The LVT DURATION (Optimal Duration of Anticoagulation for LV Thrombus) is a pilot study planned to assess the practicalities of conducting a randomised control trial (RCT) whilst establishing data around the ideal duration of anticoagulation in the treatment of LV thrombus. The main objectives of the study are:
* To assess the practicalities of conducting an RCT with regard to recruitment, retention, and outcome measurement.
* To identify the optimal length of anticoagulation in the treatment of LV Thrombus
After randomisation participants will:
* Continue their prescribed oral anticoagulant for the remainder of the trial
* Discontinue their prescribed oral anticoagulant for the remainder of the trial

开始日期2026-12-01

申办/合作机构

Queen Mary University of London

NCT07468448

/ Not yet recruiting临床3期IIT

Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe (CATIS- ICAS)

CATIS-ICAS is a double-blind, randomized, placebo-controlled (RCT), phase III study seeking to demonstrate that oral rivaroxaban 2.5 mg twice daily plus aspirin daily is superior to clopidogrel 75 mg daily plus aspirin daily for 90 days followed by placebo plus aspirin daily for preventing recurrent stroke in those with ischemic stroke secondary to intracranial atherosclerotic disease (ICAD) of 30-99%, when started within 30 days of index stroke.

开始日期2026-09-30

申办/合作机构

Population Health Research Institute

NCT05900388

/ Not yet recruitingN/A

Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).
VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening.
Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information.
The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old.
The main information that researchers will collect in this study:
* Age, gender, and other information about the child and their illness
* Type of VTE treatment given to the child
* Occurrence of medically important bleeding and its severity
Further information that researchers will collect:
* Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE
* Return of VTE symptoms
* Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study.
The data for this study will be collected from electronic health records and health insurance claims data until 2026.
Researchers will observe each child during treatment until:
* end of the anticoagulation treatment period e.g. discontinuation of all study drugs,
* their information is no longer available, or
* the study ends.

开始日期2026-09-01

申办/合作机构

Bayer AG

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100 项与利伐沙班相关的临床结果

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100 项与利伐沙班相关的转化医学

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100 项与利伐沙班相关的专利（医药）

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8,473

项与利伐沙班相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of apixaban compared with other oral anticoagulants for the treatment of non-valvular atrial fibrillation in a Belgian healthcare setting

Article

作者: Salter, Chloe ; Stawowczyk, Ewa ; Subash, Rupesh ; Goovaerts, Hannah ; Ricci-Pacifici, Luca ; Dickerson, Carissa

AIMS:

Direct oral anticoagulants (DOACs) are recommended for stroke and systemic embolism prevention in patients with non-valvular atrial fibrillation (NVAF) in preference to vitamin K antagonists (VKAs, e.g. warfarin). This study assessed the cost-effectiveness of apixaban versus warfarin, dabigatran, edoxaban, and rivaroxaban for patients with NVAF from the Belgian payer perspective.

METHODS:

Based on a previously-validated model, a lifetime cohort-level Markov model was built in Microsoft Excel for the Belgian setting, incorporating costs (2025) representative of a DOAC market following patent expiry. The cohort (n = 1,000) included patients with NVAF eligible for oral anticoagulation. Different study types provided clinical inputs for event risk in the base case analysis (based on a network meta-analysis of randomised controlled trials) and in a scenario analysis (based on real-world evidence). The primary model outcome was the incremental cost-effectiveness ratio (ICER), measured by the cost per quality-adjusted life year (QALY) gained. Cost-effectiveness was determined by a willingness-to-pay threshold of €30,000/QALY gained.

RESULTS:

Driven by a reduction in clinical event risk, apixaban treatment was associated with QALY gains of 0.306, 0.068, 0.115 and 0.034 compared with warfarin, dabigatran, edoxaban, and rivaroxaban, respectively. In the base case analysis, apixaban treatment was associated with lower total costs due to a reduction in acute event costs and long-term management costs, resulting in apixaban dominating (i.e. more effective and less costly) all comparators from a Belgian payer perspective. Similar conclusions were observed in a scenario analysis using clinical inputs derived from real-world evidence.

CONCLUSIONS:

Apixaban is associated with fewer clinical events and lower total costs versus warfarin, dabigatran, edoxaban, and rivaroxaban for patients with NVAF, dominating (i.e. more effective and less costly) all comparators from a Belgian payer perspective under post-patent-expiry assumptions. The consistency of model outcomes between base case and scenario analyses suggests a level of robustness to these findings.

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Plain language summary examining clinical event related costs associated with changing medication from apixaban to rivaroxaban in people with non-valvular atrial fibrillation in the USA and Germany

Article

作者: Dworatzek, Elke ; Duan, Cecilia ; Kongnakorn, Thitima ; Zhang, Michelle ; Hines, Dionne M. ; Subash, Rupesh ; Kisser, Agnes

2026-12-31·RENAL FAILURE

Comparative efficacy and safety of apixaban and rivaroxaban versus warfarin in atrial fibrillation patients with end-stage renal disease: a systematic review and meta-analysis

Review

作者: Liu, Xin ; Meng, Jie ; Zhou, Yilun ; Wu, Xiaoyuan ; Yang, Yu ; Sheng, Dacheng

