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上海醫藥(02607.HK):注射用美羅培南通過仿製藥一致性評價

格隆匯1月17日丨上海醫藥(02607.HK)公吿,近日,上海醫藥集團股份有限公司(以下簡稱“上海醫藥”或“公司”)控股子公司上海上藥新亞藥業有限公司(以下簡稱“上藥新亞”)收到國家藥品監督管理局(以下簡稱“國家藥監局”)頒發的關於注射用美羅培南(以下簡稱“該藥品”)的《藥品補充申請批准通知書》(通知書編號:2024B00079、2024B00080),該藥品通過仿製藥一致性評價。

注射用美羅培南主要適用於成人和兒童由單一或多種對美羅培南敏感的細菌引起的感染:肺炎(包括院內獲得性肺炎)、尿路感染、腹腔內感染、婦科感染(如子宮內膜炎和盆腔炎)、皮膚軟組織感染、腦膜炎、敗血症。該藥品最早由日本住友研發,1995在日本上市。2022年11月,上藥新亞就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。截至本公吿日,公司針對該藥品的一致性評價已投入研發費用約人民幣887萬元。

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