譽衡藥業(002437.SZ)：氯化鉀緩釋片通過一致性評價
格隆匯12月26日丨譽衡藥業(002437.SZ)公佈，2019年12月26日，公司下屬公司廣州譽東健康製藥有限公司(“廣州譽東”)收到國家藥品監督管理局核准簽發的氯化鉀緩釋片的《藥品補充申請批件》，該藥品通過仿製藥質量和療效一致性評價(“一致性評價”)。廣州譽東為全國首家通過該品種一致性評價的企業。
藥品名稱：氯化鉀緩釋片；劑型：片劑；規格：0.5g；註冊分類：化學藥品；申請內容：一致性評價申請；批件號：2019B04576；原藥品批准文號：國藥準字H20178003；
審批結論：根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發〔2015〕44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定，經審查，本品通過仿製藥質量和療效一致性評價。質量標準、説明書執行所附。有效期為12個月。注：1、基於申報的生產線與生產設備，本品生產批量為72萬片/批。今後的商業化生產如需放大批量，請注意開展相應的放大研究及驗證，必要時應針對生產規模放大提出補充申請。2、本品有效期12個月，後續積累的穩定性研究數據支持延長本品有效期時，請按相關程序申請。3、請在本品獲批後三個月之內向藥典委提出修訂國家藥品標準的申請。
氯化鉀緩釋片為電解質補充類藥物，用於治療和預防伴或不伴代謝性鹼中毒的低鉀血癥，其屬於國家醫保目錄品種(2019年版)和基本藥物目錄品種(2018年版)。
氯化鉀緩釋片最早由Upsher-Smith公司研發，1986年4月17日在美國上市，商品名為Klor-Con，被原國家食品藥品監督管理總局公告為一致性評價用參比製劑。
廣州譽東選用Upsher-Smith公司在美國生產並上市的氯化鉀緩釋片為參比製劑，進行了一致性評價研究。截至公告披露日，廣州譽東成為全國首家通過該品種一致性評價的企業。
目前國外主要通過口服補鉀，國內口服補鉀趨勢向好。此次獲批，廣州譽東在原有24片包裝規格上，新增32片和48片包裝規格。該品種通過一致性評價，有利於擴大產品的市場銷售，提高市場競爭力。
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