Tenecteplase by Roche/Boehringer Ingelheim Granted NMPA Approval for Acute Ischemic Stroke in China

On May 21, the official website of the National Medical Products Administration (NMPA) showed,Roche/Boehringer Ingelheim (BI)'s Tenecteplase Approved for Marketing. Based on clinical trial progress, the Insight database speculates thatInThrombolytic Therapy for Acute Ischemic Stroke（AIS）。

Source:NMPA Official Website

In early March this year, TenecteplaseAIS Indication Also Approved for Marketing in the US, Becoming the First Stroke Drug Approved by the FDA in Nearly 30 Years. This product is not a new therapy, 2000It was already launched in the United States in [Year], for the treatment of adult acute ST-segment elevation myocardial infarction. 

Tenecteplase is a tissue plasminogen activator, clot dissolver, and thrombolytic agent administered as a single intravenous injection. (IV)Administered by injection,The administration time is five seconds.. Standard stroke treatment drug Alteplase(Intravenous push, infusion over 60 minutes)In comparison, tenecteplase is administered more quickly and simply.

In December 2023, Boehringer Ingelheim announced that the Phase III clinical trial of tenecteplase conducted in China, the ORIGINAL study, met its expectations. ORIGINAThe L study is a Phase III, multi-center, prospective, randomized, open-label, blinded-endpoint, positive-controlled parallel group clinical trial, aimedIn ChinaAIS Evaluation of Tenecteplase in PatientsWith AlteplaseIn StrokeEfficacy and Safety within 4.5 Hours Post-Procedure。

The results showed,Within 4.5 hours after AIS symptom onset, tenecteplase is non-inferior to alteplase in achieving favorable outcomes (mRS 0 or 1) among eligible Chinese patients for intravenous thrombolysis, with similar safety profiles.

According to Roche's financial report, the total sales of tenecteplase and alteplase in 2024 were $1.362 billion, a year-on-year increase of 5%.

Source: Insight Database

Insight database shows that there are currently 6Tenecteplase Analog, 1 ProductImproved new drugs are under research. There are 3 similar drugs in China, among which the tenecteplase similar drug produced by CSPC has been launched. It was approved in January 2015 and January 2024 respectively for thrombolytic treatment of acute myocardial infarction and acute ischemic stroke.

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