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白雲山(00874.HK):注射用頭孢嗪脒鈉近期啟動臨牀I期試驗
格隆匯 10-25 18:50

格隆匯10月25日丨白雲山(00874.HK)公告,廣州白雲山醫藥集團股份有限公司分公司廣州白雲山醫藥集團股份有限公司白雲山製藥總廠研製的1類化學新藥注射用頭孢嗪脒鈉於近期正式啟動臨牀I期試驗。現將相關情況公告如下:

注射用頭孢嗪脒鈉為白雲山製藥總廠自主研發的化學藥1類新藥,適應症為社區獲得性肺炎。白雲山製藥總廠於2017年12月獲得國家藥品監督管理局簽發的《藥物臨牀試驗批件》。 獲得注射用頭孢嗪脒鈉臨牀試驗批件後,公司及白雲山製藥總廠積極推進該新藥臨牀試驗的前期工作,已獲得《北京大學第一醫院生物醫學研究倫理委員會審查批件》,近期正式啟動臨牀I期試驗。

頭孢菌素類抗生素具有抗菌譜廣、抗菌作用強、耐青黴素酶、過敏反應較青黴素類少等優點,被廣泛應用於臨牀,在全球抗生素市場具有重要地位。根據中國醫藥工業信息中心PDB藥物綜合數據庫,2005-2018年,頭孢菌素類抗生素在抗感染藥物治療大類中銷售佔比始終保持第一,2018年銷售額達人民幣125.39億元,銷售佔比為36.29%。

目前國內外暫無與頭孢嗪脒鈉結構一致的藥物上市或註冊申報信息,亦無其國內外銷售金額。頭孢嗪脒鈉的同類藥品是頭孢硫脒,頭孢硫脒是第一代頭孢菌素的代表品種,近5年穩居第一代頭孢菌素銷量榜首,2018年在國內重點城市醫院銷售額為人民幣4億元,被臨牀專家確認為抗革蘭陽性球菌感染的安全有效的一線首選藥物。

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