魯抗醫藥(600789.SH):賽特公司格列齊特緩釋片通過仿製藥一致性評價
格隆匯4月11日丨魯抗醫藥(600789.SH)公佈,近日,山東魯抗醫藥股份有限公司控股子公司山東魯抗醫藥集團賽特有限責任公司(簡稱“賽特公司”)收到國家藥品監督管理局頒發的關於格列齊特緩釋片(以下簡稱“該藥品”)的《藥品補充申請批件》(批件號:2022B01434),該藥品通過仿製藥質量和療效一致性評價。
格列齊特緩釋片(Gliclazide Modified Release Tablets)為第二代磺酰脲類藥物,用作口服糖尿病治療藥物,主治用於當單用飲食療法不足以控制血糖的非胰島依賴型糖尿病,其降血糖強度介於甲磺丁脲和優降糖之間。
據米內網數據顯示,格列齊特緩釋片020年中國城市公立醫院、縣級公立醫院、城市社區中心以及鄉鎮衞生院(簡稱中國公立醫療機構)終端格列齊特緩釋片銷售額超過13億元。塞特公司該藥品2020年銷售額為1090.03萬元,2021年前三季度銷售額570.48萬元。目前國內共有22個格列齊特緩釋片生產批文。
截至公吿日,共有6個廠家(宜昌人福藥業有限責任公司、天津君安生物製藥有限公司、北京福元醫藥股份有限公司、江蘇黃河藥業股份有限公司、天津中新藥業集團股份有限公司新新制藥廠、山東魯抗醫藥集團賽特有限責任公司)通過國家藥品監督管理局一致性評價審批。
截至公吿披露日,公司在該藥品的研發投入約為560.48萬元人民幣(未經審計)。
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