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白雲山(00874.HK):子公司收到化學原料藥上市申請批准通知書

格隆匯7月31日丨白雲山(00874.HK)公佈,2023年7月28日,公司子公司廣州白雲山漢方現代藥業有限公司("白雲山漢方")收到國家藥品監督管理局核准簽發的精製橄欖油化學原料藥上市申請批准通知書(通知書編號:2023YS00486)。

精製橄欖油為長鏈脂肪乳注射液、脂肪乳/氨基酸/葡萄糖注射液及多種油脂肪乳注射液等製劑的關鍵原料。適用於口服或腸內營養攝取不能、不足或禁忌的患者,進行腸外營養補充脂肪。

白雲山漢方於2019年12月向國家藥品監督管理局藥品審評中心提交該原料藥備案登記。截至公吿日,白雲山漢方用於該產品研發投入累計約人民幣1,060萬元(未經審計)。

目前,公司暫無法從公開渠道查詢該產品的生產和銷售數據。米內網數據顯示,2022年中國城市公立、縣級公立醫院長鏈脂肪乳注射液、脂肪乳/氨基酸/葡萄糖注射液及多種油脂肪乳注射液三個製劑品種銷售額為人民幣27,394萬元。

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