罗欣药业(002793.SZ)：注射用帕瑞昔布钠通过一致性评价
格隆汇1月13日丨罗欣药业(002793.SZ)公布，公司下属子公司山东罗欣药业集团股份有限公司(“山东罗欣”)于近日收到国家药品监督管理局核准签发的注射用帕瑞昔布钠《药品补充申请批准通知书》。
药品名称：注射用帕瑞昔布钠；剂型：注射剂；注册分类：化学药品；规格：20mg、40mg；原药品批准文号：国药准字H20193380、国药准字H20193381；通知书编号：2020B05514、2020B05513；上市许可持有人：山东罗欣药业集团股份有限公司；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。
帕瑞昔布钠属于非甾体抗炎药，用于手术后疼痛的短期治疗，是全球唯一可同时静脉、肌肉注射用的COX-2(环氧化酶-2)抑制剂，具有镇痛效果好，起效迅速，作用持久，能有效抑制痛觉超敏，且胃肠安全性高，不影响血小板功能，不会额外增加心血管风险等特点。
注射用帕瑞昔布钠(商品名：Dynastat®)是由辉瑞和法玛西亚公司联合开发，剂型为冻干粉针剂，于2002年在欧洲首次上市，目前已在德国、法国、英国等至少15个国家上市。2008年，注射用帕瑞昔布钠(商品名：特耐)获准在中国上市，规格为20mg、40mg。山东罗欣于2019年首次获得注射用帕瑞昔布钠生产批件，批准文号为国药准字H20193380、国药准字H20193381。
根据IQVIA数据，注射用帕瑞昔布钠2019年度在全球的销售金额为2.19亿美元(以出厂价计算)，在我国境内销售金额为15.20亿元人民币(以招标价计算)。
注射用帕瑞昔布钠一致性评价申请被国家药品监督管理局批准，根据国家相关政策，通过一致性评价的药品品种，质量和疗效等同原研产品，在医保支付及医疗机构采购方面将予以适当支持。
注射用帕瑞昔布钠是公司的首个COX-2抑制剂药品，其通过一致性评价将进一步提高市场竞争力，扩大市场份额，同时为公司后续一致性评价产品研究及仿制药开发积累了宝贵经验。
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