人福醫藥(600079.SH):宜昌人福氨酚羥考酮緩釋片獲批臨牀
格隆匯2月10日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福近日收到國家藥監局核准簽發的氨酚羥考酮緩釋片的《藥物臨牀試驗批准通知書》。經審查,2021年11月30日受理的氨酚羥考酮緩釋片符合藥品註冊的有關要求,同意該藥品開展用於中至重度疼痛的臨牀試驗。
氨酚羥考酮緩釋片是在已有速釋片氨酚羥考酮片基礎上的改良,為含有中樞神經鎮痛作用的鹽酸羥考酮和周圍神經鎮痛作用的對乙酰氨基酚組成的複方片劑。目前國內外尚無同類型產品上市,國內已上市產品為氨酚羥考酮速釋製劑,主要為氨酚羥考酮片。
根據米內網數據顯示,2020年度在國內使用的氨酚羥考酮片主要為SpecGxLLC生產的進口藥品,在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為3.7億元人民幣。
截至目前,宜昌人福在該項目上的累計研發投入約1400萬元人民幣。
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