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浙江醫藥(600216.SH):黃體酮軟膠囊通過仿製藥一致性評價
格隆匯 02-21 15:45

格隆匯2月21日丨浙江醫藥(600216.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的黃體酮軟膠囊(規格:0.1g)6粒/瓶、12粒/瓶、30粒/瓶三個包裝規格的《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價。

黃體酮軟膠囊用於治療由黃體酮缺乏引起的機能障礙:排卵機能障礙引起的月經失調;痛經及經期前綜合症;出血(由纖維瘤等所致);絕經前紊亂,絕經(用於補充雌激素治療)。黃體酮軟膠囊也助於妊娠。

根據國家藥品監督管理局網站信息顯示,中國大陸已批准上市的黃體酮軟膠囊生產企業有 3家(含浙江醫藥股份有限公司新昌製藥廠)。根據PDB藥物綜合數據庫顯示,2021年黃體酮全球銷售額為9.51億美元,銷售額同比增加19.32%。根據米內網數據顯示,2021年國內醫療市場黃體酮軟膠囊銷售額為4.82億元人民幣。公司2022年黃體酮軟膠囊銷售額為1.12億元(未經審計)。

公司於2021年10月28日向國家藥品監督管理局提交一致性評價獲得受理。截至目前,公司用於開展黃體酮軟膠囊一致性評價已累計投入研發費用1960萬元。

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