证券研究报告 | 2026年2月26日 海外制药企业2025Q4&全年业绩回顾 ——2026会是下一个BD大年吗？ 行业研究 · 行业专题 请务必阅读正文之后的免责声明及其项下所有内容 2 ◼ 2026会是下一个BD大年吗？ • 2025年跨国制药企业创新药资产交易创新高：2025年创新药交易案例数达到142个，其中并购/合作开发分别36/106个，均创2015年至今新高；交易总金额达到2645亿美元，其中并购/合作 开发分别1060/1584亿美元，交易总额及合作开发金额均为2015年至今新高，并购金额仅次于2019及2023年。 • 剔除大额并购后，近年并购/合作开发交易对价趋于稳定：2645亿美元交易总金额中，对应首付款（包括一次性现金/股份支付的收购款）1074亿美元，其中并购/合作开发分别950/124亿美 元，站在跨国药企现金流角度，并购是主要影响因素，且不同年份间的波动主要由总对价50亿美元以上的大额并购影响，剔除后近几年的平均并购金额基本稳定在~15亿美元水平，这类 bolt-on并购对自由现金流及公司杠杆率压力均较小。 • 哪些因素可能会影响药企并购决策？1）需求：应对核心产品专利到期在即所 ...

证券研究报告 | 2026年2月26日 海外制药企业2025Q4&全年业绩回顾 ——2026会是下一个BD大年吗？ 行业研究 · 行业专题 医药生物 投资评级：优于大市（维持评级） 证券分析师：马千里 010-88005445 maqianli@guosen.com.cn S0980521070001 证券分析师：陈曦炳 0755-81982939 chenxibing@guosen.com.cn S0980521120001 证券分析师：彭思宇 0755-81982723 pengsiyu@guosen.com.cn S0980521060003 请务必阅读正文之后的免责声明及其项下所有内容 摘要 请务必阅读正文之后的免责声明及其项下所有内容 2 ◼ 2026会是下一个BD大年吗？ • 2025年跨国制药企业创新药资产交易创新高：2025年创新药交易案例数达到142个，其中并购/合作开发分别36/106个，均创2015年至今新高；交易总金额达到2645亿美元，其中并购/合作 开发分别1060/1584亿美元，交易总额及合作开发金额均为2015年至今新高，并购金额仅次于2019及2023年。 • 剔除大额并购 ...

明星减重药司美格鲁肽生产商、丹麦制药巨头诺和诺德经历了艰难的一年。该公司于去年8月更换领导 层，由马齐亚尔·迈克·杜斯塔德（Maziar Mike Doustdar）接替周赋德（Lars Fruergaard Jorgensen）担任 CEO。 2025年，苏博科获得了高达430万英镑的年度奖金，较2024年的水平增长了约22%。阿斯利康也是伦敦 证交所上市公司中市值最高的企业，最新市值超过3200亿美元。 当地时间2月24日，阿斯利康的一份备案文件显示，该公司CEO苏博科（Pacal Soriot）2025年的薪酬增 至1770万英镑（约合1.64亿元人民币），跻身英国富时100指数中薪酬最高的高管之列。 阿斯利康也是伦敦证交所上市公司中市值最高的企业，最新市值超过3200亿美元（约合2.2万亿元人民 币）。受益于公司强劲的业绩和股价表现，2025年，苏博科获得了高达430万英镑的年度奖金，较2024 年的水平增长约22%。 截至本月，欧洲制药公司高管2025年度年薪陆续披露。近日，瑞士制药巨头诺华披露，该公司首席执行 官万思瀚（Vas Narasimhan）在2025年获得薪酬达2490万瑞士法郎（约合2 ...

