百利天恆(688506.SH)注射用BL-M07D1(HER2-ADC)獲II/III期臨牀試驗批准通知書

智通財經

02-18

智通財經APP訊，百利天恆(688506.SH)公告，公司於近日收到國家藥品監督管理局(NMPA)正式批准簽發的《藥物臨牀試驗批准通知書》,公司自主研發的創新生物藥注射用BL-M07D1(HER2-ADC)的II/III期臨牀試驗獲得批准。

據悉，BL-M07D1是一種靶向HER2的創新ADC，具有best-in-class潛力，已在臨牀試驗中展示出顯著的抗腫瘤功效。截至本公告披露日，除本次新獲得批准的臨牀試驗外，BL-M07D1正於中國及美國的10項I/II/III期臨牀試驗中作爲單藥或聯用進行評估。各項臨牀研究包括各種HER2表達/突變的實體瘤(包括非小細胞肺癌、乳腺癌、尿路上皮癌、婦科腫瘤及消化道腫瘤)的患者。

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