復星醫藥(600196.SH):鹽酸替納帕諾片獲藥品註冊申請受理
格隆匯7月12日丨復星醫藥(600196.SH)公佈,公司控股子公司上海復星醫藥產業發展有限公司(以下簡稱“復星醫藥產業”)獲許可產品Tenapanor片(即鹽酸替納帕諾片,以下簡稱“該新藥”)用於控制正在接受血液透析治療的慢性腎臟病(CKD)成人患者的高磷血癥的藥品註冊申請於近日獲國家藥品監督管理局審評受理。
該新藥為化學藥品。復星醫藥產業於2017年12月獲美國Ardelyx,Inc.(以下簡稱“Ardelyx”)授予該新藥在區域內(即中國內地、香港及澳門特別行政區,下同)的獨家臨牀開發和商業化等權利許可,Ardelyx仍為該新藥在區域內的權利人。
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