Core Insights - The FDA has approved Dupixent (dupilumab) as the first and only treatment for allergic fungal rhinosinusitis (AFRS) in patients aged 6 years and older with a history of sino-nasal surgery, marking a significant advancement in the treatment of this condition [2][3][4] Group 1: Approval and Indications - Dupixent is now approved for treating nine distinct diseases driven by type 2 inflammation, including sino-nasal, skin, gut, and respiratory system diseases [6] - The approval was based on the LIBERTY-AFRS-AIMS phase 3 study, which demonstrated significant improvements in sinus opacification scores and nasal symptoms compared to placebo [4][10] Group 2: Clinical Study Results - In the LIBERTY-AFRS-AIMS study, Dupixent improved sinus opacification scores by 50% compared to 10% for placebo at Week 52, with a significant reduction also observed at Week 24 [4][11] - Patient-reported nasal congestion improved by 67% at Week 24 and 81% at Week 52 compared to 25% and 11% for placebo, respectively [7][13] - Dupixent reduced the risk of systemic corticosteroid use and/or surgery by 92%, with only 3% of patients on Dupixent requiring systemic corticosteroids compared to 31% on placebo [13] Group 3: Safety Profile - The safety profile of Dupixent in the LIBERTY-AFRS-AIMS study was consistent with its known safety profile in chronic rhinosinusitis with nasal polyps (CRSwNP), with common adverse reactions including injection site reactions and conjunctivitis [8][9] Group 4: Market Impact and Future Plans - Dupixent's approval is expected to establish a new standard of care for patients with AFRS, addressing a high unmet need in the treatment landscape [9] - Sanofi and Regeneron plan to submit additional applications to regulatory authorities worldwide to expand access to Dupixent [9][17]

Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis Approval in adults and children aged 6 years and older supported by phase 3 study demonstrating Dupixent significantly reduced nasal signs and symptoms and systemic corticosteroid use or surgery compared to placeboAFRS is a chronic type 2 inflammatory disease of the sinuses characterized by an allergic hypersensitivity to fungi, often requiring surgery with high rates of post-operative recurr ...

Approval in adults and children aged 6 years and older supported by Phase 3 trial demonstrating Dupixent significantly reduced nasal signs and symptoms, and systemic corticosteroid use or surgery compared to placebo AFRS is a chronic type 2 inflammatory disease of the sinuses characterized by an allergic hypersensitivity to fungi, often requiring surgery with high rates of post-operative recurrence Dupixent is now approved in the U.S. to treat nine distinct diseases driven in part by type 2 inflammation, i ...

【国泰海通医药】春节期间创新药领域重点新闻梳理-海外公司 1）2/12 公司自2019年起任职的CEO PaulHudson不再续聘，前默沙东CEO BelénGarijo上任（#过去3年赛诺菲临床失 败多管线青黄不接）； 2）2/17 赛诺菲&TEVA更新了共同开发的TL1A单抗duvakitug IIb期更长期随访的数据，其中44周时接受900mg药物维 持治疗的UC患者临床缓解率达到58%（较安 【国泰海通医药】春节期间创新药领域重点新闻梳理-海外公司 赛诺菲： 1）2/12 公司自2019年起任职的CEO PaulHudson不再续聘，前默沙东CEO BelénGarijo上任（#过去3年赛诺菲临床失 败多管线青黄不接）； 2）2/17 赛诺菲&TEVA更新了共同开发的TL1A单抗duvakitug IIb期更长期随访的数据，其中44周时接受900mg药物维 持治疗的UC患者临床缓解率达到58%（较安慰剂提高27%），CD患者的内镜应答率达到55%（较安慰剂提高 35%），相比16周均有提高，数据亮眼； 阿斯利康： 1）2/20 FDA批准阿斯利康阿克替尼联合维奈托克全口服、固定疗程方案针对一线CLL ...

Sanofi (NASDAQ:SNY) is among the 7 Oversold Pharma Stocks to Buy Now. Sanofi's (SNY) R&D Track Record Remains Investor Concern, Says BofA Sanofi (NASDAQ:SNY) is one of the most oversold stocks. TheFly reported that on February 20, SNY’s price target was lowered at Citi by EUR 5. On the other hand, earlier on February 12, BofA reduced its price target for SNY from EUR 102 to EUR 92 and downgraded the stock from Buy to Neutral. Following the announcement that Belén Garijo, the former CEO of Merck KGaA, wi ...

