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 创新药盘点系列报告(23):MNC药企在心血管领域密集布局,聚焦PCSK9及Lp(a)两大靶点
 国信证券· 2025-11-03 19:59
 报告行业投资评级 - 行业投资评级:优于大市(维持评级)[1]   报告核心观点 - ASCVD疾病负担沉重,血脂异常是重要的始动因素,LDL-C与ASCVD风险相关性已有充分证据,但他汀治疗后相当比例患者仍未达标,Lp(a)作为独立于LDL-C的"尾部风险"因子通过动脉粥样硬化、促凝及促炎通路影响心血管事件风险[2] - MNC药企在心血管领域密集布局,聚焦PCSK9及Lp(a)两大靶点,预计PCSK9全球市场规模110~190亿美元,Lp(a)抑制剂市场30~70亿美元[2] - 未来几年多个心血管事件终点Ph3临床研究将读出数据,包括VESALIUS-CV、HORIZON、OCEAN(a)-Out_comes等关键催化剂[2] - 相关标的包括恒瑞医药(HRS-5346授权给Merck)和石药集团(YS2302018授权给AstraZeneca)等国内药企通过授权合作参与全球竞争[2]   ASCVD疾病负担 - ASCVD是全球首要致死原因,1990与2021年缺血性心脏病均位列全球死因第1位,年龄标准化死亡率从159/10万人下降至109/10万人,但总数仍接近900万人,占全部死亡原因约13%[5] - 美国2022年冠心病死亡37万例、卒中16万例,≥20岁人群中约1870万人至少经历过一次ASCVD事件[5] - 中国2021年缺血性心脏病死亡196万例、卒中约230万例,约7000万人至少有一次ASCVD病史[5] - 动脉粥样硬化形成机制中,含有apoB的脂蛋白胆固醇在动脉壁内沉积是始动环节,LDL-C被巨噬细胞吞噬形成泡沫细胞累积成动脉粥样硬化斑块[6]   LDL-C治疗现状与未满足需求 - 美国ASCVD患者中约75%使用他汀治疗,但仅25%患者LDL-C控制在70 mg/dL推荐值以下,1130万未达标人群中仅60万人使用附加疗法[26] - 高风险ASCVD患者CVD事件发生率为非高风险患者的3倍以上,指南推荐他汀基础上使用EZM/PCSK9i附加疗法但渗透率低[26] - PCSK9抑制剂临床数据显示LDL-C降幅显著,Evolocumab在FOURIER研究中使LDL-C从92 mg/dL降至30 mg/dL,3P-MACE风险下降20%[32][53]   Lp(a)作为新兴靶点 - Lp(a)是独立于LDL的ASCVD风险因子,水平由基因决定,几乎不受生活方式干预影响,通过致动脉粥样硬化、促凝和促炎作用增加心血管风险[35][37] - 美国人群中Lp(a)中位数14 mg/dL,>50 mg/dL占比14.7%;中国人群中位数11 mg/dL,>50 mg/dL占比8.4%[40] - Lp(a)抑制剂研发进展包括Pelacarsen(ASO)、Olpasiran(siRNA)等,其中siRNA药物可实现90%以上Lp(a)降幅,多项Ph3研究将于2026-2031年读出数据[41][42][47]   MNC药企布局与市场空间 - PCSK9药物全球市场规模预计110~190亿美元,Lp(a)抑制剂市场预计30~70亿美元,基于患者分层和渗透率假设(二级预防10%~15%,一级预防5%~10%)[66][68] - PCSK9药物截至2025Q2 LTM销售额约40亿美元,美国市场占比50%,年用药费用约4000美元,远期渗透率提升驱动市场增长[68][69] - MNC药企如Eli Lilly、Novartis、Merck等通过多机制产品矩阵覆盖心血管疾病人群,包括PCSK9靶点(单抗、siRNA、口服药)和Lp(a)靶点(ASO、siRNA、小分子)[72]   临床事件催化剂 - VESALIUS-CV(Amgen,PCSK9 mAb,一级预防)将于2025年11月AHA大会公布完整数据[2][32] - HORIZON(Novartis,Lp(a) ASO,二级预防)topline数据预计2026H1读出[2][41] - OCEAN(a)-Out_comes(Amgen,Lp(a) siRNA,二级预防)topline数据预计2026H2读出[2][41] - ORION-4/VICTORION-2P(Novartis,PCSK9 siRNA,二级预防)数据读出时间2026/2027年[2][32]
 AMGEN ANNOUNCES 2025 FOURTH QUARTER DIVIDEND
 Prnewswire· 2025-11-01 04:01
Accessibility StatementSkip Navigation THOUSAND OAKS, Calif., Oct. 31, 2025 /PRNewswire/ --Â Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $2.38 per share dividend for the fourth quarter of 2025. The dividend will be paid on December 12, 2025, to all stockholders of record as of the close of business on November 21, 2025. About AmgenAmgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's to ...
