九典制藥(300705.SZ):吲哚美辛凝膠貼膏獲臨牀試驗通知書
格隆匯3月2日丨九典制藥(300705.SZ)公佈,公司於近日收到國家藥品監督管理局簽發的《臨牀試驗通知書》,在完成相關準備工作後將開展臨牀試驗研究。
藥品名稱:吲哚美辛凝膠貼膏;註冊分類:化藥3類;受理號:CYHS1900344;申請人:湖南九典制藥股份有限公司;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2019年05月13日受理的吲哚美辛凝膠貼膏符合藥品註冊的有關要求,同意本品進行臨牀試驗。
吲哚美辛凝膠貼膏最早由日本帝國製藥株式會社、久光製藥株式會社、興和製藥株式會社同時獲批,上市規格為每貼10cm×14cm;含吲哚美辛70mg。該規格產品暫未在國內進口上市。
公司於2019年5月向國家藥品監督管理局藥品審評中心申報臨牀試驗申請,於近日獲得臨牀試驗許可,本品註冊分類為化學藥品3類:仿製境外上市但境內未上市原研藥品的藥品。
吲哚美辛(Indometacin)屬於非甾體類抗炎藥,具有抗炎、抗風濕、解熱鎮痛等作用,其通過抑制環氧化酶活性而減少前列腺素的合成,直至炎症組織痛覺神經衝動的形成,解除內源性前列腺素的致炎作用。將吲哚美辛這一傳統的非甾體抗炎藥製備成凝膠貼膏劑,能克服口服給藥所帶來的不良反應,更好地發揮其局部抗炎、鎮痛的效果。
吲哚美辛凝膠貼膏獲得臨牀試驗資格對公司的財務狀況、經營業績不構成重大影響,公司將按照國家藥品監督管理局臨牀試驗通知書的要求開展臨牀試驗,但其進度、審評和審批的結果以及未來產品市場競爭格局都具有一定的不確定性。
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