受理号CYHB2600219药品名称丙戊酸钠口服溶液药品类型化药申请类型补充申请注册分类企业名称赛 诺菲（杭州）制药有限公司;赛诺菲（杭州）制药有限公司;承办日期2026年2月4日 来源：新浪财经-鹰眼工作室 国家药品监督管理局药品审评中心数据显示，2026年2月4日，赛诺菲（杭州）制药有限公司的丙戊酸钠 口服溶液申请已获受理，受理号为CYHB2600219。 股东名称持股比例认缴出资额认缴出资日期首次持股日期法国赛诺菲药业发展公司75%2160万美元2023 年12月31日2006年10月26日赛诺菲（中国）投资有限公司25%720万美元2023年12月31日2007年05月08 日 声明：市场有风险，投资需谨慎。本文基于第三方数据库自动发布，不代表新浪财经观点，任何在本文 出现的信息均只作为参考，不构成个人投资建议。如有出入请以实际公告为准。如有疑问，请联系 biz@staff.sina.com.cn。 天眼查数据显示，赛诺菲（杭州）制药有限公司成立日期1995年11月30日，法定代表人孙博弘，所属行 业为化学药品原料药制造，企业类型为有限责任公司（外商投资、非独资），企业规模为中型，参保人 数498，注 ...

Key Takeaways SNY said its phase III LEAP2MONO study met all primary endpoints in GD3 patients versus ERT.Sanofi reported significant, clinically meaningful neurological gains at 52 weeks on SARA and RBANS.SNY said venglustat improved spleen and liver size, was well tolerated, and will advance to filings.Sanofi (SNY) announced that a late-stage study, evaluating venglustat, an investigational oral glucosylceramide synthase inhibitor (GCSi), in patients aged 12 years and older with type 3 Gaucher disease (GD ...

Core Viewpoint - Sanofi has announced a share buyback program of up to €1 billion, set to take place between February 3, 2026, and December 31, 2026 [1] Company Overview - Sanofi is an R&D driven, AI-powered biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare and societal challenges [2] Share Buyback Program Details - The share buyback program is authorized for a total consideration of up to €1 billion, with a mandate signed with an investment service provider on February 2, 2026 [1][6]

Group 1 - The core point of the article is that French drugmaker Sanofi's experimental treatment for a genetic disorder shows promise in a late-stage study for Gaucher disease, but did not meet the main goal in a separate trial [1] Group 2 - The treatment demonstrated potential effectiveness in patients with a specific type of Gaucher disease during the late-stage study [1] - However, the results from another trial did not achieve the primary endpoint, indicating challenges in the development process [1]

Market Performance - The pan-European Stoxx 600 closed up by 0.64%, with the U.K.'s FTSE 100 climbing 0.51%, Germany's DAX gaining 0.68%, and France's CAC 40 also increasing by 0.68% [2] - Positive performances were noted in Austria, Belgium, Denmark, Ireland, Netherlands, Norway, Portugal, and Spain, while Greece, Iceland, Poland, Russia, and Sweden ended weak [2] Company Highlights - Lloyds Banking Group gained 3.3% after launching a share buyback program to repurchase up to £1.75 billion of its ordinary shares [3] - Other banks such as Natwest Group, Barclays, Standard Chartered, and HSBC Holdings saw gains between 1.2% and 2% [3] - In the German market, SAP increased by about 4.2%, and Adidas rose 3.7% after reporting record revenues and announcing a €1 billion ($1.2 billion) stock buyback [5] - In the French market, companies like Edenred, Sanofi, and LVMH closed up by 1%-3% [6] Sector Performance - Gains in financials and consumer sectors in the UK market offset losses in the mining sector [2] - The German market saw a mix of performances, with several companies gaining while others like Volkswagen and Continental closed weak [5] Economic Indicators - In Germany, import prices declined by 2.3% in December year-on-year, with a month-on-month decrease of 0.1% [8] - The German economy expanded by 0.3% quarter-on-quarter in the last three months of 2025, marking the strongest performance in three quarters [10] - France's GDP growth was reported at 0.2% for the fourth quarter, with overall economic growth softening to 0.9% in 2025 from 1.1% in 2024 [12][13]

Core Insights - Regeneron Pharmaceuticals reported strong fourth-quarter performance, with total revenue of $3.9 billion and notable growth in key products like Dupixent, Libtayo, and EYLEA HD, despite challenges in the EYLEA 2 mg segment [5][12] EYLEA HD Performance - EYLEA HD U.S. net product sales reached $506 million in Q4, a 66% increase, and projected to be $1.6 billion for 2025, up 36% [2] - EYLEA 2 mg U.S. net sales declined 15% sequentially to $577 million, indicating competitive pressures [1][8] Libtayo and Dupixent Growth - Libtayo's global net product sales rose 13% to $425 million in Q4, with full-year sales of $1.45 billion, driven by recent FDA approvals [3] - Dupixent's global net sales increased 32% year-over-year to $4.9 billion in Q4, with over 1.4 million patients on therapy [4] Financial Highlights - Regeneron's non-GAAP diluted earnings per share were $11.44, with net income of $1.2 billion, attributed to collaboration revenue and growth in key products [12] - Collaboration revenue from Sanofi was approximately $1.6 billion, a 42% year-over-year increase [13] Regulatory and Pipeline Developments - The company anticipates at least four FDA approvals in the next 12 months, including a prefilled syringe for EYLEA HD [10] - Plans to initiate 18 additional Phase III studies in 2026, targeting a cumulative enrollment of about 35,000 patients [10] Research and Development Focus - R&D budget is projected between $5.9 billion to $6.1 billion, with a gross margin on net product sales expected to be 83% to 84% [15]

