綠葉製藥(02186.HK)抗抑鬱1類創新藥(LY03021)獲准開展臨牀試驗
格隆匯11月11日丨綠葉製藥(02186.HK)宣佈,集團的1類創新藥LY03021已獲得中國國家藥品監督管理局藥品審評中心批准開展臨牀試驗,擬用於治療抑鬱症。
LY03021為去甲腎上腺素轉運體(「NET」)╱多巴胺轉運體("DAT")抑制劑、γ-氨基丁酸A受體正向變構調節劑(GABAAR PAM)。該產品基於集團新分子實體╱新治療實體技術平台(NCE/NTE)自主開發,是全新的三靶點作用機制抗抑鬱藥物,具有同類首創(First-in-Class)的潛質。據公司所知,目前尚未檢索到相同機制的產品在研。
抑鬱症是由各種原因引起的,以顯着和持久的抑鬱症狀羣為主要臨牀特徵,並損害社會功能的一類心境障礙。流行病學數據顯示:我國抑鬱症患病呈上升趨勢,抑鬱症的終生患病率為3.4%、12個月患病率為2.1%。抑鬱症伴隨高複發率、高自殺率、高致殘率,嚴重影響患者、其家庭和社會。現有抗抑鬱藥總體有效率和治癒率低,且普遍存在起效較慢、殘留症狀多、復發風險高、不良反應多等侷限。因此,如何快速有效的控制抑鬱症的臨牀症狀,進一步改善治療效果和預後成為當下抗抑鬱藥物研發中需要攻克的難題。
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