绿叶制药(02186.HK)注射用醋酸戈舍瑞林缓释微球于美国完成人体药代动力学研究
格隆汇9月19日丨绿叶制药(02186.HK)发布公告,本集团已于美国完成一项有关注射用醋酸戈舍瑞林缓释微球(LY01005)的人体药代动力学试验。该临床试验旨在评估LY01005单次给药的药代动力学(PK)、药效动力学(PD)及安全性特征,并与其诺雷得进行比较。美国拥有丰富经验的4家试验基地为本临床试验招募了19名前列腺癌患者。
研究结果显示,LY01005与参考药品相比,在人体内具有更加平稳的释药行为,而各PD指标(睾酮,黄体生成素和卵泡刺激素)主要参数的差异无统计学意义,表明LY01005与诺雷得?在人体内的药物效应无显着性差异。LY01005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。本集团拟就LY01005于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。
LY01005是本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,用于前列腺癌、乳腺癌及子宫内膜异位症等病症的治疗。除美国之外,目前LY01005正在中国进行关键临床试验。本集团已在中国、美国、欧洲、日本、俄罗斯获得戈舍瑞林微球药物组合物专利。
根据IQVIA的资料,2018年美国促性腺激素释放激素激动剂产品的市场总值为约10.2亿美元,2016年至2018年的复合年增长率为20.8%。本公司相信,LY01005具有良好的市场潜力,并将有力推进本集团在肿瘤治疗领域的发展。
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