DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis (excluding TAVI) at least 7 days after cardiac surgery.
Experimental group:
Patients treated with apixaban 5 mg twice daily (BID)
Active Comparator group:
Aspirin 75 to 100mg once a day
The primary objective is to demonstrate that antithrombotic treatment with apixaban is superior to aspirin in patients with recent surgical bioprosthetic aortic valve replacement for the primary composite efficacy endpoint of death from any cause, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis after 105 days of follow-up.

开始日期2025-09-01

申办/合作机构

Eske Corp. SAC

NCT06933056

/ Not yet recruiting早期临床1期IIT

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

开始日期2025-09-01

申办/合作机构

University of Michigan

[+1]

NCT07005024

/ Not yet recruiting临床3期IIT

A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial

Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns about bleeding and inconvenience.
This study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of blood clots and death in cancer patients who are at moderate risk for VTE. The study focuses on people who have a "Khorana score" of 2, which puts them at intermediate risk for developing blood clots.
The study will include approximately 996 participants with solid tumors or lymphoma who are starting or recently started cancer-directed therapy. Participants will be randomly assigned to one of three groups:
Group 1: Apixaban 2.5 mg twice a day (standard prophylactic dose)
Group 2: Apixaban 5 mg once a day (an alternative, more convenient dose)
Group 3: No anticoagulant (standard care)
Participants will take the assigned treatment (if applicable) for 6 months. Researchers will monitor whether participants develop blood clots, experience serious bleeding events, or die from any cause during the study period.
By comparing these three groups, the researchers hope to learn whether a once-daily dose of apixaban can work as well as the standard twice-daily dose, and whether either dosing strategy is better than no anticoagulation at all. If successful, the study may help increase the safe use of VTE prevention in cancer patients and improve overall outcomes, especially in patients at intermediate risk.
This is a pragmatic trial, meaning it is designed to fit into real-world clinical practice with minimal extra procedures. The study drug is not provided by the sponsor and will be prescribed and filled through usual care channels. Participants and their doctors will decide whether to continue the medication after the study ends.

开始日期2025-08-01

申办/合作机构

University of Vermont

100 项与阿哌沙班相关的临床结果

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100 项与阿哌沙班相关的转化医学

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100 项与阿哌沙班相关的专利（医药）

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项与阿哌沙班相关的文献（医药）

2026-01-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Harmonizing drug analysis and sustainability: Spectroscopic quantification of antiplatelet-anticoagulant regimens

Article

作者: Elama, Heba Samir ; El Abass, Samah Abo ; Altamimi, Abdulmalik S A ; Elmansi, Heba ; Abdallah, Nora A ; Alossaimi, Manal A

One of the most commonly prescribed medications are antithrombotic agents which consisting of antiplatelet and anticoagulant medications. Currently, millions of patients rely on them to avoid blood-clot-related issues across various cardiovascular diseases. The combined administration of apixaban, aspirin and clopidogrel is an example of this therapy which can be used for the risk reduction in cardiovascular death. The importance of such medications encourages us to investigate novel analytical assay methods for determination of such drugs in dosage forms as well as in human plasma. Spectroscopic technique was the best choice to design new analytical methods due to its applicability and simplicity. Three spectroscopic methods were introduced for concurrent determination of apixaban, aspirin and clopidogrel. The designed methods were; A direct measurement for determination of apixaban without interference from the other two drugs (method I), Ratio spectra (method II) and first derivative ratio spectra (method III). The first method enables us to determine apixaban through direct measurement of its absorption spectrum at 310 nm with no reading from aspirin or clopidogrel. Ratio spectra method (method II) was performed at ΔP = 223.6-245.2 nm for aspirin, ΔP = 293.2-307.0 nm for apixaban and ΔP = 251.0-260.0 nm for clopidogrel. The third first derivative ratio spectra method was based on measuring apixaban at 255 nm, aspirin at 242 nm and clopidogrel at 260 nm using the other two analytes as a double divisor. The linearity of the designed methods was 0.5-18 μg/mL for apixaban by the three methods while were 2.0-28 μg/mL for both aspirin and clopidogrel by method II & III. These developed approaches were effectively applied for estimation of the three studied drugs in their raw materials, synthetic mixtures and dosage forms simultaneously. The co-administration of these treatments enables us to extend the application for determination of them in spiked human plasma without complicated procedures. The applied methods were validated following the ICH Q2(R1) guidelines. The greenness of the designed methods was evaluated using six different tools including; Analytical Eco-scale, GAPI, AGREE metrics, NEMI, whiteness and blueness assessment.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Nationwide extrapolation of economic benefit of therapeutic innovation: a 10-year retrospective budget impact of direct oral anticoagulants introduction in France

Article

作者: Belhassen, M. ; Lesage, H. ; Moreau, R. ; Née, M. ; Cotté, F. E. ; Guilmet, C. ; Danchin, N. ; Marant Micallef, C. ; Guitard-Dehoux, D.

