This is a prospective, single-arm, open-label study to evaluate the efficacy of intra-arterial tenecteplase in improving microvascular reperfusion following successful large vessel recanalization. Acute ischemic stroke patients with large anterior circulation large vessel occlusion will receive a single weight-based dose of intra-arterial tenecteplase after achieving successful large vessel recanalization (defined as TICI ≥ 2b) via standard of care mechanical thrombectomy. Microvascular flow will be assessed by quantitative angiography before and after the intra-arterial drug administration in order to quantify the impact of targeted thrombolysis on microvascular reperfusion. Reperfusion will be secondarily assessed with 24-hour imaging, final infarct volume will be quantified 72 hours following treatment, and functional outcome will be assessed in the short-term by the NIHSS and in the long-term by the 90-day modified Rankin Scale.

开始日期2025-11-15

申办/合作机构

University of Pennsylvania

[+1]

NCT07168278

/ Not yet recruiting临床3期IIT

Tenecteplase vs Medical Management in 4.5-24h Anterior Circulation Large Vessel Occlusion With no Access to EVT

The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.

开始日期2025-11-01

申办/合作机构-

NCT07203625

/ Not yet recruiting临床4期IIT

Intravenous Tenecteplase Before Interhospital Transfer for Thrombectomy in Acute Basilar Artery Occlusion at 4.5 to 24 Hours

This study is designed to investigate the efficacy and safety of intravenous tenecteplase before interhospital transfer from a non-endovascular capable center(nECC) to an endovascular capable center (ECC) for thrombectomy in patients with acute ischemic stroke (AIS) caused by neuroimaging-confirmed acute basilar artery occlusion (BAO) between 4.5-24 hours of symptom onset.

开始日期2025-11-01

申办/合作机构

首都医科大学宣武医院

100 项与替奈普酶相关的临床结果

登录后查看更多信息

100 项与替奈普酶相关的转化医学

登录后查看更多信息

100 项与替奈普酶相关的专利（医药）

登录后查看更多信息

1,045

项与替奈普酶相关的文献（医药）

2025-12-31·Hospital practice (1995)

Assessment of transition from use of alteplase to tenecteplase in the treatment of acute ischemic stroke in a large system of community hospitals

Article

作者: Hasse, Adam ; Poland, Russell E. ; Korwek, Kimberly ; Guy, Jeffrey

OBJECTIVE:

Pharmacologic thrombolytic treatment for acute ischemic stroke has primarily been managed by intravenous alteplase. Tenecteplase is a variant that has been shown to be non-inferior to alteplase in clinical trials. In this study, we present a real-world assessment of patient outcomes with the facility-wide transition to the use of tenecteplase versus altepase for acute ischemic stroke in a large system of community hospitals in the United States.

METHODS:

This retrospective analysis assessed adult patients who received either alteplase or tenecteplase between 1 April 2020 and 31 March 2023. Propensity matching was used to estimate the covariate-adjusted association with outcomes of discharge expired/hospice, intracranial hemorrhage and readmission to a facility in the same healthcare system within 30, 60, or 90 days.

RESULTS:

Among 12,766 patients, gross mortality was 7.6% (n = 285) with tenecteplase and 8.2% (n = 739) with alteplase (p = 0.314); intracranial hemorrhage was 2.4% with either. The propensity match analysis found that the relative risk of mortality/hospice for patients given tenecteplase versus alteplase was 0.993 (95% CI: 0.848-1.162, p = 1.000). When limited to five facilities with the highest volume of thrombolytic use, there were no significant differences in outcomes. While the time from emergency department arrival to thrombolytic administration (door-to-needle) was shorter among patients receiving tenecteplase, there was no significant difference in the odds of mortality based on door-to-needle time.

CONCLUSION:

In alignment with previous studies, these findings demonstrate the lack of potential harm with a transition from alteplase to tenecteplase in clinical practice for acute ischemic stroke patients treated in community hospitals.

2025-12-01·American journal of ophthalmology case reports

Reversal of ischemic cortical blindness with tenecteplase

Article

作者: Naser, Maryam ; Lee, Andrew G ; Al Deyabat, Osama ; Alryalat, Saif Aldeen ; Tang, Rui

Purpose:

Tenecteplase (TNK) is a bioengineered variant of alteplase that has a longer half-life, a higher fibrin binding specificity, and a lower effect on systemic fibrinolytic activity. We reported a case of reversible bilateral vision loss to homonymous hemianopsia after TNK administration.

Case description:

A 56-year-old African American male presented with acute onset of visual loss to no light perception (NLP) in both eyes (OU), left hemiparesis, decreased sensation, and dysarthria. Brain MRI revealed acute infarct involving the right posterior cerebral artery distribution without evidence of hemorrhagic transformation. CTA showed 4mm long segmental occlusion on the right P2 PCA. After the patient was given intravenous 23mg TNK after two and half hours since symptom onset, he recovered vision from NLP OU to 20/25 OU, but he had a residual left homonymous hemianopsia (HH), in addition to hemiparesis and decreased sensation on the left. The patient was eventually discharged to rehabilitation and outpatient follow up.At the two-month follow up, patient only had residual left HH.

