上海醫藥(601607.SH):甲硫酸新斯的明注射液通過仿製藥一致性評價
格隆匯2月17日丨上海醫藥(601607.SH)公佈,近日,公司全資子公司上海信誼金朱藥業有限公司(“信誼金朱”)收到國家藥品監督管理局(“國家藥監局”)頒發的關於甲硫酸新斯的明注射液的《藥品補充申請批准通知書》(通知書編號:2023B00131),該藥品通過仿製藥一致性評價。
甲硫酸新斯的明注射液主要用於手術結束時拮抗非去極化肌肉鬆弛藥的殘留肌松作用,用於重症肌無力,手術後功能性腸脹氣及尿瀦留等。由日本鹽野義株式會社研發,最早於1936年10月在日本上市。2021年06月,信誼金朱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。截至公吿日,公司針對該藥品的一致性評價已投入直接研發費用約人民幣424萬元。
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