以嶺藥業(002603.SZ):抗感染類藥物鹽酸環丙沙星片通過一致性評價
格隆匯11月6日丨以嶺藥業(002603.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的鹽酸環丙沙星片的《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。公司為全國第一家通過該品種一致性評價的企業。
鹽酸環丙沙星片為抗感染類藥物,用於治療或預防確診或高度懷疑的敏感菌感染,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)。
鹽酸環丙沙星片最早由Bayer(拜耳)公司研發,1987年1月30日在德國上市,商品名為Ciprobay,被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。
公司選用拜耳公司在德國生產並上市的鹽酸環丙沙星片為參比製劑進行了產品一致性評價研究。通過對參比製劑的質量屬性進行詳細研究,採用風險評估的方法,對影響產品質量的關鍵處方因素和工藝參數進行研究,保證產品質量穩定、可控;通過對健康受試者的空腹和餐後生物等效性試驗,證實公司的鹽酸環丙沙星片與原研藥生物等效。綜上,公司研發的鹽酸環丙沙星片達到了質量和療效上與原研藥一致。
目前國內共有108個鹽酸環丙沙星片生產批文,截至本公告日,只有本公司研發的鹽酸環丙沙星片通過了國家藥品監督管理局一致性評價審批。
根據國家相關政策規定,對於通過一致性評價的藥品品種,在醫保支付方面予以適當支持;醫療機構應優先採購併在臨牀中優先選用;同時,通過一致性評價的產品將具備參加國家藥品集中採購的資格。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,對公司的經營業績產生積極影響,併為公司進行中的其他產品一致性評價工作積累寶貴的經驗。
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