A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of the Recombinant Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset (FRIDA-CT)

Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial. At the clinical sites, patients with acute ischemic stroke within 4.5-24 hours of symptom onset will be randomized to receive a single bolus injection of the recombinant non-immunogenic staphylokinase (Fortelyzin®, LLC "SuperGene", Russia) or placebo.

开始日期2026-02-01

申办/合作机构

Supergene Co., Ltd.

NCT07245927

/ RecruitingN/A

An Open, Prospective, Non-interventional, Multicentre, Controlled Study of Safety and Efficacy of the Thrombolysis With the Non-immunogenic Staphylokinase in Patients With Massive Pulmonary Embolism (FORPE Registry)

The aim of FORPE Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with massive pulmonary embolism in routine clinical practice.

开始日期2025-06-01

申办/合作机构

Supergene Co., Ltd.

[+1]

NCT06362746

/ Recruiting临床3期

Multicenter, Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of a Single Bolus Administration of Non-immunogenic Recombinant Staphylokinase in Patients With Intermediate High-risk Pulmonary Embolism (FORPE-2)

Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)

开始日期2024-05-23

申办/合作机构

Supergene Co., Ltd.

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100 项与 Recombinant staphylokinase(Supergene Co. Ltd.) 相关的转化医学

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项与 Recombinant staphylokinase(Supergene Co. Ltd.) 相关的文献（医药）

2026-02-09·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

Fortelyzin for acute ischaemic stroke treatment in an extended (4.5 to 24 hours from the onset of symptoms) time window: data from the observational study FORPI registry

Article

作者: Karpova, E.A. ; Bogatyreva, M.D. ; Guseva, M.K. ; Ivanov, S.V. ; Khan, D.S. ; Alasheev, A.M. ; Marskaya, N.A. ; Kulesh, A.A. ; Chefranova, Z.Yu. ; Kutsenko, V.A. ; Romashova, Yu.A. ; Soplenkova, A.G. ; Ivlev, O.E. ; Semenov, M.P. ; Zhukovskaya, N.V. ; Korsunskaya, L.L. ; Semenov, A.M. ; Voznuk, I.A. ; Nesterova, V.N. ; Timchenko, L.V. ; Martynov, M.Yu. ; Khalo, N.V. ; Khasanova, D.R. ; Shamalov, N.A. ; Beregovykh, V.V. ; Gusev, E.I. ; Markin, S.S. ; Kharitonova, T.V. ; Yarovaya, E.B. ; Sutormin, M.V. ; Androphagina, O.V. ; Khoroshavina, K.V.

Objective. To evaluate the safety and efficacy of Fortelyzin thrombolytic drug (non-immunogenic staphylokinase) in AIS patients in an «extended» therapeutic window from 4.5 to 24 h from symptoms’ onset based on data from the FORPI registry. Material and methods. Functional outcomes and the risk of intracranial hemorrhage after thrombolytic therapy (TLT) for acute ischemic stroke (AIS) are known to be directly dependent on the treatment time initiation. Although the most safe and effective time for TLT is the first 4.5 h from symptoms’ onset, a significant proportion of patients are hospitalized beyond this time window. The objective of this study is The FORPI registry is an open-label, prospective, non-interventional observational study of Fortelyzin in AIS patients in real-world clinical practice. A comparative analysis of safety and efficacy outcomes was conducted in groups of patients who received TLT in the first 4.5 h after symptom onset and beyond 4.5 h time window. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) according to ECASS III and SITS-MOST criteria, as well as all-cause mortality at day 90. The efficacy endpoint was good functional recovery, defined by a modified Rankin Scale (mRS) of 0—2 score at day 90. Results. The analysis included 17.636 patients with TLT performed in the first 4.5 h after symptom onset and 358 patients with TLT performed beyond 4.5 h time window (up to 24 hours). In the group of patients with TLT performed in the interval of 4.5—24 hours, there were statistically significantly fewer people over 80 years old (8% vs 16%, p=0.001), and a lower median age (66 vs 68 years, p=0.002) compared with the group of TLT within 4.5 hours. The NIHSS median was slightly higher in the group of patients with TLT performed beyond 4.5 h time window (11 (8—16) vs 11 (8—15), p=0.036). The incidence of sICH (ECASS III) within 4.5 h was 2% compared with 2.5% beyond 4.5 h time window (p=0.454). All-cause mortality at 90 days in the main population was 9%, which is comparable with the mortality rate in the 4.5—24 h group — 7% (p=0.160). Good functional recovery (mSR 0—2) at day 90 was achieved in 61% of patients in the group who received TLT within 4.5 h, compared with 65% of patients who received TLT beyond 4.5 h time window (p=0.227). Conclusion. FORPI registry demonstrates similar data on the safety and efficacy of TLT with Fortelyzin in AIS patients both within 4.5 hours and beyond 4.5 hours from symptoms’ onset.

