Delving into the Latest Updates on Recombinant human TNK tissue-type plasminogen activator(Recomgen Biotech) with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

RHTNK-TPA, Recombinant Human TNK Tissue-type Plasminogen Activator(rhTNK-tPA), 重组人TNK组织型纤溶酶原激活剂 (石药集团)

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Target

PLG

Mechanism

PLG stimulants(Plasminogen stimulants)

Therapeutic Areas

Cardiovascular DiseasesNervous System Diseases

Active Indication

Acute Ischemic StrokeMyocardial Infarction

Inactive Indication-

Originator Organization

Recomgen Biotech

Active Organization

Recomgen Biotech

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (14 Jan 2015),

Myocardial Infarction

Regulation-

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Gene Sequence

Sequence Code 431641667

Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA), a genetically modified variant of conventional alteplase with longer half-life and higher fibrin specificity, has now emerged as a reasonable choice for thrombolytic treatment of acute ischemic stroke (AIS) in China. Orolingual angioedema is a rare but potentially life-threatening complication of intravenous thrombolysis. Currently, there is no documented evidence of orolingual angioedema occurring after thrombolysis with rhTNK-tPA. In this report, we present a unique case of a 75-year-old Chinese man who developed ipsilateral orolingual angioedema following the administration of rhTNK-tPA for AIS. Our case emphasizes the need for caution when using rhTNK-tPA due to its potential to induce ipsilateral orolingual angioedema.

05 Feb 2024·Chinese Medical Journal

Tenecteplase versus alteplase in treatment of acute ST-segment elevation myocardial infarction: A randomized non-inferiority trial

Article

Author: Zhao, Xingshan ; Yang, Yuwang ; Guo, Qiang ; Dang, Wanjun ; Cheng, Guanchang ; Wang, Limei ; Gao, Wen ; Wang, Haibo ; Xu, Haiyan ; Ma, Liping ; Xia, Qingde ; Yang, Qin ; Zhu, Yidan ; Tao, Guizhou ; Yan, Xiaoyan ; Ding, Yutian ; Wu, Yangfeng ; Rong, Juwen ; Yao, Chen ; Qiao, Shubin ; Qi, Liping ; Gao, Runlin ; Zhang, Zheng ; Li, Wanke

AbstractBackground:A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods:In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results:From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA (n = 384) or rt-PA (n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups.Conclusion:rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration: www.ClinicalTrials.gov (No. NCT02835534).

01 Feb 2024·Stroke and Vascular Neurology

Rationale and design of Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events III (TRACE III): a randomised, phase III, open-label, controlled trial

Article

Author: Wang, Yongjun ; Pan, Yuesong ; Meng, Xia ; Li, Hao ; Zhao, Xingquan ; Fisher, Marc ; Xiong, Yunyun ; Schwamm, Lee H ; Parsons, Mark ; Campbell, Bruce C V

Background and purposeRecombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) was not inferior to alteplase for ischaemic stroke within 4.5 hours. Our study aimed to investigate the efficacy and safety of rhTNK-tPA in patients who had an ischaemic stroke due to large vessel occlusion (LVO) of anterior circulation beyond 4.5 hours.Methods and designTenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-III (TRACE III) is a multicentre, prospective, randomised, open-label, blind endpoint, controlled clinical trial. Patients who had an ischaemic stroke due to anterior circulation LVO (internal carotid artery, middle cerebral artery M1 and M2 segments) within 4.5–24 hours from last known well (including wake-up stroke and no witness stroke) and with salvageable tissue (ischaemic core volume <70 mL, mismatch ratio ≥1.8 and mismatch volume ≥15 mL) based on CT perfusion or MRI perfusion-weighted imaging (PWI) were included and randomised to rhTNK-tPA 0.25 mg/kg (single bolus) to a maximum of 25 mg or standard medical therapy. Specially, we will exclude patients who are intended for direct thrombectomy. All will be followed up for 90 days.Study outcomesPrimary efficacy outcome is modified Rankin Scale (mRS) score ≤1 at 90 days. Secondary efficacy outcomes include ordinal distribution of mRS at 90 days, major neurological improvement defined by a decrease ≥8 points compared with the initial deficit or a score ≤1 on the National Institutes of Health Stroke Scale (NIHSS) at 72 hours, mRS score ≤2 at 90 days, the rate of improvement on Tmax >6 s at 24 hours and NIHSS score change from baseline at 7 days. Safety outcomes are symptomatic intracerebral haemorrhage within 36 hours and mortality at 90 days.DiscussionTRACE III will provide evidence for the efficacy and safety of rhTNK-tPA in patients who had an ischaemic strokes due to anterior circulation LVO beyond 4.5 hours.Trial registration numberNCT05141305.

100 Deals associated with Recombinant human TNK tissue-type plasminogen activator(Recomgen Biotech)

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