綠葉製藥(02186.HK):1類新藥LY03015在中國獲准進行臨牀試驗
格隆匯9月29日丨綠葉製藥(02186.HK)發佈公吿,集團開發的中國1類化學新藥LPM3770164緩釋片(LY03015)已獲中國國家藥品監督管理局藥品審評中心批准進行臨牀試驗。LY03015為集團自主研發的治療遲發性運動障礙(TD)和亨廷頓舞蹈病(HD)的創新小分子化合物產品。
囊泡單胺轉運蛋白2(VMAT2)抑制劑是治療遲發性運動障礙和亨廷頓舞蹈病臨牀療效和安全性得到確證的唯一藥物類型,但目前已上市的VMAT2抑制劑存在不同程度的臨牀痛點。
LY03015是新一代VMAT2抑制劑,可通過抑制突觸前神經元多巴胺(DA)的釋放,避免DA對超敏D2受體刺激的同時也不阻滯突觸後膜的D2受體,從而減輕遲發性運動障礙和亨廷頓舞蹈病的症狀。其臨牀前研究結果表明,與市售產品相比,LY03015的活性更高,藥代動力學性質更好,且具有較長的半衰期,預期可降低心心臟安全性風險和其他不良反應的發生。此前,該產品的相關研究已在《European Journal of Medicinal Chemistry》上發表。除中國外,LY03015的臨牀試驗也將在美國同步開展。
根據公開數據顯示,目前已獲美國食品藥品監督管理局(FDA)批准的三款VMAT2抑制劑原研藥於2020年的全球銷售額合計約為16.59億美元,較2019年增長37.9%,具有較大的市場潛力。
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