This study aimed to evaluate the comparative efficacy and safety of apixaban and rivaroxaban versus vitamin K antagonists (VKAs) in anticoagulation management in a dialysis population. PubMed, Embase, and the Cochrane Library were searched for studies comparing apixaban or rivaroxaban with VKAs in patients with atrial fibrillation (AF) undergoing dialysis. The primary efficacy endpoints included stroke/systemic embolism (SSE) and all-cause mortality. Safety outcomes encompassed major bleeding, intracranial hemorrhage, and gastrointestinal bleeding. Risk ratios (RR) with 95% confidence intervals (CI) were synthesized using random-effects models. The meta-analysis included three randomized controlled trials (RCTs) and eight observational studies. Pooled analyses showed that apixaban and rivaroxaban were associated with lower risks of major bleeding (RR 0.57, 95% CI: 0.51-0.63), gastrointestinal bleeding (RR 0.66, 95% CI: 0.57-0.76), and intracranial hemorrhage (RR 0.54, 95% CI: 0.36-0.83) compared with VKAs. Additionally, apixaban and rivaroxaban were associated with reduced risk of SSE (RR 0.57, 95% CI: 0.46-0.72) and all-cause mortality (RR 0.73, 95% CI:0.63-0.83), although substantial heterogeneity was present. Exploratory dose-stratified analyses suggested both standard- and low-dose apixaban regimens were associated with favorable efficacy and hemostatic safety relative to warfarin. Consistent numerical trends were observed in the RCT-only analysis, though none reached statistical significance owing to limited sample size. In conclusion, apixaban and rivaroxaban are associated with lower risks of bleeding compared with VKAs in patients with AF and ESRD. However, evidence regarding their efficacy in preventing SSE, all-cause mortality and the optimal apixaban dosing regimen remains inconclusive and requires validation in large, dedicated RCTs.

