generation B-cell depleting therapy for the treatment of ...