天宇股份(300702.SZ):孟魯司特鈉咀嚼片獲得藥品註冊證書
格隆匯6月17日丨天宇股份(300702.SZ)公佈,公司全資子公司諾得藥業於近日收到國家藥監局核准簽發的關於孟魯司特鈉咀嚼片的《藥品註冊證書》。
孟魯司特鈉咀嚼片適應症為本品適用於2歲至14歲兒童哮喘的預防和長期治療,包括預防白天和夜間的哮喘症狀,治療對阿斯匹林敏感的哮喘患者以及預防運動誘發的支氣管收縮。本品適用於減輕過敏性鼻炎引起的症狀(2歲至14歲兒童的季節性過敏性鼻炎和常年性過敏性鼻炎)。
根據國家藥監局網站數據查詢,截至公吿日,該規格製劑除諾得藥業外,國內生產商另有石藥集團歐意藥業有限公司、合肥英太製藥有限公司、魯南貝特製藥有限公司等8家企業。
據統計,2021年孟魯司特鈉咀嚼片在國內樣本醫院(包括城市公立醫院,城市社區醫院,縣級公立醫院,鄉鎮衞生院)和城市實體藥店的銷售額約人民幣5億元(數據來源於米內網)。
諾得藥業孟魯司特鈉咀嚼片5mg規格於2020年12月獲得國家藥監局受理,目前公司及子公司累計投入費用約1335萬元。
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