人福醫藥(600079.SH):宜昌人福藥業美國公司他噴他多片獲美國FDA暫定批准文號
格隆匯5月5日丨人福醫藥(600079.SH)公佈,近日,人福醫藥集團股份公司控股子公司Humanwell Pharmaceutical US, Inc.(簡稱“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)收到美國食品藥品監督管理局(FDA)關於他噴他多片的暫定批准文號。
他噴他多片用於治療急性疼痛。宜昌人福藥業美國公司於2020年提交他噴他多片的ANDA申請,項目累計研發投入約為1500萬元人民幣。根據IQVIA數據統計,2021年該藥品(原研藥)在美國市場的總銷售額約為1.9億美元,原研藥屬於Collegium,已經獲得暫定批准的廠商包括Actavis、Alkem、Roxane、Rhodes。國內目前尚無他噴他多片上市,安徽省新星藥物開發有限責任公司、江蘇恩華藥業股份有限公司、江蘇華泰晨光藥業有限公司以及公司控股子公司宜昌人福藥業有限責任公司正在開展他噴他多片的臨牀研究。
目前,Collegium持有他噴他多片的兩項專利,到期日分別為2022年8月5日、2025年6月27日。待以上專利到期並且獲得正式批准後,宜昌人福藥業美國公司方可上市銷售此次獲得ANDA批准文號的他噴他多片。
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