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珍寶島(603567.SH):仿製藥枸櫞酸託法替布片(5mg)獲美國FDA藥品註冊上市許可的受理通知書
格隆匯 03-15 16:59

格隆匯3月15日丨珍寶島(603567.SH)公佈,近日,黑龍江珍寶島藥業股份有限公司獲得美國食品藥物管理局下發的《受理通知書》。相關產品為枸櫞酸託法替布片。

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,後續還需根據FDA審評意見,完成相關研究獲得上市許可。截止目前累計研發投入約1271.86萬元。

枸櫞酸託法替布片(規格:5mg)原研公司為輝瑞,商品名:XELJANZ/尚傑,適應症為甲氨蝶呤療效不足或對其無法耐受的中度至重度活動性類風濕關節炎(RA),2012年在美國首先批准上市,目前已在美國、日本等50多個國家和地區獲得上市批准,2017年獲批中國上市。

截至2021年12月,枸櫞酸託法替布片共有37家申報,其中通過一致性評價14家,在審評審批狀態16家。2020年抗炎和抗風濕藥物銷售額共251億元,枸櫞酸託法替布片2020年全國總銷售額約3.48億元,其中,國家公立醫療終端銷售額約1.57億元,重點城市零售終端銷售額1.91億元。

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