 Demographic Megatrend: Stocks Poised to Benefit From Global Aging
 ZACKS· 2025-11-01 00:20
 全球人口老龄化趋势 - 全球60岁及以上人口比例持续增长,预计到2050年将占全球总人口的近22%,其中近80%居住在中低收入国家[2] - 2020年,60岁及以上人口数量首次超过5岁以下儿童数量,成为重要的人口结构转折点[2]   老年护理服务市场规模 - 全球老年护理服务行业当前市场规模约为1.21万亿美元,预计到2034年将增长至约2.12万亿美元[3] - 预测期间的年复合增长率为6.4%[3]   医疗保健模式演变 - 医疗保健利用模式正在演变,为养老社区、专业护理机构、辅助生活设施和急性后期护理提供商开辟了长期增长途径[4] - 以社区为基础的全面医疗计划(如PACE计划)得到推进,旨在为同时符合医疗保险和医疗补助资格的老年人服务[4]   年龄相关疾病需求增长 - 随着预期寿命延长,心血管疾病、神经退行性疾病、骨质疏松和糖尿病等年龄相关疾病的患病率上升[6] - 这放大了对老年护理和急性后期服务公司的需求,同时家庭护理和社区支持模式的扩展增强了该行业的吸引力[6]   行业参与者与投资机会 - 医疗保健巨头如波士顿科学、艾伯维、安进和爱德华生命科学正通过提高运营效率,扩大在老年人口领域的影响力[5] - 老年护理服务领域在经济下行期间表现出韧性,对基本护理、长期支持和专业护理的稳定需求提供了稳定的现金流[8] - 专注于专业护理和老年住房的医疗保健房地产投资信托基金(如Omega Healthcare Investors和CareTrust REIT)为该行业提供了基础设施支持[7]   波士顿科学公司 - 公司开发了多款满足老年人需求的医疗设备,包括用于降低非瓣膜性房颤患者中风风险的WATCHMAN左心耳封堵器[9] - SYNERGY生物可吸收聚合物冠状动脉支架系统在老年患者中显示出良好效果,特别是那些需要较短双联抗血小板治疗疗程的患者[9] - 公司持续强调其SYNERGY支架平台在老年患者中的支持性临床数据,并加强其LATITUDE NXT远程患者管理生态系统[10]   艾伯维公司 - 公司通过收购Aliada Therapeutics,获得了其用于治疗阿尔茨海默病的主要研究资产ALIA-1758抗体,该药物目前处于1期临床试验阶段[11] - ALIA-1758采用了一种新型的血脑屏障穿透技术[12] - 在肿瘤学领域,公司通过授权协议获得了开发SIM0500(一种三特异性抗体)的独家权利,并与Xilio Therapeutics合作开发肿瘤激活免疫疗法[13] - 公司于2024年投资2.23亿美元扩建其新加坡生物制剂制造设施,以提高产能满足老龄化人口需求[14]   安进公司 - 公司报告了MariTide的完整2期结果,显示在不伴有2型糖尿病的肥胖患者中平均体重减轻高达20%,在伴有2型糖尿病的肥胖患者中减轻17%[15] - 公司的骨骼健康产品线保持强劲,Prolia在降低骨质疏松性骨折风险方面显示出显著疗效[16] - 公司正在推进其心脏代谢研究,MariTide旨在解决老年人肥胖问题,特别是那些伴有或不伴有2型糖尿病的患者[16]   爱德华生命科学公司 - 公司正在推进对患有主动脉瓣狭窄的老年患者的护理,早期治疗可显著降低成本并改善结局[17] - 公司SAPIEN 3 Ultra RESILIA瓣膜获得FDA批准用于无症状严重AS,加强了其在早期干预中的作用[17] - 2025年第三季度,公司全球结构性心脏业务销售额同比增长12.6%,经导管主动脉瓣置换术销售增长由对及时干预的关注、有利的指南更新和成熟市场的强劲吸收所驱动[18] - 公司的二尖瓣和三尖瓣业务(以PASCAL和EVOQUE平台为基础)同比增长53%,表明这些疗法在患有晚期瓣膜病的老年患者中的采用正在加速[19]
 A Look Into Amgen Inc's Price Over Earnings - Amgen (NASDAQ:AMGN)
 Benzinga· 2025-10-31 22:01
In the current session, Amgen Inc. (NASDAQ:AMGN) is trading at $291.80, after a 0.07% drop. Over the past month, the stock fell by 2.04%, and in the past year, by 7.92%. With performance like this, long-term shareholders are more likely to start looking into the company's price-to-earnings ratio. Amgen P/E Compared to CompetitorsThe P/E ratio is used by long-term shareholders to assess the company's market performance against aggregate market data, historical earnings, and the industry at large. A lower P/E ...
