上海醫藥(02607.HK)鹽酸多西環素膠囊及片劑獲得美國FDA批准文號
格隆匯10月15日丨上海醫藥(02607.HK)公佈，近日，公司下屬控股子公司常州製藥廠有限公司收到美國食品藥品監督管理局（美國FDA）的通知，鹽酸多西環素膠囊100mg、鹽酸多西環素片100mg（以下簡稱“鹽酸多西環素膠囊及片劑”）的簡略新藥申請（“ANDA”，即美國仿製藥申請）已獲得批准。
鹽酸多西環素膠囊及片劑均為口服抗菌藥，用於治療立克次體感染、性病、呼吸道感染、特定細菌感染、眼科感染、炭疽，對青黴素過敏者某些特定感染的替代治療，輔助治療急性腸道阿米巴病和嚴重痤瘡，並可用於預防瘧疾。常州製藥廠分別於2016年7月與2018年2月完成鹽酸多西環素膠囊及片劑的研發工作，分別於2016年8月與2018年3月向美國FDA提交了ANDA申請；近日獲得美國FDA批准文號。截至目前，鹽酸多西環素膠囊及片劑累計投入研發費用分別約人民幣571萬元和人民幣473.85萬元。
鹽酸多西環素膠囊原研廠為輝瑞製藥公司，國外生產、銷售廠商主要有輝瑞製藥公司、特瓦製藥美國公司及邁蘭製藥公司等。IQVIA數據顯示（IQVIA是全球領先的為醫藥健康產業提供專業信息和戰略諮詢服務的提供商），鹽酸多西環素膠囊2018年在美國實現銷售額4.05億美元。鹽酸多西環素片原研廠為輝瑞製藥有限公司，目前已退出市場，國外生產、銷售廠商主要有海克曼國際製藥集團及邁蘭製藥公司等。IQVIA數據顯示，鹽酸多西環素片2018年在美國實現銷售額2.06億美元。
公司稱，本次常州製藥廠鹽酸多西環素膠囊及片劑的ANDA申請獲美國FDA批准，對公司拓展仿製藥海外市場具有積極推動作用，同時也有助於該產品進入國內綠色通道優先評審，符合公司國內外製劑業務協同發展的戰略目標，對公司未來經營業績具有一定積極的影響。公司後續將積極推進鹽酸多西環素膠囊及片劑的美國上市。
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