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绿叶制药(02186.HK)在研产品完成人体药代动力学研究
阿思达克 09-20 04:12

绿叶制药(02186.HK)公布,已於美国完成一项有关注射用醋酸戈舍瑞林缓释微球「LY 01005」的人体药代动力学试验。研究结果显示,LY 01005安全性耐受性良好,未发生严重不良事件、导致受试者退出试验或死亡的不良事件。集团拟就LY 01005於美国的进一步开发计划与美国食品和药品管理局(FDA)进行磋商。

LY 01005 是集团利用自身微球注射技术研发的每月一次采用肌肉注射的醋酸戈舍瑞林缓释微球制剂,为肿瘤科在研产品,用於前列腺癌、乳腺癌及子宫内膜异位症等病症的治疗。除美国之外,目前正在中国进行关键临床试验。

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