一品紅(300723.SZ):鹽酸左西替利嗪口服滴劑獲批上市
格隆匯5月25日丨一品紅(300723.SZ)宣佈,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關於鹽酸左西替利嗪口服滴劑(20ml;100mg)的《藥品註冊證書》。
公司研發的鹽酸左西替利嗪口服滴劑用於治療下述疾病的過敏相關的症狀,過敏性鼻炎(包括季節性持續性過敏性鼻炎和常年性持續性過敏性鼻炎)及慢性特發性蕁麻疹。説明書中具有明確的兒童用法用量和兒童用藥研究數據。
公司獲批的鹽酸左西替利嗪口服滴劑是國內按化學藥品新註冊分類申報,首家獲得批准的仿製藥,視同通過一致性評價。
鹽酸左西替利嗪作為第三代抗組胺藥,具有抗組胺、抗炎雙重抗過敏作用。根據米內網數據統計,全身用抗組胺藥2019年市場銷售額為47.13億元,其中左西替利嗪2019年市場銷售額為4.38億元。
此次獲得鹽酸左西替利嗪口服滴劑註冊證書,標誌着公司具備了在國內市場生產銷售該藥品的資格,將進一步豐富公司兒童藥產品的管線和品類,增強公司在兒童藥領域的競爭力,對公司業績產生積極影響。
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