人福醫藥(600079.SH):布洛芬軟膠囊獲得藥品註冊證書
格隆匯6月21日丨人福醫藥(600079.SH)公佈,公司子公司人福普克藥業(武漢)有限公司(“武漢普克”,公司持有其85.80%的股權,根據增資協議的遠期回購約定,公司持有其100%權益。)近日收到國家藥品監督管理局核准簽發的布洛芬軟膠囊的《藥品註冊證書》。
布洛芬用於緩解輕至中度疼痛如關節痛、神經痛、肌肉痛、偏頭痛、頭痛、痛經、牙痛,也可用於普通感冒或流行性感冒引起的發熱。人福醫藥控股子公司Pura Cap Pharmaceutical LLC (公司持有其72%的股權)於2016年6月獲得美國FDA關於布洛芬軟膠囊的ANDA批文,其後轉移給武漢普克。武漢普克於2017年11月按照化學藥品新註冊分類的要求提交了布洛芬軟膠囊的註冊申請,截至目前該項目(含ANDA申報)累計研發投入約人民幣180萬元。本次布洛芬軟膠囊在國內獲得《藥品註冊證書》,視同通過仿製藥質量和療效一致性評價(“一致性評價”)。根據國家食品藥品監督管理總局網站顯示,國內共有4家獲得布洛芬軟膠囊生產批文,武漢普克為該劑型首家通過一致性評價的公司。根據米內網數據統計,2021年布洛芬軟膠囊在我國城市、縣級及鄉鎮三大終端公立醫院及城市實體藥店的銷售額約為人民幣186萬元,主要生產廠商包括石藥集團恩必普藥業有限公司、大連天宇奧森製藥有限公司等。2021年武漢普克關於布洛芬軟膠囊的銷售額約為人民幣1.3億元,主要銷往美國市場。
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