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人福醫藥(600079.SH):用於瘙癢症治療的RFUS-144注射液獲批開展藥物臨牀試驗
格隆匯 07-18 15:49

格隆匯7月18日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福藥業有限責任公司(“宜昌人福”,公司持有其80%的股權)近日收到國家藥品監督管理局核准簽發的RFUS-144注射液的《藥物臨牀試驗批准通知書》。

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,2022年4月21日受理的RFUS-144注射液符合藥品註冊的有關要求,同意開展臨牀試驗。申請的適應症:用於瘙癢症的治療。

RFUS-144注射液臨牀擬用於治療疼痛和瘙癢,是一種選擇性阿片受體激動劑,國內目前尚無同類型產品上市。宜昌人福於2022年6月獲得適應症為鎮痛的臨牀批件,本次獲得適應症為瘙癢症的臨牀批件。根據IQVIA數據統計,2021年,全球治療瘙癢領域的市場銷售額為4.5億美元,其中阿片受體的治療瘙癢總佔比為13.98%。截止目前,宜昌人福該項目累計投入約1300萬元人民幣。

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