1,390

项与利伐沙班相关的新闻（医药）

2026-09-09

·知乎专栏

信立泰A股刚刚跌没300亿，420亿广东富豪家族转身赴港又要IPO了！

你在病房走廊、在药店柜台、在无数家庭的药箱里，或许都见过它的身影，一片用于心血管慢病的常用药。对中国数亿心血管病患者来说，这是每天雷打不动的“必修课”。这门生意背后，站着一家深圳公司。2026年9月3日，深圳信立泰药业股份有限公司（下称“信立泰”，002294.SZ）更新递交H股发行上市申请，拟冲刺A+H；这距离其首次递表，刚过去不到七个月。信立泰的主场，正是心血管领域。按公司委托的第三方机构弗若斯特沙利文的数据，按2024年收入计，它是中国心血管创新药领域排名第二的企业。2025年，公司营收43.53亿元，创新药收入首次突破药品收入的一半。故事到这里，本该是一个“老牌药企成功转型”的样本。转折发生在2026年5月10日。信立泰公告，核心在研心衰药JK07的II期临床试验主要终点未达统计学显著。次日，公司股价一字跌停，市值从4月初约760亿元回落至约400亿元。营收回来了，利润却不到七年前的一半。这家靠仿制药起家的公司，到底要在港股讲一个怎样的故事？01二十年转型路：营收回巅峰，净利却腰斩信立泰的转型，得从一片药说起。2000年，信立泰推出硫酸氢氯吡格雷片“泰嘉”，抢在原研药赛诺菲“波立维”之前获批，拿下约12年市场独占期。靠着这款抗血栓首仿药，名不见经传的小药厂一路长成心血管龙头，2009年登陆深交所。泰嘉有多赚钱？2018年，这款大单品销售额约32亿元，占公司总营收近七成。同一年，信立泰营收46.52亿元、归母净利润14.58亿元，双双创下历史峰值。但转折点来得比预期更猛。2019年9月，全国集采扩围，赛诺菲报出2.54元的全场最低价，信立泰3.13元的报价成了最高价，泰嘉丢标出局。次年销售额同比骤降约六成，公司营收下滑38.74%，净利润断崖式下跌91.49%。真正的至暗时刻在2020年：营收仅27.39亿元，归母净利润6086.5万元，扣非净利润只有386万元。一款仿制药，撑起了公司，也拖垮了公司。危机之下，信立泰开始“大象转身”。一方面，陆续打包出售盐酸达泊西汀、厄洛替尼、利伐沙班、伊马替尼等数十个低端仿制药项目，回笼资金；另一方面，把早年引进的1类新药信立坦推到前台。信立坦接过了泰嘉的班。这款2013年获批的国产首个ARB类降压药，2017年纳入医保后持续放量，2021年销售额破10亿元，2024年已达约15亿元，成为国内最畅销的ARB药物之一。转型的代价，写在了利润表上。2025年，公司营收43.53亿元，同比增长8.48%，已基本追平2018年峰值。但归母净利润6.52亿元，不到2018年14.58亿元的一半；扣非归母净利润5.54亿元，同比还下滑2.84%。规模回来了，净利却腰斩，这背后，是钱花在了两端。一边是销售费用不降反升。2023年至2025年，信立泰销售费用从10.16亿元增至17.63亿元，费用率由30.18%攀升至40.5%。另一边是研发投入高企。2025年，公司研发投入12.66亿元，占营收的29.1%。近七年创新科研投入累计已超60亿元。更微妙的是收入结构的倒挂。2025年，创新药收入19.99亿元，同比增长47.25%，首次占到药品收入的一半以上；而仿制药等其他收入18.38亿元，同比下滑18.21%。这意味着，信立泰正在用更高的销售投入和更高的研发占比，去置换一个尚未完全兑现的利润率。规模回来了，成色还没回来。流动性的信号同样值得留意。公司流动比率从2023年的4.1降至2025年9月末的2.4，速动比率从3.5降至2.1。截至2025年9月末，流动负债18.06亿元，其中一年内到期需赎回的负债4.21亿元。02信立坦部分专利到期，市值一月蒸发350亿真正撑起“创新药企”名片的，是信立坦。信立坦（阿利沙坦酯片）是信立泰目前最核心的创新药产品。2025年，它销售收入14.84亿元，占药品总收入的38.7%；作为国产首个ARB类降压药，它在所有ARB类药物中市场份额排名第一。但一道“专利悬崖”已经到来。涵盖信立坦活性成分的化合物发明专利，已于2026年7月届满。《招股书》坦言，未来数年，随着低价仿制药引入，信立坦将面临加剧的竞争、定价压力与份额流失。公司并非毫无准备。化合物专利之外，制剂专利有效期至2028年1月，晶型专利更到2034年；以信立坦为核心的“阿利沙坦家族”也已铺开，复立坦（ARB+CCB复方）、复立安（ARB+利尿剂复方），以及对标诺华诺欣妥的ARNI类药物信超妥（S086），其化合物专利到2037年。《招股书》提示，公司通过多层次专利与产品矩阵延缓仿制药冲击，但“化合物专利到期意味着仿制药企业可以合法生产销售相同活性成分的产品”。专利能续命，研发却未必时时顺利。在研发过程中，信立泰已多次遭遇挫折。2024年及2025年，因临床试验结果不理想，公司分别确认了1.37亿元和1.51亿元的递延开发成本减值。《招股书》解释，公司自愿终止了一款治疗新冠的候选药物、以及一款预防及治疗血栓的候选药物的临床开发。2025年，信立泰对3个在研项目计提开发支出减值1.51亿元，理由包括“药效未达预期、研发周期长、竞争激烈、预估未来收益不达预期”。剔除这1.51亿元一次性减值影响后，当年归母净利润约8.02亿元。这些减值，直接侵蚀了净利润。管线里还有备选。《招股书》显示，公司在研创新药项目79个（截至最后实际可行日期），研发人员827人；心衰药S086预计2026年申报上市许可申请（NDA），GLP-1口服周制剂SAL0150已提交临床试验申请（IND）。但远水难救近火，多数仍处更早期。真正让市场紧张的，还是JK07。JK07（SAL007）是一款重组人神经调节蛋白1（NRG-1）与抗HER3抗体融合蛋白，用于治疗慢性心力衰竭。在信立泰的管线里，它是最接近商业化、也最被寄予厚望的重磅创新药。对信立泰，JK07 不只是管线里的一款药，而是“仿转创”成色的试金石。它是公司第一个中美双报的创新生物药，由美国子公司自研、具全球知识产权，在研 79 个创新药里进度最靠前。它最大的价值，是一条“全球首创”的心肌修复机制。心衰治疗的最大瓶颈不是延缓，而是心肌重构难逆转；现有药物只减负、不修复。JK07被国联民生、国金等称为具全球首创（FIC）潜质，全球暂无同通路疗法获批。叠加心衰全球超 6400 万患者的大适应症、NRG-1 赛道仅 3 款在研的干净格局，以及出海想象（东吴测算海外峰值超 100 亿美元；公司曾称全球销售有望达 200 亿美元），让它顶着“重磅炸弹”光环。正因如此，它对股价的影响被放大到极致。华创、东吴都曾给出 954 亿元估值、目标价 85.5元/股，其中JK07单项约414亿，总估值超四成押在这款药；2026年4月股价27元/股飙至67元/股，493家机构抱团，市值冲高近750亿元。2026年5月10日，公司公告RENEU-HF II期临床结果：主要终点左室射血分数（LVEF）未达统计学显著性。次要终点中，患者生活质量评分（KCCQ）和6分钟步行距离（6MWD）有改善。更关键的是，这次披露仅包含26周中期数据，52周完整数据尚未出炉。公告次日，信立泰一字跌停；自4月初约760亿元高点，市值一路回落至约400亿元，一个多月蒸发超350亿元。和君咨询史天一指出，主要终点未达预期“显著削弱市场对信立泰心血管创新研发能力的信心”；UCSI 商学院欧程曦则认为管线结构单一、价值高度绑定 JK07，暴露接替品种不足。03从副市长到药企老板，叶氏家族的资本棋局信立泰的故事，绕不开创始人叶澄海。1943年生于广东梅州的叶澄海，是中国医疗企业家群体里履历最特别的一个。中国人民大学毕业后，他从深圳基层干起，1983年39岁出任广东省委常委、深圳市副市长，主管外经贸，是当时最年轻的副省级干部之一。1986年，他辞官下海，先在深圳办起丝绸服装厂、电子验钞机厂，又涉足电子、焦炭、房地产、钢铁，还曾赴美国、南美经商。1989年，他合伙创办深圳海滨制药厂，正式扎根医药；1998年，信立泰成立。图源：罐头图库如今接过这副担子的，是其子叶宇翔。1974年出生的他，拥有美国密歇根大学学士、耶鲁大学MBA背景，2004年加入信立泰，2022年接任董事长。上任后，他果断砍掉数十个低端仿制药项目，把资源收缩到心血管-肾脏-代谢（CKM）这一优势赛道。目前公司由三代同堂治理。叶澄海任终身名誉主席，仍管战略；其女叶宇筠任总经理助理；29岁的外孙女陈茜渝2023年底进入董事会，任高级项目经理。一个家族企业，正完成代际交接。叶澄海家族对信立泰的控制，也较为集中。控股股东信立泰香港（信立泰药业有限公司）持有上市公司56.99%股份；信立泰香港由"美洲"公司及叶澄海各持50%，美洲公司再由叶澄海与配偶廖清清各持50%。穿透之后，叶氏家族通过美洲公司间接控制着逾56%的表决权。《招股书》披露，自2009年A股上市以来，信立泰累计向股东派发股息超78亿元，为A股融资款的两倍以上。换句话说，从A股融来的钱，早已加倍奉还。叶澄海家族也是各大富豪榜的常客。据胡润研究院榜单，叶澄海、廖清清夫妇 2016 年以 225 亿元身家位列胡润百富榜第 89 位；2025 年胡润百富榜，叶澄海家族以 275 亿元财富排第 240 位；2026 年胡润全球富豪榜，其身家随信立泰股价水涨船高至 420 亿元、列第 742 位。财富的起伏，几乎与信立泰的市值曲线同步，JK07 受挫前市值冲高，家族身家也被推到阶段高点。市场波动之下，公司也在用回购稳定信心。2026年5月底，信立泰推出3亿至5亿元回购方案，回购上限45元/股，其中含不超过4.5亿元银行专项贷款；截至6月末，已斥资1.14亿元回购375.2万股。另一条边，分拆创新业务平台信泰医疗独立上市，目前尚无实质进展。信泰医疗主营神经、心血管、外周血管介入器械，核心产品Maurora支架在椎动脉介入领域份额居前；信立泰持有其89.74%股份，叶氏家族合计控制89.4%表决权。2023年3月，公司曾宣布拟分拆信泰医疗至科创板，至今未落地。《招股书》里，公司给自己定了一个更远的标：2026年至2030年实现百亿营收目标。从43.53亿元到100亿元，五年要接近翻1.3倍。对一家净利刚过6亿、仍靠高费用高研发撑着转型、核心单品又临专利悬崖的公司来说，这个目标并不轻松。从泰嘉的失标，到信立坦的接棒，再到JK07的哑火，信立泰的“仿转创”走过了二十余年。营收回到了2018年，净利却还停在半山腰。你或家人用过信立坦、泰嘉这类心血管药吗？怎么看这家老牌药企的转型？欢迎下方留言讨论。