Conclusions and importance:

Clinicians should be aware of the various treatment options in acute ischemia related cortical visual loss such as TNK. Future providers should also add comprehensive ophthalmological exam before and after patient receiving TNK to determine if our case is generalizable.

2025-11-11·NEUROLOGY

Thrombolysis Alone vs With Argatroban or Eptifibatide

Article

作者: Elm, Jordan ; Streib, Christopher ; Sabagha, Noor ; Barreto, Andrew D. ; Adeoye, Opeolu ; Huang, Josephine F. ; Vagal, Achala ; Bentho, Oladi ; Ranasinghe, Tamra ; Grotta, James C. ; Wintermark, Max ; Derdeyn, Colin P. ; Khatri, Pooja ; Roy, Akash ; Broderick, Joseph P. ; Concha, Mauricio ; Ingles, James R.

BACKGROUND AND OBJECTIVES:

IV thrombolysis only (IVT-O) is the primary reperfusion therapy for most stroke patients. At least 50% of IVT-O patients remain disabled. We assessed 2 therapies added to IVT-O aimed at increasing clot lysis or preventing arterial reocclusion.

METHODS:

This 3-arm, adaptive, single-blinded, randomized controlled phase III clinical trial was conducted at 57 US sites. Patients with acute ischemic stroke (AIS) within 3 hours of onset receiving IV tissue plasminogen activator or tenecteplase were randomized to argatroban (100 μg/kg bolus and 12-hour infusion at 3 μg/kg/min), eptifibatide (135 μg/kg bolus and 2-hour infusion at 0.75 μg/kg/min), or placebo (bolus and 12-hour infusion). The primary end point was utility-weighted 90-day modified Rankin Scale score (uwmRS score; worst = 0, best = 10). This prespecified secondary analysis was conducted on the intent-to-treat population in the IVT-O cohort using a Bayesian normal dynamic linear model.

RESULTS:

Of 514 patients enrolled into Multi-arm Optimization of Stroke Thrombolysis (MOST) before the study was stopped for futility, 260 were in the IVT-O cohort (118 treated with placebo, 114 with eptifibatide, and 28 with argatroban; mean age 66 years, 46.9% female). Baseline variables were similar across groups (median NIH Stroke Scale score 8, mean time from symptom onset to IVT 105 minutes, mean time from IVT bolus to study drug start 62 minutes). A clot was visible in 30.8% of patients. There was only a 1% or 2.5% chance that argatroban or eptifibatide, respectively, was superior to placebo for the primary outcome (mean uwmRS scores [SD] of 5.5 [3.6], 6.6 [3.2], and 7.4 [2.6] for argatroban, eptifibatide, and placebo, respectively). No secondary outcomes favored either treatment group. The risk difference for symptomatic hemorrhage between the argatroban and eptifibatide arms vs placebo was -0.8% (p = 0.82) and 1.8% (p = 0.36). Mortality was 3.4% with placebo, 14.3% for argatroban (p = 0.03), and 11.4% for eptifibatide (p = 0.02). There was no benefit in any subgroup.

DISCUSSION:

Outcomes in patients treated with IVT-O were not improved by adding either argatroban or eptifibatide. Increased bleeding was not observed, but mortality was higher in both investigational arms. Limitations included small sample size in the argatroban subgroup.

TRIAL REGISTRATION INFORMATION:

This study was registered on ClinicalTrials.gov (registration number: NCT03735979) on November 8, 2018. The first patient was enrolled on October 15, 2019.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that in patients with AIS treated with IVT within 3 hours of onset, argatroban or eptifibatide does not improve outcomes vs thrombolysis alone but does increase mortality.

