A股異動 | 貝達藥業漲停 BPI-28592藥品臨牀試驗申請獲得受理
格隆匯2月20日丨貝達藥業(300558.SZ)漲停,報82.5元,暫成交7.3億元,最新總市值330億元。貝達藥業昨日晚間發公告稱,公司申報的BPI-28592片的藥品臨牀試驗申請已獲得國家藥監局受理。BPI-28592是公司自主研發的新分子實體化合物,擬用於攜帶NTRK基因變異的局部晚期或轉移性實體瘤患者的治療。據悉,BPI-28592屬於“境內外均未上市的創新藥”,其註冊分類為化學藥品1類。在臨牀試驗申請獲得受理後,若在受理繳費之日起60日內未收到藥品審評中心的否定或質疑意見,公司便可以按照提交的方案開展臨牀試驗,在開展一系列臨牀試驗並經國家藥品監督管理局批准後方可上市,短期內對公司經營業績不會產生大的影響。
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