Core Viewpoint - Regeneron Pharmaceuticals is showing potential for business development deals following a strong fourth-quarter report, as indicated by RBC Capital Markets analyst Brian Abrahams [1] Group 1: Financial Performance - Regeneron stock experienced volatility after the market opened, reflecting investor reactions to its fourth-quarter performance [1] - The company's press release was noted to be "more direct" regarding business development opportunities compared to previous communications [1] Group 2: Market Position and Analyst Insights - Analyst Brian Abrahams suggested that Regeneron could actively seek deals in the upcoming year, indicating a strategic shift in its approach to business development [1] - The stock's relative strength rating has risen to 82, showcasing improved market performance [1]

Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease Recommendation supported by safety and efficacy results from several clinical studies and real-world evidenceIf approved, Rezurock would offer a new treatment option in the EU for adult patients and in children aged 12 years and older in late line chronic GVHD Paris, January 30, 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending ...

Core Insights - Regeneron Pharmaceuticals reported strong financial performance in 2025, driven by four blockbuster medicines and a promising late-stage clinical portfolio [2][3] - The company achieved significant label expansions and new approvals for its key products, including EYLEA HD and Dupixent, enhancing their commercial potential [2][4] Financial Highlights - Total revenues for Q4 2025 were $3,884 million, a 3% increase from Q4 2024, while full year revenues reached $14,343 million, up 1% from 2024 [3][14] - GAAP net income for Q4 2025 was $845 million, down 8% from Q4 2024, with a full year GAAP net income of $4,505 million, an increase of 2% [3][14] - Non-GAAP net income for Q4 2025 was $1,249 million, a decrease of 10% from Q4 2024, while full year non-GAAP net income was $4,888 million, down 8% [3][14] Business Highlights - Dupixent global net sales increased by 34% in Q4 2025 to $4.9 billion, with full year sales rising 26% to $17.8 billion [4][14] - EYLEA HD U.S. net sales surged 66% in Q4 2025 to $506 million, with full year sales increasing 36% to $1.6 billion [4][14] - Libtayo received additional approvals and is now the leading immunotherapy for non-melanoma skin cancers [2][4] Pipeline Progress - Regeneron has approximately 45 product candidates in clinical development, with several key updates expected in 2026 [4][10] - Upcoming milestones include FDA decisions for EYLEA HD pre-filled syringe and Dupixent's regulatory submissions for new indications [13][28] Capital Allocation - The company repurchased $671 million of its common stock in Q4 2025 and $3.5 billion for the full year, with $1.5 billion remaining for future repurchases [26] - A cash dividend of $0.94 per share was declared, payable on March 5, 2026 [27] 2026 Financial Guidance - Regeneron projects GAAP R&D expenses between $6.450 billion and $6.680 billion for 2026, with non-GAAP R&D expenses expected to be between $5.900 billion and $6.100 billion [28][29] - The company anticipates a GAAP effective tax rate of 12% to 14% for 2026 [28]

全球最新、最好的创新药物，什么时候能来中国？跨国药企赛诺菲正在用实际行动表明，中国可以是全球新药"第一站"。 2025年12月到2026年1月，短短数周内，赛诺菲连续有两款心血管药物在中国获批。它们分别是全球首发的新药阿夫凯泰片（商品名：星舒平 ），有着同类 最佳潜力，以及全球首创的普乐司兰钠注射液（商品名：瑞达普 ），填补了一处重要疾病领域的治疗空白。 实际上，赛诺菲的"心血管双子星"接连获批，也是与中国合作伙伴深度交融的结果，也是赛诺菲创新的BD（business development，业务拓展）模式的明 证。 2025年，堪称中国创新药BD交易爆发元年。医药魔方数据显示，中国创新药BD出海授权2025年交易总金额达到1356.55亿美元，再创历史新高。 在中国创新药纷纷借船出海时，赛诺菲中国则另辟蹊径。2022年底，总部授权赛诺菲中国引进管线的权力。此后，赛诺菲立足中国，主动深入中国本土创新 药生态，发掘最有潜力的药物分子，凭借自身雄厚的开发和商业化实力，让药物最早惠及中国患者。 2024年末以来，赛诺菲分别通过与箕星药业、维亚臻的BD合作，获得了阿夫凯泰片和普乐司兰钠注射液的大中华区开发及商业化权益 ...