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仁和藥業(000650.SZ):恩替卡韋片獲批上市
格隆匯 03-25 16:41

格隆匯 3 月 25日丨仁和藥業(000650.SZ)公佈,公司控股子公司江西製藥有限責任公司近日收到國家藥品監督管理局核准簽發的關於恩替卡韋片的《藥品註冊證書》。

恩替卡韋片產品適應症為:本品適用於病毒複製活躍,血清丙氨酸氨基轉移酶(ALT)持續升高或肝臟組織學顯示有活動性病變的慢性成人乙型肝炎的治療(包括代償及失代償期肝病患者)。也適用於治療2歲至<18歲慢性HBV感染代償性肝病的核苷初治兒童患者,有病毒複製活躍和血清ALT水平持續升高的證據或中度至重度炎症和/或纖維化的組織學證據。

公司首次提交本品生產申請的受理時間為2019年06月12日(受理號:CYHS1900411國)。截至公吿日,恩替卡韋片累計投入的研發費用約為人民幣812.72萬元。

公司高度重視藥品研發工作,並嚴格控制藥品研發、製造及銷售環節的質量及安全。公司恩替卡韋片獲得國家藥監局的《藥品註冊證書》,標誌着公司具備了在國內市場生產和銷售該藥品的資格,進一步豐富了公司的產品線,有助於提升公司產品的市場競爭力。

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