天士力(600535.SH):養血清腦丸增加阿爾茨海默病(AD)適應症獲准臨牀試驗
格隆匯3月31日丨天士力(600535.SH)公佈,近日,公司收到國國家藥監局核准簽發的養血清腦丸新增適應症的《臨牀試驗通知書》,並將於近期開展臨牀試驗。
養血清腦丸系天士力心腦血管領域重要品種之一,為公司產品養血清腦顆粒改劑型品種,2006年獲批上市(國藥準字Z20063808),功能主治為養血平肝,活血通絡。用於血虛肝旺所致頭痛,眩暈眼花,心煩易怒,失眠多夢。該產品是中國藥典、國家基本藥物目錄、國家醫保目錄納入品種,並獲得國家二級中藥保護品種證書、國家教育部科學技術進步二等獎等多個獎項。
上市後藥理研究證實,養血清腦製劑通過抑制腦組織Aβ沉積、提高腦內乙酰膽鹼水平、保護突觸、抑制神經元凋亡、減輕氧化應激和神經炎症反應,以及改善腦微循環障礙等多個環節,從而發揮其改善阿爾茨海默病實驗動物學習和認知功能障礙的藥理作用。截至本公告日,公司對該項目累計研發投入為人民幣747.90萬元。
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