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绿叶制药(02186.HK):利斯的明单日透皮贴剂获德国上市批准
格隆汇 07-15 12:13

格隆汇7月15日丨绿叶制药(02186.HK)公布,集团剂量为13.3mg/24h的利斯的明单日透皮贴剂,以低剂量(4.6和9.5mg/24h)作为现有销售许可的延伸提交,获得德国药品和医疗器械管理局(BfArM)非集中审评程序(DCP)上市批准。

公告显示,集团的利斯的明单日透皮贴剂已经在全球超过25个国家商业化。在欧洲,该新计量产品将补充原有剂量为4.6和9.5mg/24h的利斯的明单日透皮贴剂产品线,而三种剂量均已在美国上市。该补充剂量亦将在其他市场上市。

此外,集团正在开发拥有专利保护的利斯的明多日透皮贴剂(LY30410),提供一种新的给药方案。

除利斯的明透皮贴剂外,集团还有多个中枢神经产品线的在研产品,同步开发中国及海外市场。其中,治疗精神分裂症和双向情感障碍的微球制剂Rykindo® (LY 03004),已在美国正式申报NDA,治疗帕金森病的注射用罗替戈汀缓释微球(LY 03003)已分别在中、美进入III期临床,并在日本开展I期临床试验;治疗抑郁症的盐酸安舒法辛缓释片(LY 03005)已在中国进入III期临床,在美国进入关键试验阶段。

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