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太極集團(600129.SH)鹽酸羥考酮緩釋片申報臨牀獲受理
格隆匯 08-15 17:29

格隆匯8月15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關於鹽酸羥考酮緩釋片的《受理通知書》,受理號為CYHS1900446國。

鹽酸羥考酮緩釋片為西南藥業與中國藥科大學聯合研製的化學藥,2018年4月,西南藥業股份有限公司獲得國家食品藥品監督管理局關於鹽酸羥考酮緩釋片的麻醉藥品和精神藥品研製立項批件。

該藥主要用於緩解持續的中度到重度疼痛。鹽酸羥考酮緩釋片作為WHO三階梯治療中重度晚期癌症患者的重要用藥,同嗎啡相比具有口服利用度高,藥效強、藥物依賴性弱、藥代動力學上有即釋和緩釋兩個時釋放相等優勢,而且被FDA和NMPA批准用於慢性非癌痛患者的長期用藥。本品適應人羣廣,安全有效,12小時服用1次簡單方便,是臨牀急需的治療藥物,具有廣闊的應用前景。截至目前,西南藥業對該藥品已投入研發費用約370萬元(未經審計)。

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