恆瑞醫藥(600276.SH):注射用卡莫司汀獲得美國FDA批准文號
格隆匯 3 月 22日丨恆瑞醫藥(600276.SH)公佈,公司近日收到美國食品藥品監督管理局(“FDA”)通知,恆瑞醫藥向美國FDA申報的注射用卡莫司汀簡略新藥申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。
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以下方面:
(1)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瘤;
(2)與潑尼松聯用治療多發性骨髓瘤;
(3)與其他淋巴瘤合併批准的藥物聯用治療複發性或難治性霍奇金淋巴瘤;
(4)合併其他批准的藥物治療複發性或難治性非霍奇金淋巴瘤。
注射用卡莫司汀最早由EMCURE PHARMACEUTICALS LTD公司開發,於1977年在美國獲批,商品名為BICNU。經查詢,目前國外已有4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。
經查詢,2019年注射用卡莫司汀全球銷售額約為7347萬美元。截至目前,卡莫司汀項目累計已投入研發費用約為1761萬元。
此次注射用卡莫司汀獲得美國FDA批准文號標誌着恆瑞醫藥具備了在美國市場銷售該藥品的資格,將對公司拓展市場帶來積極影響。
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