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君實生物(01877.HK):特瑞普利單抗治療鼻咽癌的生物製品許可申請獲FDA受理
格隆匯 10-31 18:49

格隆匯10月31日丨君實生物(01877.HK)公佈,近日,公司子公司TopAlliance Biosciences, Inc.收到美國食品藥品監督管理局(以下簡稱"FDA")的受理信,特瑞普利單抗(項目代號"TAB001/JS001")聯合吉西他濱/順鉑作為晚期復發或轉移性鼻咽癌患者的一線治療和單藥用於復發或轉移性鼻咽癌含鉑治療後的二線及以上治療的兩項適應症的生物製品許可申請(Biologics LicenseApplication,以下簡稱"BLA")獲得正式受理。

根據受理信,FDA 就該 BLA 授予優先審評的認定且表示不計劃召開諮詢委員會會議審評該 BLA,擬定的處方藥用户付費法案(PDUFA)目標審評日期為 2022 年 4 月。

由於藥品的研發週期長、審批環節多,容易受到一些不確定性因素的影響,本次藥品上市申請能否獲得批准存在不確定性,敬請廣大投資者謹慎決策,注意防範投資風險。

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