OBJECTIVES:

Patients with atrial fibrillation (AF) face increased risks of strokes and systemic thromboembolism (SE), traditionally managed with vitamin K antagonists (VKAs), which are associated with major bleeding (MB) risks. The nationwide real-life data-based NAXOS study, comparing Direct Oral Anticoagulants (DOACs: apixaban, dabigatran, rivaroxaban) to VKAs in over 400,000 AF patients in France, showed that DOACs are more effective, safer, and associated with lower total costs. This study evaluates the 10-year budget impact of DOACs in France, focusing on reductions in strokes/SE, MB, and monitoring costs (INRt).

METHODS:

A retrospective budget impact model from 2014 to 2023 compared scenarios with and without DOACs, using clinical and cost data from the NAXOS study. The target population of DOAC-eligible patients ranged from 725,000 in 2014 to 1.4 million in 2023. Market shares trends were derived from the public national drugs database, indicating that VKAs' use decreased from 67% to 11%, while DOACs, especially apixaban, rose sharply (2% to 55%) over the same period. Costs included treatment acquisition, strokes/SE, MB, and international normalized ratio testing (INRt) for VKAs.

RESULTS:

Over a 10-year horizon, the introduction of DOACs is estimated to have prevented 73,009 strokes, 97,234 major bleeding, and 19,567 stroke-related deaths among patients with NVAF. DOAC introduction increased treatment costs by €5.15 billion over 10 years, and reduced costs for strokes/SE (-€4.24 billion), MB (-€3.22 billion), and INRt (-€1.14 billion), leading to €3.45 billion of savings for National Insurance over 10 years, with apixaban contributing 55% of savings.

LIMITATIONS:

This analysis may not account for all contextual variables, such as indirect costs related to productivity losses.

CONCLUSION:

Over 10 years, the introduction of DOACs in France has generated substantial savings in AF-related costs, highlighting their clinical and economic benefits and the importance for authorities to valorise the external effects of therapeutic innovations.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Comparative analysis of all-cause health care resource utilization and costs among patients with non-valvular atrial fibrillation and high risk of gastrointestinal bleeding in France: a nationwide cohort analysis

Article

作者: Gusto, Gaelle ; Subash, Rupesh ; Quignot, Nadia ; Sedjelmaci, Fouad ; Chaves, Jose ; Khachatryan, Artak ; Mokgokong, Ruth ; Pesce, Giancarlo ; Dai, Feng

AIMS:

This population-based cohort study compared healthcare resource utilization (HCRU) and direct HCRU costs (medical and non-medical) in French patients with non-valvular atrial fibrillation (NVAF) and at high-risk of gastrointestinal bleeding (GIB) after initiating an anticoagulant treatment with vitamin-K antagonists (VKAs) or with direct-oral anticoagulants (DOACs).

METHODS:

NVAF patients at high risk of GIB who initiated apixaban, rivaroxaban, dabigatran, or VKAs between 2016 and 2019 were identified from the French National Healthcare Data System (SNDS) database. The first anticoagulant reimbursement set the index date and patients were followed-up until drug discontinuation/switch, death, or study end, whichever came first. Differences in patient characteristics were balanced using 1:1 propensity score matched (PSM) cohorts. Direct (medical and non-medical) HCRU and costs per patient per month (PPPM) were compared using two-part generalized linear models.

RESULTS:

A total of 314,184 patients were identified (mean age 79.0 years; 51.0% female). In PSM cohorts, patients treated with DOACs had less outpatient visits, laboratory tests, and hospitalizations as compared to patients treated with VKAs. Each DOAC was associated with lower direct HCRU costs PPPM than VKAs (apixaban/VKAs: €1,868/€2,082; rivaroxaban/VKA: €1,788/€1,982; dabigatran/VKA: €1,461/€1,665; all p < .001). In DOAC-DOAC comparisons, apixaban was associated with lower direct HCRU costs than rivaroxaban and dabigatran (apixaban/rivaroxaban: €1,424/€1,460; apixaban/dabigatran: €1,444/€1,460), while rivaroxaban was associated with lower direct HCRU costs than dabigatran (rivaroxaban/dabigatran: €1,447/€1,459; all p < .001).

CONCLUSIONS:

In patients at high-risk of GIB, DOACs were associated with reduced direct HCRU costs compared to VKAs. Among DOACs, apixaban was associated with reduced direct HCRU costs.

