衞信康(603676.SH):子公司獲得小兒複方氨基酸注射液(19AA-I)藥品註冊證書
格隆匯5月16日丨衞信康(603676.SH)公佈,近日,公司全資子公司白醫製藥收到國家藥監局核准簽發的小兒複方氨基酸注射液(19AA-I)《藥品註冊證書》。經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品批准文號。
2020年9月30日,公司全資子公司白醫製藥向國家藥品監督管理局遞交的小兒複方氨基酸注射液(19AA-I)的藥品註冊申請獲得受理,2022年5月10日獲得國家藥監局批准。根據國家相關政策規定,本次獲得《藥品註冊證書》視同通過一致性評價。截至2022年4月30日,截至2022年4月30日,公司針對該藥品累計研發投入為人民幣1048.52萬元。
小兒複方氨基酸注射液(19AA-I)為多種氨基酸組成的複方製劑,為靜脈用胃腸外營養輸液,適用於嬰幼兒(包括低體重兒)及小兒的腸外營養支持。該產品可防止氮流失和體重下降,並可糾正負氮平衡。
小兒複方氨基酸注射液(19AA-I)已被納入2019年國家醫保目錄(乙類)。
根據米內網數據顯示,2021年兒童複方氨基酸在我國公立醫院終端市場銷售金額6.8億元,其中,小兒複方氨基酸注射液(19AA-I)銷售金額約2.7億元,小兒複方氨基酸注射液(18AA-I)銷售金額約3.8億元,小兒複方氨基酸注射液(18AA-Ⅱ)銷售金額約0.3億元。
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