Tasly Pharmaceutical's Subsidiary Receives Drug Registration Certificate for New Indication of Recombinant Human Prourokinase Injection for Acute Ischemic Stroke

Stock News09-22

Tasly Pharmaceutical Group Co.,Ltd. (600535.SH) announced that its wholly-owned subsidiary, Tasly Biopharmaceutical Co., Ltd., has recently received a Drug Registration Certificate issued by the National Medical Products Administration. The certificate approves a new indication for the company's proprietary innovative biological drug, recombinant human prourokinase injection (Puyouke), for thrombolytic treatment of acute ischemic stroke.

Puyouke is a Class 1 innovative biological drug (for acute ST-elevation myocardial infarction indication) that was approved under the support of the national "Major New Drug Creation" major science and technology project during the 11th Five-Year Plan period. The acute ischemic stroke indication represents the second indication approved for this drug in China.

As the only approved recombinant human prourokinase product currently available in China, Puyouke is also the first Class 1 innovative biological drug approved under the support of the national "Major New Drug Creation" major science and technology project during the 11th Five-Year Plan period. The drug's existing approved indication is for acute ST-elevation myocardial infarction.

The approval of this new indication for acute ischemic stroke thrombolytic treatment enriches the company's neurology/psychiatry product portfolio, further expands the target patient population for the product, and is beneficial for enhancing the company's and product's market competitiveness.

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