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海正藥業(600267.SH):枸櫞酸託法替布片獲批上市
格隆匯 04-19 16:57

格隆匯4月19日丨海正藥業(600267.SH)宣佈,公司於近日收到國家藥監局核准簽發的枸櫞酸託法替布片的《藥品註冊證書》。截至目前,公司在該藥品研發項目已投入1947萬元人民幣左右。

枸櫞酸託法替布片適用於甲氨蝶呤療效不足或對其無法耐受的中度至重活動性類風濕關節炎(RA)成年患者,可與甲氨蝶呤或其他非生物改善病情抗風濕藥(DMARD)聯合使用。公司枸櫞酸託法替布片按新4類獲得國家藥監局批准上市,視同通過一致性評價。

枸櫞酸託法替布(Tofacitinib citrate)由輝瑞公司開發,於2012年11月6日獲得美國FDA批准上市,商品名為XELJANZ®。枸櫞酸託法替布片國內生產廠商主要有齊魯製藥有限公司、湖南科倫製藥有限公司等。

經查詢IMS數據庫,枸櫞酸託法替布片2019年全球銷售額約為30.79億美元,其中國內銷售額約為980.00萬美元;2020年全球銷售額約為35.84億美元,其中國內銷售額約為1824.44萬美元。

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