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貝達藥業(300558.SZ):BPI-460372片獲批開展晚期實體瘤臨牀試驗
格隆匯 01-04 17:32

格隆匯1月4日丨貝達藥業(300558.SZ)公佈,今日,公司收到國家藥品監督管理局(簡稱“NMPA”)簽發的《藥物臨牀試驗批准通知書》(通知書編號:2023LP00011、2023LP00012),公司申報的BPI-460372片藥品臨牀試驗已獲得NMPA批准開展。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2022年10月20日受理的BPI-460372片符合藥品註冊的有關要求,同意按照提交的方案開展晚期實體瘤的臨牀試驗。

截至該公吿披露日,全球尚無靶向TEAD蛋白的小分子抑制劑上市。BPI460372屬於“境內外均未上市的創新藥”,其註冊分類為化學藥品1類。

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