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君實生物(688180.SH):合作伙伴Coherus正在準備特瑞普利單抗在美國商業化的相關工作

格隆匯6月8日丨有投資者向君實生物(688180.SH)提問,“請問公司自從美國FDA檢查後股價連續八天下跌。請問公司是否收到美國FDA的483表格?美國FDA是否認為公司生產記錄真實可信,生產體系穩健可靠?”

君實生物回覆稱,關於公司特瑞普利單抗鼻咽癌適應症於美國FDA的上市申請,截至目前已經順利完成了生產基地的許可前檢查(Pre-License Inspection,PLI)。公司合作伙伴Coherus正在準備特瑞普利單抗在美國商業化的相關工作。相關上市申請後續進展歡迎持續關注公司公吿及官方新聞。

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