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健友股份(603707.SH):注射用鹽酸苯達莫司汀獲得美國FDA暫時批准文號
格隆匯 04-21 16:05

格隆匯4月21日丨健友股份(603707.SH)公佈,公司子公司健進製藥有限公司(“健進製藥”)近日收到美國食品藥品監督管理局(“FDA”)通知,健進製藥向美國FDA申報的注射用鹽酸苯達莫司汀ANDA申請已獲得暫時批准(暫時批准的原因為美國FDA已經完成該藥品的所有審評流程,但存在相關專利未到期的情形)。

鹽酸苯達莫司汀鹽酸苯達莫司汀是一種雙功能基烷化劑,用於慢性淋巴細胞白血病和非霍奇金淋巴瘤的治療。注射用鹽酸苯達莫司汀由Cephalon Inc開發,商品名:TREANDA,於2008年3月20日獲得美國FDA批准上市,於2008年12月17日獲得中國藥監局批准上市,商品名為存達。目前本品不包括原研在內的同規格國內獲批企業僅有1家,即正大天晴。經查IMS數據庫,2019年注射用鹽酸苯達莫司汀美國銷售額約為5.3億美元,

截至目前,公司在該產品研發項目上已投入研發費用約為1136.62萬元人民幣。

此次注射用鹽酸苯達莫司汀獲得美國FDA的暫時批准文號,標誌着該產品滿足仿製藥的所有審評要求,但需在相關專利到期並得到美國FDA最終批准後才可獲得在美國市場銷售該產品的資格。公司將積極推動該產品在美國市場的上市準備。

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