843

项与阿哌沙班相关的新闻（医药）

2025-09-05

·CPHI制药在线

诺华重要转型信号，得PIP者得天下

关注并星标CPHI制药在线 1. 诺华的PIP开发三重奏诺华首席医学官Shreeram Aradhye日前公开指出，公司的研发重心正在逐步聚焦免疫学，而这背后最重要的支撑是三款被寄予厚望的"pipeline-in-a-product"候选资产：ianalumab、remibrutinib 和 YTB323。这三款药物覆盖了抗体、口服小分子和细胞疗法三种不同类型，背后却共享着同一个核心逻辑：通过机制的跨疾病适用性，把单一分子打造成一条完整的管线。首先是 ianalumab。这是一款靶向 BAFF-R 的单抗，能够同时阻断信号通路并通过抗体依赖的细胞毒作用清除 B 细胞。诺华最初曾在化脓性汗腺炎（HS）中测试这一分子，但在 II 期概念验证研究中，尽管对比安慰剂展现了一定疗效，公司仍选择果断放弃该适应症。其原因并非完全无效，而是疗效不足以在竞争激烈的 HS 市场中建立差异化优势。Aradhye 将这一决策解释为公司 PIP 策略的一部分：在管线化思维下，每一条适应症路径都要经过严格的商业门槛筛选，若缺乏竞争力，就必须及时止损，把资源集中在更具潜力的领域。相较之下，干燥综合征成为了 ianalumab 的重点突破口。其在 II 期试验中显著改善了患者症状与疾病控制，随后两项 III 期研究（NEPTUNUS 1 和 2）共纳入 780 名患者，预计将在 2025 年三季度读出主要结果。更广泛的探索还包括系统性红斑狼疮、系统性硬化症以及免疫性血小板减少症等多个适应症。ianalumab 的研发路径充分体现了 PIP 模式的"筛选-聚焦-外延"的逻辑。其次是 remibrutinib。作为一款高选择性的口服 BTK 抑制剂，它在研发定位上被称为"fifth-in-class"，但诺华的目标是打造"best-in-class"。与此前几代 BTK 抑制剂不同，remibrutinib 几乎完全避免了对其他酶的抑制，安全性和选择性成为它得以横向扩展的基础。2024 年底，诺华已向 FDA 提交了针对慢性自发性荨麻疹（CSU）的上市申请，核心数据来自 REMIX-1 与 REMIX-2 两项长期随访研究，显示患者症状能在 52 周内持续缓解，且安全性良好。与此同时，remibrutinib 的适应症布局远不止 CSU：它已经进入慢性诱发性荨麻疹的 III 期临床，另有超过 1100 名患者参与的 HS 研究正在进行，此外还在探索多发性硬化、重症肌无力和食物过敏等多个适应症。Aradhye 将其称为"典型的 PIP药物"，一款口服小分子具备覆盖过敏、免疫和神经肌肉疾病的多适应症平台的潜质。最后是 YTB323。这是一款基于 T-Charge 平台的次世代 CAR-T 细胞疗法。不同于传统 CAR-T 需要漫长的体外扩增过程，T-Charge 能在 10 天内完成回输，让细胞在患者体内扩增。这一速度和可及性的大幅提升，为其跨越肿瘤与自身免疫疾病之间的界限创造了条件。2025 年 EULAR 大会上公布的早期研究结果显示，在 21 名系统性红斑狼疮患者中，YTB323 能实现强效 B 细胞清除，并改善疾病活动，安全性与传统 CAR-T 相当。诺华计划将其进一步扩展至狼疮性肾炎、肌炎、血管炎、多发性硬化和重症肌无力，构建一个覆盖多种 B 细胞驱动型自身免疫病的"细胞治疗平台"。这意味着 CAR-T 正在从单一癌症治疗，转型为潜在的免疫疾病 PIP。 2. 当前诺华资产布局 2025 年第二季度，诺华前 20 大畅销药物中，肿瘤（44%）与心血管（26%）占据了公司收入的七成。其中肿瘤药物收入超过 51 亿美元，心血管则达到 30 亿美元。相比之下，免疫学（22%）虽然份额较小，但已经成为诺华明确标注为未来重点突破的方向，对应的正是 ianalumab、remibrutinib 和 YTB323 这样的 pipeline-in-a-product 项目。图1. 诺华2025年Q2销售额前20药物适应症分布图。这意味着诺华正在经历一次"去多元化"的深度转型。过去的诺华是一个典型的多元化医药集团，心血管、肿瘤、中枢神经、眼科、代谢等领域全面布局，但诺华的头牌产品Entresto在2025年第二季度的销售表现上（23.57亿美元）落后于大多数制药巨头的当家花魁，例如诺和诺德的Ozempic（49.6亿美元）、礼来的Mounjaro（51.99亿美元）、强生的Darzalex（35.39亿美元）、艾伯维的Skyrizi（76.31亿美元）、罗氏的Hemlibra（24.21亿瑞郎）、默沙东的Keytruda（79.56亿美元）、吉利德的Biktarvy（35.3亿美元）、赛诺菲的Dupixent（44.64亿美元）和百时美施贵宝的Eliquis（36.8亿美元）。相较而言，诺华对于修美乐和Keytruda那样"一剑能挡百万敌兵"的超巨产品内心是充满渴望的。 3. 酝酿中的转型，以PIP为支撑自 2022 年以来，诺华通过剥离山德士（Sandoz，仿制药与生物类似药业务）、压缩研发战线，逐步塑造自己为 "纯粹的创新药公司"。而这种转型的标志，就是把有限资源集中在几个能形成 PIP 效应的赛道上。从财务构成上看，肿瘤和心血管已经形成坚实的现金流基盘，而免疫正是下一块战略拼图。