君實生物(01877.HK)獲FDA回覆 製品許可申請覈查因疫情受阻
君實生物(01877.HK)公佈,收到FDA(美國食品藥品監督管理局)關於特瑞普利單抗(項目代號「TAB001/JS001」)聯合吉西他濱/順鉑作爲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的完整回覆信,要求進行一項公司認爲較容易完成的質控流程變更。公司計劃與FDA直接會面,並預計於2022年仲夏之前重新提交有關申請。
回覆信中提到,待完成的現場覈查因新型冠狀病毒肺炎疫情相關的旅行限制而受阻。具體現場覈查時間將另行通知。
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