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三生制药(01530.HK)盐酸纳呋拉啡口腔崩解片获临床试验批准
格隆汇 09-18 20:37

格隆汇9月18日丨三生制药(01530.HK)发布公告,本集团用于治疗血液透析患者瘙痒症的药物盐酸纳呋拉啡口腔崩解片(TRK-820)的临床试验申请于2019年9月16日获得国家药品监督管理局批准,准予开展临床试验。2018年1月,Toray Industries,Inc.授权香港三生医药有限公司(本公司全资附属公司)于中华人民共和国(不包括香港、澳门及台湾)开发及商业化TRK-820(Toray开发代码;通用属名:盐酸纳呋拉啡;亦以REMITCH的名称于日本获批)若干口腔崩解片制剂配方的独家权利。

TRK-820是Toray开发的高选择性к(kappa)-opioid受体激动剂。TRK-820的软胶囊剂型已自2009年起于日本出售,用于治疗血液透析相关尿毒症瘙痒(仅在现有疗法或治疗的疗效不足够时使用)。TRK-820的其他适应症,慢性肝病患者瘙痒症及腹膜透析患者瘙痒症已分别于2015年及2017年在日本获得批准。此外,口腔崩解片于2017年在日本获批并推出。口腔崩解片可水服或乾服,因此方便了吞咽功能受损的患者或饮水量受到限制的患者,且预期将会提高用药依从性。

本公司的主席兼行政总裁娄竞博士评论道:公司很高兴看到TRK-820的临床试验申请获国家药品监督管理局批准并期待于中国部署该产品的临床试验。透析患者的瘙痒症是终末期肾病患者中常见的皮肤并发症,目前,该疾病缺乏有效的治疗方法。公司期望藉由该产品的研发为缓解中国透析患者的瘙痒作出贡献,并丰富本集团肾脏科的产品线。

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