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九典制藥(300705.SZ):“鹽酸左西替利嗪膠囊”通過仿製藥一致性評價
格隆匯 08-07 17:22

格隆匯 8 月 7日丨九典制藥(300705.SZ)公佈,公司於近日收到國家藥品監督管理局核准下發的《藥品補充申請批准通知書》,公司產品鹽酸左西替利嗪膠通過仿製藥質量與療效一致性評價。

鹽酸左西替利嗪膠囊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。

過敏性疾病的發病率在全世界範圍內呈逐年增高趨勢,世界變態反應組織(WAO)的調查數據表明,在30個國家共12億人中進行的流行病學調查顯示,2.5億人(22%)罹患有過敏性疾病,我國過敏性疾病發病率達37.3%

鹽酸左西替利嗪片原研製劑由UCB公司於2001年首次在德國上市,後相繼在英國、美國、法國等國家上市。其抗組胺活性優於西替利嗪,在臨牀抗過敏鼻炎方面優於氯雷他定;同時,左西替利嗪不易通過血腦屏障,相對第一代抗組胺藥中樞抑制作用明顯減弱,且臨牀應用未見明顯副作用。自2004年起,相繼批準了鹽酸左西替利嗪原料藥、片劑、膠囊劑、口服溶液上市。研究顯示鹽酸左西替利嗪的DDC值比較適中,易於患者接受,在臨牀上受到歡迎。

根據中國醫藥工業信息中心PDB藥物綜合數據庫的數據,2019年公司在我國22個地區重點城市醫院統計樣本中鹽酸左西替利嗪製劑方面的市場佔有率為24.29%,是行業領先企業之一。

截至公告日,公司為國內第一家通過鹽酸左西替利嗪膠囊一致性評價的企

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