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麗珠醫藥(01513.HK):司美格魯肽注射液註冊上市許可申請獲受理
格隆匯 06-12 21:45

格隆匯6月12日丨麗珠醫藥(01513.HK)公吿,近日,麗珠醫藥集團股份有限公司(以下簡稱“公司”)控股附屬公司麗珠集團新北江製藥股份有限公司(以下簡稱“新北江製藥”)收到國家藥品監督管理局(以下簡稱“藥監局”)核准簽發的《受理通知書》(受理號:CXSS240005),新北江製藥申請的司美格魯肽注射液的境內生產藥品註冊獲藥監局受理。

司美格魯肽注射液(以下簡稱“本品”)是公司自主研發的生物類似藥,本次註冊申請的適應症為:用於在飲食控制和運動基礎上,接受二甲雙胍和/或磺脲類藥物治療血糖仍控制不佳的成人2型糖尿病患者的血糖控制,及降低伴有心血管疾病的2型糖尿病成人患者的主要心血管不良事件(心血管死亡、非致死性心肌梗死或非致死性卒中)風險。

根據藥監局及藥品審評中心網站數據庫顯示,截至本公吿披露日,司美格魯肽注射液國內原研1家產品上市,2家企業申請註冊上市(包含新北江製藥)。根據IQVIA抽樣統計估測數據,2023年糖尿病用藥國內終端銷售金額為人民幣345.80億元,其中GLP-1激動劑藥物國內終端銷售金額為人民幣60.58億元。

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