健友股份(603707.SH):香港健友產品注射用培美曲塞二鈉獲美國FDA批准
格隆匯12月14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(簡稱“香港健友”)於近日收到美國食品藥品監督管理局(“美國FDA”)簽發的注射用培美曲塞二鈉,100mg/瓶,500mg/瓶,750mg/瓶和1g/瓶,單劑量ANDA批准通知(ANDA號:215479)。
經查詢,當前美國已有ACCORD HEALTHCARE INC、APOTEX INC、BAXTER HEALTHCARE CORP、DR REDDYS LABORATORIES LTD、EUGIAPHARMA SPECIALITIES LTD、FRESENIUS KABI USA LLC和香港健友實業有限公司等數家注射用培美曲塞二鈉,100mg/瓶,500mg/瓶,750mg/瓶和1g/瓶仿製藥獲批上市;該產品2021年美國市場銷售額約為12.33億美元。
截至目前,公司在注射用培美曲塞二鈉,100mg/瓶,500mg/瓶,750mg/瓶和1g/瓶研發項目上已投入研發費用約人民幣1508.91萬元。
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