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信立泰(002294.SZ):獲得鹽酸帕羅西汀腸溶緩釋片藥品註冊證書
格隆匯 08-17 19:10

格隆匯 8 月 17日丨信立泰(002294.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的鹽酸帕羅西汀腸溶緩釋(信立平®)藥品註冊證書》。

“鹽酸帕羅西汀腸溶緩釋片”用於治療成人抑鬱症。目前國內已上市的帕羅西汀多為口服常釋劑型緩釋片僅有GLAXOSMITHKLINE INC.GSK銷售,是常用抗抑鬱藥之一。201911,帕羅西汀腸溶緩釋片通過談判進入國家醫保目錄乙類範圍。

抑鬱症具有高發病率、高複發性、高致殘率,但總體診斷率及治療率偏低。據統計,全球有超過3.5億人患抑鬱性疾病,我國抑鬱症患病率達到2.1%,並呈現逐年上升趨勢,市場空間廣闊。

公司“鹽酸帕羅西汀腸溶緩釋片”為國內首家按照一致性評價的要求完成生物等效性試驗,並視同通過一致性評價。該產品的上市,將進一步豐富公司品管線,為患者提供更多用藥選擇。

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