九典制藥(300705.SZ):“鹽酸阿考替胺片”獲批臨牀試驗
格隆匯 8 月 17日丨九典制藥(300705.SZ)公佈,近日收到國家藥品監督管理局簽發的《藥物臨牀試驗批准通知書》,在完成相關準備工作後將開展臨牀試驗研究。
藥品名稱:鹽酸阿考替胺片
註冊分類:化藥3類
受理號:CYHS1900862
申請人:湖南九典制藥股份有限公司
適應症:功能性消化不良(FD)引起的餐後飽脹、上腹脹、早飽等症狀。
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,本品符合藥品註冊的有關要求,同意開展臨牀試驗。
鹽酸阿考替胺片最早由日本澤裏新藥株式會社與安斯泰萊製藥公司聯合開發,於2013年6月在日本上市。公司於2019年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。
鹽酸阿考替胺是一種新型選擇性乙酰膽鹼酯酶(AChE)抑制劑,能抑制從副交感神經末梢釋放的ACh的分解,增加突觸間隙中的ACh的量,改善由於功能性消化不良的胃能動性和胃排空能力的降低,並藉此改善餐後飽脹、上腹脹、早飽等諸多由於功能性消化不良引起的症狀。
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