Sanofi (NASDAQ:SNY) is one of the Best Dip Stocks to Buy According to Hedge Funds. On February 17, Sanofi (NASDAQ:SNY) announced Manuela Buxo will replace Brian Foard as the Head of its Specialty Care Global Business Unit. Brian Foard, after serving for nearly 9 years, is leaving on February 28 to take on a leadership role elsewhere. ​Manuela Buxo will take over as the Head of Specialty Care Unit on March 1, 2026. She is currently the head of Sanofi’s (NASDAQ:SNY) Global Immunology Alliance Franchise. Fo ...

Core Insights - The biotech industry experienced significant developments this week, including FDA approvals, clinical trial results, and licensing agreements, indicating a dynamic landscape for investment opportunities and advancements in healthcare [1]. FDA Approvals & Rejections - NRx Pharmaceuticals is on track for FDA approval of NRX-100, with existing clinical data and real-world evidence from over 65,000 patients potentially supporting a New Drug Application (NDA) under Fast Track Designation [2][3]. - Kane Biotech received FDA clearance for its Revyve Antimicrobial Skin and Wound Cleanser, which targets wound bacteria and biofilms, with plans for manufacturing scale-up in 2026 [4][5]. - Johnson & Johnson's RYBREVANT FASPRO received FDA approval for a simplified monthly dosing schedule, enhancing treatment options for patients with advanced non-small cell lung cancer [6][7]. - Spruce Biosciences reported positive feedback from FDA Type B meetings for its enzyme replacement therapy for Sanfilippo syndrome type B, with a targeted BLA filing in Q4 2026 [8][9]. - Moderna's seasonal influenza vaccine submission (mRNA-1010) is under FDA review, with a PDUFA date set for August 5, 2026, aiming for availability in the 2026/2027 flu season [10][11]. - Disc Medicine received a Complete Response Letter (CRL) for its NDA for Biopertin in erythropoietic protoporphyria, citing insufficient correlation with sunlight exposure endpoints [13][14]. - AbbVie and Genentech's combination regimen of VENCLEXTA and Acalabrutinib for chronic lymphocytic leukemia (CLL) received FDA approval, showing a 35% reduction in disease progression risk compared to standard treatment [15][16]. Deals - Theriva Biologics entered an exclusive licensing agreement with Rasayana Therapeutics for SYN-020, receiving a $3 million upfront payment and potential milestone payments totaling up to $38 million [17][18]. - Sensei Biotherapeutics acquired Faeth Therapeutics, expanding its oncology portfolio with the investigational asset PIKTOR, and announced a concurrent private placement of $200 million to advance clinical milestones [19][20]. Clinical Trials - Breakthroughs - Eli Lilly's Taltz and Zepbound combination therapy showed positive results in a Phase 3 trial for plaque psoriasis and obesity, achieving superior outcomes compared to Taltz alone [21][22]. - Zealand Pharma reported positive Phase 1a results for ZP9830, a Kv1.3 channel blocker, demonstrating safety and tolerability in healthy volunteers [23][24]. - Novartis' Remibrutinib met primary endpoints in a Phase 3 trial for chronic inducible urticaria, showing significant response rates compared to placebo [26][27]. - Ocular Therapeutix's AXPAXLI demonstrated superiority over aflibercept in a Phase 3 trial for wet age-related macular degeneration, although stock prices fell due to investor disappointment [28][29]. - Rallybio's RLYB116 Phase 1 study showed promising results for immune platelet transfusion refractoriness, with plans for a Phase 2 trial in 2026 [31][32]. - Teva and Sanofi's Duvakitug Phase 2b trial demonstrated durable efficacy in ulcerative colitis and Crohn's disease, reinforcing the rationale for ongoing Phase 3 programs [35][36]. - Genentech's Gazyva met primary endpoints in a Phase III study for primary membranous nephropathy, showing significant remission rates compared to tacrolimus [38][39].