项与替奈普酶相关的新闻（医药）

2025-10-13

·勃林格殷格翰中国

欧唐宁®本地化生产计划启动，勃林格殷格翰深耕中国再提速

全球领先的生物制药企业勃林格殷格翰今日宣布旗下明星降糖药欧唐宁®（利格列汀）在华本地化生产计划正式启动。此举是勃林格深化在华战略布局的关键一步，标志着公司在中国市场实现了从商业运营向产业链纵深发展的新跨越。（从左至右：浦东新区科经委副主任凌刚、上海市药监局二级巡视员张清、上海勃林格殷格翰药业有限公司总经理殷雪林、勃林格殷格翰大中华区人药业务总经理陈文汉）勃林格殷格翰全球股东委员会主席冯保和(Hubertus von Baumbach)、大中华区总裁兼CEO高皓廷（Mohammed Tawil）、以及各方代表共同出席在上海张江人用药品生产基地举行的启动仪式，见证勃林格深耕中国市场三十年来的又一重要里程碑。该计划将显著提升欧唐宁®在中国市场的供应稳定性与韧性，进一步提高药物可及性，同时推动上海人用药品生产基地设备升级与产能优化，巩固其作为辐射亚太区域核心供应枢纽的战略地位。高皓廷勃林格殷格翰大中华区总裁兼CEO 在勃林格进入中国市场三十周年之际，欧唐宁®本地化生产计划落户上海具有特殊意义。三十年来，我们始终与中国发展同频共振，与上海、浦东共成长。如今，中国已成为勃林格全球的重要市场与创新高地。未来，我们将继续依托中国市场的速度、规模与影响力，深耕本土、服务全球，致力于成为中国高质量发展的实践者与全球创新合作的推动者，让创新成果更快惠及全球患者与动物健康。站在三十年的新起点，勃林格殷格翰将全面升级在华发展战略，加速研发成果落地，以更开放姿态融入中国医疗健康创新生态，于而立之年开启在华发展的新篇章。作为研发驱动的跨国药企，勃林格持续深化“中国关键”（China Key）战略，在跨国药企中率先将中国全面纳入全球早期研发当中，推动前沿创新疗法“零时差”带入中国。今年以来，公司新一代溶栓药物美通立®（注射用替奈普酶）与全球首个口服HER2酪氨酸激酶抑制剂圣赫途®（宗艾替尼片）相继在华获批，为卒中和肺癌患者带来新的治疗选择。此外，肺纤维化疗法nerandomilast是十年来首个递交注册申请的用于治疗成人特发性肺纤维化的新疗法，目前在中国优先审评中。在动物保健领域，勃林格今年在华推出犬用口服外驱新品福味恩®（阿福拉纳咀嚼片）、马用炎症及疼痛治疗药物美达佳®（美洛昔康内服混悬液（马用））等创新产品，引领行业创新。未来5年，公司计划在华研发投入超50亿元人民币，人用药品研发管线将聚焦于代谢、炎症、眼健康和肿瘤学领域，通过“中国关键”战略，这些新产品和新适应症有望在中国实现与全球同步甚至更早获批；动物保健业务也将加速动物疫苗的研发创新，引入全球领先的创新产品，覆盖经济动物和伴侣动物的关键物种。面对中国医疗健康产业蓬勃发展的机遇，勃林格殷格翰坚持开放式创新，携手各方伙伴合作构建创新生态。公司通过跨边界研究、业务拓展及许可和风险投资等方式，不断丰富研发管线，为生物医药创新者提供全方位支持。目前，公司已成功投资孵化4家亚洲地区生物医药初创企业。在动物保健领域，勃林格携手广州金苗动保加速动物疫苗研发，真正做到了动保研发合作“在中国，为全球”。三十年来，勃林格殷格翰持续加大对华投入，建立了涵盖早期研发、临床开发、生产制造、商业化和外部创新合作的全价值链布局。在服务本土市场的同时，公司在华的人用药品和动物保健生产基地已发展为辐射区域乃至全球的供应枢纽——人用药品生产基地的产品供应至澳大利亚、新西兰、新加坡等多个亚太国家和地区；动保南昌工厂也升级为全球化生产基地，目前已实现向包括巴西和阿根廷在内的多个国家稳定供货，未来每年将向30多个国家提供超50亿羽份疫苗。此外，勃林格殷格翰也将于金秋时节连续第七年亮相中国国际进口博览会，携多款全新上市的创新产品，全面展示公司在华加速管线研发、赋能新质发展的创新蓝图，践行“扎根中国、服务全球”的坚定承诺。关于勃林格殷格翰勃林格殷格翰是全球领先的生物制药企业，布局人用药品、动物保健两大业务领域。公司研发投入位居行业前列，致力于研究突破性疗法，解决巨大未满足的医疗需求，从而帮助改善或延长生命。自1885年成立以来，勃林格殷格翰一直是独立的家族企业，始终着眼长远发展，将可持续发展理念贯穿全价值链。公司在全球有近5.45万名员工，服务逾130个市场，致力于打造一个更健康、更可持续的未来。勃林格殷格翰于1994年进入中国，总部位于上海，业务遍布全国，拥有约3,200名员工。公司致力于人用药品、动物保健、生物制药合同开发与生产三大业务，实现研发、生产、商业运营、外部创新合作的全价值链布局。中国是勃林格殷格翰的重点市场和创新高地之一，公司将中国患者的需求纳入全球研发策略，致力于把更多更好的创新产品更早地带给中国的患者，助力中国健康产业的高质量发展，全面改善人与动物的健康。近年来，勃林格殷格翰在中国收获长足发展，并连续十二年荣获“中国杰出雇主”认证。更多详情，请访问：www.boehringer-ingelheim.cn， www.boehringer-ingelheim.com