2026-02-01·STROKE

Thrombolysis With the Non-Immunogenic Staphylokinase for Acute Ischemic Stroke in the FORPI Registry: An Observational Study

Article

作者: Kutsenko, Vladimir A. ; Azarova, Alla G. ; Alifirova, Valentina M. ; Kladova, Irina V. ; Batueva, Yulia V. ; Chefranova, Zhanna Yu ; Zinovieva, Natalya P. ; Bogatyreva, Madina D. ; Markin, Sergey S. ; Tikhomirova, Olga V. ; Kulesh, Alexey A. ; Zhukovskaya, Natalia V. ; Shamin, Andrey A. ; Ulimbasheva, Emma S. ; Khan, Dmitry S. ; Philippov, Pavel G. ; Gusev, Eugene I. ; Andreyko, Nadezhda V. ; Shatunova, Anna V. ; Khasanova, Dina R. ; Marskaya, Natalia A. ; Ternovskaya, Valeria A. ; Chirkov, Alexander N. ; Bort, Anton A. ; Korsunskaya, Larisa L. ; Volkova, Alexandra K. ; Timchenko, Ludmila V. ; Dzugaeva, Fatima K. ; Tekeev, Magomed B. ; Balaeva, Marem Kh. ; Komissarova, Natalya V. ; Mnev, Andrey A. ; Brutyan, Gegetsik S. ; Evdokimova, Veronika A. ; Bukaeva, Alexandra N. ; Voznuk, Igor A. ; Soplenkova, Anna G. ; Alasheev, Andrey M. ; Farenbrukh, Svetlana V. ; Daynikova, Elena I. ; Lebedeva, Anastasia Yu. ; Ivanova, Vera V. ; Batukaeva, Laila A. ; Kuzmin, Eugeny L. ; Kharitonova, Tatiana V. ; Martynov, Mikhail Yu ; Androphagina, Olga V. ; Birukov, Andrey E. ; Ivanov, Sergey V. ; Gaponenko, Ivan A. ; Terentyeva, Anna E. ; Rakhmatullin, Airat R. ; Maslova, Natalia N. ; Lykov, Yuriy A. ; Kirukhina, Nadezhda N. ; Shamalov, Nikolay A. ; Maltsev, Vasily G. ; Nesterova, Valentina N. ; Kholopov, Maxim A. ; Karasev, Alexander A. ; Timofeev, Artem A. ; Cherepyansky, Maxim S. ; Golubeva, Eugenia A. ; Karamova, Irina M. ; Abramcheva, Viktoria V. ; Mamina, Regina M. ; Khalo, Natalya V. ; Ivlev, Oleg E. ; Stepushenkova, Darya L. ; Fedyanin, Sergey A. ; Sharina, Sargylana F. ; Uskova, Natalia I. ; Maximov, Vladislav I. ; Yarovaya, Elena B. ; Chuprina, Svetlana E. ; Semenov, Mikhail P. ; Shishkina, Elena N. ; Kurnosov, Sergey I. ; Sutormin, Maxim V. ; Vakazheva, Saida A. ; Slasten, Elena V. ; Lisin, Sergey A. ; Sazhnev, Alexey I. ; Teryaeva, Irina V. ; Saskin, Vitaly A. ; Mongush, Kherelmaa D. ; Schegolev, Alexander Yu. ; Korobeynikov, Ivan V. ; Strambovskaya, Natalya N. ; Khoroshavina, Ksenia V. ; Tabakman, Sergey V. ; Gasambekova, Safinat N. ; Semenov, Andrey M.

