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德琪醫藥-B(06996.HK):ATG-101用於治療實體瘤及非霍奇金淋巴瘤I期試驗獲美國FDA授予IND批准
格隆匯 11-01 08:09

格隆匯11月1日丨德琪醫藥-B(06996.HK)發佈公吿,2021年10月29日,美國食品藥品監督管理局(“FDA”)已批准ATG-101的新藥臨牀試驗(“IND”)申請,德琪醫藥可於美國在實體瘤及非霍奇金淋巴瘤患者中啟動I期臨牀試驗(PROBE研究)。此為公司在美國獲得的首項IND批准。

根據披露,ATG-101是一款新型PD-L1/4-1BB雙特異性抗體,正被開發用於治療癌症。ATG101可同時阻斷PD-L1/PD-1結合以及激活4-1BB共刺激信號,從而激活抗腫瘤免疫效應細胞。在PD-L1過表達腫瘤細胞存在時,ATG-101表現出顯着的PD-L1交聯依賴的4-1BB激動劑活性,因此能在潛在提高治療效果的同時減輕肝毒性。

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