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億帆醫藥(002019.SZ):目前美國FDA正在進行現場核查
格隆匯 06-06 08:59

格隆匯6月6日丨億帆醫藥(002019.SZ)召開業績説明會,互動環節中,就“美國FDA現場核查情況、獲批時間及歐洲EMA現場檢查與獲批時間,以及上市後銷售預期。”

公司回覆稱,目前美國FDA正在進行現場核查,完成現場核查以後可能會收到一份FDA表格483,該表格列出了對當前問題和/或潛在問題情況的檢查意見,我們會盡可能迅速就FDA的483表格做出迴應;預計2023年8月歐洲EMA將對北京億一的億立舒上市申請進行原液現場核查,具體時間以公司最終收到監管機構通知為準;後續進展將根據信息披露規則進行披露,力爭在年底獲得美歐上市批件。

億立舒作為國內為數不多的就同一產品向美國、歐洲和中國遞交生物製品新藥上市申請的中國企業之一,除了在已有的臨牀數據上有的差異性外,還有較PEG化產品在成本上的比較優勢,未來的全球市場將會有很好的表現。

未來,億立舒將有望成為首個大分子創新藥走向全球100多個國家或地區的產品,努力成為G-CSF的領導者,實現研發成果商業化、價值化。

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