綠葉製藥(02186.HK)創新制劑LY03010在美關鍵臨牀完成首例患者入組給藥
綠葉製藥集團(02186.HK)自主研發的創新制劑——棕櫚酸帕利哌酮緩釋混懸注射液(LY03010)在美國開展的關鍵性臨牀試驗已於近期完成首例患者入組給藥。LY03010用於治療精神分裂症和分裂情感性障礙,是綠葉製藥在中樞神經系統治療領域的核心在研產品之一。
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。作為嚴重的精神疾病,精神分裂症患者因治療依從性低而導致複發率高,已成為該疾病治療中的一大難點。LY03010可改善口服抗精神病藥物在患者中普遍存在的用藥依從性。此外,與另一種市售同類藥物相比,LY03010通過優化初始給藥方案,有望使患者的用藥更為方便,從而進一步提升用藥依從性。
目前,全球已有超過2100萬人受到精神分裂症的困擾,且每2名患者中就有1人未接受治療。精神分裂症與大量的殘疾有關,患者的早年死亡可能較普通人羣高出2~3倍[ 數據來源於世界衞生組織官網]。“該疾病不僅對患者本人造成嚴重傷害,亦對其家人及社會造成較大負擔。我們正在迅速推進LY03010的臨牀相關工作,期待早日為患者提供新的治療選擇,”綠葉製藥集團管理層表示。
精神分裂症所在的中樞神經系統治療領域是綠葉製藥戰略佈局的核心治療領域之一。目前,公司圍繞該領域已擁有一系列在研產品,涵蓋抑鬱症、帕金森病、雙相情感障礙、阿爾茨海默病等多種疾病。除了LY03010,公司另有多個新藥已在中國、美國、歐洲等國家和地區進入後期臨牀或新藥上市申請階段。
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