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桂林三金(002275.SZ):控股孫公司寶船生物獲得藥物臨牀試驗批准
格隆匯 09-21 15:45

格隆匯9月21日丨桂林三金(002275.SZ)宣佈,近日,公司控股孫公司寶船生物收到國家藥監局核准簽發的藥物臨牀試驗批准通知書:同意開展一項評價全人源抗PD-L1抗體注射液(產品代號:LDP)聯合重組抗EGFR人鼠嵌合單克隆抗體注射液(產品代號:CDP1)在晚期惡性腫瘤患者中的探索性臨牀研究。寶船生物擬於近期條件具備後於中國境內開展該治療方案臨牀試驗。

LDP是寶船生物自主研發的1類治療用生物製品,CDP1是寶船生物自主研發的2.4類治療用生物製品,目前均處於臨牀試驗階段。

2020年7月9日,國家藥監局受理了寶船生物提交的全人源抗PD-L1抗體注射液(LDP)聯合重組抗EGFR人鼠嵌合單克隆抗體注射液(CDP1)用於晚期惡性腫瘤治療的臨牀試驗申請(受理號:CXSL2000200、CXSL2000201),並於近期同意寶船生物在晚期惡性腫瘤患者中開展探索性研究(通知書編號:2020LP00473、2020LP00474)。

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