沃森生物(300142.SZ):子公司双价HPV疫苗获得药品注册证书
格隆汇3月28日丨沃森生物(300142.SZ)公布,公司于2022年3月28日收到控股子公司上海泽润生物科技有限公司的全资子公司泽润生物的通知,泽润生物于近日收到由国家药品监督管理局批准颁发的双价人乳头瘤病毒疫苗(毕赤酵母)(以下简称“双价HPV疫苗”)的《药品注册证书》。经审查,本品符合药品注册的有关要求,批准注册,发给药品注册证书。
泽润生物双价HPV疫苗的开发历经十七年。该疫苗于2011年6月获得国家食品药品监督管理总局颁发的《药物临床试验批件》。临床试验工作历时九年,该疫苗通过了样本量为12000例的随机、双盲、多中心的保护效力临床试验的确证,2020年6月申请新药上市许可获得《受理通知书》,2021年7月正式纳入优先审评审批品种,2022年3月22日获得国家药品监督管理局签发的《药品注册证书》。
泽润生物的双价HPV疫苗研发过程中多次获得国家科技部“重大新药创制”专项支持、上海市科委“科技创新行动计划”重点项目支持;2015年,该项目还获得比尔及梅琳达·盖茨基金会专项资金资助。
泽润生物研发的双价HPV疫苗适用于预防女性因高危型HPV16、18型所致的宫颈癌等疾病。目前,全球已上市销售的HPV疫苗包括美国默沙东的四价HPV疫苗和九价HPV疫苗、英国葛兰素史克的双价HPV疫苗以及厦门万泰的双价HPV疫苗。根据上述公司的年报,2021年上述HPV疫苗全球销售额合计约63亿美元。
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