濟川藥業(600566.SH):子公司取得丙戊酸鈉注射用濃溶液的藥品註冊證書
格隆匯2月3日丨濟川藥業(600566.SH)公佈,近日,公司全資子公司濟川藥業集團有限公司(“濟川有限”)收到國家藥品監督管理局(“國家藥監局”)核准簽發的丙戊酸鈉注射用濃溶液《藥品註冊證書》。
丙戊酸鈉注射用濃溶液,主要成份為丙戊酸鈉,由 Desitin Arzneimittel GmbH開發並在歐洲各國上市,劑型為注射劑,規格為 3ml:0.3g 和 10ml:1g,商品名:Orfiril,適應症為用於曾經服用過丙戊酸鈉口服劑型並獲得滿意療效,但暫時無法繼續服用該口服劑型的癲癇患者。目前,原研產品暫未在中國上市。據國際抗癲癇聯盟(ILAE) 、中國抗癲癇協會(CAAE)等眾多權威指南、共識推薦,丙戊酸鈉注射用濃溶液是多種癲癇類型和癲癇綜合徵的一線用藥,同時還具有吸收迅速起效快等優點。
目前,除濟川有限外,國內已有包括福安藥業、匯宇製藥、成都苑東、長春海悦、海南倍特等在內10家企業獲批生產丙戊酸鈉注射用濃溶液。丙戊酸鈉注射用濃溶液已被列入《國家基本醫療保險、工傷保險和生育保險藥品目錄》(2022版)乙類藥品。
據米內網數據顯示,2021年中國城市公立醫院丙戊酸鈉注射劑型銷售額超過11.93億元,同比增長約11.38%。
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