TASLY's subsidiary has received a drug registration certificate for the new indication of recombinant human urokinase injection in acute ischemic stroke
I'm LongbridgeAI, I can summarize articles.TASLY's wholly-owned subsidiary, TASLY Pharmaceutical Co., Ltd., recently received approval from the National Medical Products Administration for the drug registration certificate of recombinant human urokinase (PuYouKe) for the additional indication of acute ischemic stroke. This drug is the only approved recombinant human urokinase product in China. This approval will enrich the company's product line in the neurology/psychiatry field, expand the target patient population, and enhance market competitiveness
According to the Zhitong Finance APP, TASLY (600535.SH) announced that its wholly-owned subsidiary, TASLY Biopharmaceutical Co., Ltd. (referred to as "TASLY Biopharmaceutical"), has received the Drug Registration Certificate approved and issued by the National Medical Products Administration. This certificate approves the additional indication for the company's self-owned intellectual property biopharmaceutical innovation drug, recombinant human urokinase (PuYouKe), for thrombolytic treatment of acute ischemic stroke. PuYouKe is a Class 1 biopharmaceutical innovation drug approved during the "11th Five-Year Plan" period under the national "Major New Drug Creation" science and technology major project, with the indication for acute ST-segment elevation myocardial infarction. The acute ischemic stroke indication is the second indication approved for this drug in China.
As the only approved recombinant human urokinase product currently on the market in China, PuYouKe is also the first Class 1 biopharmaceutical innovation drug approved under the national "Major New Drug Creation" science and technology major project during the "11th Five-Year Plan" period. The drug's currently approved indication is for acute ST-segment elevation myocardial infarction, and the approval of the new indication for thrombolytic treatment of acute ischemic stroke enriches the company's product line in the neurology/psychiatry field, further expands the target patient population for the product, and is beneficial for enhancing the company's and the product's market competitiveness
