【上海莱士:子公司蛋白C临床试验申请获受理】上海莱士公告称,公司全资子公司广西莱士生物制药有限公司收到国家药监局下发的“蛋白C”临床试验申请《受理通知书》,受理号为CXSL2600893。该药品为治疗用生物制品3.2类,规格500IU/瓶,用于先天性蛋白C缺乏症患者的治疗,属国内Ⅱ类新药,列入第三批鼓励研发申报儿童药品清单,目前国内尚无同类人蛋白C制剂获批上市。本次受理后60日内未收到药审中心否定或质疑意见的,可按提交方案开展临床试验。该产品若成功获批上市,将提升公司血浆综合利用率及相关领域竞争力,药物研发尚存不确定性。
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