石藥(01093.HK)晚期實體瘤藥物I期臨床試驗完成首例患者給藥
石藥集團(01093.HK)公布,附屬公司石藥集團中奇製藥技術開發的「注射用多西他賽(白蛋白結合型)」已為參與美國I期臨床試驗的首例患者完成給藥。該項研究之目的為評估多西他賽新劑型針對晚期實體瘤的安全性、耐受性、藥物代謝動力學及初步療效。
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,多西他賽(白蛋白結合型)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依從性。在臨床前研究中,多西他賽(白蛋白結合型)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。集團及其他製藥公司於市場上銷售的紫杉醇產品已採用了相似的白蛋白包裹技術。
集團正同時在中國及美國進行該產品的臨床開發。初始的實體瘤適應症包括胃癌及前列腺癌。集團將致力加快單藥使用及與PD-1靶向藥物聯合使用的臨床試驗。
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