绿叶制药(02186.HK)：精神疾病新药LY03010在美开始关键性试验
格隆汇12月21日丨绿叶制药(02186.HK)宣布，集团研发的用于精神分裂症和分裂情感性障碍的治疗的新药棕榈酸帕利哌酮缓释混悬注射液(“LY03010”)的关键临床试验方案已被美国食品药物管理局(“FDA”)接受，已于美国开始关键性临床试验。
据悉，LY03010是一种缓释混悬注射液，每月给药一次，以肌肉注射的方式用于精神分裂症和分裂情感性障碍的治疗。LY03010可以改善口服抗精神病药物在精神分裂症患者中普遍存在的用药依从性。与另一种市售同类药物相比，LY03010通过优化初始给药方案有可能让患者使用更加方便从而进一步提高用药依从性。早在IND申报前会议(pre-IND会议)中，FDA已确认可以通过证明多次给药达到稳态的生物等效性即可支持LY03010的505(b) (2)NDA上市申请。LY03010在美国完成两项临床试验后，近期向FDA提交了该关键临床试验的试验方案，FDA完成了审评并同意该方案。
而精神分裂症是一种严重的精神类疾病，具有中断思维、影响语言、观念和自我认知的特征。据世界卫生组织统计，全球有超过2100万人受到精神分裂症的困扰，并且每两名精神分裂症患者中有一人未接受治疗。集团预期，LY03010能被用于改善精神分裂症和╱或分裂情感性障碍患者的用药依从性，这对于患者、其家人及社会而言，都是一项十分重大的医疗需求。
集团相信，LY03010拥有良好的市场潜力，并将丰富集团的产品组合。
值得注意的是，除LY03010外，集团还有多个中枢神经系统的在研项目，同步在中国及海外市场进行开发，如LY03004(精神分裂症和双相I型情感障碍)、LY03003(帕金森病和中至重度不宁腿综合症)、LY03005(抑郁症)、LY30410/LY03013(中轻度阿尔兹海默症)和LY03012(慢性疼痛)等项目。上述在研产品在中国、美国、欧洲和日本等战略市场注册进展良好，未来将在这些国家上市并进一步扩展到全球市场。
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