优先审批

2025-09-22

·lystherapeutics.com

Lys Therapeutics Receives $5 Million Grant from The Michael J. Fox Foundation to Advance Innovative Immunotherapy for Parkinson’s Disease - Lys Therapeutics

Lyon & Caen, France, September 22, 2025 – Lys Therapeutics, a French biotechnology company pioneering an innovative approach targeting the blood-brain barrier (BBB) to treat neurodegenerative and neurovascular diseases, today announces the renewed support and the grant award of USD $5 million from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to accelerate the clinical development of LYS241, its first-in-class monoclonal antibody for the treatment of Parkinson’s disease and other neurodegenerative disorders. This significant new funding, part of MJFF’s Therapeutic Pipeline Program, will support the completion of preclinical development and the launch of first-in-human clinical trials, marking a major milestone in Lys Therapeutics’ mission to bring transformative treatments to patients suffering from neurological diseases. “We are honored by the continued trust of The Michael J. Fox Foundation. This grant is both a strong validation of the science behind LYS241 and a powerful catalyst for our development program. It enables us to move with confidence toward clinical evaluation, with the goal of offering patients a truly novel therapeutic option.” said Dr. Manuel Blanc, CEO and co-founder of Lys Therapeutics. LYS241 is a monoclonal antibody designed to neutralize the pathological mechanisms associated with BBB dysfunction, a central process in many neurological diseases. Impairment of the BBB promotes the entry of toxic molecules and inflammatory cells into the central nervous system, leading to neuroinflammation, excitotoxicity, and neuronal death. Specifically, LYS241 is designed to block the interaction between tissue plasminogen activator (tPA) and the NMDA receptor (NMDAr) in the vascular compartment — a key driver of BBB dysfunction, neuroinflammation, and dopaminergic neuron degeneration in Parkinson’s disease. Unlike conventional therapeutic approaches that must cross the BBB to reach their target, LYS241 works from within the blood vessels. By restoring vascular NMDA receptor function, it re-establishes BBB integrity, halts the infiltration of harmful immune cells into the brain, and interrupts a cascade of events leading to neurodegeneration, a hallmark of disease progression in Parkinson’s and other neurological disorders. This approach tackles a fundamental cause of disease progression instead of limiting treatment to symptom control. “Our collaborative work with Lys Therapeutics and INSERM in France has shown that the tPA–NMDAr interaction plays a central role in Parkinson’s pathology. By blocking this mechanism, LYS241 targets a root cause of disease progression rather than simply managing symptoms — representing a true paradigm shift,” said Prof. Daniel A. Lawrence, Department of Internal Medicine and Department of Molecular & Integrative Physiology at the University of Michigan, USA. The MJFF award comes as Lys Therapeutics advances its “pipeline-in-a-drug” strategy — developing LYS241 for multiple neurological diseases driven by BBB dysfunction and neuroinflammation. Beyond Parkinson’s disease, LYS241 has demonstrated potent disease-modifying effects in validated preclinical models of multiple system atrophy, ischemic stroke, and multiple sclerosis, underscoring its multi-indication potential and transformative impact. These findings have been featured in peer-reviewed publications, showcased at major international scientific congresses, and recognized with substantial non-dilutive funding, including previous MJFF support, competitive public grants, and private investment. Following the positive Scientific Advice from national drug agencies, Lys Therapeutics is now accelerating its regulatory studies to complete its dossier in preparation for clinical trial initiation. The company is fully financed to progress through early-stage clinical development, strengthened by this MJFF grant and a significant equity capital increase in 2024. “The Michael J. Fox Foundation continues its pursuit toward our singular and urgent mission of delivering improved therapies and a cure for patients living with Parkinson’s disease,” said Dr. Jessica Tome Garcia, MJFF’s lead scientific program manager. “This work with Lys Therapeutics on a novel approach targeting neuroinflammation is an example of the field’s robust pipeline of new class treatments that goes beyond symptom management by targeting the underlying disease biology.” About Parkinson’s Disease Parkinson’s disease is a progressive neurodegenerative disorder affecting more than 10 million people worldwide. It is characterized by motor symptoms (tremor, bradykinesia, rigidity) and non-motor complications (cognitive decline, sleep disorders, mood disturbances). Despite available treatments, there is currently no cure or approved disease-modifying therapy. About LYS241 LYS241 is a fully humanized IgG1 monoclonal antibody with an Fc-silent backbone, designed to neutralize key pathological mechanisms underlying blood-brain barrier dysfunction—a central driver of many neurological disorders. When the BBB is compromised, toxic molecules and inflammatory cells can infiltrate the central nervous system, triggering neuroinflammation, excitotoxicity, and ultimately neuronal death. By restoring BBB integrity and protecting brain tissue, LYS241 addresses both acute and chronic neurological conditions, truly embodying a pipeline-in-a-drug. Its mechanism of action offers therapeutic benefits across multiple indications: in ischemic stroke, whether administered alone or alongside standard thrombolytic agents (alteplase or tenecteplase), LYS241 counteracts tPA-induced vascular injury, preserves BBB integrity, enhances reperfusion, and reduces the risk of hemorrhage and inflammation; in neurodegenerative diseases such as Parkinson’s disease, multiple sclerosis, and other severe inflammatory disorders, it holds strong potential to slow or halt disease progression. Lys Therapeutics is advancing an ambitious clinical development program to fully unlock the broad therapeutic potential of LYS241. About Lys Therapeutics First-in-class biotherapies against neurological diseases. Lys Therapeutics is a biotechnology company developing first-in-class monoclonal antibodies to treat patients suffering from neurodegenerative and neurovascular diseases with high unmet medical needs. Its lead candidate, LYS241, is a vascular-targeting immunotherapy with a unique mode of action restoring BBB integrity by blocking the pathological interaction between tPA and vascular NMDA receptors. This mechanism is central to the pathogenesis of several major neurological disorders, including Parkinson’s disease, ischemic stroke, and multiple sclerosis. With operations in Lyon and Caen (France), and strategic collaborations with international research institutions, Lys Therapeutics is advancing a robust and versatile pipeline, supported by prestigious funding partners including The Michael J. Fox Foundation, Bpifrance, and private investors. Lys Therapeutics’ approach of targeting neuroinflammation to combat neurodegeneration represents a promising avenue in the search for effective treatments for these debilitating disorders. More information on lystherapeutics.com