2026-09-09

·搜狐新闻

信立泰A股刚刚跌没300亿，420亿广东富豪家族转身赴港又要IPO了！

来源：野马财经你在病房走廊、在药店柜台、在无数家庭的药箱里，或许都见过它的身影，一片用于心血管慢病的常用药。对中国数亿心血管病患者来说，这是每天雷打不动的“必修课”。这门生意背后，站着一家深圳公司。2026年9月3日，深圳信立泰药业股份有限公司（下称“信立泰”，002294.SZ）更新递交H股发行上市申请，拟冲刺A+H；这距离其首次递表，刚过去不到七个月。信立泰的主场，正是心血管领域。按公司委托的第三方机构弗若斯特沙利文的数据，按2024年收入计，它是中国心血管创新药领域排名第二的企业。2025年，公司营收43.53亿元，创新药收入首次突破药品收入的一半。故事到这里，本该是一个“老牌药企成功转型”的样本。转折发生在2026年5月10日。信立泰公告，核心在研心衰药JK07的II期临床试验主要终点未达统计学显著。次日，公司股价一字跌停，市值从4月初约760亿元回落至约400亿元。营收回来了，利润却不到七年前的一半。这家靠仿制药起家的公司，到底要在港股讲一个怎样的故事？ 01 二十年转型路：营收回巅峰，净利却腰斩信立泰的转型，得从一片药说起。 2000年，信立泰推出硫酸氢氯吡格雷片“泰嘉”，抢在原研药赛诺菲“波立维”之前获批，拿下约12年市场独占期。靠着这款抗血栓首仿药，名不见经传的小药厂一路长成心血管龙头，2009年登陆深交所。泰嘉有多赚钱？2018年，这款大单品销售额约32亿元，占公司总营收近七成。同一年，信立泰营收46.52亿元、归母净利润14.58亿元，双双创下历史峰值。但转折点来得比预期更猛。2019年9月，全国集采扩围，赛诺菲报出2.54元的全场最低价，信立泰3.13元的报价成了最高价，泰嘉丢标出局。次年销售额同比骤降约六成，公司营收下滑38.74%，净利润断崖式下跌91.49%。真正的至暗时刻在2020年：营收仅27.39亿元，归母净利润6086.5万元，扣非净利润只有386万元。一款仿制药，撑起了公司，也拖垮了公司。危机之下，信立泰开始“大象转身”。一方面，陆续打包出售盐酸达泊西汀、厄洛替尼、利伐沙班、伊马替尼等数十个低端仿制药项目，回笼资金；另一方面，把早年引进的1类新药信立坦推到前台。信立坦接过了泰嘉的班。这款2013年获批的国产首个ARB类降压药，2017年纳入医保后持续放量，2021年销售额破10亿元，2024年已达约15亿元，成为国内最畅销的ARB药物之一。转型的代价，写在了利润表上。 2025年，公司营收43.53亿元，同比增长8.48%，已基本追平2018年峰值。但归母净利润6.52亿元，不到2018年14.58亿元的一半；扣非归母净利润5.54亿元，同比还下滑2.84%。规模回来了，净利却腰斩，这背后，是钱花在了两端。一边是销售费用不降反升。2023年至2025年，信立泰销售费用从10.16亿元增至17.63亿元，费用率由30.18%攀升至40.5%。另一边是研发投入高企。2025年，公司研发投入12.66亿元，占营收的29.1%。近七年创新科研投入累计已超60亿元。更微妙的是收入结构的倒挂。2025年，创新药收入19.99亿元，同比增长47.25%，首次占到药品收入的一半以上；而仿制药等其他收入18.38亿元，同比下滑18.21%。这意味着，信立泰正在用更高的销售投入和更高的研发占比，去置换一个尚未完全兑现的利润率。规模回来了，成色还没回来。流动性的信号同样值得留意。公司流动比率从2023年的4.1降至2025年9月末的2.4，速动比率从3.5降至2.1。截至2025年9月末，流动负债18.06亿元，其中一年内到期需赎回的负债4.21亿元。 02 信立坦部分专利到期，市值一月蒸发350亿真正撑起“创新药企”名片的，是信立坦。信立坦（阿利沙坦酯片）是信立泰目前最核心的创新药产品。2025年，它销售收入14.84亿元，占药品总收入的38.7%；作为国产首个ARB类降压药，它在所有ARB类药物中市场份额排名第一。但一道“专利悬崖”已经到来。涵盖信立坦活性成分的化合物发明专利，已于2026年7月届满。《招股书》坦言，未来数年，随着低价仿制药引入，信立坦将面临加剧的竞争、定价压力与份额流失。公司并非毫无准备。化合物专利之外，制剂专利有效期至2028年1月，晶型专利更到2034年；以信立坦为核心的“阿利沙坦家族”也已铺开，复立坦（ARB+CCB复方）、复立安（ARB+利尿剂复方），以及对标诺华诺欣妥的ARNI类药物信超妥（S086），其化合物专利到2037年。《招股书》提示，公司通过多层次专利与产品矩阵延缓仿制药冲击，但“化合物专利到期意味着仿制药企业可以合法生产销售相同活性成分的产品”。专利能续命，研发却未必时时顺利。在研发过程中，信立泰已多次遭遇挫折。2024年及2025年，因临床试验结果不理想，公司分别确认了1.37亿元和1.51亿元的递延开发成本减值。《招股书》解释，公司自愿终止了一款治疗新冠的候选药物、以及一款预防及治疗血栓的候选药物的临床开发。 2025年，信立泰对3个在研项目计提开发支出减值1.51亿元，理由包括“药效未达预期、研发周期长、竞争激烈、预估未来收益不达预期”。剔除这1.51亿元一次性减值影响后，当年归母净利润约8.02亿元。