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一品紅(300723.SZ):子公司鹽酸文拉法辛緩釋膠囊獲批
格隆匯 05-09 11:52

格隆匯5月9日丨一品紅(300723.SZ)公佈,公司全資子公司廣州一品紅製藥有限公司於近日收到國家藥監局核准簽發的關於鹽酸文拉法辛緩釋膠囊的《藥品註冊證書》。根據核准的藥品説明書,公司獲批的鹽酸文拉法辛緩釋膠囊用於治療抑鬱症(包括伴有焦慮的抑鬱症)及廣泛性焦慮障礙。

文拉法辛是選擇性5-羥色胺(簡稱“5-HT”)和去甲腎上腺素(簡稱“NE”)再攝取抑制劑(SNRIs)類抗抑鬱藥。其作用機制是對5-HT和NE兩種中樞神經遞質及受體產生作用,增強神經中樞5-HT和NE的功能,發揮抗抑鬱作用,同時對毒蕈鹼樣或組胺樣受體不具有明顯親和力。因此,文拉法辛在抗抑鬱作用的同時,並沒有明顯的三環類抗抑鬱藥所致不良反應特點,表現了較為獨特的藥理性質。是多個國家抑鬱症和廣泛性焦慮障礙防治指南推薦的一線治療藥物。

公司獲批的鹽酸文拉法辛緩釋膠囊是以化學藥品4類申報註冊,視同通過仿製藥一致性評價。鹽酸文拉法辛緩釋膠囊屬於國家醫保甲類產品,國家基藥品種。米內網數據顯示,2021年文拉法辛在中國城市公立醫院、縣終端銷售額達12.52億元。

此次獲得鹽酸文拉法辛緩釋膠囊註冊證書,標誌着公司具備了在國內市場生產銷售該藥品的資格,將進一步豐富了公司產品管線和品類,增強公司在慢病藥領域的競爭力。

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