苑東生物(688513.SH):獲得富馬酸丙酚替諾福韋片藥品註冊證書
格隆匯 4 月 16日丨苑東生物(688513.SH)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的富馬酸丙酚替諾福韋片《藥品註冊證書》。
富馬酸丙酚替諾福韋片由美國製藥公司吉利德(Gilead)研製,於2016年11月被FDA批准上市,商品名為Vemlidy®,2018年11月被NMPA批准上市,商品名為韋立得®。本品是治療成人和青少年慢性乙型肝炎的強效藥,富馬酸丙酚替諾福韋在血漿中穩定性更高,能更有效地傳遞到肝細胞,故達到相似抗病毒作用所需的劑量遠低於富馬酸替諾福韋二吡呋酯,從而顯著降低其副作用風險,具有更好的骨骼安全性和腎臟安全性。根據國家藥監局網站數據查詢,目前國內富馬酸丙酚替諾福韋片生產廠家有Gilead、成都倍特、江西青峯、齊魯製藥等。此外,另有正大天晴、上海迪賽諾、東陽光等多家公司提交仿製藥申請。米內網重點省市公立醫院數據庫顯示,2020年丙酚替諾福韋在中國重點省市公立醫院終端銷售額約為1.40億元。
2019年6月28日,公司向國家藥監局提交的富馬酸丙酚替諾福韋片註冊申請獲得受理。截止公吿日,該產品累計已投入研發費用約2098.13萬元。
公司富馬酸丙酚替諾福韋片按照化藥新註冊分類4類申報,按照與參比製劑質量和療效一致的技術要求審評並獲批,因此批准後視為通過仿製藥質量和療效一致性評價。富馬酸丙酚替諾福韋片獲批上市後,標誌着公司具備在國內市場銷售該藥品的資格,對公司經營發展具有一定的積極作用。
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