China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that a supplementary market filing for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) has been accepted for review by the National Medical Products Administration (NMPA). The new indication filing is for the drug’s use as a thrombolytic therapy in patients with acute ischemic stroke.
rhTNK-tPA Profile
RhTNK-tPA is a recombinant protein produced via mammalian cells and genetic engineering technology. Launched in China in 2015, it is used as a 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, offering significant clinical application advantages over products that require intravenous infusion for 1 hour.
Future Development
Based on its mechanism of action characteristics and existing clinical data, CSPC Pharma plans to develop rhTNK-tPA as an ischemic stroke bridging therapy combined with endovascular therapy. The company also aims to explore its use in treating deep vein thrombosis, pulmonary embolism, and central retinal artery occlusion. This strategic move underscores CSPC’s commitment to expanding the therapeutic applications of rhTNK-tPA, addressing significant unmet medical needs.-Fineline Info & Tech
