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片仔癀(600436.SH):地氯雷他定口服溶液收到《藥品補充申請批准通知書》
格隆匯 02-09 17:37

格隆匯2月9日丨片仔癀(600436.SH)公佈,近日,公司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》,同意地氯雷他定口服溶液的上市許可持有人變更為公司。

地氯雷他定是一種非鎮靜性的長效組胺拮抗劑,用於緩解慢性特發性蕁麻疹及過敏性鼻炎的全身及局部症狀。根據PDB藥物綜合數據庫,2020年地氯雷他定全球市場的銷售額達到約5.82億元美元,2020年國內市場樣本醫院用藥的銷售額達到約3.25億元人民幣。

地氯雷他定口服溶液的劑型原研公司是默沙東,於2007年首先在歐洲獲批上市,但未在國內獲批上市。目前,該產品在國內獲批生產的企業有山東達因海洋生物製藥股份有限公司、合肥恩瑞特藥業有限公司、廣東九明製藥有限公司等其他三家。

截至目前,公司在地氯雷他定口服溶液項目累計投入約1638.50萬元人民幣(未經審計)。

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