一品紅(300723.SZ)：注射用阿昔洛韋取得藥品補充申請批准
格隆匯 3 月 2日丨一品紅(300723.SZ)公佈，公司全資子公司廣州一品紅製藥有限公司於近日收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》，公司生產的注射用阿昔洛韋成為該類品種首家通過一致性評價的品種。
申請事項：仿製藥質量和療效一致性評價；同時申請：1.變更處方工藝；2.修訂藥品註冊標準；3.修訂藥品説明書。
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)、《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號) 和《國家藥監局關於開展化學藥品注射劑仿製藥質量和療效--致性評價工作的公吿》(2020年第62號)的規定，經審查，本品通過仿製藥質量和療效一致性評價。同時同意以下變更: 1.變更處方工藝: 2.修訂藥品註冊標準;3.修訂藥品説明書。生產工藝、質量標準和説明書照所附執行，標籤相關內容應與説明書保持一致。藥品有效期為24個月。
公司研發的注射用阿昔洛韋適應症如下：1.單純皰疹病毒感染:用於免疫缺陷者初發和複發性粘膜皮膚感染的治療以及反覆發作病例的預防;也用於單純皰疹性腦炎的治療。2.帶狀皰疹:用於免疫缺陷者嚴重帶狀皰疹病人或免疫功能正常者彌散型帶狀皰疹的治療。3.免疫缺陷者水痘的治療。
注射用阿昔洛韋是2020版國家醫保乙類藥品。根據國家藥監局網站查詢，截至公吿日，國產藥品中包含公司在內有輔仁藥業集團有限公司、石藥集團歐意藥業有限公司等30家企業獲得了注射用阿昔洛韋的生產批文。其中，公司是市場首家獲批通過該劑型一致性評價企業。
公司注射用阿昔洛韋首家通過一致性評價，標誌着公司產品在終端市場準入推廣中將獲得政策上的先發優勢，進一步豐富了公司在銷產品管線和品類，增強公司在抗感染領域的競爭力。
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