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上海醫藥(02607.HK):鹽酸布比卡因注射液通過仿製藥一致性評價

格隆匯7月17日丨上海醫藥(02607.HK)公吿,近日,公司控股子公司上海禾豐製藥有限公司收到國家藥品監督管理局頒發的關於鹽酸布比卡因注射液的《藥品補充申請批准通知書》(通知書編號:2024B03024),該藥品通過仿製藥質量和療效一致性評價。

鹽酸布比卡因注射液主要用於局部浸潤麻醉、外周神經阻滯和椎管內阻滯,由Hospira研發,最早於1972年在美國上市。2023年11月,上藥禾豐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,公司針對該藥品該規格的一致性評價已投入研發費用約人民幣137萬元。

截至本公吿日,中國境內該藥品的主要生產廠家包括上海朝暉藥業有限公司、安徽長江藥業有限公司、山東華魯製藥有限公司等。IQVIA數據庫顯示,2023年該藥品醫院採購金額為人民幣23,923萬元。

根據國家相關政策,通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。因此上藥禾豐的鹽酸布比卡因注射液通過仿製藥一致性評價,有利於擴大該藥品的市場份額,提升市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。

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