和鉑醫藥-B(02142.HK):HBM9027臨牀試驗啟動獲美國食品及藥物監督管理局新藥研究許可
格隆匯1月24日丨和鉑醫藥-B(02142.HK)宣佈,公司已獲美國食品及藥物監督管理局(FDA)的新藥研究申請許可("IND")在美國啟動我們的雙特異性抗體HBM9027的首次人體(FIH)的臨牀試驗。該試驗為一項評估HBM9027在晚期實體瘤患者中的安全性、耐受性、藥代動力學和抗腫瘤活性的I期研究。
HBM9027源自集團專有的全人源HBICE®平台。其為一種新型PD-L1xCD40雙特異性抗體,旨在激活依賴PD-L1交聯的CD40,具有良好的安全性。PD-L1在多種實體惡性腫瘤中過度表達,憑藉其對腫瘤的交聯依賴性和有效的免疫調節活性,HBM9027在臨牀前研究中顯示出優異的安全性和強大的抗腫瘤功效。
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