美諾華(603538.SH):阿哌沙班片獲批上市
格隆匯4月21日丨美諾華(603538.SH)公佈,公司全資子公司寧波美諾華天康藥業有限公司(“美諾華天康”)於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的阿哌沙班片《藥品註冊證書》。
該藥品適應症及作用機理:阿哌沙班片主要用於髖關節或膝關節擇期置換手術的成年患者,預防靜脈血栓栓塞事件(VTE)。阿哌沙班是一種可逆的、高選擇性的直接 Xa 因子抑制劑,屬於新型口服抗凝藥物。與其他常用的抗凝劑如華法林相比,阿哌沙班的安全性和耐受性好,治療窗寬,能有效地降低腦卒中和全身性栓塞的發生率,同時不增加出血風險。與食物相互作用少,劑量固定,且無需進行常規血液學檢測,應用更為方便。
2020年11月28日,美諾華天康就阿哌沙班片向國家藥監局首次提交國產藥品註冊的申請並獲得受理。截至公吿日,公司已投入研發費用人民幣1259萬元(未經審計)。
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