与肿瘤的高竞争度不同，免疫学在干燥综合征、系统性硬化症、免疫性血小板减少症等多个领域仍有"空白市场"，一旦 ianalumab、remibrutinib 和 YTB323 获批并顺利扩展适应症，免疫学有望像当年的 Humira 一样，成长为诺华新的长期增长极。支撑诺华这一转型的底气，正是正在孕育管线的PIP资产。通过 ianalumab、remibrutinib 和 YTB323 的组合，诺华向外界展示了 PIP 模式在大药企层面的系统化落地：以机制为导向，提前画出适应症版图，在不同疾病赛道中同时推进；通过临床和商业门槛进行动态筛选，把资源投向最具潜力的路径；并通过分子多元化（抗体、小分子、细胞疗法）确保风险分散。这种模式的核心，不仅是提升研发投资的产出效率，更是构建企业未来十年增长的生态。诺华的这三款资产展现出一种新的研发范式：药物不再以单一疾病为归宿，而是从立项之初就被设计成跨病种的平台。以机制为起点，设置清晰的商业阈值，用适应症扩展形成持续增长曲线。这种模式与过去"先单病种成功、再逐步扩展"的传统路径相比，更具主动性和前瞻性，也更依赖研发与商业团队的紧密协同。它不仅提高了研发投入的产出效率，还使药物从一开始就承载着"管线化"的预期。这也解释了为什么资本市场越来越把 PIP 资产等同于小型管线，愿意给予其远超单一产品的估值溢价。 4. PIP，孕育药王的模式 PIP 模式在新老以及未来药王Humira、Keytruda和Ozempic身上都得到了最明显的体现。从 Humira 到 Keytruda，再到 GLP-1，可以清晰看到 PIP 模式的演进轨迹。Humira 代表了从单一产品到多适应症的自然演化，它的成功更多依赖真实世界证据和循序渐进的扩展；Keytruda 则体现了主动设计、系统推进的战略转变，从研发初期就被塑造成一个跨癌种平台；而 GLP-1 的崛起则进一步证明基础机制的跨疾病价值可以在代谢病这样的慢病领域被放大，甚至通过并发症管理开辟出全新的治疗生态。它们的共同点是，均凭借 PIP 逻辑从"单品"成长为"平台"，并最终晋升为全球药王。Humira 曾经创造过 210 亿美元的历史性峰值，Keytruda 正在刷新 300 亿美元的新纪录，而 GLP-1 药物则以代谢病的高发性与并发症的广谱性，正在形成未来十年的超级品类。因此可以说，PIP 是孕育药王的温床。它不仅是一种研发策略，更是一种商业与资本的放大器：机制跨疾病的迁移性，为药物提供了适应症横向扩展的路径；多病种收入曲线的叠加，赋予了资产极长的生命周期；而资本市场也正是因为这种"药物即管线"的特质，愿意持续赋予它们高估值。每一代药王的诞生，背后都有 PIP 模式在发挥作用。 Humira：免疫领域的先行者 2002 年，Humira 首次获批用于类风湿关节炎。彼时，它只是 TNF-α 抑制剂家族中的新成员，并没有人预料到它会成为史上最畅销的药物。然而随着临床研究的不断深入，Humira 的适应症迅速扩展到银屑病关节炎、强直性脊柱炎、克罗恩病、溃疡性结肠炎、银屑病、葡萄膜炎以及儿童炎症性疾病。它从风湿科一路扩展到消化科、皮肤科、眼科，几乎横跨整个免疫炎症领域。2012 至 2022 年间，Humira 十年蝉联全球药物销售冠军，年峰值收入超过 210 亿美元，占据了艾伯维营收的半壁江山。Humira 的成功，让业界切看到，一个单一抗体分子可以被开发成一条横跨多病种的完整管线。 Keytruda：肿瘤免疫的集大成者如果说 Humira 的成功更多是"边走边扩展"的路径依赖，那么 Keytruda 则代表了更具战略主动性的 PIP 模式。2014 年，Keytruda 首次获批用于黑色素瘤。默沙东在早期就意识到 PD-1 通路的广谱潜力，因此迅速推动一系列篮式试验和平行适应症研究，几乎同时在肺癌、胃癌、肾癌、头颈癌、膀胱癌等多个瘤种上建立临床证据。到 2024 年，Keytruda 已覆盖 20 多个癌种，年销售额突破 290 亿美元，成为新的药王。Keytruda是公司在研发初期就主动设计的 PIP 战略：通过机制的广谱性和临床路径的并行推进，构建起了一个庞大的肿瘤免疫生态。这种"药物即平台"的思路，把 PIP 从偶然经验提升为可以复制的方法论。 GLP-1：代谢病时代的接力者进入 2020 年代，PIP 的逻辑在代谢病领域再次得到印证。诺和诺德的 semaglutide（Ozempic、Wegovy、Rybelsus）和礼来的 tirzepatide（Mounjaro、Zepbound），最初都定位于 2 型糖尿病治疗。但很快，人们发现 GLP-1 及其衍生分子不仅能控制血糖，还能显著减重，并带来心血管、肾脏乃至肝脏方面的获益。于是，临床开发快速向肥胖、心衰、慢性肾病、MASH等多个领域延伸。2025 年第二季度，诺和诺德的 GLP-1 产品收入接近 90 亿美元，礼来更是超过 85 亿美元，两家公司几乎凭借单一分子家族就重塑了整个企业的增长曲线。GLP-1 的成功表明，PIP 并不限于免疫或肿瘤领域，而是可以延伸至代谢类慢病，并通过并发症治疗形成全新的疾病生态。 5. 汲汲于PIP的制药巨头如果说 Humira、Keytruda 与 GLP-1 代表了 PIP 的历史、当下与未来，那么 2025 年第二季度各大制药巨头的财报，则清晰展现了这一模式在现实中的分量。PIP 不再只是个别产品的偶然现象，而已经深度渗透进公司的增长引擎之中。在代谢病领域，GLP-1 药物无疑是最耀眼的 PIP 样本。