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太極集團(600129.SH):鹽酸嗎啡緩釋片獲申報臨牀試驗受理通知書
格隆匯 01-03 16:10

格隆匯1月3日丨太極集團(600129.SH)公佈,近日,公司控股子公司西南藥業股份有限公司(以下簡稱:西南藥業)收到國家藥品監督管理局核准簽發的鹽酸嗎啡緩釋片(24h滲透泵型)臨牀試驗《受理通知書》。

鹽酸嗎啡緩釋片(24h滲透泵型)為西南藥業研發的新型緩釋製劑。該藥主要適用於其他鎮痛藥無效的,需要每天、連續不斷、長期阿片類鎮痛治療的疼痛。根據世界衞生組織和國家藥品監督管理局提出的癌痛治療三階梯方案的要求,嗎啡是治療重度癌痛的代表性藥物。鹽酸嗎啡緩釋片(24h滲透泵型)為含有已知活性成份的新劑型,境內外均未上市的改良型2.2類新藥。本品採用單室滲透泵技術,製成一日服用一次的鹽酸嗎啡新劑型緩釋片,可以使患者體內血藥濃度更平穩,毒副作用更小,鎮痛作用更穩定持久。西南藥業已完成本品動物藥代動力學試驗,結果顯示:本品具有顯著的緩釋效果,能維持24h的有效血藥濃度,作用時間明顯長於鹽酸嗎啡普通片和12h鹽酸嗎啡緩釋片,初步顯現在臨牀應用上將有明顯優勢。

截至目前,西南藥業對該藥品已投入研發費用約637萬元人民幣(未經審計)。

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