健友股份(603707.SH):注射用鹽酸美法侖獲ANDA批文
格隆匯5月31日丨健友股份(603707.SH)宣佈,公司子公司香港健友實業有限公司(簡稱“香港健友”)於近日收到美國食品藥品監督管理局(簡稱“美國FDA”)簽發的注射用鹽酸美法侖(50mg/瓶)ANDA批准通知(ANDA號:212960)。該藥品用於不適合口服給藥治療的多發性骨髓瘤患者的姑息治療。
注射用鹽酸美法侖原研產品是APOTEX INC持有,商品名為ALKERAN,於1992年11月18日獲得美國FDA批准上市。
經查詢,當前美國已有MYLAN、FRESENIUS KABI、DR REDDYS等13家注射用鹽酸美法侖仿製藥獲批上市,國內僅有1家ACROTECH進口獲批。注射用鹽酸美法侖2020年美國銷售額約是5466萬美元。
截至目前,公司在注射用鹽酸美法侖研發項目上已投入研發費用約人民幣1536.55萬元。
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