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億帆醫藥(002019.SZ):在研產品F-627上市申請獲得EMA正式受理
格隆匯 10-07 23:26

格隆匯10月7日丨 億帆醫藥(002019.SZ)公佈,控股子公司 Evive Biotech Ltd.(以下簡稱"億一生物",含其下屬子公司,下同)於歐洲當地時間 2021 年 9月 30 日收到歐洲藥品管理局(以下簡稱"EMA")簽發的受理函,EMA 正式確認並受理億一生物自主研發的在研品種重組人粒細胞集落刺激因子-Fc 融合蛋白(以下簡稱"F-627")用於預防及治療腫瘤患者在化療過程中引起的嗜中性粒細胞減少症的上市許可申請(以下簡稱"MAA"),並進入審評程序。

此次EMA對F-627上市許可申請的正式受理,是F-627繼美國FDA受理上市申請後,在全球範圍內取得的又一重要進展。歐盟是F-627全球商業化的重要區域,此次上市申請適用於歐盟全部27個成員國,及挪威、冰島和列支敦士登,為F-627歐洲商業化及打開歐洲市場奠定了堅實的基礎。此次F-627上市申請獲得EMA正式受理,對公司近期業績不會產生影響,如未來獲批,對公司業績將產生積極影響。

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