嘉和生物-B(06998.HK):國家藥品監督管理局批准兩項GB491(LEROCICLIB)橋接試驗的臨牀試驗申請
格隆匯 3 月 8日丨嘉和生物-B(06998.HK)宣佈,公司已收到國家藥品監督管理局關於GB491(Lerociclib)(細胞週期蛋白依賴性激酶4/6(“CDK4/6”)抑制劑)兩項1b期橋接試驗的臨牀試驗申請(“IND”)批准:(1)GB491聯合來曲唑治療一線激素受體陽性╱人類表皮生長因子受體2陰性(HR+╱HER2-)晚期乳腺癌;及(2)GB491聯合氟維司羣治療二線激素受體陽性╱人類表皮生長因子受體2陰性(HR+╱HER2-)晚期乳腺癌。同時,公司欣然宣佈,截至2021年3月6日,這兩項臨牀試驗已經獲得倫理委員會批准。
根據披露,GB491(Lerociclib)為一款用於治療乳腺癌的高選擇性口服型CDK4/6抑制劑。公司於2020年6月向G1 Therapeutics, Inc.(納斯達克股票代碼:GTHX)取得若干亞太地區(不包括日本)的專有權許可。根據2020年歐洲腫瘤學術大會(ESMO)上最新發表的數據,GB491相比現有中國市場上已經獲批上市的CDK4/6抑制劑,呱柏西利,顯示出更好的安全性,可能成為潛在的同類最佳CDK4/6候選藥物。
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