綠葉製藥(02186.HK)治療精神分裂症藥物擬向美國提交新藥上市申請
綠葉製藥(02186.HK)公布,集團研發的用於精神分裂症和分裂情感性障礙的治療新藥LY03010在美國開展的關鍵臨床試驗已經完成數據分析,結果顯示達到預設終點,基於前期和FDA的溝通交流結果,LY03010計劃通過505(b)(2)的途徑向美國食品藥物管理局(FDA)提交新藥上市申請(NDA)。
LY03010是一種緩釋混懸注射液,每月給藥一次,以肌肉注射的方式用於精神分裂症和分裂情感性障礙的治療。LY03010可以改善口服抗精神病藥物在精神分裂患者中普遍存在的用藥依從性。
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