免疫疗法

2025-09-15

·石药集团

立足中国证据，引领溶栓新时代：中国替奈普酶在卒中救治中的价值与地位

明刻·纵横：纵览中国替奈普酶系列研究，解析卒中标准治疗的中国方案过去二十年，中国缺血性脑血管病临床研究实现了从无到有，从起步到引领的跨越式发展。6月14日，首都医科大学附属北京天坛医院王拥军教授团队的研究成果“缺血性脑血管病再灌注治疗创新药物与方法”入选2024年度中国生命科学十大进展。面对人民生命健康的迫切需求，该研究成果在中国溶栓治疗领域实现了重大突破，为彻底解决溶栓治疗难题奠定了坚实的基础，迈出了关键的一步。其中，王拥军教授团队主导的“TRACE系列研究”成果闪耀国际顶刊，为急性缺血性卒中再灌注治疗带来重要突破。其核心药物替奈普酶的自主研发和成功应用，更体现中国生物药实现关键核心技术“自立自强”。“中国方案”得到国际广泛认可，这也体现了中国在全球卒中研究领域的领导地位不断增强，尤其是在影响循证实践和指南制定方面做出了重要贡献（BMJ评价）。核心循证 TRACE系列研究奠定“中国方案”的基石再灌注治疗是急性缺血性卒中（AIS）最有效的治疗措施之一1。替奈普酶作为一种新型纤溶酶原激活物，近年来已成为再灌注治疗领域的研究热点。中国替奈普酶拥有庞大、完整的中国人群循证医学证据体系，其安全有效性经中国临床实践充分验证，相关研究成果已成为国内外指南制定的重要依据。 ➤ 从剂量探索到时间窗拓展，TRACE系列研究引领静脉溶栓新征程由首都医科大学附属北京天坛医院王拥军教授团队主导的TRACE系列研究中，TRACE研究2作为多中心前瞻性Ⅱ期临床试验，聚焦超急性期缺血性卒中患者（发病3h内），在中国人群中评估并确立了0.25mg/kg替奈普酶静脉溶栓的优势剂量，其安全性与0.9mg/kg阿替普酶相当，为后续研究奠定基础。随后的TRACE-2研究3首次在亚洲人群（n=1430）中验证了中国替奈普酶治疗发病4.5h内AIS的疗效与安全性，证实其非劣于阿替普酶，两组症状性颅内出血（sICH）与死亡率无显著差异。该研究成果发表于Lancet。这推动《英国和爱尔兰国家卒中临床指南（2023版）》和《中国急性缺血性卒中诊治指南2023》将替奈普酶列为阿替普酶等效替代药的溶栓选择4。 TRACE-3研究5则实现进一步突破，结果于2024年发表在NEJM。作为全球首项针对4.5～24h扩展时间窗静脉溶栓研究，TRACE-3研究在我国58家中心纳入1208例患者，显示中国替奈普酶组90d功能独立（mRS评分≤1分）率达33.0%，显著高于标准治疗组（24.2%），且两组sICH发生率无显著差异。该研究为基层医院提供了无血管内治疗条件下的再灌注方案4，更直接推动《中国卒中学会急性缺血性卒中再灌注治疗指南2024》6将溶栓时间窗扩展至24h。 ➤ 双重突破，中国替奈普酶在桥接和反桥接治疗中的价值验证针对大血管闭塞性AIS（LVO-AIS）的治疗争议，陆军军医大学第二附属医院杨清武教授和资文杰教授团队牵头，联合全国39家卒中中心开展的BRIDGE-TNK研究7，成果登顶NEJM并同步在2025年欧洲卒中组织会议开幕式发布。研究证实，对于发病4.5h内就诊且适合静脉溶栓的LVO-AIS患者，中国替奈普酶联合血管内取栓治疗组的90d功能独立（mRS评分0-2分）率达52.9%，显著高于直接取栓组的44.1%（P=0.04），且安全性良好。该研究的阳性结果破解了“桥接取栓vs直接取栓“治疗难题，为缺血性卒中再灌注的桥接治疗策略提供了新的选择。在反桥接治疗方面，首都医科大学附属北京天坛医院缪中荣教授和北京安贞医院霍晓川教授牵头，联合全国19家卒中中心完成的ANGEL-TNK研究8，进一步拓展了中国替奈普酶的临床应用维度，成果登顶JAMA。该研究针对发病4.5~24h内且经血管内治疗实现成功再灌注的急性LVO患者，证实动脉内使用中国替奈普酶增加90天极好功能（mRS 0-1）恢复的比例，且不会增加sICH或死亡风险。这项突破为时间窗延长的反桥接治疗提供了高级别证据，凸显了中国替奈普酶在急性卒中救治体系中的重要价值。落地有声中国自研替奈普酶解决临床与患者多元需求坚实的循证证据是药物应用的基石，而能否真正惠及患者，还需兼顾临床效率、用药便捷性、品质稳定性及医保可及性等需求。中国替奈普酶以临床需求为中心，在多维度展现显著优势，实现溶栓治疗“落地有声”。 ➤ 高标质控，保障用药安全中国替奈普酶遵循完整、严格的创新型新药路径进行研发与申报，在实现生产工艺技术突破的同时，显著提升了药品质量。技术上，该药物是国内首个采用CHO细胞连续灌流工艺的重组t-PA类药物，其HCP残留不仅严格控制在中国药典限定标准，且上市后监测未出现HCP相关不良反应；质量方面，高达75%的单链比例保障了用药的安全性优势9。