桂林三金(002275.SZ):寶船生物BC008抗體注射液獲得藥物臨牀試驗默示許可
格隆匯4月1日丨桂林三金(002275.SZ)公佈,近日,公司控股孫公司寶船生物獲得了國家藥品監督管理局核准簽發的BC008抗體注射液的臨牀試驗批准通知書,但因上海市疫情管控原因,寶船生物暫時無法拿到該臨牀試驗批准通知書的文本信息。
BC008抗體注射液是寶船生物自主研發的抗CLDN18.2人源化納米抗體融合蛋白,能夠特異性靶向結合細胞表面CLDN18.2分子,激活機體NK細胞活性,通過抗體依賴細胞毒作用(ADCC)、補體依賴細胞毒作用(CDC)等Fc端功能對CLDN18.2陽性腫瘤細胞進行特異性殺傷,發揮抗腫瘤作用。BC008抗體注射液將開展用於CLDN18.2陽性晚期實體瘤治療的臨牀試驗。
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