苑東生物(688513.SH):丙戊酸鈉注射用濃溶液獲批上市
格隆匯5月5日丨苑東生物(688513.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》。相關藥品名稱為丙戊酸鈉注射用濃溶液。
丙戊酸鈉注射用濃溶液,其主要成份為丙戊酸鈉,該藥品用於治療癲癇,在成人和兒童中,當暫時不能服用口服劑型時,用於替代口服劑型。據包括國際抗癲癇聯盟(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經典的廣譜抗癲癇藥物,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。
丙戊酸鈉注射用濃溶液的原研公司為DesitinArzneimittelGmbH公司,最早於1996年10月在德國上市,原研產品暫未在中國上市,目前為國家醫保乙類品種。國家藥監局官網顯示,國內已有包括福安藥業、匯宇製藥、苑東生物等在內,共7家企業的同品種獲批生產。另據米內網數據,丙戊酸鈉注射劑2021年在中國公立樣本醫院數據銷售額約4.03億元。
截至目前,公司在該產品累計已投入研發費用人民幣約384.90萬元。
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