珍寶島(603567.SH):ZBD0276片獲得臨牀試驗申請受理通知書
格隆匯6月1日丨珍寶島(603567.SH)公告,近日,黑龍江珍寶島藥業股份有限公司(以下簡稱“公司”)獲得國家藥品監督管理局(以下簡稱“國家藥監局”)下發的《受理通知書》。此次申請臨牀研究的ZBD0276片共有三個不同規格(5mg、20mg、100mg),每個規格藥理作用相同,每份受理通知書及每個受理號分別對應一個規格。
公司收到的《受理通知書》為抗特發性肺纖維化1類創新藥物ZBD0276片的臨牀試驗受理,待國家藥品監督管理局藥品審評中心審評通過後方可開展臨牀相關工作。
創新藥物的研發,從申請臨牀、批准臨牀、臨牀試驗、申報生產到最終取得生產批件,週期較長,環節較多,風險較高,將受到多種不確定因素的影響。敬請廣大投資者注意投資風險。
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