2025 年第二季度，诺和诺德的 semaglutide 产品线（Ozempic、Wegovy、Rybelsus）合计收入超过 89 亿美元，其中 Wegovy 同比大涨 75%，已占公司总收入的四分之一以上。礼来的 tirzepatide（Mounjaro、Zepbound）则以超过 85 亿美元的季度收入，占据了公司营收的半壁江山。两大巨头几乎以"产品即管线"的姿态在兑现 PIP 的潜力。已获批适应症：2 型糖尿病、肥胖、心血管风险降低（既往有心血管事件人群）、慢性肾病（2024 年 FDA 批准）、阻塞性睡眠呼吸暂停（2025 年 FDA 批准）、MASH（代谢相关脂肪性肝炎，2025 年 FDA 批准）。在研扩展：心衰（HFpEF/HFrEF）、中风预防、阿尔茨海默病（探索阶段）。这种从代谢出发，快速外延到心血管、肾脏、肝脏和呼吸疾病的跨领域扩展，使 GLP-1 成为真正意义上的"超级 PIP"，未来十年有望创造前所未有的商业体量。在免疫炎症领域，赛诺菲的 Dupixent 与艾伯维的 Skyrizi、Rinvoq 组合则发挥着承前启后的作用。 Dupixent：Q2 收入达到 44.6 亿美元，同比增长 16%。已在特应性皮炎、哮喘、鼻息肉、嗜酸性食管炎（EoE）获批，并在 COPD 中取得关键突破。 Skyrizi（risankizumab）：Q2 收入 76.3 亿美元，同比增长 62%。已在银屑病、银屑病关节炎、克罗恩病获批，并在溃疡性结肠炎中进入后期开发。 Rinvoq（upadacitinib）：Q2 收入 20.3 亿美元，同比增长 42%。已在类风湿关节炎、银屑病关节炎、强直性脊柱炎、非放射学脊柱炎、溃疡性结肠炎、克罗恩病、特应性皮炎获批。这三款药物共同接替 Humira，形成新的 PIP 矩阵，横跨皮肤科、风湿免疫科和消化科，构成艾伯维与赛诺菲在免疫炎症领域的双重增长极。诺华的 Cosentyx 也在不断拓展，从银屑病、银屑病关节炎、强直性脊柱炎、非放射学脊柱炎延伸到溃疡性结肠炎与克罗恩病，逐渐展现出 PIP 的特征。在肿瘤领域，默沙东的 Keytruda 依然是 PIP 模式的现象级代表。2025 年第二季度，Keytruda 销售额达到 79.6 亿美元，占公司整体收入的一半以上。已获批适应症：黑色素瘤、非小细胞肺癌、小细胞肺癌、肾癌、膀胱癌、胃癌、食管癌、宫颈癌、头颈鳞癌、霍奇金淋巴瘤、三阴性乳腺癌等，覆盖超过 20 种瘤种。在研扩展：广泛的联合疗法（ADC、放疗、IO+IO 组合）、新辅助与辅助治疗路径。百时美施贵宝的 Opdivo 同样延续了 PIP 的逻辑，单季收入 25.6 亿美元，适应症横跨黑色素瘤、肺癌、肾癌、胃癌、食管癌，并与 Yervoy、Opdualag 等组合在多癌种中形成互补。罗氏的 Tecentriq 虽然在 2025 年上半年录得小幅下滑，但凭借在肺癌、TNBC、肝癌等适应症中的应用，依然体现了 PIP 的特征。综合来看，2025 年第二季度财报表明，PIP 模式已经成为全球制药公司的主流增长逻辑。无论是代谢病、免疫炎症还是肿瘤，真正的龙头药物都在按照PIP的思路被开发和经营。与过去依赖专利保护延长生命周期不同，当下的竞争已经转向比拼谁能更快、更系统地把一个机制的潜力挖掘出来，并让一个分子覆盖尽可能多的疾病版图。 6. 展望：得PIP者得天下从诺华的实践到 Humira 和 Keytruda 的历史轨迹，再到 GLP-1 带来的代谢病热潮，以及 Biotech 企业的积极尝试，Pipeline-in-a-Product 已经不再是孤立的成功故事，而是逐渐演化为制药行业的核心模式。它改变了研发的逻辑：从以疾病为中心转向以机制为中心；它重塑了商业模式：从单一重磅炸弹资产转向多适应症收入曲线；它也重构了资本市场的估值体系：一个分子可以被视作一整条管线。在研发层面，PIP 模式意味着临床开发越来越强调并行和跨适应症的规划，篮式试验和平台化设计将成为常态。企业在立项之初就必须回答一个问题：这个分子是否具备跨疾病的可迁移性？在商业层面，PIP 让药物的生命周期得以不断延长，也形成了强有力的市场壁垒。当一个产品已经在多个适应症上确立标准治疗地位时，后来者很难撼动它的统治力。资本层面，PIP 资产往往成为并购与授权的焦点，因为它们不仅能带来短期收入，更能在长期内支撑企业的估值。 2025 年第二季度的财报数据验证了这一趋势：无论是 GLP-1 在代谢病的爆发式增长，还是 Dupixent、Skyrizi、Rinvoq 在免疫领域的接力，抑或 Keytruda 在肿瘤中的持续扩展，几乎所有增长最快的资产都具备典型的 PIP 特征。可以说，未来的行业竞争将不再是"谁能开发出一个新药"，而是"谁能把一个药物做成一条管线展望未来，PIP 模式的价值还可能进一步扩大。RNA 药物、双特异性抗体、细胞与基因疗法等新兴技术，如果能够证明机制的跨病种适用性，同样有潜力复制 PIP 的路径。对于 Biotech 而言，如何在有限资源下平衡聚焦与扩展，将是能否成功的关键。而对大型药企而言，谁能在研发、临床与市场的衔接中更高效地执行 PIP 战略，谁就更有机会在下一个周期中保持领先。 Ref. Grogan, K. Novartis's 'Pipeline-In-A-Product' Assets Pro END 智药研习社近期直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

