东瑞制药(02348.HK)合营PCSK9抑制剂在中国IIb期临床试验提前完成患者入组
格隆汇12月2日丨东瑞制药(02348.HK)公布，康融东方为一间合营公司，由集团持有35%的权益及中山康方(康方生物科技(开曼)有限公司(一家临床阶段生物制药公司，致力于自主发现、开发及商业化首创及同类最佳疗法及其股份于香港联交所上市(股份代号: 9926)) 的全资附属公司)持有65%的权益，主要从事Ebronucimab(PCSK9抑制剂， 研发代号：AK102 )及AK109 (康融东方研发的VEGFR-2新型全人源化单克隆抗体药物)的开发。
公司已获康融东方告知 Ebronucimab (AK102)在中国用于治疗高危或极高危高胆固醇血症的IIb期临床试验提前完成260例患者入组。针对该适应症的III期临床试验将在中国开展。 Ebronucimab早期临床资料显示，Ebronucimab相比同靶点药物Repatha（依洛优单抗），能够完全的抑制PCSK9。Ebronucimab均可明显降低所有给药患者的胆固醇。公司期待Ebronucimab成为首款中国本土开发上市的PCSK9抑制药物， 满足大量心血管病患者的需求。
据悉，Ebronucimab (AK102)主要用于治疗原发性高胆固醇血症，包括纯合子家族性高胆固醇血症(HoFH)、杂合子家族性高胆固醇血症(HeFH)及其他原发性高胆固醇血症患者。与他汀类药物一起使用或代替他汀类药物使用时，PCSK9抑制剂（安进的Repatha（依洛优单抗）及赛诺菲╱再生元的Praluent（阿利珠单抗））已证明可显著降低胆固醇，并降低患者心脏病发作或中风的发病率。Ebronucimab(AK102) 的靶点与依洛优单抗和阿利珠单抗相同。根据弗若斯特沙利文谘询公司的资料，Repatha（依洛优单抗）和Praluent（阿利珠单抗）的全球销售额从2015年推出时的2千万美元迅速增长至2018年的8.58亿美元，复合年增长率为250.2%。
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