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一品紅(300723.SZ):獲得非諾貝特酸膽鹼緩釋膠囊藥品補充申請批准通知書
格隆匯 07-01 11:53

格隆匯7月1日丨一品紅(300723.SZ)公佈,公司全資子公司廣州市聯瑞製藥有限公司(以下簡稱"聯瑞製藥")於近日收到國家藥品監督管理局核准簽發的關於非諾貝特酸膽鹼緩釋膠囊的《藥品補充申請批准通知書》。

根據核准的藥品説明書,公司獲批的非諾貝特酸膽鹼緩釋膠囊適應症:

在成人控制飲食基礎上:

-用於降低重度高甘油三酯血癥患者的甘油三酯(TG)水平。

-用於原發性高膽固醇血癥或混合型血脂異常患者的治療。

非諾貝特膽鹼鹽為氯貝丁酸衍生物類血脂調節藥,通過抑制極低密度脂蛋白和甘油三酯的生成並同時使其分解代謝增多,降低血低密度脂蛋白、膽固醇和甘油三酯;還使載脂蛋白A1和A11生成增加,從而增高高密度脂蛋白。實驗表明:非諾貝特的疏水性導致其生物利用度低,並且受食物的影響大;與非諾貝特相反,非諾貝特膽鹼在小腸區有較高的溶解度,因此增加了非諾貝酸的生物利用度,並且生物利用度不受食物的影響,同時,使用劑量減少,毒副作用也隨之降低。

公司獲批的非諾貝特酸膽鹼緩釋膠囊是按照新的化學藥品註冊分類及註冊管理要求申報,視同通過仿製藥一致性評價。根據米內網數據,非諾貝特2023年在中國城市公立醫院、縣級公立醫院銷售額約為47,359萬元人民幣。

此次公司新增獲得非諾貝特酸膽鹼緩釋膠囊(規格:45mg)藥品補充申請批准通知書,標誌着公司具備了在國內市場銷售該規格藥品的資格,將進一步增強公司在慢病藥領域的競爭力,對公司業績產生積極影響。

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