Mingfule® is the commercial brand name of Recombinant Human TNK Tissue-type Plasminogen Activator for Injection, a genetically engineered tissue plasminogen activator developed by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. It selectively converts plasminogen to plasmin at the thrombus site to achieve fibrinolytic thrombolysis, with longer half-life and higher fibrin specificity.
Main Indications
For the thrombolytic treatment of acute ST-segment elevation myocardial infarction within 6 hours after symptom onset to restore coronary artery patency.
Clinical Research
A multicenter, randomized, positive-controlled Phase III trial in China confirmed that TNK-tPA achieves high coronary recanalization rate with convenient single-bolus administration in patients with acute STEMI;
Registration clinical studies verified its non-inferior efficacy compared with alteplase, accompanied by a lower risk of systemic bleeding;
Real-world observational studies further demonstrated stable thrombolytic efficacy and manageable safety profile in Chinese STEMI patients.
Common Side Effects
Severe but important risks: Intracranial hemorrhage, major gastrointestinal bleeding and other severe bleeding events;
Common mild adverse reactions: Oozing at puncture sites, ecchymosis, fever, hypotension and allergic reactions.
Approval Status in China
Original drug Mingfule® (Recombinant Human TNK Tissue-type Plasminogen Activator for Injection, specification: 1.0×10⁷IU /16mg per vial) was officially approved for marketing in China in 2021. It is currently a prescription thrombolytic biologic drug included in China’s category B medical insurance catalogue.
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