珍寶島(603567.SH):枸櫞酸託法替布片獲得境內生產藥品註冊上市許可的受理通知書
格隆匯12月20日丨珍寶島(603567.SH)公佈,近日,公司獲得國家藥品監督管理局下發的《受理通知書》,為仿製藥枸櫞酸託法替布片(規格:5mg)的註冊上市許可,待取得國家藥品監督管理局註冊批件或上市許可批件後方可進行銷售。
託法替布是一種酪氨酸激酶(JAK)抑制劑,作用於JAK信號轉導通路,防止轉錄激活因子(STAT)磷酸化和激活,從而抑制有關炎性細胞因子的釋放,達到有效抗炎,緩解類風濕關節炎的治療效果。與傳統治療藥物及生物類抗風濕藥相比,託法替布兼具可改善病情、安全性好、口服用藥便捷等優勢,先後被國內外權威臨牀指南推薦,用於生物製劑型抗風濕藥治療失敗和傳統合成抗風濕藥反應不足的類風濕關節炎患者。
公司枸櫞酸託法替布片(規格:5mg)項目已完成註冊申報並獲得受理通知書,後續還需完成註冊檢驗、根據國家藥監局審評意見完成相關研究後方可獲得生產批件。截止目前累計研發投入約1271.86萬元。
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