一品紅(300723.SZ)全資子公司獲得藥品補充申請批准
格隆匯 7 月 31日丨一品紅(300723.SZ)發佈公告,公司全資子公司一品紅生物醫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》。藥品補充申請批准藥品通用名稱為乙酰吉他黴素幹混懸劑(英文名/拉丁名:Acetylkitasamycin for Suspension)。
乙酰吉他黴素幹混懸劑主要成分為乙酰吉他黴素,是臨牀常用大環內酯類抗菌藥物之一,主要適用於革蘭陽性菌,特別是金黃色葡萄球菌,肺炎球菌及表皮葡萄球菌引起的下列各種感染性疾病。據米內網數據庫信息顯示,2019年大環內酯、林科酰胺和鏈黴素類終端市場規模共約110億元/年。
乙酰吉他黴素幹混懸劑是公司獨家劑型產品,用於抗感染治療,適用人羣廣泛。此外,該產品有明確的兒童用法用量,兒童用藥依從性高,符合兒童用藥習慣,亦可用於三歲以內低齡兒童,是兒童常見感染指南推薦藥物。可治療兒童常見上、下呼吸道感染及表皮組織感染及百日咳、猩紅熱、中耳炎等。
此次獲得乙酰吉他黴素幹混懸劑補充申請,公司將按新標準生產運營,進一步豐富了公司產品管線和品類,增強公司在兒童抗感染領域競爭力。
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