華潤雙鶴(600062.SH)：別嘌醇片、格列喹酮片通過仿製藥質量和療效一致性評價
格隆匯1月25日丨華潤雙鶴(600062.SH)公佈，近日，公司及全資子公司北京萬輝雙鶴藥業有限責任公司(以下簡稱“萬輝雙鶴”)收到了國家藥監局頒發的別嘌醇片、格列喹酮片《藥品補充申請批准通知書》，上述藥品通過仿製藥質量和療效一致性評價。
別嘌醇片適用於患有原發性或繼發性痛風(急性發作，痛風石，關節破壞，尿酸結石和/或腎病)的患者。截至本公吿日，華潤雙鶴就別嘌醇片(含製劑和原料藥)開展一致性評價累計研發投入為人民幣2875萬元(未經審計)。1966年，SEBELA IRELAND LTD公司在美國上市別嘌醇片，商品名為“ZYLOPRIM”。根據目前獲取的全球71國家藥品銷售數據庫顯示，2020年“ZYLOPRIM”全球銷售額為285萬美元。
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別嘌醇片生產企業有15家(含華潤雙鶴)。根據米內網數據顯示，2020年國內市場別嘌醇片銷售總額(終端價)為9,651萬元，其中市場份額排名前5的企業分別為合肥久聯製藥37.88%，世貿天階製藥(江蘇)20.12%，上海信誼萬象藥業13.93%，廣東彼迪藥業12.48%，重慶青陽藥業7.83%。
格列喹酮片適用於配合飲食和運動，改善成人 2型糖尿病患者的血糖控制。截至本公吿日，萬輝雙鶴就格列喹酮片開展一致性評價累計研發投入為人民幣1337萬元(未經審計)。975年，德國Boehringer Ingelheim公司在德國上市格列喹酮片，商品名為“Glurenorm”。根據目前獲取的全球71國家藥品銷售數據庫顯示，2020年“Glurenorm”全球銷售額為2597萬美元。
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格列喹酮片生產企業有8家(含萬輝雙鶴)。根據米內網數據顯示，2020年國內醫療市場格列喹酮片銷售總額(終端價)為4.10億元，其中市場份額排名前5名的企業分別為萬輝雙鶴93.93%，吉林金恆製藥4.19%，天津藥物研究院藥業1.69%，杭州國光藥業0.12%，吉林集安益盛藥業0.01%。萬輝雙鶴格列喹酮片2020年銷售收入為2.96億元人民幣。
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