上海醫藥(601607.SH):子公司鹽酸多巴胺注射液及鹽酸利多卡因注射液通過仿製藥一致性評價
格隆匯9月13日丨上海醫藥(601607.SH)公佈,近日,公司控股子公司上海禾豐製藥有限公司(“上藥禾豐”)分別收到國家藥品監督管理局頒發的關於鹽酸多巴胺注射液及鹽酸利多卡因注射液的《藥品補充申請批准通知書》(通知書編號:2021B02191;2021B02874),上述藥品通過仿製藥質量和療效一致性評價。
鹽酸多巴胺注射液主要用於心肌梗死、創傷、內毒素敗血症、心臟手術、腎功能衰竭、充血性心力衰竭等引起的休克綜合徵;補充血容量後休克仍不能糾正者,尤其有少尿及周圍血管阻力正常或較低的休克,由Hospira製藥研發,最早於1974年在美國上市。2020年9月,上藥禾豐就鹽酸多巴胺注射液仿製藥一致性評價向國家藥監局提出申請並獲受理。
截至公吿日,公司針對鹽酸多巴胺注射液的一致性評價已投入研發費用約人民幣454萬元。IQVIA數據庫顯示,2020年鹽酸多巴胺注射液醫院採購金額為人民幣5.014億元。2020年,上藥禾豐的鹽酸多巴胺注射液未上市銷售。
鹽酸利多卡因注射液主要用於浸潤麻醉、硬膜外麻醉、表面麻醉(包括在胸腔鏡檢查或腹腔手術時作黏膜麻醉用)及神經傳導阻滯;可用於急性心肌梗死後室性早搏和室性心動過速,亦可用於洋地黃類中毒、心臟外科手術及心導管引起的室性心律失常,由Astra製藥研發,最早於1948年在美國上市。2020年11月,上藥禾豐就鹽酸利多卡因注射液仿製藥一致性評價向國家藥監局提出申請並獲受理。
截至公吿日,公司針對鹽酸利多卡因注射液的一致性評價已投入研發費用約人民幣386萬元。
IQVIA數據庫顯示,2020年鹽酸利多卡因注射液醫院採購金額為人民幣4.4093億元。2020年,上藥禾豐鹽酸利多卡因注射液的銷售收入為人民幣2528萬元。
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