君實生物(01877.HK)治療鼻咽癌新藥收到美國FDA回覆信
君實生物(01877.HK)公佈,近日公司收到美國食品藥品監督管理局(FDA)寄發的一封關於特瑞普利單抗聯合吉西他濱/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(簡稱BLA)的完整回覆信。
公司指,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,並預計於今年仲夏之前重新提交該BLA。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。
公司已順利完成了FDA關於生產基地現場覈查的線上部分。公司將與監管機構保持密切溝通,積極做好FDA現場覈查的準備工作以便隨時接受現場覈查,推動特瑞普利單抗在美國儘快實現商業化。
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