中源协和干细胞抗肝纤维化注射液新药申请未获准

2015-03-18 佚名 不详

因不符合《药品注册管理办法》的规定,中源协和重磅干细胞新药注册申请未获批准,今日开盘后大幅下跌。 中源协和昨晚公告称,重磅干细胞药物脐带间充质干细胞抗肝纤维化注射液注册申请未获批准。上周,据大智慧通讯社报道,该药的审评状态离奇倒退,从“在审批”重新退回到“在审评”,质疑其短期能否获批临床。 据了解,脐带间充质干细胞抗肝纤维化注射液是由公司下属天津和泽干细胞科技有限公司和和泽生物科技有限公司

因不符合《药品注册管理办法》的规定,中源协和重磅干细胞新药注册申请未获批准,今日开盘后大幅下跌。

中源协和昨晚公告称,重磅干细胞药物脐带间充质干细胞抗肝纤维化注射液注册申请未获批准。上周,据大智慧通讯社报道,该药的审评状态离奇倒退,从“在审批”重新退回到“在审评”,质疑其短期能否获批临床。

据了解,脐带间充质干细胞抗肝纤维化注射液是由公司下属天津和泽干细胞科技有限公司和和泽生物科技有限公司联合申报的,该药申报状态在月初变为“在审批”后公司股价连续走高,市场期待这是干细胞新政发布后第一个获批临床的干细胞药物。

脐带间充质干细胞抗肝纤维化注射液用于肝纤维化治疗,目前治疗并无特效药物。公告显示,未获批准的原因为不符合《药品注册管理办法》的规定。公司还公告称,中源协和参股的北科生物同期申报的两个药物的注册申请也未获批准。

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    2015-06-17 1dd82894m82(暂无匿称)

    国内有些人急功近利!

    0

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    2015-03-20 黄庆

    重磅干细胞药物脐带间充质干细胞抗肝纤维化注射液注册申请未获批准。上周,据大智慧通讯社报道,该药的审评状态离奇倒退,从“在审批”重新退回到“在审评”,质疑其短期能否获批临床。

    0

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    2015-03-18 medcardio

    本来效果就受怀疑

    0

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