復旦復華(600624.SH)子公司收到藥品補充申請批件
格隆匯10月30日丨復旦復華(600624.SH)公佈,近日,公司控股子公司江蘇復旦復華藥業有限公司收到國家藥品監督管理局核准簽發的《藥品補充申請批件》,藥品通用名稱注射用硫普羅寧。
根據《中華人民共和國藥品管理法》及有關規定,經審查,本品此次申請事項符合藥品註冊的有關要求,同意上海復旦復華藥業有限公司(生產地址:上海市閔行區曙光路1399號)注射用硫普羅寧品種技術轉讓至江蘇復旦復華藥業有限公司。硫普羅寧是一種與青黴胺性質相似的含巰基藥物,具有保護肝臟組織及細胞的作用。動物試驗顯示,硫普羅寧能夠通過提供巰基,防止四氯化碳、乙硫氨酸、對乙酰氨基酚等造成的肝臟損害,並對慢性肝損傷的甘油三酯的蓄積有抑制作用。硫普羅寧可以使肝細胞線粒體中ATP酶的活性降低,從而保護細胞線粒體結構,改善肝功能。此外,硫普羅寧還可以通過巰基與自由基的可逆結合,清除自由基。
藥品適應症:1、用於改善各類急慢性肝炎的肝功能。2、用於脂肪肝、酒精肝、藥物性肝損傷及重金屬的解毒。3、用於降低放化療的不良反應,並可預防放化療所致的外周白細胞減少。4、用於老年性早期白內障和玻璃體渾濁。
公司稱,本次控股子公司江蘇復旦復華藥業有限公司取得注射用硫普羅寧藥品註冊批件,有利於江蘇復華藥業首次取得凍乾粉針劑車間GMP證書。
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