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廣生堂(300436.SZ):抗新冠病毒小分子口服藥尚處於臨牀前研究階段
格隆匯 01-17 23:41

格隆匯1月17日丨廣生堂(300436.SZ)發佈股價異動公吿,公司控股子公司福建廣生中霖生物科技有限公司的抗新型冠狀病毒小分子口服創新藥項目尚處臨牀前研究階段,後續還需經過化合物性質表徵研究確定臨牀前候選化合物(PCC),完成臨牀前藥學研究和符合臨牀註冊申報的藥代動力學、藥效、藥理和毒理研究,並在獲得NMPA的臨牀(默示)許可後開展I期、II期和III期臨牀研究,在獲得相應的安全性和療效數據後才能向NMPA提交藥品註冊申請,取得藥品註冊證書並通過原料藥的GMP符合性檢查後,才可生產銷售項目產品

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