石藥集團(01093.HK)注射用多西他賽(白蛋白結合型)獲美國臨牀試驗批件
格隆匯9月17日丨石藥集團(01093.HK)發佈公告,公司附屬公司石藥集團中奇製藥技術(石家莊)有限公司開發的新藥"注射用多西他賽(白蛋白結合型)"已獲美國食品藥品監督管理局批准在美國開展臨牀試驗。
該產品採用創新的人血白蛋白包裹技術,將多西他賽納米粒輸送至患者體內。憑藉該項技術,該產品將可避免現時市場上多西他賽產品注射前的預先給藥、減少與注射有關的過敏反應以及提高患者順從性。在臨牀前研究中,該產品在多種動物模型中顯示了安全性及對多種實體瘤增強的抗腫瘤療效。相似的白蛋白包裹技術已成功應用於集團現時於市場上銷售的紫杉醇產品。
集團將同時於中國及美國開展該產品針對實體瘤包括胃癌及前列腺癌適應症的臨牀開發。
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