BACKGROUND::

The non-immunogenic staphylokinase is a recombinant staphylokinase with low immunogenicity, high thrombolytic activity, and fibrin selectivity approved in Russia for the acute ischemic stroke (AIS) thrombolytic therapy within 4.5 hours after symptom onset. We evaluated safety and efficacy outcomes of the non-immunogenic staphylokinase usage in patients with AIS in the Fortelyzin Population Investigation registry.

METHODS::

Between March 2021 and October 2024, patients with AIS treated with the non-immunogenic staphylokinase were enrolled in the prospective, open-label, internet-based, monitored, observational Fortelyzin Population Investigation registry. Demographics, risk factors, baseline stroke severity (defined by National Institutes of Health Stroke Scale), and onset to treatment time were recorded. Safety outcomes included symptomatic intracerebral hemorrhage (according to the ECASS III [European Cooperative Acute Stroke Study III] and SITS-MOST [Safe Implementation of Thrombolysis in Stroke—Monitoring Study] criteria) within 36 hours and all-cause mortality on day 90. Efficacy outcome was evaluated by functional independence using of modified Rankin Scale score of 0 to 2 on day 90.

RESULTS::

A total of 17 636 patients with AIS were treated with the non-immunogenic staphylokinase in 329 centers participated in the Fortelyzin Population Investigation registry during the study period (median age 68 [60–75]; 56% male; median baseline National Institutes of Health Stroke Scale score, 11 [8–16] points; median onset to treatment time, 2.4 hours [1.8–3.1]). The rate of symptomatic intracerebral hemorrhage according to the ECASS III criteria was 2% (356/17 636; 1.8–2.2), to the SITS-MOST criteria, 2% (330/17 636; 1.8–2.1). All-cause mortality on day 90 was 9% (1588/17 636; 8.6–9.4). The number of patients with a modified Rankin Scale score of 0 to 2 on day 90 was 61% (10 799/17 636; 60.5–61.9). These safety and efficacy outcomes were comparable with FRIDA (Fortelyzin Randomized Investigation Compared With Alteplase) randomized clinical trial results.

CONCLUSIONS::

The presented data suggest that intravenous thrombolysis with the non-immunogenic staphylokinase is safe and effective in routine clinical practice when used within 4.5 hours of AIS symptoms onset. These findings should encourage the wider usage of thrombolytic therapy with the non-immunogenic staphylokinase for suitable patients.

REGISTRATION::

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT06707987.

2026-01-01·Quantitative Imaging in Medicine and Surgery

Cardiac magnetic resonance assessment of long-term cardiac function after early recombinant staphylokinase thrombolysis before primary percutaneous coronary intervention for ST-segment elevation myocardial infarction patients

Article

作者: Zhou, Ying ; Xu, Yi ; Wang, Yunfei ; Chen, Pengsheng ; Li, Chunjian ; Gong, Hao ; Wang, Jun ; Zhu, Xiaomei ; Yin, Jiani ; Li, Chen

Background:

The long-term effects of early thrombolytic therapy administered within 120 minutes of the first medical contact and before primary percutaneous coronary intervention (PCI) on left ventricular (LV) and left atrial (LA) function in ST-segment elevation myocardial infarction (STEMI) patients remain unknown. This study aimed to explore the long-term effects of early recombinant staphylokinase (r-SAK) thrombolysis administered up to 120 minutes before primary PCI on the LV and LA function of STEMI patients using cardiac magnetic resonance (CMR) imaging.

Methods:

This retrospective study analyzed the one-year follow-up CMR imaging data of STEMI patients enrolled in the multi-center, prospective OPTIMA-5 trial, conducted from November 2021 to August 2022. Patients were randomized to receive either a single half-dose of 5 mg r-SAK or normal saline (NS) before primary PCI. LV and LA functional parameters were compared between groups using appropriate statistical tests.