这些减值，直接侵蚀了净利润。管线里还有备选。《招股书》显示，公司在研创新药项目79个（截至最后实际可行日期），研发人员827人；心衰药S086预计2026年申报上市许可申请（NDA），GLP-1口服周制剂SAL0150已提交临床试验申请（IND）。但远水难救近火，多数仍处更早期。真正让市场紧张的，还是JK07。 JK07（SAL007）是一款重组人神经调节蛋白1（NRG-1）与抗HER3抗体融合蛋白，用于治疗慢性心力衰竭。在信立泰的管线里，它是最接近商业化、也最被寄予厚望的重磅创新药。对信立泰，JK07 不只是管线里的一款药，而是“仿转创”成色的试金石。它是公司第一个中美双报的创新生物药，由美国子公司自研、具全球知识产权，在研 79 个创新药里进度最靠前。它最大的价值，是一条“全球首创”的心肌修复机制。心衰治疗的最大瓶颈不是延缓，而是心肌重构难逆转；现有药物只减负、不修复。JK07被国联民生、国金等称为具全球首创（FIC）潜质，全球暂无同通路疗法获批。叠加心衰全球超 6400 万患者的大适应症、NRG-1 赛道仅 3 款在研的干净格局，以及出海想象（东吴测算海外峰值超 100 亿美元；公司曾称全球销售有望达 200 亿美元），让它顶着“重磅炸弹”光环。正因如此，它对股价的影响被放大到极致。华创、东吴都曾给出 954 亿元估值、目标价 85.5元/股，其中JK07单项约414亿，总估值超四成押在这款药；2026年4月股价27元/股飙至67元/股，493家机构抱团，市值冲高近750亿元。 2026年5月10日，公司公告RENEU-HF II期临床结果：主要终点左室射血分数（LVEF）未达统计学显著性。次要终点中，患者生活质量评分（KCCQ）和6分钟步行距离（6MWD）有改善。更关键的是，这次披露仅包含26周中期数据，52周完整数据尚未出炉。公告次日，信立泰一字跌停；自4月初约760亿元高点，市值一路回落至约400亿元，一个多月蒸发超350亿元。和君咨询史天一指出，主要终点未达预期“显著削弱市场对信立泰心血管创新研发能力的信心”；UCSI 商学院欧程曦则认为管线结构单一、价值高度绑定 JK07，暴露接替品种不足。 03 从副市长到药企老板，叶氏家族的资本棋局信立泰的故事，绕不开创始人叶澄海。 1943年生于广东梅州的叶澄海，是中国医疗企业家群体里履历最特别的一个。中国人民大学毕业后，他从深圳基层干起，1983年39岁出任广东省委常委、深圳市副市长，主管外经贸，是当时最年轻的副省级干部之一。 1986年，他辞官下海，先在深圳办起丝绸服装厂、电子验钞机厂，又涉足电子、焦炭、房地产、钢铁，还曾赴美国、南美经商。1989年，他合伙创办深圳海滨制药厂，正式扎根医药；1998年，信立泰成立。图源：罐头图库如今接过这副担子的，是其子叶宇翔。1974年出生的他，拥有美国密歇根大学学士、耶鲁大学MBA背景，2004年加入信立泰，2022年接任董事长。上任后，他果断砍掉数十个低端仿制药项目，把资源收缩到心血管-肾脏-代谢（CKM）这一优势赛道。目前公司由三代同堂治理。叶澄海任终身名誉主席，仍管战略；其女叶宇筠任总经理助理；29岁的外孙女陈茜渝2023年底进入董事会，任高级项目经理。一个家族企业，正完成代际交接。叶澄海家族对信立泰的控制，也较为集中。控股股东信立泰香港（信立泰药业有限公司）持有上市公司56.99%股份；信立泰香港由"美洲"公司及叶澄海各持50%，美洲公司再由叶澄海与配偶廖清清各持50%。穿透之后，叶氏家族通过美洲公司间接控制着逾56%的表决权。《招股书》披露，自2009年A股上市以来，信立泰累计向股东派发股息超78亿元，为A股融资款的两倍以上。换句话说，从A股融来的钱，早已加倍奉还。叶澄海家族也是各大富豪榜的常客。据胡润研究院榜单，叶澄海、廖清清夫妇 2016 年以 225 亿元身家位列胡润百富榜第 89 位；2025 年胡润百富榜，叶澄海家族以 275 亿元财富排第 240 位；2026 年胡润全球富豪榜，其身家随信立泰股价水涨船高至 420 亿元、列第 742 位。财富的起伏，几乎与信立泰的市值曲线同步，JK07 受挫前市值冲高，家族身家也被推到阶段高点。市场波动之下，公司也在用回购稳定信心。2026年5月底，信立泰推出3亿至5亿元回购方案，回购上限45元/股，其中含不超过4.5亿元银行专项贷款；截至6月末，已斥资1.14亿元回购375.2万股。另一条边，分拆创新业务平台信泰医疗独立上市，目前尚无实质进展。信泰医疗主营神经、心血管、外周血管介入器械，核心产品Maurora支架在椎动脉介入领域份额居前；信立泰持有其89.74%股份，叶氏家族合计控制89.4%表决权。2023年3月，公司曾宣布拟分拆信泰医疗至科创板，至今未落地。《招股书》里，公司给自己定了一个更远的标：2026年至2030年实现百亿营收目标。从43.53亿元到100亿元，五年要接近翻1.3倍。对一家净利刚过6亿、仍靠高费用高研发撑着转型、核心单品又临专利悬崖的公司来说，这个目标并不轻松。从泰嘉的失标，到信立坦的接棒，再到JK07的哑火，信立泰的“仿转创”走过了二十余年。营收回到了2018年，净利却还停在半山腰。你或家人用过信立坦、泰嘉这类心血管药吗？怎么看这家老牌药企的转型？欢迎下方留言讨论。返回搜狐，查看更多

