人福醫藥(600079.SH):RFUS-144注射液獲得美國FDA臨牀試驗資格
格隆匯2月20日丨人福醫藥(600079.SH)公佈,公司控股子公司Humanwell Pharmaceutical US,Inc. (“宜昌人福藥業美國公司”,公司持有宜昌人福藥業有限責任公司80%的股權,宜昌人福藥業有限責任公司持有宜昌人福藥業美國公司100%的股權)近日收到美國食品藥品監督管理局(“美國FDA”)關於同意RFUS144注射液進行臨牀試驗的函(IND編號:163116)。宜昌人福藥業美國公司擬於條件具備後於美國進行該新藥的臨牀試驗。
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,截至目前,該項目累計投入約2100萬元人民幣。美國市場已上市同類產品為Kala Pharmaceuticals, Inc.的Kosuva,該藥品於2022年4月上市,公司尚未獲知該產品的市場銷售情況。根據IQVIA數據統計,2021年全球疼痛領域的市場銷售額為34.77億美元,其中阿片受體的鎮痛藥總佔比為66.8%。
根據美國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗資格後,尚需開展臨牀試驗並經美國FDA審評審批通過後方可生產上市。
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