東瑞製藥(02348.HK)合營PCSK9抑制劑在中國IIb期臨牀試驗提前完成患者入組
格隆匯12月2日丨東瑞製藥(02348.HK)公佈，康融東方為一間合營公司，由集團持有35%的權益及中山康方(康方生物科技(開曼)有限公司(一家臨牀階段生物製藥公司，致力於自主發現、開發及商業化首創及同類最佳療法及其股份於香港聯交所上市(股份代號: 9926)) 的全資附屬公司)持有65%的權益，主要從事Ebronucimab(PCSK9抑制劑， 研發代號：AK102 )及AK109 (康融東方研發的VEGFR-2新型全人源化單克隆抗體藥物)的開發。
公司已獲康融東方告知 Ebronucimab (AK102)在中國用於治療高危或極高危高膽固醇血癥的IIb期臨牀試驗提前完成260例患者入組。針對該適應症的III期臨牀試驗將在中國開展。 Ebronucimab早期臨牀資料顯示，Ebronucimab相比同靶點藥物Repatha（依洛優單抗），能夠完全的抑制PCSK9。Ebronucimab均可明顯降低所有給藥患者的膽固醇。公司期待Ebronucimab成為首款中國本土開發上市的PCSK9抑制藥物， 滿足大量心血管病患者的需求。
據悉，Ebronucimab (AK102)主要用於治療原發性高膽固醇血癥，包括純合子家族性高膽固醇血癥(HoFH)、雜合子家族性高膽固醇血癥(HeFH)及其他原發性高膽固醇血癥患者。與他汀類藥物一起使用或代替他汀類藥物使用時，PCSK9抑制劑（安進的Repatha（依洛優單抗）及賽諾菲╱再生元的Praluent（阿利珠單抗））已證明可顯著降低膽固醇，並降低患者心臟病發作或中風的發病率。Ebronucimab(AK102) 的靶點與依洛優單抗和阿利珠單抗相同。根據弗若斯特沙利文諮詢公司的資料，Repatha（依洛優單抗）和Praluent（阿利珠單抗）的全球銷售額從2015年推出時的2千萬美元迅速增長至2018年的8.58億美元，複合年增長率為250.2%。
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