君實生物(01877.HK)尚未收到特瑞普利生物製品許可申請審評結論
君實生物(01877.HK)公布,本月23日止,公司尚未收到美國食品藥品監督管理局(FDA)有關特瑞普利單抗(產品代號「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生物製品許可申請(BLA)的審評結論。
受到新型冠狀病毒肺炎疫情相關的旅行限制的持續影響,FDA在當前審評週期內無法進行現場核查。特瑞普利單抗的BLA仍在審評中。
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