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康辰藥業(603590.SH):子公司申請撤回特立帕肽注射液臨牀試驗申請
格隆匯 03-14 16:29

格隆匯3月14日丨康辰藥業(603590.SH)公佈,公司於2022年3月11日獲悉控股子公司北京康辰生物科技有限公司(“康辰生物”)收到國家藥品監督管理局(“國家藥監局”)的有關同意撤回藥品註冊申請的通知。

因需進一步完善申報資料,經審慎研究決定,康辰生物向國家藥監局申請撤回特立帕肽注射液臨牀試驗申請。

特立帕肽是一種由34個氨基酸組成的重組人甲狀旁腺激素(PTH)類似物(rhPTH[1-34]),能調節骨代謝、腎小管對鈣和磷的重吸收,以及腸道鈣吸收,適用於治療絕經後婦女高骨折風險的骨質疏鬆症,以及糖皮質激素持續治療誘發的高骨折風險的骨質疏鬆症截至目前特立帕肽注射液尚未開展臨牀試驗,發費用主要系辦理註冊申請相關事宜

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