上海醫藥(02607.HK):艾曲泊帕乙醇胺片獲得批准生產
格隆匯7月23日丨上海醫藥(02607.HK)公佈,近日,公司控股子公司常州製藥廠有限公司(以下簡稱"常州製藥廠")的艾曲泊帕乙醇胺片(以下簡稱"該藥品")收到國家藥品監督管理局(以下簡稱"國家藥監局")頒發的《藥品註冊證書》(證書編號:2024S01665),該藥品獲得批准生產。
艾曲泊帕乙醇胺片適用於既往對糖皮質激素、免疫球蛋白等治療反應不佳的成人和6歲及以上兒童慢性免疫性(特發性)血小板減少症(ITP)患者,使血小板計數升高並減少或防止出血;用於因血小板減少和臨牀條件導致出血風險增加的ITP患者。該藥品最早於2008年獲FDA批准在美國上市。2023年5月,常州製藥廠就該藥品向國家藥監局提出註冊上市申請,並獲受理。截至本公吿日,公司針對該藥品已投入研發費用約人民幣2,159.07萬元。
截至公吿日,中國境內該藥品的主要生產廠家包括齊魯製藥有限公司、正大天晴藥業集團股份有限公司、四川科倫藥業股份有限公司、江蘇奧賽康藥業有限公司等。
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