白雲山(00874.HK)子公司辛夷鼻炎丸獲澳大利亞藥物管理局藥品註冊證書
白雲山(00874.HK)公吿,近日,廣州白雲山醫藥集團股份有限公司(以下簡稱“公司”)全資子公司廣州白雲山中一藥業有限公司(以下簡稱“中一藥業”)收到澳大利亞藥物管理局(TGA)(以下簡稱“澳大利亞TGA”)的藥品註冊證書,TGA是Therapeutic Goods Administration的簡寫,全稱是藥物管理局。
現將相關情況公吿如下:藥品名稱“辛夷鼻炎丸”,辛夷鼻炎丸功能主治為祛風,清熱,解毒,用於鼻炎。2022年5月,中一藥業通過澳大利亞TGA-GMP認證(具體內容詳見本公司日期為2022年5月17日、編號為2022-025的公吿);2022年10月,中一藥業向澳大利亞TGA遞交辛夷鼻炎丸註冊申請。經查詢,目前無國外企業生產、銷售辛夷鼻炎丸,國內的主要生產廠家為四川琦雲藥業有限責任公司、廣州粵華藥業有限公司等。根據米內網數據,2022年辛夷鼻炎丸在國內城市零售藥店的銷售額為人民幣254.95萬元。截至目前,中一藥業在辛夷鼻炎丸研發項目上已投入研發費用合計約人民幣280萬元(未審計)。
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