 AMGEN'S LANDMARK PHASE 3 REPATHA DATA TO BE PRESENTED AS LATE BREAKER AT THE AMERICAN HEART ASSOCIATION SCIENTIFIC SESSIONS 2025
 Prnewswire· 2025-10-31 21:00
Accessibility StatementSkip Navigation Repatha VESALIUS-CV Trial Met Dual Primary Endpoints Demonstrating Reduction in CV Events in High-Risk Patients Who Have Never Had a Heart Attack or Stroke Real-World Evidence from the Repatha-CE Trial Reinforces Its Position as a Leading LDL-C Lowering Therapy for Reducing Cardiovascular Events THOUSAND OAKS, Calif., Oct. 31, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that new data from its cardiovascular portfolio, including late-breaking results from t ...
 Amgen Stock: Analyst Estimates & Ratings
 Yahoo Finance· 2025-10-31 19:37
 Amgen Inc. (AMGN) is a leading biopharmaceutical company headquartered in California. The company harnesses advanced biology and technology to discover, develop, manufacture, and deliver innovative medicines for serious illnesses, including cancer, heart disease, osteoporosis, inflammation, and rare diseases. The company’s market capitalization stands at $157.2 billion.  Shares of Amgen have underperformed the broader market over the past 52 weeks. AMGN has declined 7.5% over this time frame, while the bro ...
 Marjorie Taylor Greene Buys Netflix Stock After Downbeat Q3 Earnings, Expands Big Tech Bet - Netflix (NASDAQ:NFLX)
 Benzinga· 2025-10-31 15:08
Rep. Marjorie Taylor Greene (R-Ga.) purchased Netflix Inc. on Oct.24, just days after the streaming giant's stock tumbled following a disappointing third-quarter earnings report.Greene Loads On NFLX, Was She ‘Buying The Dip’?The purchase, valued between $1,001 and $15,000, was one of 14 new investments disclosed in a Periodic Transaction Report filed on Oct. 28.Netflix reported its earnings on Oct. 21, missing analyst expectations and causing its stock to drop significantly on Oct. 22. Rep. Greene's purchas ...
 Amgen (AMGN) Q3 Earnings Preview: What You Should Know Beyond the Headline Estimates
 ZACKS· 2025-10-30 22:16
Analysts on Wall Street project that Amgen (AMGN) will announce quarterly earnings of $5.00 per share in its forthcoming report, representing a decline of 10.4% year over year. Revenues are projected to reach $8.94 billion, increasing 5.2% from the same quarter last year.Over the past 30 days, the consensus EPS estimate for the quarter has been adjusted downward by 0.9% to its current level. This demonstrates the covering analysts' collective reassessment of their initial projections during this period.Prio ...
 U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo)
 The Manila Times· 2025-10-30 15:53
 The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 29, 2025The interchangeability (IC) designations of STOBOCLO and OSENVELT were granted based not only on the comparative clinical data - including pharmacokinetics, efficacy, safety and an immunogenicity study in postmenopausal women with osteoporosis[1] - but also on ana ...
 AMGEN ANNOUNCES WEBCAST OF 2025 THIRD QUARTER FINANCIAL RESULTS
 Prnewswire· 2025-10-30 04:01
Accessibility StatementSkip Navigation THOUSAND OAKS, Calif., Oct. 29, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its third quarter 2025 financial results on Tuesday, November 4, 2025, after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 4:30 p.m. ET. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen's seni ...