恩華藥業(002262.SZ):與靈北就抗精神分裂症藥物LuAF35700在大中華區達成獨家許可協議
格隆匯11月25日丨恩華藥業(002262.SZ)宣佈,公司為了加強新產品的開發力度,豐富公司在中樞神經治療領域的產品線,增強公司的核心競爭力,公司近期與丹麥靈北製藥公司(簡稱“Lundbeck”)就中樞神經領域新藥LuAF35700的研發合作事宜進行商談並簽署《許可協議》。
恩華與Lundbeck就抗精神分裂症藥物LuAF35700在大中華區(包含中國大陸、香港、澳門和台灣)(簡稱“許可區域內”)達成獨家許可協議。LuAF35700最初由Lundbeck開發用於治療難治性精神分裂症(TRS),可靶向多巴胺受體、血清素受體和腎上腺素受體。與現有抗精神病藥物不同,LuAF35700對多巴胺D1受體的親和力高於D2受體,其獨特的藥理學機制有望減少錐體外系反應(EPS)、高泌乳素血癥等副作用的發生率。截至目前,已在數個臨牀試驗(包括III期關鍵臨牀試驗)中驗證了LuAF35700的安全性和耐受性良好。恩華將在許可區域內針對不同適應症設計試驗方案並開展臨牀研究,力爭早日將其成功開發上市。
據悉,Lundbeck創立於1915年,總部位於丹麥哥本哈根,業務遍佈全球50多個國家。是一家集研發、開發、生產和商業化於一體的綜合性全球製藥企業。專注於精神和神經系統領域,產品主要針對腦部疾病,包括抑鬱症、精神分裂症、阿爾茲海默症及帕金森病等。
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