2026-09-09

·BioSpace

BAYER INITIATES PHASE II STUDY OF INVESTIGATIONAL GIRK4 INHIBITOR IN PATIENTS WITH ATRIAL FIBRILLATION

GIRK4 (BAY 3670549) is an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor being evaluated as a potential new approach to control the electrical activity of cardiomyocytes in patients with atrial fibrillation (AFib) AFib is the most common type of sustained cardiac arrhythmia (irregular heart rhythm), affecting more than 60 million people worldwide, and a significant risk factor for stroke and heart failure 1,2,3 Positive data from the Phase I first-in-human, dose-escalation study supports advancing GIRK4 inhibitor to the next phase of development Derived from the strategic research alliance with the Broad Institute of MIT and Harvard, BAY 3670549 further strengthens Bayer’s cardiovascular development portfolio Not intended for UK Media WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today the initiation of a global Phase II clinical trial ( NCT07625215 ) evaluating BAY 3670549, an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, which has the potential as a new approach to control the electrical activity of heart cells in patients with atrial fibrillation (AFib). The Phase II single-treatment study in a randomized, double-blind, placebo-controlled, parallel-group, multi-cohort design, will investigate the efficacy, safety and tolerability, as well as pharmacodynamics and pharmacokinetics of BAY 3670549 in adult patients with AFib. BAY 3670549 showed a generally favorable safety and tolerability pro healthy participants in the completed first-in-human single-ascending-dose Phase I study, supporting its continued clinical advancement and strengthening Bayer’s cardiovascular development portfolio. BAY 3670549, which emerged from Bayer’s strategic research alliance with the Broad Institute, is being investigated as a novel approach for rapid cardioversion to normal sinus rhythm. If successful, it could provide a potential alternative to electrical cardioversion, the current gold standard for AFib. AFib is the most common type of sustained cardiac arrhythmia (irregular heart rhythm), affecting more than 60 million people worldwide, and a significant risk factor for stroke and heart failure. 4,5,6 About GIRK4 inhibitor (BAY 3670549) BAY 3670549 is an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor being evaluated as a potential new approach to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib). GIRK4 channels are specialized proteins that regulate the electrical activity of heart cells by facilitating the flow of potassium ions (K+) in response to the neurotransmitter acetylcholine (ACh). This mechanism is particularly crucial during the later phases of the heart’s electrical signaling, specifically during the atrial effective refractory period (AERP). Increased activity of these channels shortens the AERP in the atria (the upper chambers of the heart), thereby reducing the recovery time after each heartbeat. This alteration in recovery time can contribute to the onset and persistence of AFib. About the study ( NCT07625215 ) A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase II study will investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with AFib. The study will compare BAY 3670549 to a placebo in patients with AFib who need a treatment called electrical cardioversion. Electrical cardioversion is a procedure that helps the heart return to a normal rhythm. In the Phase I study, BAY 3670549 was generally well-tolerated in healthy male and female participants. About Atrial fibrillation AFib is one of the most common sustained cardiac rhythm disorders (arrhythmias). It results from rapid, disorganized electrical signals in the upper chambers (atria) of the heart, causing them to quiver and contract quickly and irregularly. As a result, the atria do not empty efficiently, leading to impaired blood flow and an increased risk of blood clot formation. These clots can break loose, travel to the brain, and cause a stroke. In addition, AFib disrupts the coordinated function of the upper and lower chambers of the heart, impairing overall cardiac performance and leading to symptoms such as palpitations, shortness of breath, fatigue, and a reduced quality of life in many patients. The prevalence of AFib continues to increase globally. Projection studies show that the number of people with AFib will rise to 15.9 million in 2050 in America and 17.9 million in 2060 in Europe. 7 People with AFib are 5 times more likely to suffer a stroke than people without AFib. 8 AFib-related strokes are also associated with a 50% likelihood of death within one year. 9 About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at Follow us on Facebook: aka (2026-0153e) Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. ____________________________ 1 Atrial fibrillation: epidemiology, screening and digital health , Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786 2 American Heart Association, Why Atrial Fibrillation Matters | American Heart Association 3 Kornej J, Benjamin EJ, Magnani JW, Atrial fibrillation: global burdens and global opportunities, Heart 2021;107:516-518. 4 Atrial fibrillation: epidemiology, screening and digital health , Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786 5 American Heart Association, Why Atrial Fibrillation Matters | American Heart Association 6 Kornej J, Benjamin EJ, Magnani JW, Atrial fibrillation: global burdens and global opportunities, Heart 2021;107:516-518. 7 Atrial fibrillation: epidemiology, screening and digital health, Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786 8 Singleton MJ, Imtiaz‐Ahmad M, Kamel H, O'Neal WT, Judd SE, Howard VJ, Howard G, Soliman EZ, Bhave PD. Association of atrial fibrillation without cardiovascular comorbidities and stroke risk: from the REGARDS study. Journal of the American Heart Association. 2020 Jun 16;9(12):e016380. 9 Alberts M, Chen YW, Lin JH, Kogan E, Twyman K, Milentijevic D. Risks of Stroke and Mortality in Atrial Fibrillation Patients Treated With Rivaroxaban and Warfarin. Stroke. 2020 Feb;51(2):549-555. doi: 10.1161/STROKEAHA.119.025554. Epub 2019 Dec 31. PMID: 31888412; PMCID: PMC7004448. Contacts Bayer U.S. Media Contact: Elaine Colon, phone +1 732 236 1587 Email: elaine.colon@bayer.com Bayer Media Contact: Anna Kanmaz, phone +49 174 146 3541 Email: anna.kanmaz@bayer.com

