盐酸阿芬太尼注射液国内首次获批上市

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-03-13 14:37
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(Summary description)近日，宜昌人福药业有限责任公司收到国家药品监督管理局核准签发的《药品注册批件》，三种规格的盐酸阿芬太尼注射液（商品名：瑞吉欣®）均以化学药品3类于2月26日获批上市，这是阿芬太尼产品在中国的首次获批上市。盐酸阿芬太尼为比利时杨森的原研产品，1983年在荷兰首次上市，1987年被引入美国市场，广泛用于欧美地区长达30年之久，临床效果经得起时间检验，但目前尚未在我国上市。盐酸阿芬太尼（Alfentan

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盐酸阿芬太尼注射液国内首次获批上市

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-03-13 14:37
Views:

Information

近日，宜昌人福药业有限责任公司收到国家药品监督管理局核准签发的《药品注册批件》，三种规格的盐酸阿芬太尼注射液（商品名：瑞吉欣®）均以化学药品3类于2月26日获批上市，这是阿芬太尼产品在中国的首次获批上市。

南京华讯知识产权顾问有限公司

盐酸阿芬太尼为比利时杨森的原研产品，1983年在荷兰首次上市，1987年被引入美国市场，广泛用于欧美地区长达30年之久，临床效果经得起时间检验，但目前尚未在我国上市。

盐酸阿芬太尼（Alfentanil Hydrochloride）

化学名称：N-[1-[2-(4-乙基-4,5-二氢-5-氧-1H-四唑-1-基)乙基]-4-(甲氧甲基)-4-哌啶基]-N-苯基丙酰胺盐酸盐一水合物结构式：

南京华讯知识产权顾问有限公司

盐酸阿芬太尼是一种芬太尼的类似物，主要作用于μ阿片受体。盐酸阿芬太尼为麻醉时用的短效强镇痛药，主要用于全身麻醉诱导和维持，特别是日间/短小手术，中长时程手术等。该药三效合一：速效，30秒起效；短效，维持时间15分钟，介于瑞芬太尼和舒芬太尼之间；强效，镇痛强度是吗啡的15倍。同时呼吸抑制、恶心呕吐、呛咳发生率低，临床应用更加安全。此外，因为阿芬太尼时量相关半衰期有相对恒定，因此是靶控输注的理想选择之一。

南京华讯知识产权顾问有限公司

药物综合数据库（PDB）显示，2018年盐酸阿芬太尼注射液全球销售额约1420万美元，同比增长4.41%。随着日间手术的快速发展，临床上对中短效的镇痛药物需求进一步扩大。另外，从2019年5月1日起，我国对芬太尼类物质实施整类列管。资料显示，此前纳入列管的25种芬太尼类物质中，芬太尼、舒芬太尼、瑞芬太尼、阿芬太尼4个品种为药品。其中，芬太尼、舒芬太尼和瑞芬太尼这3个品种此前已在我国上市。

宜昌人福是国家麻醉药品定点生产企业，以麻醉科用药为核心，明星产品包括瑞芬太尼、舒芬太尼、纳布啡、氢吗啡酮等，2019年上半年实现净利润4.99亿元。此次宜昌人福的盐酸阿芬太尼注射液获批上市，使其成为首家占领国内阿芬太尼市场的企业，率先拥有了全系列四种芬太尼类药品，创立了中国麻醉镇痛药物发展的新里程碑，也推动了宜昌人福实现“大麻药布局”（麻醉镇痛+镇静）。

人福医药的盐酸阿芬太尼的申报上市之路并非一帆风顺。2004年9月，人福向NMPA提交定点研制申请并获受理；2008年10月，获临床试验批件并于2013年1月申报生产；但在2015年7月主动撤回待临床数据完善；2018年3月重新申报并被纳入优先审评；2019年5月NMPA对该药注册申请进行临床数据核查；2020年2月，终于获批上市。

除了人福医药外，目前盐酸阿芬太尼国外主要生产厂商包括Akorn、Hospira等，国内江苏恩华药业也已于2019年10月提交上市申请。阿芬太尼由于具备上述速效、短效、强效等特点，其在国内获批上市将为我国临床医生提供更多的用药选择，为日间手术提供“量身定制”的治疗方案，更好的满足不同患者的用药需求，为推动我国医疗服务高质量发展增添了新的动力。

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Electronic Arts pledges free use for five accessibility patents

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