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石藥集團:自願公告 - 司美格魯肽注射液用於超重/肥胖適應症獲臨床試驗批准

CSPC PHARMA: VOLUNTARY ANNOUNCEMENT - SEMAGLUTIDE INJECTION FOR OVERWEIGHT/OBESITY INDICATION OBTAINS CLINICAL TRIAL APPROVAL

香港交易所 ·  Mar 25 17:07
Summary by Futu AI
石藥集團宣佈,其開發的司美格魯肽注射液獲中國國家藥品監督管理局批准進行臨床試驗,用於成人超重或肥胖患者的體重管理。這是繼2型糖尿病血糖控制後,該產品獲批的第二個適應症。司美格魯肽注射液採用化學合成法製備,具有更高純度和較低雜質水平,並在臨床前研究中顯示出與DNA重組技術製備的同類產品相似的生物活性和減重效果。石藥集團於2024年3月25日發布此消息。
石藥集團宣佈,其開發的司美格魯肽注射液獲中國國家藥品監督管理局批准進行臨床試驗,用於成人超重或肥胖患者的體重管理。這是繼2型糖尿病血糖控制後,該產品獲批的第二個適應症。司美格魯肽注射液採用化學合成法製備,具有更高純度和較低雜質水平,並在臨床前研究中顯示出與DNA重組技術製備的同類產品相似的生物活性和減重效果。石藥集團於2024年3月25日發布此消息。
The pharmaceutical group announced that its developed Smegreptide injection has been approved for clinical trials by China's National Drug Administration for weight management in overweight or obese patients. This is the second indication for this product to be approved after glycemic control for type 2 diabetes. Simegropeptide injection was prepared using a chemical synthesis method with higher purity and lower impurity levels, and demonstrated similar bioactivity and weight loss effects in preclinical studies to similar products prepared by DNA remodeling technology. Pesticide Group made this announcement on March 25, 2024.
The pharmaceutical group announced that its developed Smegreptide injection has been approved for clinical trials by China's National Drug Administration for weight management in overweight or obese patients. This is the second indication for this product to be approved after glycemic control for type 2 diabetes. Simegropeptide injection was prepared using a chemical synthesis method with higher purity and lower impurity levels, and demonstrated similar bioactivity and weight loss effects in preclinical studies to similar products prepared by DNA remodeling technology. Pesticide Group made this announcement on March 25, 2024.

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