四环医药(00460.HK)抗精神分裂症用药富马酸喹硫平缓释片获药品注册批件
格隆汇8月27日丨四环医药(00460.HK)发布公告,公司与附属公司佛山德芮可制药有限公司共同开发的抗精神分裂症用药富马酸喹硫平缓释片已获得国家药品监督管理局颁发的药品注册批件。此药品的规格为50mg、150mg、200mg、300mg及400mg。此药品于2017年获得美国食品药品监督管理局(“美国FDA”)批件并在美国上市。
此药品主要成分为富马酸喹硫平,是一种非经典抗精神病药物。此药品主要适用于治疗精神分裂症和治疗双相情感障碍症。此药品主要作用机理为阻断脑神经中 D2及5 -HT2两种感受体与脑部神经传导物质的结合,因而降低脑神经的之间传导,达到治疗的作用。
根据艾美仕市场研究公司资料显示,2018年中国治疗精神分裂药物整体市场约为人民币64.0亿元。其中,喹硫平的整体市场约为人民币7.8亿元,排名第三位,市场占比约12.2%。此药品目前于中国市场只有原研药在市场销售。德芮可为中国第二家获得国家药监局颁发此药品注册批件的药品生产企业,同时也是中国首家获得此药品仿制药注册批件的公司。
德芮可坐落于广东省佛山市,设置有两座符合美国FDA的生产基地,运用先进的制药技术生产高质量的仿制药。此药品注册批件将进一步完善并丰富集团产品线,进一步满足市场的需求。在满足患者用药需求的同时,为集团带来理想的回报。
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