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江蘇吳中(600200.SH):鹽酸曲美他嗪緩釋片獲批上市
格隆匯 12-08 16:37

格隆匯12月8日丨江蘇吳中(600200.SH)公佈,近日,公司全資子公司江蘇吳中醫藥集團有限公司下屬分支機構江蘇吳中醫藥集團有限公司蘇州製藥廠(簡稱“蘇州製藥廠”)收到了國家藥監局核准簽發的關於“鹽酸曲美他嗪緩釋片”(以下簡稱“該藥品”或“本品”)的《藥品註冊證書》(證書編號:2021S01210)。

鹽酸曲美他嗪緩釋片作為添加藥物,用於對一線抗心絞痛治療控制不佳或無法耐受的穩定型心絞痛成年患者的對症治療。曲美他嗪通過保護細胞在缺氧或缺血情況下的能量代謝,阻止細胞內三磷酸腺苷(ATP)水平的下降,從而保證了離子泵的正常功能和透膜鈉-鉀流的正常運轉,維持細胞內環境的穩定。曲美他嗪通過阻斷長鏈3-酮脂酰輔酶A硫解酶(3-KAT)抑制脂肪酸的β-氧化,從而促進葡萄糖氧化。在缺血細胞中,相比於β-氧化過程,通過葡萄糖氧化獲得能量需要較低的耗氧量。增強葡萄糖氧化可以優化細胞的能量過程,從而維持缺血過程中適當的能量代謝。

公司鹽酸曲美他嗪緩釋片項目於2017年立項,於2020年3月提交鹽酸曲美他嗪緩釋片藥品上市許可申請,並於近日獲得藥品註冊證書。國內已有多家企業相關產品獲批上市,除公司外,齊魯製藥有限公司、江蘇恆瑞醫藥股份有限公司等多家企業已獲批上市,且視同通過一致性評價。

經查詢,鹽酸曲美他嗪緩釋片2020年國內樣本醫院銷售額約為9919.02萬元(PDB數據庫)。截至2021年11月末,公司鹽酸曲美他嗪緩釋片項目共計已投入研發費用約為1991.73萬元人民幣。

公司表示,鹽酸曲美他嗪緩釋片按化學藥品4類批准生產視同通過一致性評價,有利於提升該藥品的市場競爭力,對該藥品的市場銷售產生積極影響,同時也為公司後續產品開展仿製藥及一致性評價工作積累了寶貴的經驗。

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