2025-08-29

·EINPresswire

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

2025-08-26

·汇聚南药

2025年上半年全球畅销药TOP10出炉，司美格鲁肽，登顶！

随着跨国药企相继披露2025年半年报，今年上半年的全球畅销药TOP10也随之出炉。诺和诺德旗下黑马司美格鲁肽今年一季度反超“K药”（默沙东的帕博利珠单抗）后，今年上半年以166.83亿美元（按1丹麦克朗=0.14796美元计算）的销售额，继续稳坐“药王”宝座。礼来的替尔泊肽作为“后起之秀”，已经追至第3位，上述三款创新药今年上半年销售额均破140亿美元。仅次于前三位，位列第四的是GMS/辉瑞的阿哌沙班。阿哌沙班是全球畅销药排行榜常客了，2023年和2024年均排行第三，2024年突破两百亿美金，今年也预计将突破两百亿美金，是全球最畅销的抗凝药。然而这款全球最畅销抗凝药，在国内市场仅不到1亿人民币。 2019年阿哌沙班专利在国内就被确定全部无效，2020年就被纳入集采，BMS和辉瑞面对直线下跌的国内市场，毅然决然选择了放弃。缺少原研企业的推广及适应症扩增，仿制药举步维艰，目前阿哌沙班在国内仅一项适应症获批，且适应人群范围狭窄。反之美国和欧洲，阿哌沙班尚在专利保护期，BMS和辉瑞联手清退了多家仿制药，保持了强竞争力。恩格列净情况类似，海外大杀四方，国内举步维艰。国内专利在2020年就被确立无效，仿制药加速跟进，2021年就被纳入集采，原研勃林格殷格翰和礼来恩格列净在欧美同样尚在专利保护期，凭借专利保护保持着百亿市场规模。未中标，也开始放弃国内推广，近些年市场逐渐被达格列净取代。事实证明，专利保护对一款药来说至关重要。此次退出全球畅销药TOP10的乌司奴单抗，也正是因为专利到期的原因。 2024年强生的乌司奴单抗全球销售额达103.6亿美元，妥妥的百亿美元重磅单品。但这个品种在美国的专利2023年9月就到期了，2024年安进率先推出生物类似药。随后自山德士、梯瓦和Biocon等仿制巨头纷纷推出生物类似药，强生这款自免药勉励维持住了2024年的市场之后，还是一如往常迅速跌入了“专利悬崖”之中。在榜单中，自免领域作为继肿瘤之后的另一大热门赛道，同样有两款重磅药物入围，分别是赛诺菲的度普利尤单抗和艾伯维的利生奇珠单抗。除此之外，吉利德的明星HIV药物必妥维、强生的达雷妥尤单抗也名列其中，而福泰制药的囊性纤维化三联疗法 Trikafta 亦成功上榜。值得注意的是，Trikafta 目前尚未进入中国市场。事实证明，从这些登上全球榜单的“超级大药”来看，国内市场对其全球销售的影响其实有限。单靠中国市场的专利到期或仿制药上市，往往难以撼动其全球营收格局。这些药企的战略重心更多放在欧美市场，因此近些年原研在中国退市的情况也屡见不鲜。相较之下，欧美市场的专利到期才是真正决定这些王牌药物命运的关键因素。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：药通社往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

