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Recombinant Human Prourokinase Product in China
Tasly Biopharma Core Product — for Injection, the product name is PUK. The new generation of fibrin-specific thrombolytic drugs developed in China is the only commercialized recombinant human prourokinase product in China. We believe that PUK has huge potential to become an important thrombolytic drug in China.
As currently China’s only approved recombinant human pro-urokinase product, PUK is the first Category I biologic drug approved in China to have received funding under the National Science and Technology Major Project — Major Innovative Drug Development during the 11th Five-Year Plan. In 2017 and 2019, this drug was among the new additions to the “Catalog of Medicines Covered by the National Medical Insurance System”. As a recommended thrombolytic drug for STEMI patients, it is widely seen in academic guides and medical authority publications like “Guidelines for the Rational Drug Use of Thrombolytic Therapy for Acute ST-segment Elevation Myocardial Infarction”, which are widely recognized by the market and academia.
At present, PUK is indicated for STEMI. In addition to treatment of STEMI, Tasly Biopharma is actively expanding the indications of PUK. Meanwhile, PUK mainly has good efficacy and outstanding safety for AIS B1140, APE B1448 and other indications, making it very promising. PUK – expansion for AIS indication B1140 received funding under the National Science and Technology Major Project — Major Innovative Drug Development in the 13th Five-Year Plan, and is now in the clinical phase III summary stage, and its new drug application is expected to be filed in 2020.