綠葉製藥(02186.HK)中樞神經領域新藥LY 03015在美國提交臨牀試驗申請
格隆匯8月2日丨綠葉製藥(02186.HK)發佈公吿，集團已就其中樞神經領域新藥LY 03015向美國食品藥品監督管理局提交臨牀試驗(IND)申請。LY 03015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，目前已上市的VMAT2抑制劑存在不同程度的臨牀痛點。
LY 03015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，LY 03015的活性更高，藥代動力學性質更好，且具有較長的半衰期，預期可降低臨牀用藥劑量，進而降低心臟安全性風險和其他不良反應的發生。LY 03015在美國提交的IND申請相關臨牀試驗為一項評價LY 03015的安全性、耐受性和藥代動力學特徵的I期臨牀試驗。計劃納入120例受試者。
根據公開資料顯示，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。除美國外，LY 03015的臨牀試驗也將在中國同步開展。
集團同時已上市多箇中樞神經系統治療領域產品，包括注射用利培酮微球(II)(瑞欣妥®)、富馬酸喹硫平片(思瑞康®)及富馬酸喹硫平緩釋片、利斯的明透皮貼劑及利斯的明多日透皮貼劑、芬太尼透皮貼劑、丁丙諾啡透皮貼劑，覆蓋包括中國、美國、歐洲及日本在內大型醫藥市場以及快速發展的新興市場等全球80個以上國家及地區。此外，集團還有多個在研項目在中國及海外市場進行同步開發，涵蓋抑鬱症、帕金森病等多種疾病，在中樞神經治療領域形成了豐富的產品組合。
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