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康泰生物(300601.SZ):吸附無細胞百白破滅活脊髓灰質炎聯合疫苗獲批藥物臨牀試驗
格隆匯 12-11 19:51

格隆匯 12 月 11日丨康泰生物(300601.SZ)公佈,公司全資子公司北京民海生物科技有限公司(“民海生物”)的吸附無細胞百白破滅活脊髓灰質炎聯合疫苗近日獲得國家藥品監督管理局出具的《藥物臨牀試驗批准通知書》,根據《中華人民共和國藥品管理法》《中華人民共和國疫苗管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,同意本品進行臨牀試驗。

民海生物將根據藥物臨牀試驗批准通知書的要求,儘快開展相關臨牀試驗工作。該文件有效期為獲得批准之日起3年,逾期未實施,通知書自行廢止。

吸附無細胞百白破滅活脊髓灰質炎聯合疫苗用於預防白喉、破傷風、百日咳和脊髓灰質炎,具有減少嬰幼兒的接種針次,增強家長和嬰幼兒接種的依從性等優勢。

吸附無細胞百白破滅活脊髓灰質炎聯合疫苗是五聯疫苗乃至六聯疫苗的基礎,本次獲得吸附無細胞百白破滅活脊髓灰質炎聯合疫苗臨牀試驗批准通知書,將進一豐富公司在多聯苗領域的產品佈局,進一步夯實了公司在聯苗領域研發的領先地位,為公司持續穩健發展奠定堅實基礎。

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