临床1期临床2期临床结果AHA会议

100 项与利伐沙班相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D07086	利伐沙班	B01AF01	DB06228

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适应症	国家/地区	公司	日期
冠状动脉疾病	美国	Janssen Pharmaceuticals, Inc.	2026-03-24
血栓栓塞	日本	Bayer Yakuhin Ltd.	2023-11-24
血栓形成	美国	Janssen Pharmaceuticals, Inc.	2021-12-20
动脉粥样硬化	欧盟	Viatris Ltd. (New Zealand)	2021-11-12
动脉粥样硬化	冰岛	Viatris Ltd. (New Zealand)	2021-11-12
动脉粥样硬化	列支敦士登	Viatris Ltd. (New Zealand)	2021-11-12
动脉粥样硬化	挪威	Viatris Ltd. (New Zealand)	2021-11-12
心房颤动	中国	Bayer AG	2009-03-31
心肌梗塞	澳大利亚	Bayer Australia Ltd.	2008-11-24
复发性深静脉血栓形成	澳大利亚	Bayer Australia Ltd.	2008-11-24
脑卒中	澳大利亚	Bayer Australia Ltd.	2008-11-24
全身性栓塞	澳大利亚	Bayer Australia Ltd.	2008-11-24
急性冠状动脉综合征	欧盟	Bayer AG	2008-09-30
急性冠状动脉综合征	冰岛	Bayer AG	2008-09-30
急性冠状动脉综合征	列支敦士登	Bayer AG	2008-09-30
急性冠状动脉综合征	挪威	Bayer AG	2008-09-30
急性冠状动脉综合征	英国	Bayer Plc	2008-09-30
栓塞	欧盟	Bayer AG	2008-09-30
栓塞	冰岛	Bayer AG	2008-09-30
栓塞	列支敦士登	Bayer AG	2008-09-30

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适应症	最高研发状态	国家/地区	公司	日期
心血管疾病	临床3期	澳大利亚	Bayer AG	2021-01-18
心血管疾病	临床3期	比利时	Bayer AG	2021-01-18
心血管疾病	临床3期	加拿大	Bayer AG	2021-01-18
心血管疾病	临床3期	法国	Bayer AG	2021-01-18
心血管疾病	临床3期	德国	Bayer AG	2021-01-18
心血管疾病	临床3期	印度	Bayer AG	2021-01-18
心血管疾病	临床3期	马来西亚	Bayer AG	2021-01-18
心血管疾病	临床3期	尼泊尔	Bayer AG	2021-01-18
心血管疾病	临床3期	沙特阿拉伯	Bayer AG	2021-01-18
心血管疾病	临床3期	新加坡	Bayer AG	2021-01-18

