綠葉製藥(02186.HK)在研產品完成人體藥代動力學研究
綠葉製藥(02186.HK)公布,已於美國完成一項有關注射用醋酸戈舍瑞林緩釋微球「LY 01005」的人體藥代動力學試驗。研究結果顯示,LY 01005安全性耐受性良好,未發生嚴重不良事件、導致受試者退出試驗或死亡的不良事件。集團擬就LY 01005於美國的進一步開發計劃與美國食品和藥品管理局(FDA)進行磋商。
LY 01005 是集團利用自身微球注射技術研發的每月一次採用肌肉注射的醋酸戈舍瑞林緩釋微球製劑,為腫瘤科在研產品,用於前列腺癌、乳腺癌及子宮內膜異位症等病症的治療。除美國之外,目前正在中國進行關鍵臨床試驗。
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