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健友股份(603707.SH):子公司產品注射用卡莫司汀獲美國FDA批准
格隆匯 08-03 18:28

格隆匯8月3日丨健友股份(603707.SH)公佈,公司子公司香港健友實業有限公司(“香港健友”)於近日收到美國食品藥品監督管理局簽發的注射用卡莫司汀,100mg/瓶ANDA批准通知(ANDA號:213460)。

卡莫司汀是一種亞硝基脲類化合物,可作為單一藥物或在姑息治療中與其他批准的化療藥物聯合治療:腦腫瘤膠質母細胞瘤、腦幹神經膠質瘤、髓母細胞瘤、星狀細胞瘤,室管膜瘤和轉移性腦腫瘤;與潑尼松聯用治療多發性骨髓瘤;與其他批准的藥物聯用治療複發性或難治性霍奇金淋巴瘤;與其他批准的藥物聯用治療複發性或難治性非霍奇金淋巴瘤。

經查詢,當前美國已有STI PHARMA LLC、NAVINTA LLC、JIANGSU HENGRUI MED、AMNEAL、DR REDDYS家企業的注射用卡莫司汀仿製藥獲批上市;國內已有天津金耀藥業、河北美圖製藥2家企業的卡莫司汀注射液獲批,目前暫無國外注射用卡莫司汀進入中國;注射用卡莫司汀2020年美國市場銷售收入超過3800萬美元。

截至目前,公司在注射用卡莫司汀研發項目上已投入研發費用約人民幣1173.20萬元。

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