衞信康(603676.SH):鹽酸多巴胺注射液上市申請獲CDE受理
格隆匯1月24日丨衞信康(603676.SH)宣佈,近日,公司全資子公司內蒙古白醫製藥股份有限公司收到國家藥監局簽發的鹽酸多巴胺注射液(簡稱“該品種”)境內生產藥品註冊《受理通知書》。
鹽酸多巴胺注射液適用於急性循環功能不全(心源性休克,出血性休克),包括以下情況:1.無尿,少尿或使用利尿劑無效;2.脈搏數增加;3.使用其他強心劑/升壓劑觀察到副作用,或無法獲得良好效果的。
該品種的參比製劑為日本協和発酵キリン株式會社上市的Inovan。目前日本參比製劑產品未進口國內。規格為5ml:100mg、2.5ml:50mg。
截至該公吿披露日,中國境內鹽酸多巴胺注射液的主要廠家有上海禾豐製藥有限公司、遠大醫藥(中國)有限公司、亞邦醫藥股份有限公司、廣州白雲山明興製藥有限公司等,規格有5ml:200mg及2ml:20mg。目前國內已有7家按照一致性評價標準申報的廠家。
根據米內網數據(注:全國放大版的中國城市及縣級公立醫院化學藥終端競爭格局)統計,2020年度鹽酸多巴胺注射劑產品銷售額合計約4.41億元。
截至2021年末,該品種已累計投入研發費用約880.69萬元人民幣(未經審計)。
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