专利到期生物类似药专利无效

100 项与阿哌沙班相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03213	阿哌沙班	B01AF02	DB06605

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性深静脉血栓形成	欧盟	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	冰岛	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	列支敦士登	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	挪威	Accord Healthcare SLU	2020-07-23
血栓形成	中国	Bristol-Myers Squibb/Pfizer EEIG	2013-01-22
缺血性卒中	日本	Bristol-Myers Squibb KK	2012-12-25
全身性栓塞	澳大利亚	Bristol Myers Squibb Co.	2011-07-21
心房颤动	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
脑卒中	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性肢体威胁性缺血	临床3期	巴西	Wyeth AB	2020-01-09
认知功能障碍	临床3期	美国	Pfizer Inc.	2018-12-19
认知功能障碍	临床3期	美国	Bristol Myers Squibb Co.	2018-12-19
基底细胞癌	临床3期	奥地利	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	比利时	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	加拿大	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	法国	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	希腊	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	意大利	Bristol Myers Squibb Co.	2018-10-11
基底细胞癌	临床3期	荷兰	Bristol Myers Squibb Co.	2018-10-11

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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


NCT05438888 (Pubmed \| Cardiol Ther)	N/A	心房颤动	-	Apixaban	蓋鑰顧積淵鹹壓廠廠餘(蓋選鏇範選觸糧遞選範) = 範願鑰鹽膚築觸簾製壓選網蓋蓋築餘鬱顧顧範 (憲鏇顧憲鹽築積襯獵餘 ) 更多	积极	2025-07-08
				Warfarin	蓋鑰顧積淵鹹壓廠廠餘(蓋選鏇範選觸糧遞選範) = 壓網膚窪糧齋築糧鹹艱選網蓋蓋築餘鬱顧顧範 (憲鏇顧憲鹽築積襯獵餘 ) 更多
NCT04504318 (CTgov)	临床1/2期	静脉血栓栓塞	82	Apixaban 2.5 MG Oral Tablet (Apixaban)	願鏇廠艱蓋範糧製膚衊 = 鑰衊鬱廠鬱遞願獵鏇蓋遞夢醖醖鏇鑰夢鬱廠網 (積簾艱網遞齋觸鹹獵膚, 築顧餘積齋糧衊糧範繭 ~ 餘築糧鏇壓蓋鏇鬱夢鏇) 更多	-	2025-06-22
				Enoxaparin (Enoxaparin)	願鏇廠艱蓋範糧製膚衊 = 網蓋鬱鹽淵範構艱鹹壓遞夢醖醖鏇鑰夢鬱廠網 (積簾艱網遞齋觸鹹獵膚, 鏇衊構窪襯簾鑰餘鏇簾 ~ 願衊蓋製積淵製積簾齋) 更多
NCT03045406 (CARAVAGGIO, CTgov)	临床3期	基底细胞癌 \| 肿瘤 \| 急性白血病 ... 更多	1,170	Apixaban (Apixaban)	鹹憲淵製構鏇衊醖蓋顧 = 糧選鹽獵艱鏇遞餘鹹簾糧顧夢積夢蓋憲構餘鏇 (鏇遞範糧壓醖蓋壓鏇繭, 繭蓋鹹廠襯鑰蓋膚鏇淵 ~ 襯壓夢簾餘壓廠糧簾觸) 更多	-	2025-06-18
