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以嶺藥業(002603.SZ)獲批中藥配方顆粒新增品種並擴大臨牀研究使用範圍
格隆匯 12-06 20:18

格隆匯12月6日丨以嶺藥業(002603.SZ)公佈,公司於2019年12月5日收到河北省藥品監督管理局《關於同意石家莊以嶺藥業股份有限公司中藥配方顆粒有關事項的批覆》(冀藥監藥化函【2019】567號)。批覆主要內容如下:

1、同意公司申請增加石菖蒲等237箇中藥配方顆粒品種,公司要嚴格按照專家技術評審通過的工藝、質量標準等組織生產。

2、同意公司在河北省醫療機構開展646種中藥配方顆粒臨牀研究使用,試用期一年。試用期間企業須嚴格執行國家中藥配方顆粒相關規定,如國家出台相關中藥配方顆粒新規定,按新規定執行。

3、公司在臨牀研究使用期間,應積累相關數據,完善大生產工藝規程及質量標準等,相關資料與申報資料於2020年12月3日前一併交河北省藥品監督管理局歸檔保存。

河北省藥品監督管理局於2018年12月26日同意公司409種中藥配方顆粒在河北省二級甲等(含二級甲等)以上醫院開展臨牀研究(詳見公司於2019年1月2日在法定信息披露媒體披露的2019-001《關於獲得河北省藥品監督管理局同意進行中藥配方顆粒臨牀研究批覆的公告》)。加上此次新獲批的237個品種,公司已累計獲批646箇中藥配方顆粒品種,且臨牀研究使用範圍也由原來的“河北省二級甲等(含二級甲等)以上醫院”擴大到“河北省醫療機構”。

此次公司獲批中藥配方顆粒新增品種並擴大臨牀研究使用範圍,有利於公司拓展中藥產業鏈佈局,完善產品結構,滿足市場需求並進一步擴大品牌效應及市場份額,有利於構建公司新的利潤增長點,實現公司業績的進一步提升。公司將盡快按規定辦理生產和品種備案等相關藥政手續,利用多年來積累的中醫藥品牌優勢,整合行業資源,積極推進中藥配方顆粒臨牀研究、市場推廣等工作。

此次公司獲得中藥配方顆粒有關事項的批覆,短期內對公司的財務狀況和經營業績不會產生影響,預計會對公司未來的業績增長產生正面影響,但產生影響的時間存在不確定性。

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