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GENERIUM Registers Biosimilar of Tenecteplase for Acute Myocardial Infarction and Ischemic Stroke Treatment

The Russian Ministry of Health has issued a marketing authorization to GENERIUM for Nekteliza® (INN: tenecteplase), a fibrinolytic agent. The approved indications for this biosimilar include thrombolytic therapy for acute myocardial infarction and ischemic stroke in adults.

Nekteliza® contains tenecteplase, a recombinant fibrin-specific plasminogen activator capable of dissolving blood clots with a single bolus injection. The drug is produced using recombinant DNA technology in CHO cell lines.

Approved Indications:

  • Thrombolytic therapy for acute myocardial infarction in adults (18+ years).
  • Thrombolytic therapy for acute ischemic stroke within 4.5 hours of symptom onset, after excluding intracranial hemorrhage.

Dosage form: Lyophilized powder for intravenous solution.


Daniil Talyansky, CEO of GENERIUM:

"Cardiovascular diseases remain a leading cause of mortality worldwide. By adding this bolus-administered thrombolytic to our portfolio, we aim to reduce emergency treatment time—a critical factor in improving outcomes for stroke and heart attack patients."

According to the World Health Organization, 17.9 million people died from cardiovascular diseases in 2019, accounting for 32% of global deaths. 85% of these fatalities were due to heart attacks and strokes.

Nekteliza® represents an important advancement in improving access to fast-acting thrombolytic therapy, potentially saving lives in time-sensitive emergencies.