				Dalteparin (Dalteparin)	鹹憲淵製構鏇衊醖蓋顧 = 醖鹽築鑰鏇糧艱觸網網糧顧夢積夢蓋憲構餘鏇 (鏇遞範糧壓醖蓋壓鏇繭, 選簾遞願鑰簾遞觸觸鹹 ~ 窪膚衊窪鏇遞壓遞憲醖) 更多
NCT05643573 (OCEANIC-AF, Pubmed \| JAMA Cardiol)	临床3期	心房颤动	-	Asundexian	鏇顧糧繭糧襯蓋鑰齋製(艱築築餘顧簾齋選壓簾) = 觸觸夢範獵艱壓顧顧憲壓糧襯衊憲鏇繭鹹繭鏇 (蓋遞積夢憲繭獵齋顧遞 )	积极	2025-06-01
				Apixaban	鏇顧糧繭糧襯蓋鑰齋製(艱築築餘顧簾齋選壓簾) = 製簾範積壓獵廠蓋選餘壓糧襯衊憲鏇繭鹹繭鏇 (蓋遞積夢憲繭獵齋顧遞 )
PB3023 (EHA2025)	N/A	多发性骨髓瘤	101	NOACs (Apixaban 2.5 mg twice daily, Rivaroxaban 10-20 mg per day)	簾網獵構顧壓觸遞壓餘(獵夢窪鹹觸窪選簾鏇簾) = Thromboembolic events were observed in only two patients as acute DVTs 窪遞窪製齋觸淵構簾廠 (鹹憲網壓願鏇製鑰鑰觸 ) 更多	积极	2025-05-14
NCT03692065 (API-CAT, Pubmed \| N Engl J Med)	临床3期	静脉血栓栓塞	1,766	Apixaban 2.5 mg	網廠衊襯窪積製築觸遞(範顧窪築繭顧淵糧獵製) = 襯簾齋艱築窪遞製製齋壓獵糧觸糧醖遞壓襯簾 (繭艱鬱齋襯鏇鹽鹽蓋膚 ) 更多	积极	2025-04-10
				Apixaban 5.0 mg	網廠衊襯窪積製築觸遞(範顧窪築繭顧淵糧獵製) = 鬱齋襯憲鬱艱繭選鑰襯壓獵糧觸糧醖遞壓襯簾 (繭艱鬱齋襯鏇鹽鹽蓋膚 ) 更多
NCT03192215 (ARCADIA, CTgov)	临床3期	卵圆孔未闭 \| 家族性心房黏液瘤 \| 心肌梗塞 ... 更多	1,015	Apixaban (Active Agent: Apixaban)	製衊鹽廠顧鬱遞網蓋壓 = 艱廠餘選鬱製網繭選廠鏇襯夢壓窪鬱網衊廠窪 (壓淵鏇繭膚艱繭廠繭艱, 夢襯構築艱遞壓觸積構 ~ 選願鹽簾鹹築簾鬱憲製) 更多	-	2025-04-09
				Aspirin (Active Control: Aspirin)	製衊鹽廠顧鬱遞網蓋壓 = 獵糧糧鬱獵窪獵憲積廠鏇襯夢壓窪鬱網衊廠窪 (壓淵鏇繭膚艱繭廠繭艱, 遞積願選淵壓夢齋糧夢 ~ 範選齋鑰築襯簾鹽製積) 更多
P9-13.008 (AAN2025)	N/A	心房颤动 systolic blood pressure \| type 2 diabetes \| LDL ... 更多	-	Apixaban (Favorable PRFP)	蓋獵簾憲範淵糧膚築鏇(選齋衊醖壓鹹鹹鹹顧衊) = 顧淵窪糧網衊繭壓淵顧鑰網襯壓廠窪憲夢廠築 (艱築壓鬱鏇選蓋積夢齋, 1.00 ~ 2.20)	积极	2025-04-07
				Apixaban (Adverse PRFP)	-
NCT02415400 (AUGUSTUS, Pubmed \| JACC Adv)	临床4期	急性冠状动脉综合征 \| 心房颤动	-	Apixaban 2.5 mg	糧蓋襯製鏇艱蓋衊襯積(襯衊廠醖鏇鹽鹽構鹽簾) = 構鑰衊網鹽醖淵憲積艱選觸膚艱繭選衊顧鏇構 (襯範願繭製範窪蓋製蓋 )	积极	2025-04-01
				Apixaban 5.0 mg	糧蓋襯製鏇艱蓋衊襯積(襯衊廠醖鏇鹽鹽構鹽簾) = 遞艱獵網構襯顧簾鬱醖選觸膚艱繭選衊顧鏇構 (襯範願繭製範窪蓋製蓋 )
NCT04650087 (CTgov)	临床3期	新冠肺炎后遗症	1,291	Placebo (Placebo)	餘鬱製遞製網糧醖糧廠 = 顧觸遞構獵遞蓋淵簾鹹製製鏇糧顧選遞襯積顧 (蓋廠遞艱願醖衊願範壓, 獵淵網齋範壓觸鏇蓋糧 ~ 選窪醖簾壓鹽製艱艱鏇) 更多	-	2025-02-25
				Apixaban 2.5 MG (Apixaban)	餘鬱製遞製網糧醖糧廠 = 鏇襯夢鹹淵願獵衊鑰積製製鏇糧顧選遞襯積顧 (蓋廠遞艱願醖衊願範壓, 鑰淵夢遞範範淵鬱製餘 ~ 夢積蓋淵簾衊鑰壓壓壓) 更多