China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the Phase III clinical study for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) in acute ischemic stroke has reached the pre-set primary endpoint.
Study Details
The multi-center, prospective, randomized, open, blinded, non-inferiority Phase III clinical study was designed to assess the efficacy and safety of rhTNK-tPA (0.25mg/kg) compared with rt-PA (0.9mg/kg) in acute ischemic stroke. The study randomly enrolled 1,430 subjects. Results show that the efficacy and safety of rhTNK-tPA are non-inferior to rt-PA, with a trend of improvement. This is consistent with the characteristics and trends of clinical results of foreign products with the same mechanism of action in the same indication, and the mortality rate within 90 days is lower. Based on these results, CSPC has filed for pre-market communication with the National Medical Products Administration (NMPA).
Product Background
RhTNK-tPA, a recombinant protein produced via mammalian cells and genetic engineering technology, was launched in China in 2015 for use as thrombolytic therapy in patients with acute myocardial infarction within six hours of onset. Compared with traditional rt-PA products, rhTNK-tPA has a longer half-life, stronger antagonistic ability of plasminogen activator inhibitor-1 (PAI-1), and enhanced ability to bind to fibrin. It can complete a single bolus intravenous injection within 5-10 seconds, which offers significant clinical application advantages over products that require intravenous bolus followed by 1-hour intravenous infusion.-Fineline Info & Tech
