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華潤雙鶴(600062.SH):子公司的左乙拉西坦片獲得藥品補充申請批件
格隆匯 09-29 16:04

格隆匯9月29日丨華潤雙鶴(600062.SH)公佈,近日,華潤雙鶴藥業股份有限公司全資子公司華潤賽科藥業有限責任公司(“華潤賽科”)收到了國家藥品監督管理局頒發的左乙拉西坦片(0.25g)《藥品補充申請批准通知書》(通知書編號:2021B03350)。

左乙拉西坦片用於成人及4歲以上兒童癲癇患者部分性發作(伴或不伴繼發性全面性發作)的治療;用於成人及16歲以上青少年癲癇患者全面性強直陣攣發作的加用治療。

截至公吿日,華潤賽科就左乙拉西坦片(0.25g)累計研發投入人民幣251萬元(未經審計)。

國內市場,根據國家藥監局網站信息顯示,中國大陸境內已批准上市的左乙拉西坦片生產企業9家。根據米內網數據顯示,2020年國內左乙拉西坦片劑銷售總額(終端價)為8.56億元,其中市場份額排名前5名的企業分別為優時比製藥公司69.44%,浙江京新藥業股份有限公司20.12%,浙江普洛康裕製藥有限公司8.72%,重慶聖華曦藥業股份有限公司1.45%,深圳信立泰藥業股份有限公司0.24%。

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