Results:

A total of 66 patients were included (r-SAK, n=32; NS, n=34). Compared to the NS group, the r-SAK group had a significantly higher cardiac index (2.77 vs. 2.41 L/min/m², P=0.018), LV stroke volume index (42.18 vs. 37.77 mL/m², P=0.029), LV wall thickening (49.86% vs. 44.36%, P<0.001), and LV wall motion (6.02 vs. 5.57 mm, P=0.015). The segmental circumferential strain of the non-infarcted myocardium was also superior (-19.36% vs. -17.90%, P<0.001). In relation to LA function, the r-SAK group showed better LA conduit function [change in left atrial volume index (△LAVI): 8.27 vs. 5.69 mL/m², P=0.004], LA passive ejection fraction (27.34% vs. 20.68%, P=0.007), passive strain (21.80% vs. 17.05%, P=0.045), and peak early negative strain rate (-1.80 vs. -1.50 1/s, P=0.043).

Conclusions:

The early administration of r-SAK thrombolysis before primary PCI significantly improves long-term LV and LA function in STEMI patients, suggesting a potential strategy for enhancing cardiac recovery.

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2025-01-07

·药时空

用于重组蛋白的酵母细胞：从细胞工程到工艺放大

导读传统的制药原料获取方式，如植物提取或依赖某些天然合成生物体，往往存在诸多弊端。植物提取面临着生长周期长、提取工艺复杂且产量有限的困境，而部分天然合成者又因生长缓慢、产量波动大等因素难以满足工业化大规模生产的需求。微生物重组蛋白合成技术的出现，为生物制药开辟了新的路径，其中酵母作为生产宿主展现出了非凡的优势。今天，就让我们一同深入探索酵母细胞工厂，看看它是如何从细胞工程的精妙设计一步步走向大规模工业化生产，为人类健康福祉贡献力量的。一、细胞工程 1.1 启动子工程与CRISPR/Cas9 在酵母细胞中，基因表达的高效调控是实现重组蛋白成功表达的关键环节，而启动子工程则是这一调控过程中的核心要素。在毕赤酵母的蛋白表达系统中，甲醇诱导型的AOX1启动子是最为核心的元件之一，研究人员对AOX1启动子的转录因子结合位点进行了深入的删除和重复操作，使其在葡萄糖耗尽时能够实现自主调控，无需额外的甲醇诱导[1]。与毕赤酵母不同的是，多形汉逊酵母的部分甲醇诱导型启动子在甘油培养基中也能保持一定的活性，利用这些特性科研人员已经成功地生产了多种重要的疫苗和药用蛋白，如乙肝疫苗抗原、胰岛素等，充分彰显了其在生物制药领域的巨大潜力和应用价值。 CRISPR/Cas9及其衍生技术让基因操作更精准高效。在毕赤酵母中，CRISPRi技术可精准调控AOX1基因表达；在多形汉逊酵母里，通过该技术引入代谢途径大幅提升了白藜芦醇产量；在解脂耶氏酵母中，确定关键整合位点促进了番茄红素合成。 1.2 酵母分泌途径优化酵母分泌途径的优化是提高治疗性蛋白产量和质量的关键环节，直接关系到生物制药的成败。