此外，该药物的生产工艺、质量控制通过国家药品监督管理局（NMPA）严格审评，获批36个月有效期10，充分证明了其在稳定性和杂质控制方面的卓越水平，也代表了官方对其质量的高度认可。 ➤ 争分夺秒，抢赢“黄金窗口” “时间就是大脑”是卒中救治的黄金法则。与传统溶栓药物60分钟持续输注相比，替奈普酶半衰期长（＞20min），可5–10秒内静脉推注完成给药，实现“一针溶栓”11,12，显著提升给药效率，为患者争取宝贵救治时间。 ➤ 医保赋能，提升药物可及中国替奈普酶的价值不仅在于“技术创新”，更在于其对“医疗可及性”的推动。此前，该药物已获批用于急性ST段抬高型心肌梗死的治疗，并成功纳入国家医保目录；2025年起，其针对AIS的治疗适应症也被纳入医保，报销时间窗覆盖0-4.5h。目前，它是中国唯一一款拥有针对心梗和脑梗双适应症、双医保的替奈普酶*，基于这一优势，临床仅需储备一款药物，即可应对心梗、脑梗两类急性心脑血管病的治疗需求。中国替奈普酶大幅减轻了患者经济负担，推动创新药物惠及更广泛人群，也为基层医疗单位开展标准化溶栓治疗提供了有力支持。 ➤ 剂量适配，兼顾疗效与医保控费我国缺血性卒中平均发病年龄为65岁13，一项基于中国卒中中心联盟登记数据库的研究纳入了2015-2022年共154,503名接受静脉溶栓治疗AIS患者，该人群的平均体重为（65.23±12.46）kg14，根据中国替奈普酶溶栓治疗的标准剂量（0.25mg/kg体重），其16mg/支的药品规格更贴合卒中人群体重分布，在确保疗效的同时提升药物经济性，为医保控费与临床合理用药提供双重支持。展望未来中国替奈普酶引领高质量溶栓黄金时代中国替奈普酶的研发与临床应用，是中国卒中领域从“跟跑”到“领跑”的缩影，也是中国生物药自主创新的典范。从TRACE系列研究突破时间窗、BRIDGE-TNK拓展桥接场景，到成果多次登顶国际顶刊、推动国内外指南改写；从高标准生产质控筑牢安全底线，到医保纳入、剂量适配惠及基层，其以“循证为盾、品质为矛”，不仅解决了临床与患者的核心需求，更推动我国卒中溶栓进入高质量发展阶段。未来，随着TRACE-Ⅴ（基底动脉闭塞患者）、TRACE-BEYOND（24~72h内溶栓）等后续研究的推进，中国替奈普酶将继续拓展卒中治疗的边界，为降低卒中致死致残率、实现“健康中国2030”战略目标贡献更多中国智慧与中国方案。 *截止日期：2025年9月参考文献： 1.中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中华神经科杂志. 2024;57(06):523-559. 2.Li S, Pan Y, Wang Z,et al. Stroke Vasc Neurol. 2022 Feb;7(1):47-53. 3.Wang Y, Li S, Pan Y,et al. Lancet. 2023 Feb 25;401(10377):645-654. 4.谭泽锋, 徐安定. 中国卒中杂志. 2025;20(5):529-548. 5.Xiong Y, Campbell BCV, Schwamm LH,et al. N Engl J Med. 2024;391(3):203-212. 6.中国卒中学会,《中国卒中学会急性缺血性卒中再灌注治疗指南2024》编写组. 中国卒中杂志，2024.19(12):1459-1477. 7.Qiu Z, Li F, Sang H, et al. N Engl J Med. Published online May 21, 2025. 8.Miao Z, Luo G, Song L, et al. JAMA. 2025 Aug 19;334(7):582-591. 9.丁有学,等.药物分析杂志.2014:1208-1211. 10.https://www.cspc.cn/details/details_92_5287.html?utm_source=chatgpt.com 11.Keyt et al. Proc Natl Acad USA 1994;91:3670-3674. 12.Davydov, et al. ClinicalTherapeutics 2001;23(7):982-97. 13.Wen-Jun Tu, et al. Mil Med Res. 2023 Jul 19;10(1):33. 14.熊俞婷, 程爱春, 尹金风, 等. 中国卒中杂志. 2025;20(8):1066-1072. 【声明】 1、本新闻来自“医脉通”，旨在分享研究成果，非广告用途； 2、本资料仅供医药专业人士参考，非产品推荐依据，也不应被视为诊疗建议。

