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科濟藥業-B(02171.HK)曾瀉36%破底 旗下藥物被美國監管當局叫停臨床試驗
阿思達克 12-13 10:29
科濟藥業-B(02171.HK)今早(13日)遭「洗倉」,低開14.9%後初段跌幅急擴,最低見6.07元,跌35.7%,見上市新低。現報6.76元,跌28.39%,成交激增至750.13萬股,涉資5,068.18萬元。 公司公布,美國子公司CARsgen Therapeutics收到美國食品藥品監督管理局(FDA)通知,因CMC(醫藥產品的開發、許可、製造和持續營銷中的化學、製造和控制流程)相關問題,要求暫停CT053、CT041和CT071的臨床試驗,等待對位於北卡羅來納州達勒姆的生產基地進行檢查後得出的結論。 公司將對現行藥品生產質量管理規範進行全面檢查和改進,並承諾與FDA密切合作,解決檢查發現的問題,以確保臨床試驗和上市申請的順利進行和高質量生產。
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