然而，在实际应用中，酵母分泌途径仍面临着诸多挑战，如糖基化异常和蛋白水解降解等问题，这些问题严重影响了重组蛋白的产量和质量。图1 分泌人源化治疗蛋白的工程酵母示意图为此，科学家开发出一系列基因工程工具（表2）。优化分泌信号方面，发现特定修饰的前导序列可提升分泌效率；在蛋白折叠环节，过表达伴侣蛋白和氧化还原酶能减少错误折叠，如在多种酵母中过表达相关蛋白促进了重组蛋白分泌[2]；增强囊泡运输上，调控相关蛋白表达加速了蛋白转运；针对蛋白酶降解，培育缺陷菌株有效保护了蛋白完整性，如在不同酵母中敲除特定蛋白酶基因提高了多种蛋白产量，保障了蛋白生产质量。表1 酵母蛋白质分泌途径的工程化 1.3 糖基化工程糖基化作为蛋白质重要的翻译后修饰方式，对蛋白的结构、功能、药代动力学和免疫原性具有深远的影响。虽然酵母能够进行N-和O-糖基化，但与人类糖基化模式存在显著差异。酵母产生的α-1,3-甘露糖连接和高甘露糖型聚糖常常导致治疗性蛋白的免疫原性增加和半衰期缩短，这成为了酵母生产人源化生物制药的主要障碍。因此，糖基化工程成为了酵母生产人源化生物制药的核心任务。在多种酵母中，删除OCH1基因是实现这一目标的关键步骤。在酿酒酵母、乳酸克鲁维酵母、多形汉逊酵母、解脂耶氏酵母和毕赤酵母等中，OCH1基因缺失株均表现出糖基化模式的改变，有效降低了蛋白的免疫原性，为后续的糖基化修饰奠定了基础。引入人类糖基转移酶和糖苷酶是实现酵母糖基化人源化的关键策略。在毕赤酵母中，通过删除α-1,6-甘露糖基转移酶基因并引入α-1,2-甘露糖苷酶和人类β-1,2-N-乙酰葡糖胺基转移酶I，成功合成了类似于人类的聚糖结构[3]。此外，通过在毕赤酵母中过表达参与唾液酸合成的酶，实现了O-糖基化聚糖的唾液酸化；在酿酒酵母中，过表达特定的糖基转移酶基因，成功合成了具有O-岩藻糖修饰的人表皮生长因子结构域。这些成果拓展了酵母在复杂糖蛋白生产中的能力，为开发新型生物制药提供了技术支持，进一步推动了酵母在生物制药领域的应用。二、发酵与规模放大策略 2.1 生长与生产动力学在酵母生产药用蛋白的工业化进程中，深入理解重组菌株的生长和生产动力学是实现高效生产的关键。毕赤酵母在不同碳源条件下的生长表现差异显著，在葡萄糖、甘油和甲醇这三种常见的碳源中，甲醇虽能支持其良好生长，但在发酵过程中常呈现出二次生长现象，即葡萄糖或甘油会抑制甲醇的利用。此外，表达重组蛋白的菌株生长速率通常低于野生型菌株。因此，精确测定最大比生长速率成为优化培养策略的必要前提。通过合理控制培养条件，确保在不同菌株背景下实现稳定高效的生长和蛋白生产，是提高生产效率的关键。蛋白生产动力学与细胞内的蛋白折叠、运输等过程紧密相关，其核心在于维持特定的碳源供应以平衡生长和生产。对于GAP启动子控制的分泌蛋白，其合成通常与生长速率呈正相关，接近最大比生长速率时达到较高产量；而AOX1启动子控制的蛋白生产动力学呈钟形曲线，这可能与甲醇利用效率、分泌途径饱和等因素有关。在实际生产中，针对AOX1启动子调控的过程，选择较低的比生长速率（如小于0.04/h）有助于实现高产量和高生产率，为发酵工艺优化提供了重要的理论指导[4]。 2.2 菌株筛选与培养优化高效筛选重组菌株是确保异源蛋白生产成功的重要环节。在批次培养中，需选择不同生产力水平的克隆群进行后续实验，并根据筛选数据优化培养条件。例如，GAP启动子菌株的筛选数据可直接应用于fed-batch培养，而AOX1启动子菌株则需进一步优化甲醇诱导策略和培养参数，确保蛋白高效合成。在生物质生长和产品形成方面，全面表征菌株生理特性至关重要。在毕赤酵母和解脂耶氏酵母等酵母培养中，合理选择碳源（如甘油、葡萄糖、甲醇等）和优化培养方式（如fed-batch、循环fed-batch等）能够显著提高蛋白产量。例如，在毕赤酵母生产人血清白蛋白的过程中，通过优化fed-batch工艺，实现了每克生物质13.4mg的蛋白产量；在胰岛素前体生产中，通过精确调控甲醇浓度和fed-batch培养参数，达到了约3g/L的高产水平，充分展示了培养优化在蛋白生产中的重要作用。 