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新天藥業(002873.SZ):獲得省藥監局同意廣藿香配方顆粒等80個品種進入臨牀研究
格隆匯 10-12 16:42

格隆匯 10 月 12日丨新天藥業(002873.SZ)公佈,近日,公司收到貴州省藥品監督管理局(“省藥監局”)下發的《省藥品監管局關於同意貴陽新天藥業股份有限公司“廣藿香配方顆粒”等80個品種進入臨牀研究的函》(黔藥監函〔2020〕409號)(“《函》”)。截至公告日,公司先後五次獲批進入臨牀研究的中藥配方顆粒品種共計401個。

根據原省食品藥品監管局《關於開展中藥配方顆粒研究試點工作的通知》要求,公司已完成了廣藿香配方顆粒等80個品種質量標準複核研究工作。經專家會議審核通過,同意公司廣藿香配方顆粒等80個品種進入臨牀研究。

《函》要求公司嚴格按照GMP等相關要求進行生產,並將醫療機構名單報省藥監局備案,在試點過程中遇到的問題,及時向省藥監局彙報。中藥配方顆粒國家標準實施後,同品種的中藥配方顆粒嚴格執行國家標準。在次年的一月向省藥監局提交中藥配方顆粒安全性、有效性及臨牀試點情況的年度總結報告。

近年來中藥配方顆粒市場保持快速增長態勢,公司此次獲得省藥監局同意廣藿香配方顆粒、靈芝配方顆粒、茯苓配方顆粒、法半夏配方顆粒、海金沙配方顆粒等80個品種進入臨牀研究,有利於加快公司完善中藥產業鏈佈局、豐富產品結構、滿足市場需求並進一步擴大品牌效應及市場份額,構建公司新的利潤增長點,實現公司業績的進一步提升。

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