奥赛康(002755.SZ):注射用右兰索拉唑新药上市申请获受理
格隆汇 1 月 11日丨奥赛康(002755.SZ)公布,公司的全资子公司江苏奥赛康药业有限公司(“子公司”)于近日收到国家药品监督管理局(“药监局”)下发的注射用右兰索拉唑新药上市申请《受理通知书》。
右兰索拉唑属于质子泵抑制剂,为兰索拉唑的R-异构体。右兰索拉唑肠溶胶囊(30mg、60mg)由武田制药(Takeda Pharma.)研究开发,于2009年首先在美国上市,用于治疗各种程度的糜烂性食管炎、非糜烂性反流性食管炎及相关症状的维持治疗,目前全球尚无右兰索拉唑注射剂上市。我公司根据其药理作用特点,按2类新药开发了注射用右兰索拉唑(制剂规格:15mg),拟用于治疗口服疗法不适用的急性上消化道出血等疾病,2016年2月获得注射用右兰索拉唑的临床批件(临床批件号:2016L02614),现已完成药学、非临床及临床相关研究,提交了生产注册申请,并获得CDE正式受理(受理号:CXHS2100001国)。
右兰索拉唑通过抑制胃壁细胞酸生成部位的H+-K+-ATP酶的活性而抑制胃酸分泌。大鼠胃酸分泌及胃溃疡等模型的药效研究结果显示,右兰索拉唑的体内活性是左兰索拉唑的5~10倍,提示右兰索拉唑是兰索拉唑的主要活性成分。与左旋体和消旋体相比,右兰索拉唑具有更好的药代动力学和药效学特性,从而发挥更强、更持久的抑酸作用。右兰索拉唑肠溶胶囊2019年全球销售额为6.34亿美元,目前国际上尚无右兰索拉唑注射剂上市销售;其消旋体兰索拉唑胶囊和注射剂已经中国上市多年,PDB数据库显示2019年中国样本医院注射用兰索拉唑的销售额达8.5亿元,市场潜力大。我公司开发的注射用右兰索拉唑若成功获批,将为临床医生、患者提供更多的用药选择。
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