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石藥集團:自願公告 - 明復樂(注射用重組人TNK組織型纖溶酶原激活劑)急性缺血性卒中適應症獲上市批准

CSPC PHARMA: VOLUNTARY ANNOUNCEMENT - INDICATION FOR ACUTE ISCHEMIC STROKE OF MINGFULE (RECOMBINANT HUMAN TNK TISSUE-TYPE PLASMINOGEN ACTIVATOR FOR INJECTION) OBTAINS MARKETING APPROVAL

香港交易所 ·  Feb 5 12:15
Summary by Futu AI
石藥集團有限公司宣佈,旗下明復樂藥業(廣州)有限公司開發的明復樂®(注射用重組人TNK組織型纖溶酶原激活劑)獲得中國國家藥品監督管理局批准,用於治療急性缺血性卒中患者的溶栓治療。這是該產品在中國獲批的第二個適應症,也是同類產品中首家獲此批准。該產品的獲批基於III期臨床試驗的有效性和安全性結果,且研究結果已發表於《柳葉刀》期刊。明復樂®具有更長的半衰期和更強的纖維蛋白特異性,提供了快速的單次彈丸式靜脉注射,顯示出顯著的臨床應用優勢。石藥集團主席蔡東晨於2024年2月5日發表此消息。
石藥集團有限公司宣佈,旗下明復樂藥業(廣州)有限公司開發的明復樂®(注射用重組人TNK組織型纖溶酶原激活劑)獲得中國國家藥品監督管理局批准,用於治療急性缺血性卒中患者的溶栓治療。這是該產品在中國獲批的第二個適應症,也是同類產品中首家獲此批准。該產品的獲批基於III期臨床試驗的有效性和安全性結果,且研究結果已發表於《柳葉刀》期刊。明復樂®具有更長的半衰期和更強的纖維蛋白特異性,提供了快速的單次彈丸式靜脉注射,顯示出顯著的臨床應用優勢。石藥集團主席蔡東晨於2024年2月5日發表此消息。
Petrochemical Group Co., Ltd. announced that Mingfu® (an injectable recombinant TNK tissue type cellulase activator) developed by Mingfu Pharmaceutical (Guangzhou) Co., Ltd. has been approved by the China National Drug Administration for the treatment of thrombus therapy in patients with acute ischemic stroke. This is the second indication for the product to be approved in China and the first of its kind to receive this approval. The product's approval is based on efficacy and safety results from Phase III clinical trials, and the results of the study have been published in the journal Willow Knife. With a longer half-life and stronger fibroprotein specificity, Mingfu® provides rapid single pellet-type intravenous injection, showing significant clinical application advantages. The Chairman of Petrochemical Group, Tung Chen, made this announcement on February 5, 2024.
Petrochemical Group Co., Ltd. announced that Mingfu® (an injectable recombinant TNK tissue type cellulase activator) developed by Mingfu Pharmaceutical (Guangzhou) Co., Ltd. has been approved by the China National Drug Administration for the treatment of thrombus therapy in patients with acute ischemic stroke. This is the second indication for the product to be approved in China and the first of its kind to receive this approval. The product's approval is based on efficacy and safety results from Phase III clinical trials, and the results of the study have been published in the journal Willow Knife. With a longer half-life and stronger fibroprotein specificity, Mingfu® provides rapid single pellet-type intravenous injection, showing significant clinical application advantages. The Chairman of Petrochemical Group, Tung Chen, made this announcement on February 5, 2024.

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