天宇股份(300702.SZ):他氟前列素原料藥通過CDE技術審評
格隆匯11月8日丨天宇股份(300702.SZ)公佈,公司他氟前列素原料藥於近日通過國家藥品監督管理局藥品審評中心(簡稱“CDE”)技術審評。
他氟前列素為前列腺素類似物,是一種選擇性FP前列腺素受體激動劑,可通過增加葡萄膜鞏膜途徑房水流出量來降低眼內壓。用於降低開角型青光眼和高眼壓症患者升高的眼壓。他氟前列素滴眼液最早在美國獲批上市銷售,現已在中國獲批上市。
公司於2019年7月向CDE遞交了他氟前列素原料藥的藥品註冊申請並獲得受理。他氟前列素原料藥現已通過CDE審評審批,尚須取得浙江省藥品監督管理局GMP符合性檢查結果為“符合要求”的公示後,方可在國內上市銷售。
根據CDE網站公示,目前他氟前列素原料藥通過CDE技術審評的廠家僅該公司1家。公司他氟前列素已完成GMP符合性檢查,目前正在等待浙江省藥品監督管理局對該品種的GMP符合性檢查結果進行公示。
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