By Fineline Cube 
Germany-based pharmaceutical leader Boehringer Ingelheim announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its drug Metalyse (tenecteplase) as a treatment for acute ischemic stroke (AIS) within 4.5 hours of symptom onset. This approval expands the therapeutic options available for stroke patients in China.
Clinical Trial Results
The NMPA endorsement is based on positive results from the ORIGINAL study, which demonstrated that tenecteplase matches alteplase in efficacy and safety while offering significant advantages. Tenecteplase has a longer half-life, eliminating the need for prolonged intravenous infusion. Administered as a single intravenous bolus injection, it facilitates pre-hospital emergency care and thrombolytic therapy during patient transport. With higher fibrin-binding specificity, it also carries a theoretically lower bleeding risk during thrombolysis.
Benefits and Clinical Impact
These benefits are expected to enhance stroke emergency systems across pre-hospital care, transportation, and in-hospital treatment, improving overall emergency protocols. Additionally, its single-dose regimen is suitable for all body weight categories, simplifying clinical workflows by eliminating dose adjustments while meeting therapeutic needs for most patients.
Global Approval and Related Developments
Metalyse is approved in over 90 countries for ST-segment elevation myocardial infarction (STEMI). In a related development, China’s CSPC Pharmaceutical Group Ltd. (HKG: 1093) secured approval for Mingfuyue—the first generic tenecteplase in China—in January 2015 for acute myocardial infarction within 6 hours of onset. The drug received a second approval in 2024 for AIS within 4.5 hours of onset, making it the first generic tenecteplase to obtain this indication in China.-Fineline Info & Tech