2.3 非传统酵母的生物过程开发除了传统的优化策略，针对不同非传统酵母的特性开发特定的生物过程也是提高蛋白产量的有效手段。在乳酸克鲁维酵母中，通过调整培养基成分和采用生物膜反应器，显著提高了人溶菌酶的产量，为乳酸克鲁维酵母在工业酶生产中的应用提供了新的范例。多形汉逊酵母在生产重组葡萄球菌激酶时，通过设计80L规模的短周期发酵工艺，优化进料技术、温度、培养基成分和pH等关键参数，成功将产量提高到1g/L[5]。氮源限制能够调控细胞代谢流向，激活脂质合成途径，进而影响蛋白生产。解脂耶氏酵母的培养过程中，培养基的C/N比被确定为影响重组蛋白合成的关键因素之一，在解脂耶氏酵母生产白藜芦醇的过程中，实现了高达12.4g/L的产量，且在低成本矿物培养基中即可实现高效生产，为利用解脂耶氏酵母生产高附加值生物制品提供了经济可行的方案。结语定制酵母细胞工厂在生物制药领域已取得显著进展，但前方仍有广阔的发展空间等待探索。未来有望实现对酵母基因表达的全方位、动态化精准调控，从而使异源蛋白的表达更加高效、稳定且质量可控。在糖基化工程方面，科研人员将不断深入探究糖基化修饰的分子机制，持续完善相关技术手段。在发酵工艺和规模放大领域，通过对发酵过程中的海量数据进行实时监测、深度分析和智能学习，实现培养过程的全自动精准调控。同时，开发新型酵母底盘细胞和拓展酵母的应用范围将成为未来研究的重点方向。定制酵母细胞工厂必将在生物制药的创新浪潮中持续领航，为人类健康事业创造更多的奇迹与可能。参考文献 [1] Hartner FS, Ruth C, Langenegger D, Johnson SN, Hyka P, Lin-Cereghino GP, Lin-Cereghino J, Kovar K, Cregg JM, Glieder A. Promoter library designed for fine-tuned gene expression in Pichia pastoris. Nucleic Acids Res. 2008, 36(12): e76. [2] Yun CR, Kong JN, Chung JH, Kim MC, Kong KH. Improved Secretory Production of the Sweet-Tasting Protein, Brazzein, in Kluyveromyces lactis. J Agric Food Chem. 2016, 64(32): 6312-6316. [3] Hamilton SR, Cook WJ, Gomathinayagam S, Burnina I, Bukowski J, Hopkins D, Schwartz S, Du M, Sharkey NJ, Bobrowicz P, Wildt S, Li H, Stadheim TA, Nett JH. Production of sialylated O-linked glycans in Pichia pastoris. Glycobiology. 2013, 23(10): 1192-1203. [4] Looser V, Bruhlmann B, Bumbak F, Stenger C, Costa M, Camattari A, Fotiadis D, Kovar K. Cultivation strategies to enhance productivity of Pichia pastoris: A review. Biotechnol Adv. 2015, 33(6):1177-1193. [5] Moussa M, Ibrahim M, El Ghazaly M, Rohde J, Gnoth S, Anton A, Kensy F, Mueller F. Expression of recombinant staphylokinase in the methylotrophic yeast Hansenula polymorpha. BMC Biotechnol. 2012, 12: 96. 识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

