智翔金泰:收到国家药品监督管理局核准签发的《药物临床试验批准通知书》

格隆汇
Jul 02, 2025

智翔金泰(688443.SH)公告称,公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,同意GR1803注射液联合抗CD38单克隆抗体在复发/难治性多发性骨髓瘤成人患者中开展临床试验。GR1803注射液是一款由公司自主研发的双特异性抗体药物,注册分类为治疗用生物制品1类。该药品完成临床试验后还需提交新药上市申请,取得药品注册证书后才可上市销售。

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