白雲山(600332.SH):國家藥監局同意撤回原料藥吉非替尼登記號
格隆匯6月11日丨白雲山(600332.SH)公佈,茲提述公司日期為2016年2月29日、編號為“2016-009”的《廣州白雲山醫藥集團股份有限公司關於吉非替尼獲得藥物臨牀試驗批件的公吿》,內容有關公司分公司廣州白雲山醫藥集團股份有限公司白雲山製藥總廠(“白雲山制藥總廠”)收到國家藥品監督管理局(“國家藥監局”)核准簽發的吉非替尼原料藥的《審批意見通知表》的事宜。
公司控股子公司廣州白雲山漢方現代藥業有限公司(“廣州漢方”)及分公司白雲山製藥總廠均為此次吉非替尼原料藥申請人(“申請人”),因吉非替尼原料藥的起始原料、有關物質等雜質控制方面研究資料不夠完善,申請人向國家藥監局主動提交了撤回登記號的申請。2021年6月10日,根據國家藥監局藥品審評中心網站查詢結果顯示,國家藥監局同意申請人撤回原料藥吉非替尼登記號。
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