基因疗法核酸药物疫苗免疫疗法

100 项与 Recombinant staphylokinase(Supergene Co. Ltd.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性肺损伤	临床3期	俄罗斯	Supergene Co., Ltd.	2022-12-26
肢体缺血	临床3期	俄罗斯	Supergene Co., Ltd.	2022-12-26
新型冠状病毒感染	临床3期	俄罗斯	Supergene Co., Ltd.	2021-12-27
肺栓塞	临床3期	俄罗斯	Supergene Co., Ltd.	2020-12-15
急性缺血性卒中	临床3期	俄罗斯	Supergene Co., Ltd.	2017-03-18
雄激素不敏感综合征	临床3期	俄罗斯	Supergene Co., Ltd.	2017-03-18
ST段抬高心肌梗死	临床3期	俄罗斯	Supergene Co., Ltd.	2014-05-16

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临床结果

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分期

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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


NCT04688320 (FORPE, CTgov)	临床3期	肺栓塞	310	Recombinant nonimmunogenic staphylokinase (Recombinant Nonimmunogenic Staphylokinase)	蓋醖築艱鑰願鹹顧積顧 = 淵觸艱艱築觸夢餘醖蓋繭鹹鹽糧餘築窪廠糧蓋 (艱襯製艱鏇壓範夢製願, 鑰餘齋糧壓糧積獵願艱 ~ 獵製鹽廠獵艱範顧鹹選) 更多	-	2025-04-02
				Alteplase (Alteplase)	蓋醖築艱鑰願鹹顧積顧 = 遞繭窪鑰觸遞糧餘夢顧繭鹹鹽糧餘築窪廠糧蓋 (艱襯製艱鏇壓範夢製願, 壓蓋範醖顧鏇鑰膚簾網 ~ 獵醖糧廠壓遞簾艱膚蓋) 更多
NCT03151993 (FRIDA, CTgov)	临床3期	雄激素不敏感综合征 \| 急性缺血性卒中	336	Recombinant staphylokinase (Recombinant Staphylokinase)	鹽齋衊鹹鏇蓋遞壓鹽夢 = 蓋簾獵鹽衊鑰糧襯構範夢膚襯憲齋鹽窪簾願衊 (齋鑰獵鏇鬱選築艱淵鏇, 餘壓鹽壓憲顧壓選製窪 ~ 窪鑰簾餘顧窪夢窪艱製) 更多	-	2025-04-02
				Alteplase (Actilyse)	鹽齋衊鹹鏇蓋遞壓鹽夢 = 襯鑰廠網夢鏇繭襯窪選夢膚襯憲齋鹽窪簾願衊 (齋鑰獵鏇鬱選築艱淵鏇, 願積齋觸繭襯蓋膚廠獵 ~ 鏇淵築蓋鹽廠窪膚齋顧) 更多
NCT02301910 (FRIDOM1, CTgov)	临床3期	ST段抬高心肌梗死	382	Recombinant staphylokinase (Recombinant Staphylokinase)	獵製築蓋衊範鑰願簾選 = 蓋鬱齋鏇顧簾廠餘衊簾網襯鏇淵鹽網壓觸鑰餘 (選衊膚醖廠衊築糧積糧, 鹽艱鑰壓鹽膚構簾簾鑰 ~ 餘選艱鏇齋顧築膚鏇繭) 更多	-	2025-03-20
				Tenecteplase (Tenecteplase)	獵製築蓋衊範鑰願簾選 = 齋鏇鹹範製餘顧網壓鏇網襯鏇淵鹽網壓觸鑰餘 (選衊膚醖廠衊築糧積糧, 鹽繭築選簾衊築醖蓋衊 ~ 築獵構網壓觸繭鑰齋淵) 更多
NCT03151993 (FRIDA, Pubmed \| Lancet Neurol)	临床3期	急性缺血性卒中	336	Non-immunogenic staphylokinase	鹹鏇積淵鏇構顧遞構繭(顧餘齋構鏇獵憲積獵範) = 糧窪膚鏇糧衊憲憲衊廠夢繭齋築繭淵餘廠壓構 (範淵壓襯膚膚鹹壓蓋網 ) 更多	积极	2021-09-01
				Alteplase	鹹鏇積淵鏇構顧遞構繭(顧餘齋構鏇獵憲積獵範) = 鑰夢餘齋艱蓋壓壓顧夢夢繭齋築繭淵餘廠壓構 (範淵壓襯膚膚鹹壓蓋網 ) 更多