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珍寶島(603567.SH)口服降血糖藥物通過仿製藥一致性評價並取得批件
格隆匯 05-10 15:21

格隆匯5月10日丨珍寶島(603567.SH)發佈公告,近日,公司全資子公司哈爾濱珍寶製藥有限公司(以下簡稱“哈珍寶”)收到國家藥品監督管理局核准簽發的鹽酸二甲雙胍片(0.25g)的《藥品補充申請批件》,該產品通過了仿製藥質量和療效一致性評價。

二甲雙胍片為經典的雙胍類口服降血糖藥,首選用於單純飲食及體育鍛煉控制血糖無效的2型糖尿病。對於成人,該品可用於單藥治療,也可與磺脲類藥物或胰島素聯合治療。對於10歲及以上的兒童和青少年,該品可用於單藥治療或與胰島素聯合治療。

二甲雙胍產品於1957年首次應用於臨牀,至今臨牀使用已有60多年,是臨牀上使用最為普遍的口服降血糖藥物之一,也是國內外指南推薦糖尿病治療的一線用藥。2016年版《二甲雙胍臨牀應用專家共識》中,二甲雙胍被推薦為治療2型糖尿病的一線首選和全程用藥,廣泛應用於2型糖尿病及糖尿病前期的治療。該品種已列入2018年《國家基藥目錄》和2019年《醫保目錄》甲類。

據國家藥品監督管理局藥品評審中心網站顯示,目前鹽酸二甲雙胍片(0.25g)通過一致性評價的有北京四環製藥有限公司、廣東華南藥業集團有限公司、貴州天安藥業股份有限公司等21家公司。二甲雙胍製劑2017-2019年國內市場規模分別為369,653萬元、458,909萬元和547,105萬元(數據來源:米內網)。該項目截至目前累計研發投入約750萬元。

哈珍寶生產的鹽酸二甲雙胍片(0.25g)通過一致性評價,是公司第二個通過一致性評價的品種,是公司向化藥、生物藥領域拓展邁出積極的一步,是公司仿製藥一致性評價工作取得成果的良好進展。該產品通過一致性評價,有利於豐富公司產品線,擴大藥品的市場份額,提升公司行業競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。

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