九芝堂(000989.SZ)：創新藥物YB209獲得美國FDA臨牀試驗批准
格隆匯7月18日丨九芝堂(000989.SZ)公佈，公司全資子公司牡丹江友搏藥業有限責任公司(“友搏藥業”) 近日收到美國食品藥品監督管理局(“美國FDA”)簽發的書面通知，批准友搏藥業研發的創新藥物YB209(即LFG項目)在美國開展臨牀試驗(IND號：153593)。
YB209為全新1類化藥，是從海洋生物中提取並經結構修飾得到的新型抗凝藥物，是一種具有全新結構、全新靶點的選擇性內源性凝血因子X酶(FiXase)的強效抑制劑。YB209具有完全自主知識產權，其化合物、製備方法及臨牀用途等核心技術均已申請國內和國際發明專利並獲授權。截止公吿日，該項目已獲得分佈於8個國家的17項專利授權證書。
血栓栓塞性疾病(如缺血性卒中、冠心病、深靜脈血栓等)是人類主要的致死性病因之一。抗血栓藥物是臨牀預防和治療血栓性疾病的重要手段，抗血栓藥物主要包括抗凝藥物、血小板抑制劑、血栓溶解劑以及纖維蛋白降解劑，其中抗凝抗血小板藥物的臨牀應用最為廣泛。近四十年來，抗凝藥物研究在改善藥效動力學特性及口服給藥方面成績顯著，但在降低出血傾向方面仍處於不斷的研究和開發過程中。雖然目前已上市的抗凝藥物眾多，且作用機制不同，但目前已上市的抗凝治療藥物均作用於凝血級聯反應中的共同凝血途徑(如作用於凝血因子Xa和/或IIa)，因而在達到抗凝治療的同時，患者難以避免出血風險，甚至部分患者存在的大出血風險可能危及生命。研發更加安全有效的新一代抗凝治療藥物，滿足抗凝治療效果的同時，減低和避免出血風險是當前未被滿足的臨牀需求。
內源性凝血因子抑制劑由於較少或不影響止血功能而成為新一代低出血傾向抗凝藥物研發的重點方向。內源性因子FiXase是內源性凝血途徑上的最後一個酶學位點，也是多種因素激發的凝血過程的限速位點，YB209正是選擇該全新靶點研製開發的新一代低出血傾向抗血栓藥物。
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