100 项与替奈普酶相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D06070	替奈普酶	B01AD11	DB00031

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
急性缺血性卒中	美国	Genentech, Inc.	2025-02-28
ST段抬高心肌梗死	美国	Genentech, Inc.	2025-02-28
急性心肌梗塞	美国	Genentech, Inc.	2000-06-02

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
闭塞	临床3期	巴西	Boehringer Ingelheim GmbH	2022-01-20
大脑中动脉梗塞	临床3期	美国	Genentech, Inc.	2019-03-02
大脑中动脉梗塞	临床3期	加拿大	Genentech, Inc.	2019-03-02
脑卒中	临床3期	美国	Genentech, Inc.	2019-03-02
脑卒中	临床3期	加拿大	Genentech, Inc.	2019-03-02
血栓形成	临床3期	美国	Genentech, Inc.	2019-03-02
血栓形成	临床3期	加拿大	Genentech, Inc.	2019-03-02
胸腔积液	临床3期	美国	Genentech, Inc.	2008-01-01
肺栓塞	临床3期	奥地利	Boehringer Ingelheim GmbH	2007-11-16
肺栓塞	临床3期	比利时	Boehringer Ingelheim GmbH	2007-11-16

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04526951 (TenCRAOS, EURETINA2025)	临床3期	视网膜动脉闭塞	78	Tenecteplase	製構鹽觸鏇積膚選鹽製(網遞醖夢顧製簾獵壓築) = 鹹淵憲膚選範觸鑰積簾網艱齋壓餘膚襯繭淵膚 (糧廠壓廠獵鹹製繭願衊 ) 更多	不佳	2025-09-04
				Aspirin	製構鹽觸鏇積膚選鹽製(網遞醖夢顧製簾獵壓築) = 鹽夢壓憲觸淵選鑰鹹顧網艱齋壓餘膚襯繭淵膚 (糧廠壓廠獵鹹製繭願衊 ) 更多
NCT04086147 \| NCT04516993 (CHABLIS-T; CHABLIS-T II, Pubmed \| J Am Heart Assoc)	临床2期	-	199	Tenecteplase	憲窪製衊襯廠鹹範糧鑰(餘淵選鹹鏇蓋願鹽淵觸) = 範憲製鹽願遞選淵繭餘顧鹽淵鏇夢醖夢壓鏇積 (範構願襯窪鏇網鹽膚鹹 ) 更多	积极	2025-06-17
NCT02777580 \| NCT00623623 (STREAM-1 and STREAM-2, Pubmed \| Am Heart J)	N/A	心肌梗塞 \| ST段抬高心肌梗死 \| 急性心肌梗塞	1,103	Full-dose TNK	壓襯積壓觸襯糧觸齋鬱(衊襯壓繭簾窪憲範襯鏇) = 鑰膚餘積憲顧鏇醖醖鬱遞遞艱廠襯蓋衊繭築觸 (觸鑰網憲鑰構鬱網選鹹 ) 更多	积极	2025-06-01
				Half-dose TNK	壓襯積壓觸襯糧觸齋鬱(衊襯壓繭簾窪憲範襯鏇) = 遞糧繭鹽鹹壓淵築淵蓋遞遞艱廠襯蓋衊繭築觸 (觸鑰網憲鑰構鬱網選鹹 ) 更多