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03969953 (Pubmed \| JAMA)	临床3期	肾脏疾病	1,458	Rivaroxaban 2.5 mg	鹹遞艱顧獵齋顧壓膚齋(壓齋簾鹹獵淵艱鬱顧鏇) = 憲構簾顧窪選構鑰壓廠繭衊淵願製範簾選夢壓 (鬱鑰繭淵餘鏇獵觸淵簾 ) 更多	不佳	2026-07-28
				Placebo	鹹遞艱顧獵齋顧壓膚齋(壓齋簾鹹獵淵艱鬱顧鏇) = 窪艱窪範築積範淵襯繭繭衊淵願製範簾選夢壓 (鬱鑰繭淵餘鏇獵觸淵簾 ) 更多
NCT03266783 (COBRRA, CTgov)	临床4期	出血 \| 静脉血栓栓塞	2,760	Apixaban (Apixaban Group)	鹹糧鑰艱範襯繭願觸獵 = 壓鬱鹹齋膚糧壓糧鹽壓築醖獵餘廠艱淵獵淵鑰 (製遞願選構膚鏇構顧積, 鹽廠觸鏇齋衊鬱齋願齋 ~ 選鹽網獵艱襯醖構範網) 更多	-	2026-06-24
				rivaroxaban (Rivaroxaban Group)	鹹糧鑰艱範襯繭願觸獵 = 範觸窪鏇願遞膚艱網觸築醖獵餘廠艱淵獵淵鑰 (製遞願選構膚鏇構顧積, 夢膚願壓積製膚膚廠鬱 ~ 願襯簾製窪廠壓鏇糧醖) 更多
ADA2026	N/A	心房颤动	369,480	Reduced-Dose Direct Oral Anticoagulants	艱鑰鏇鑰遞壓獵鹹範繭(選繭夢繭壓蓋顧鹹餘膚): HR = 1.13, P-Value = 0.04	积极	2026-06-20
				Standard-Dose Direct Oral Anticoagulants
NCT03746275 (XATOA, Pubmed \| Drugs Context)	N/A	冠心病 \| 外周动脉疾病	311	Rivaroxaban 2.5 mg twice daily + Aspirin	願鑰鹹窪選遞衊鏇築鏇(衊窪鏇繭簾顧築鹹鬱襯) = 選製壓鹽蓋艱醖糧網鬱膚簾餘選夢願膚鹽願願 (齋觸鹽衊艱齋製觸選顧 ) 更多	积极	2026-06-02
NCT06901466 \| NCT07007143 (STAR-TEER, Pubmed \| Am Heart J)	临床4期	二尖瓣关闭不全	1,912	Rivaroxaban plus clopidogrel (Requiring long-term OAC)	繭糧夢選廠蓋顧壓衊築(襯蓋鬱鑰襯鏇鑰願製範) = 憲襯衊構衊襯鑰築淵齋鏇遞衊衊願膚餘窪艱淵 (壓簾衊憲積鏇積築襯齋 )	积极	2026-06-01
				Aspirin plus clopidogrel (No OAC indication)	繭糧夢選廠蓋顧壓衊築(襯蓋鬱鑰襯鏇鑰願製範) = 餘糧構齋壓窪鬱鏇鏇製鏇遞衊衊願膚餘窪艱淵 (壓簾衊憲積鏇積築襯齋 )
ASCO2026	N/A	静脉血栓栓塞 hemoglobin \| thrombocytopenia \| CKD ... 更多	11,380	Apixaban 5 mg	鹹淵窪觸夢遞糧艱鬱糧(觸選網遞廠淵淵積衊鑰) = 鹽鑰艱鹽膚遞網蓋網醖壓襯選憲窪積願蓋積壓 (遞簾鹽鹹簾蓋顧簾衊構 ) 更多	相似	2026-05-29
				Rivaroxaban 20 mg	鹹淵窪觸夢遞糧艱鬱糧(觸選網遞廠淵淵積衊鑰) = 糧艱艱鹽獵鹹製繭繭範壓襯選憲窪積願蓋積壓 (遞簾鹽鹹簾蓋顧簾衊構 ) 更多
NCT03702582 (NEW-AF, CTgov)	临床3期	出血 \| 脑卒中 \| 心房颤动	100	Warfarin (Warfarin)	顧鹽顧觸糧鬱壓襯繭淵(範遞餘製觸淵鏇醖衊構) = 夢簾醖壓簾鑰壓顧遞簾鹽襯鬱鑰積夢醖憲淵廠 (齋餘構齋鏇鬱膚窪願積, 蓋顧顧襯淵餘顧願願憲 ~ 範鹽選膚艱壓築壓範衊) 更多	-	2026-05-19
				rivaroxaban (Rivaroxaban)	顧鹽顧觸糧鬱壓襯繭淵(範遞餘製觸淵鏇醖衊構) = 膚廠製壓壓築願繭繭製鹽襯鬱鑰積夢醖憲淵廠 (齋餘構齋鏇鬱膚窪願積, 遞願糧夢築構鹹膚膚齋 ~ 鬱齋襯遞繭餘網襯醖鹹) 更多
ATS2026	N/A	慢性血栓栓塞性肺动脉高压	8,061	DOACs (apixaban or rivaroxaban)	獵襯製簾願鹹襯觸餘襯(膚膚夢憲鬱鑰醖壓遞鬱) = 觸窪積構積簾憲築繭窪鬱範繭蓋築夢壓蓋窪襯 (憲艱觸觸顧衊築築淵齋 ) 更多	积极	2026-05-15
				Warfarin	獵襯製簾願鹹襯觸餘襯(膚膚夢憲鬱鑰醖壓遞鬱) = 觸願窪網顧醖範夢衊廠鬱範繭蓋築夢壓蓋窪襯 (憲艱觸觸顧衊築築淵齋 ) 更多
EHA2026	N/A	心房颤动 \| 静脉血栓栓塞	200	Apixaban 5 mg twice daily	獵網積壓糧鹹範膚夢齋(蓋範憲簾壓網獵製衊築) = 壓蓋製衊鑰製襯夢構憲膚蓋廠膚廠壓蓋獵鹹築 (廠夢夢願築簾窪憲範餘 ) 更多	积极	2026-05-12
				reduced DOAC doses	獵網積壓糧鹹範膚夢齋(蓋範憲簾壓網獵製衊築) = 膚醖憲艱鏇鹽齋蓋鏇衊膚蓋廠膚廠壓蓋獵鹹築 (廠夢夢願築簾窪憲範餘 ) 更多
DDW2026	N/A	肝细胞癌	934	Warfarin (Hepatocellular carcinoma with portal vein thrombosis)	鏇鬱製範夢齋積選襯製(鹽憲憲顧選夢襯觸網觸) = 範糧齋糧廠衊鏇製廠艱網網觸窪願齋鏇衊衊製 (範願糧觸範積淵襯齋衊 ) 更多	积极	2026-05-02
				Direct oral anticoagulants (rivaroxaban, apixaban) (Hepatocellular carcinoma with portal vein thrombosis)	鏇鬱製範夢齋積選襯製(鹽憲憲顧選夢襯觸網觸) = 遞繭鏇繭齋窪襯窪獵餘網網觸窪願齋鏇衊衊製 (範願糧觸範積淵襯齋衊 ) 更多