哈藥股份(600664.SH)：辛伐他汀片通過仿製藥質量和療效一致性評價
格隆匯6月7日丨哈藥股份(600664.SH)公佈，近日，公司所屬企業哈藥集團三精明水藥業有限公司(以下簡稱“三精明水”)收到國家藥品監督管理局頒發的關於辛伐他汀片(規格10mg)的《藥品補充申請批件》(批件號：2021B01606)，該藥品通過仿製藥質量和療效一致性評價。
據悉，辛伐他汀片是常用的口服降血脂藥物，主要適應症為：
(1)高脂血症。①對於原發性高膽固醇血癥、雜合子家族性高膽固醇血癥或混合性高膽固醇血癥的患者，當飲食控制及其他非藥物治療不理想時，辛伐他汀可用於降低升高的總膽固醇、低密度脂蛋白膽固醇、載脂蛋白B和甘油三酯，且辛伐他汀升高高密度脂蛋白膽固醇，從而降低低密度脂蛋白/高密度脂蛋白和總膽固醇/高密度脂蛋白的比率。②對於純合子家族性高膽固醇血癥患者，當飲食控制及非飲食療法不理想時，辛伐他汀可用於降低升高的總膽固醇、低密度脂蛋白膽固醇和載脂蛋白B。
(2)冠心病。①減少死亡的危險性。②減少冠心病死亡及非致死性心肌梗死的危險性。③減少腦卒中和短暫性腦缺血的危險性。④減少心肌血管再通手術(冠狀動脈搭橋術及經皮氣囊冠狀動脈成形術)的危險性。⑤延緩動脈粥樣硬化的進展，包括新病灶及全堵塞的發生。
辛伐他汀片原研由默沙東公司(MerckSharp&DohmeLimited)開發，於1988年4月6日在瑞典首次獲得批准；1989年4月在英國獲得批准，同年在歐洲上市；1991年在美國獲得批准上市；2002年6月在日本獲得批准上市；2000年12月在中國獲得批准上市。三精明水針對該藥品質量和療效一致性評價已投入研發費用約1,230萬元人民幣。
目前國內該品生產企業共有74家；批准文號總計123個。截至該公吿日，共有7個廠家的辛伐他汀片通過國家藥品監督管理局仿製藥質量和療效一致性評價審批，通過廠家包括浙江海正瀚暉製藥有限公司、浙江京新藥業有限公司、山東羅欣藥業集團股份有限公司、山德士製藥有限公司、揚子江藥業有限公司、上海信宜萬象藥業有限公司、海南海靈化學制藥有限公司。米內數據顯示：辛伐他汀片劑2020年市場銷售額為88,812萬元。由於市場原因，2020年三精明水辛伐他汀片的銷售額為66萬元。
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