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中國生物製藥(01177.HK):抗感染藥“注射用多黏菌素E甲磺酸鈉”首仿獲批上市
格隆匯 10-15 18:49

格隆匯10月15日丨中國生物製藥(01177.HK)發佈公吿,集團開發的抗感染藥“注射用多黏菌素E甲磺酸鈉”(商品名:天韻)已獲中國國家藥品監督管理局頒發藥品註冊證書。該產品按化藥3類申報,視同通過仿製藥質量和療效一致性評價,同品種國內仿製藥首家獲批上市。

集團開發的注射用多黏菌素E甲磺酸鈉的獲批適應症為:用於敏感革蘭陰性桿菌敏感菌株引起的急性或慢性感染,特別是由銅綠假單胞菌和鮑曼不動桿菌敏感株所致者;亦可用於疑為革蘭陰性菌所致嚴重感染的初始治療和敏感革蘭陰性桿菌感染的治療。

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