AAN2025	N/A	急性缺血性卒中	917	Tenecteplase	選範鑰繭鹽製遞齋齋鹽(選壓廠製鬱憲膚窪憲網): RR = 0.8 (95% CI, 0.35 ~ 1.83), P-Value = 0.597 更多	积极	2025-04-07
				Alteplase
NCT03889249 (FDA_CDER) 人工标引	临床3期	急性缺血性卒中	1,147	TNKase	構廠襯壓積範憲壓糧網(鏇艱繭獵顧蓋襯製鑰鏇) = 繭廠積夢繭鑰糧窪積窪觸獵鹽製觸蓋壓簾鑰餘 (壓遞夢窪遞淵蓋鬱顧廠 )	积极	2025-02-28
				Activase	構廠襯壓積範憲壓糧網(鏇艱繭獵顧蓋襯製鑰鏇) = 窪齋積鬱觸選築夢淵選觸獵鹽製觸蓋壓簾鑰餘 (壓遞夢窪遞淵蓋鬱顧廠 )
NCT05172934 (ALLY Pilot Trial, Pubmed \| Stroke)	临床2期	血栓形成	20	Intraarterial Tenecteplase	簾選遞鹽膚積淵簾獵蓋(窪願鑰網蓋艱艱構鑰鹹) = 願糧餘製觸艱夢鹹顧繭網廠艱築顧夢選鑰夢網 (製構鏇夢糧選願醖製醖 )	积极	2025-02-01
NCT04516993 (CHABLIS-T II, Pubmed \| Stroke)	临床2期	脑卒中	224	Tenecteplase 0.25 mg/kg	衊築顧壓鏇廠憲鑰願艱(膚醖餘蓋餘觸壓遞廠夢): adjusted relative risk = 3.0 (95% CI, 1.6 ~ 5.7), P-Value = 0.001 更多	积极	2025-02-01
				Tenecteplase (Best Medical Treatment)
NCT02398656 (TEMPO-2, CTgov)	临床3期	缺血性卒中 \| 急性缺血性卒中 \| 闭塞	1,274	Tenecteplase (Tenecteplase (tNK))	獵餘壓觸襯蓋糧鏇襯憲 = 壓顧顧構鹽夢築醖繭範餘繭鹹憲醖憲餘艱願廠 (構夢選顧積築壓構觸鑰, 蓋餘鑰構鹽襯窪鹽範鏇 ~ 鹽艱衊觸鹽鬱醖鬱膚餘) 更多	-	2025-01-31
				Antiplatelet treatment (Control (Antiplatelet Agents))	獵餘壓觸襯蓋糧鏇襯憲 = 餘鏇鑰願觸積鑰鏇繭夢餘繭鹹憲醖憲餘艱願廠 (構夢選顧積築壓構觸鑰, 願構遞憲窪艱繭夢觸簾 ~ 簾衊鬱顧遞鹽鏇糧壓蓋) 更多
ISC2025	N/A	脑卒中	886	Tenecteplase	築遞築淵鹽選簾觸觸簾(夢蓋醖淵淵製壓繭繭構) = 範鑰範夢糧願膚夢鬱餘積壓夢簾鏇衊範獵襯艱 (積襯衊夢壓廠餘淵築選 ) 更多	不佳	2025-01-30
				Tenecteplase (Standard of care)	築遞築淵鹽選簾觸觸簾(夢蓋醖淵淵製壓繭繭構) = 襯窪製齋積窪顧夢鹹遞積壓夢簾鏇衊範獵襯艱 (積襯衊夢壓廠餘淵築選 ) 更多
Shift to Tenecteplase (ISC2025)	N/A	脑卒中	1,644	Tenecteplase (TNK)	築範餘襯願積膚鏇醖壓(積鬱淵廠憲遞廠築鏇膚) = 餘顧襯願簾襯範構獵繭繭鬱製顧齋鏇觸構簾鏇 (觸製繭顧網積鬱夢鹹淵 ) 更多	积极	2025-01-30
				Alteplase (tPA)	築範餘襯願積膚鏇醖壓(積鬱淵廠憲遞廠築鏇膚) = 淵蓋製廠鏇範繭衊夢構繭鬱製顧齋鏇觸構簾鏇 (觸製繭顧網積鬱夢鹹淵 ) 更多