丽珠医药(01513.HK):注射用奥美拉唑钠通过仿制药质量和疗效一致性评价
格隆汇6月14日丨丽珠医药(01513.HK)公布,近日,公司全资子公司丽珠集团丽珠制药厂(“丽珠制药厂”)收到国家药品监督管理局核准签发的《药品补充申请批准通知书》,丽珠制药厂生产的注射用奥美拉唑钠通过仿制药质量和疗效一致性评价。
审批结论:根据《中华人民共和国药品管理法》、《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)、《关于仿制药质量和疗效一致性评价工作有关事项的公告》(2017年第100号)和《国家药监局关于开展化学药品注射剂仿制药质量和疗效一致性评价工作的公告》(2020年第62号)的规定,经审查,本品通过仿制药质量和疗效一致性评价,同意丽珠集团丽珠制药厂为本品的药品上市许可持有人。
注射用奥美拉唑钠是《国家基本医疗保险、工伤保险和生育保险药品目录》(医保发〔2020〕53号)乙类品种,适应症为:①消化性溃疡出血、吻合口溃疡出血;②应激状态时并发的急性胃黏膜损害、非甾体类抗炎药引起的急性胃黏膜损伤;③预防重症疾病(如脑出血、严重创伤等)应激状态及胃手术后引起的上消化道出血等;④作为当口服疗法不适用时下列病症的替代疗法:十二指肠溃疡、胃溃疡、反流性食管炎及Zollinger-Ellison综合症。
截至公告披露日,注射用奥美拉唑钠一致性评价已累计投入的直接研发费用约人民币547.1万元。
目前,国内共有103家企业持有注射用奥美拉唑钠(40mg)生产批文,其中10家通过本品的一致性评价(包括丽珠制药厂)。根据IQVIA抽样统计估测数据,奥美拉唑注射剂产品2020年国内样本医院销售金额约为人民币32.05亿元。公司注射用奥美拉唑钠2020年度的销售收入为人民币198.30万元。
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